Effects of a counselling intervention to improve contraception in deprived neighbourhoods: a randomized controlled trial

Effects of a counselling intervention to improve contraception in deprived neighbourhoods: a... Abstract Background This study aims to evaluate the effects of a community-based counselling intervention to improve contraception use among immigrant and native residents in deprived neighbourhoods. Methods Randomized controlled trial. Women aged 14–49 years and men aged 14–39 years from two low-income neighbourhoods with high proportion of immigration in Barcelona (Catalonia, Spain) who had not undergone irreversible contraception and were not planning a pregnancy were recruited (2011–13). A culturally developed and theoretically based brief counselling intervention was delivered in community settings. The primary outcome was the consistent use of effective contraceptive methods (optimal use). Secondary outcomes were the incorrect use of effective methods and the use of less effective methods stratified by sex and migrant status. Differences within subgroups from baseline to the 3-month follow-up were analysed by intention to treat and per protocol. The effects were assessed with adjusted robust Poisson regressions. Results The study enrolled and randomized 746 eligible participants. There were no differences between the intervention and control groups in demographic characteristics. Optimal use significantly increased in men, women, immigrants and natives in the intervention group, with no changes in the control group. In the intervention group, inconsistent use of effective methods decreased by 54.9% and that of less effective methods by 47.2%. The overall adjusted prevalence ratio of optimal use in the intervention group versus the control group was 1.138 (95% CI: 1.010–1.284). Conclusion This brief counselling intervention increased the consistent use of effective contraception in low-income neighbourhoods with a high proportion of immigration. Introduction Birth control is crucial for the healthy development of countries.1 Although unintended pregnancy rates have progressively decreased worldwide in the last 50 years, inequalities in reproductive health persist both within and between countries.2 They are associated with determinants such as migrant status and income.3 Increasing the uptake of highly effective contraceptive methods and improving contraceptive use are important strategies to decrease unintended pregnancy. Contraceptive counselling based on theory and behavioural methods has been recommended to promote informed contraceptive choice, but there is a need for evaluative research on brief interventions for improving contraceptive use in socially disadvantaged groups, distinct ethnic groups and low resources settings.4–7 Spain is among the countries with the lowest fertility rates in the world.2 In the first decade of the 21st century, it experienced an unprecedented influx of economic migrants from poorer countries, especially to major cities. This was associated with increased fertility and teenage pregnancy rates in Barcelona. Abortion rates among immigrants were three times the native rates.8 In this context, public health services of Barcelona were commissioned to set up and evaluate a pilot intervention the aim of which was to lower these inequalities as well as to assess the intervention extension for the future. As economic immigrants tend to live in less affluent areas, where housing is more affordable, we developed a counselling intervention (SIRIAN programme) and tested it in deprived areas with a high proportion of the newly arrived. The objective of this study was to evaluate whether a community brief intervention improved optimal contraceptive use at 3 months, by sex and migration status (immigrants or natives) among residents living in two deprived neighbourhoods. Methods Study aims, setting and participants A randomized, controlled, parallel-group trial was conducted over 36 months, from October 2011 to September 2014, in two neighbourhoods in the lowest quintile of available family income of Barcelona (Bon Pastor and Baró de Viver) and with a high proportion of immigrants.9,10 The trial protocol was approved by the institutional ethics committee, and was conducted in accordance with the principles of the Declaration of Helsinki. All participants provided signed informed consent. Participants were recruited for the study from residents in the selected neighbourhoods by flyers and posters in the streets and referrals from civic, community and primary health centres. The participants were asked to invite neighbours, relatives and friends, with a view to generating a snowball recruiting strategy. Eligible participants were women aged 14–49 years and men aged 14–39 years, regardless of their partnership status. Adolescents and young adult men were included because previous investigations had shown that they had limited knowledge about contraceptive methods and could be receptive to changing their sexual behaviour.6,11 We excluded those who had undergone an irreversible contraceptive method and those who desired a pregnancy. Randomization Stratified blocked randomization by country of origin was performed with a web-based system for the first 10 cases of every country in a 1:1 ratio. The following cases were assigned by minimisation to balance recruitment12,13 (Supplementary Material S1). Participants were assigned to either a group receiving a counselling intervention on contraceptive methods or to a control group without intervention. Both groups completed a questionnaire at baseline and 3 months later. Accepting an alpha risk 0.05 and a beta risk below 0.2 in a bilateral contrast, we estimated that a sample size of 250 participants assigned to receive the contraceptive counselling and 250 in the control group would allow an 80% power to detect a between-group difference of 12.5% in the primary end point of the trial with a baseline proportion of use of effective methods of 55%.3 The participants underwent an initial screening for eligibility and a study counsellor obtained informed consent. Then, the counsellor opened a randomization list and administered the questionnaire or the counselling intervention. By telephone, interviews were arranged to take place 3 months after baseline at a time convenient to the participant (Supplementary Material S2). For ethical reasons, the control group underwent the intervention after the follow-up assessment. The community counselling intervention The counselling sessions lasted up to 45 min, depending on individual need.4,14 The interview was based on World Health Organization guidelines and communication tools.14,15 They were structured on the basis of social cognitive theory, addressing factors that could help reduce risk-taking and improve self-efficacy and motivation, and in motivational interviewing, with active listening and a non-judgemental attitude.16,17 The intervention was culturally adapted in line with the results of formative investigation.18 Given the limited information on the reproductive health needs of immigrant women, we conducted a qualitative study prior to the development of the programme. The study populations were prioritized according to the classification of non-EU citizen’s residents, abortion rates and the opinion of experts. We studied communities from Latin America, Morocco, Romania, Senegal, Pakistan, China and the Philippines. We conducted interviews with key informants and 15 focus groups in which 108 women participated. We explored their views on motherhood, the importance of having children, relationships and sexuality, contraception, teenage pregnancy, abortion and social and religious norms. The sample was intentional. In light of these results the research group structured the intervention. According to the psychosocial determinants emerged in the qualitative study, materials were prepared for each community, which were refined with pre-test interviews. The development and implementation of the intervention followed the Intervention Mapping planning model, which relies on theoretical and logic models.19 All counselling was specifically tailored to individual needs. Throughout the interview, topics were proposed using materials written to discuss the main benefits of contraception from the perspective of the immigrant communities. These included guided discussions on family planning during the life course, the amount of time required to care for children, the economic resources required for newborns and children, along with an assessment of knowledge on contraceptive methods, and of their actual use (whether optimal or not). Samples of contraceptive methods were presented and abortion and emergency contraception were addressed. Knowledge on access to primary health care centres and sexual and reproductive health clinics was reinforced. Participants were given condoms, the leaflet, and a 10-trip urban travel card, as an incentive. Counselling was provided mainly (92%) by two public health nurses and one health psychologist, and the rest was provided by physicians, all of them with specific training. Fidelity to the protocol was assessed in the training sessions. The satisfaction of participants was very high. All interviews were performed in community facilities (public library, community centres…) or in a separate facility within the primary health care centre. The questionnaire was developed according to the results of a formative investigation and was adapted from the Barcelona Health Survey questionnaire and other studies assessing contraceptive use and knowledge in the city.11,20 It covered demographic variables (sex, age, country of birth, educational attainment, occupational situation, partner relationships and parity with categories as described in table 1). Use of methods was assessed by asking which form or forms of contraception (if any) were they currently using (oral contraception, male condoms, ring, implant, patches, intrauterine device, injections, female condoms, female sterilization, vasectomy and tubal occlusion, withdrawal and periodic abstinence) and how these methods were used. The questionnaire was administered by the counsellors within the counselling in the intervention group, and in an interview in the control group. Table 1 Characteristics of participants at baseline   Intervention (n = 293) %  Control (n = 278) %  P  Sex            Female  73.4  75.9  0.502  Age group (years)            14–19  24.9  20.5  0.360      20–29  23.5  24.1        30–39  32.4  30.9        40–49  19.1  24.5    Median (IQR)  30 (18.5)  31 (19)    Birth country            Spain  61.8  57.2  0.177      Morocco  12.6  10.4        Ecuador  9.9  11.2        Other countries  15.7  21.2    Educational level            Less than primary  4.9  7.9  0.496      Primary  31.7  31.4        Secondary  58.1  53.7        University  5.3  6.9    Occupational situation            Housework  17.7  16.9  0.812      Student  22.9  21.2        Worker  23.2  27.7        Unemployed  28.7  26.6        Other  7.5  7.6    Partner relationship            Yes  72.7  72.3  0.926  Parity            0  49.8  41.7  0.112      1  17.7  17.6        2  18.4  26.3        3 or more  14.0  14.4      Intervention (n = 293) %  Control (n = 278) %  P  Sex            Female  73.4  75.9  0.502  Age group (years)            14–19  24.9  20.5  0.360      20–29  23.5  24.1        30–39  32.4  30.9        40–49  19.1  24.5    Median (IQR)  30 (18.5)  31 (19)    Birth country            Spain  61.8  57.2  0.177      Morocco  12.6  10.4        Ecuador  9.9  11.2        Other countries  15.7  21.2    Educational level            Less than primary  4.9  7.9  0.496      Primary  31.7  31.4        Secondary  58.1  53.7        University  5.3  6.9    Occupational situation            Housework  17.7  16.9  0.812      Student  22.9  21.2        Worker  23.2  27.7        Unemployed  28.7  26.6        Other  7.5  7.6    Partner relationship            Yes  72.7  72.3  0.926  Parity            0  49.8  41.7  0.112      1  17.7  17.6        2  18.4  26.3        3 or more  14.0  14.4    SIRIAN randomized controlled trial Outcomes and statistics The primary outcome was the consistent use of effective methods. Such methods included oral contraception, male condoms, ring, implant, patches, intrauterine device, injections, female condoms, female sterilization, vasectomy and tubal occlusion.21 Secondary outcomes were: (i) Inconsistent use of effective methods (common examples are condoms used in some intercourse episodes and not in others, or condoms used improperly, or taking birth control pills but missing too many doses for pregnancy prevention), and (ii) Use of less effective methods (withdrawal and periodic abstinence).21 Practices such as douching were not considered a contraceptive method. We used two analysis strategies. Changes in the primary outcome were analysed by using data from the full-analysis set, which included all participants who underwent randomization (intention to treat). In intention-to-treat analyses, the only imputation performed on the missing values was last-data-carried-forward,22 in this case, the baseline data. The secondary outcomes were analysed among participants assessed after baseline (per protocol). We calculated within-group participant changes in the outcome measures between baseline and follow-up with McNemar tests on dichotomous variables of the primary endpoint and the secondary endpoints. Then, a per protocol analysis was performed to estimate relative risks and the prevalence ratio derived from robust variance Poisson regression models.23 The models included the intervention group, with the baseline value of the relevant variable as a covariate, and were adjusted by sex, age, migration status, ethnicity, educational attainment and partner status. Finally, in the intention-to-treat strategy, the latter models were repeated for the whole randomized sample. Results Participant flow is presented in figure 1. Of 838 individuals screened, 80 did not meet the eligibility criteria, 12 didn’t want to participate and 746 were enrolled and randomized. Table 1 characterizes the total samples by the assigned condition and analysis strategy. There were no significant differences between the intervention and control groups in any demographic characteristics or between those followed-up and those lost to follow-up. Figure 1 View largeDownload slide Participant enrollment and follow-up. SIRIAN randomized controlled trial of community contraceptive counselling. Barcelona 2013 Figure 1 View largeDownload slide Participant enrollment and follow-up. SIRIAN randomized controlled trial of community contraceptive counselling. Barcelona 2013 Table 2 shows the baseline and 3-month follow-up percentages of participants incorrectly using an effective contraceptive method, those using less effective methods and those employing optimal contraception. At follow-up, the overall percentage of participants in the intervention group who had been inconsistently using effective methods was reduced by 54.9%, those using less effective methods decreased by 47.2% and optimal use increased by 22.2% in the intervention group (P < 0.001) and 10.4% in the control group (P = 0.036). Optimal use significantly increased in men, women, immigrants and natives in the intervention group, with no changes in those in the control group. Table 2 Inconsistent use of effective contraception, use of less effective methods and optimal use of contraception at baseline and month 3 by intervention group, stratified by sex and migrant status   Intervention  Control    Pre  Post  Varb  P  Pre  Post  Varb  P    %  %  %    %  %  %      Inconsistent use of effective methodsa  Menc  19.2  3.8  −80.2  0.004  20.9  17.9  −14.4  0.754  Womend  8.4  5.6  −33.3  0.286  9.0  6.2  −31.1  0.238  Migrantse  8.9  5.4  −39.3  0.424  10.1  12.6  24.8  0.508  Nativesf  12.7  5.7  −55.1  0.007  13.2  6.3  −52.3  0.013  Allg  11.3  5.1  −54.9  0.005  11.9  9.0  −24.4  0.185    Use of less effective methodsh  Menc  14.1  3.8  −73.0  0.008  13.4  14.9  11.2  1.000  Womend  11.6  7.4  −36.2  0.064  15.6  12.3  −21.2  0.167  Migrantse  10.7  4.5  −57.9  0.039  17.6  16.0  −9.1  0.774  Nativesf  13.3  7.7  −42.1  0.031  13.2  10.7  −18.9  0.424  Allg  12.3  6.5  −47.2  0.002  15.1  12.9  −14.6  0.327    Optimal usei  Menc  57.7  78.2  35.5  0.002  50.7  56.7  11.8  0.454  Womend  54.4  63.7  17.1  0.012  51.7  57.3  10.8  0.065  Migrantse  60.7  71.4  17.6  0.036  57.1  60.5  6.0  0.503  Nativesf  51.9  65.2  25.6  0.001  47.2  54.7  15.9  0.050  Allg  55.3  67.6  22.2  0.000  51.8  57.2  10.4  0.036    Intervention  Control    Pre  Post  Varb  P  Pre  Post  Varb  P    %  %  %    %  %  %      Inconsistent use of effective methodsa  Menc  19.2  3.8  −80.2  0.004  20.9  17.9  −14.4  0.754  Womend  8.4  5.6  −33.3  0.286  9.0  6.2  −31.1  0.238  Migrantse  8.9  5.4  −39.3  0.424  10.1  12.6  24.8  0.508  Nativesf  12.7  5.7  −55.1  0.007  13.2  6.3  −52.3  0.013  Allg  11.3  5.1  −54.9  0.005  11.9  9.0  −24.4  0.185    Use of less effective methodsh  Menc  14.1  3.8  −73.0  0.008  13.4  14.9  11.2  1.000  Womend  11.6  7.4  −36.2  0.064  15.6  12.3  −21.2  0.167  Migrantse  10.7  4.5  −57.9  0.039  17.6  16.0  −9.1  0.774  Nativesf  13.3  7.7  −42.1  0.031  13.2  10.7  −18.9  0.424  Allg  12.3  6.5  −47.2  0.002  15.1  12.9  −14.6  0.327    Optimal usei  Menc  57.7  78.2  35.5  0.002  50.7  56.7  11.8  0.454  Womend  54.4  63.7  17.1  0.012  51.7  57.3  10.8  0.065  Migrantse  60.7  71.4  17.6  0.036  57.1  60.5  6.0  0.503  Nativesf  51.9  65.2  25.6  0.001  47.2  54.7  15.9  0.050  Allg  55.3  67.6  22.2  0.000  51.8  57.2  10.4  0.036  a Inconsistent use of effective methods: Inconsistent use of oral contraception, male condoms, ring, implant, injection, patches, intrauterine device, female condoms, female sterilization, vasectomy or tubal occlusion. b Var, percentage of variation = [(%Post − %Pre)/%Pre]. c Men (n = 145): intervention (n = 78), control (n = 67). d Women (n = 426): intervention (n = 215), control (n = 211). e Migrants (n = 231): intervention (n = 112), control (n = 119). f Natives (n = 340): intervention (n = 181), control (n = 159). g All (n = 571): intervention (n = 293), control (n = 278). h Use of less effective methods: Withdrawal or periodic abstinence. i Optimal use: consistent use of at least one effective contraceptive method (oral contraception, male condoms, ring, implant, injection, patches, intrauterine device, female condoms, female sterilization, vasectomy or tubal occlusion). Table 3 shows that, in the per-protocol analysis, optimal use increased with the intervention among men [aPR: 1.402 (1.092–1.799)] and in the whole sample [aPR: 1.184 (1.040–1.349)]. By intention to treat, these effects remained significant [aPR: 1.344 (1.053–1.716)] [aPR: 1.138 (1.010–1.284)]. Table 3 Prevalence ratios of optimal contraceptive usea in the intervention group versus the control group at 3 months stratified by sex and migrant status   Per protocol (n = 571)  Intention to treat (n = 746)    RR (95% CI)b  aPR (95% CIc  aPR (95% CIc  Women  1.306 (0.885 − 1.929)  1.111 (0.953 − 1.296)  1.075 (0.935 − 1.236)  Men  2.738 (1.329 − 5.642)  1.402 (1.092 − 1.799)  1.344 (1.053 − 1.716)  Migrants  1.632 (0.941 − 2.830)  1.187 (0.984 − 1.432)  1.120 (0.939 − 1.336)  Natives  1.550 (1.001 − 2.400)  1.191 (0.196 − 1.424)  1.158 (0.983 − 1.363)  All  1.560 (1.109 − 2.194)  1.184 (1.040 − 1.349)  1.138 (1.010 − 1.284)    Per protocol (n = 571)  Intention to treat (n = 746)    RR (95% CI)b  aPR (95% CIc  aPR (95% CIc  Women  1.306 (0.885 − 1.929)  1.111 (0.953 − 1.296)  1.075 (0.935 − 1.236)  Men  2.738 (1.329 − 5.642)  1.402 (1.092 − 1.799)  1.344 (1.053 − 1.716)  Migrants  1.632 (0.941 − 2.830)  1.187 (0.984 − 1.432)  1.120 (0.939 − 1.336)  Natives  1.550 (1.001 − 2.400)  1.191 (0.196 − 1.424)  1.158 (0.983 − 1.363)  All  1.560 (1.109 − 2.194)  1.184 (1.040 − 1.349)  1.138 (1.010 − 1.284)  a Consistent use of at least one effective contraceptive method: oral contraception, male condoms, ring, implant, injection, patches, intrauterine device, female condoms, female sterilization, vasectomy or tubal occlusion. b Relative risk. c Adjusted prevalence ratio derived from robust variance Poisson regression models adjusted by sex, age, migration status, ethnicity, educational attainment and partner status. Discussion This study demonstrates that a brief theory-based counselling intervention can lead to an improvement in the reported use of effective contraception by residents in deprived urban neighbourhoods with a high proportion of immigrants. Among men, optimal contraceptive use rose by 35%. Counselling was associated with an 80.2% decrease in inconsistent use of effective methods and a 73% reduction in the use of less effective methods. These results highlight the importance of gender-inclusive approaches in reducing unmet need for family planning.24 Most interventions on sexual health among men aim to reduce sexually transmitted diseases and HIV infections through condom use, which prevents unintended pregnancy, but not as a primary goal. Low involvement among men has been related to the following issues: gender roles in sexual, family and reproductive health, leading to the perception that reproductive health is a woman’s domain; poor knowledge of contraception and the misconception that contraceptive methods disrupt sexual activity; the limited choice of available male contraceptives, mainly restricted to the condom, including fears about vasectomy; the preference for large families and concerns that women’s use of contraceptives will lead to extramarital sexual relations in rural and traditional settings; clinical settings perceived as unfriendly by men, and educational status.3,25,26 The decrease in the proportion of inconsistent contraceptive use among men was of the utmost importance. In our study, the only inconsistently used methods reported by men were condoms (data not shown). Our results are consistent with the few interventions aiming to reduce condom use errors among males, proven to be quite effective.27 A brief, single-session programme, similar to ours, though performed in a clinical setting, modestly reduced the rate of condom use errors in a sample of young black men.28 Most men in the study used effective contraception, but 14% reported using less effective methods (all used withdrawal), a similar proportion to that reported in many developed countries.2 Withdrawal use has been associated with the perception by men that condoms are likely to diminish sexual pleasure,29 and is more likely to be used by men with low incomes or lower educational levels.30 In our intervention, men’s use of withdrawal was substantially reduced in the intervention group. Consistent optimal use of contraception is the primary determinant of its effectiveness.31 Worldwide, hormonal contraceptives are among the most popular reversible methods. Despite their high theoretical effectiveness, typical use results in much lower effectiveness. This disparity largely reflects difficulties in adherence to the contraceptive regimen and low rates of long-term continuation.32 Even when effective contraceptives are readily available, behavioural practices such as switching and discontinuation of contraceptive methods may have a detrimental effect on the efficacy of contraception. Among women, optimal contraceptive use rose with the intervention but this increase lost significance in the multivariate analysis; a similar randomized controlled trial (RCT) reported a lower use of ineffective contraception at 4 months (OR 0.56; 95% CI 0.31–0.98).33 In contrast to the results for men, women in the specific behaviour analysis did not report changes in less effective or inconsistent contraception use, and change concentrated on greater use of effective contraception. In our study, women’s inconsistent use was much lower than men’s and remained unchanged, as in other strategies to aid women’s contraceptive adherence which have proved elusive.32,34 Migrants, even within the same country, may be at a greater risk for poor health due to circumstances which include their economic transition, decreased access to health services, the complications of the host health systems and, usually, a kind of ethnic and racial intolerance and hostility in the host community.35 Being an immigrant can also be a risk factor for unmet family planning needs.3,4,7,36 In this study, use of less effective methods decreased by 57.9% and optimal use increased by 17.6% among migrants in the intervention group. However, these increases did not remain significant in the adjusted models. Most immigrant participants were from Latin America, the most populous community in Spain. Studies in countries hosting Latin community immigrants have documented gaps in reproductive health and contraception knowledge, gendered attitudes about condoms and contraception and associations between family planning and power relationships in couples.37 This pattern may be changing in recent times, as a qualitative study observed no patriarchal ideology supporting women’s subordination to men or cultural influences discouraging access to and use of birth control in the Hispanic community.26 Our results are consistent with this finding, as immigrants were open to participating in this study and in discussing and changing sexual behaviours, as in other culturally tailored interventions.35,38 Strengths and limitations This study has several strengths. First, the internal validity of the findings was reinforced by the randomized trial design, the small percentage of losses to follow-up (24%),6 and the lack of differences in losses to follow-up between the groups. Regarding external validity, the results of this RCT could easily be replicated in other neighbourhoods in Barcelona and cities with similar contexts. Furthermore, a large proportion of the target populations were reached. A total of 15.2% (571/3751) of residents in the targeted age group participated in the study (12.7% of men, 11.8% of women, 23.4% of immigrants and 12.3% of natives). This may be due to the overall planning of the intervention,19 to the outreach approach4,7 and to our taking advantage of community-based infrastructures, enhancing accessibility and word-of-mouth dynamics, a most powerful communicator. In addition, the 10-trip urban transport card (costing about 10€) offered in each interview probably acted as a selective incentive, enhancing motivation for participation and adherence among those experiencing greatest economic hardship. Like other behaviours, family planning behaviours are sensitive to incentives.39 Finally, another strength of the study is that the overall analyses were carried out on an intention-to-treat basis, even though the sample size limited the statistical power of the subgroups analysis. Thus, behaviours were analysed per protocol, allowing a better understanding of the intervention effects among those actually receiving the intervention. Admittedly, this study also has a few limitations. One is that, since the intervention involved behavioural change, participants could not be blinded to their treatment allocation. However, blinding is often not feasible for participants or providers in educational interventions. Another limitation is the use of self-report measures on protected sex, which has the potential for several biases. Although self-report measures are standard in contraceptive research, they have been shown to overestimate contraceptive use because of social desirability and other types of information bias. However, this bias probably acts in both measures of each arm and may therefore be less important in terms of evaluating the counselling effects. Effects in the control group are not unusual in this kind of intervention, and this could have occurred in our study, reducing the evidence of its true effectiveness. Three factors might have been in play: the attention received in the control group may have been sufficiently powerful to facilitate a change because all participants had access to clinical care; Hawthorne effects (changes in behaviour resulting from awareness of being observed);40 and contamination, especially in the community setting, as participants in the intervention arms may have passed on the information to participants in the control arm. A further limitation is that this study did not measure long-term effects. Few studies have examined contraceptive use after a short intervention for an extended period, and have not shown consistent results.16 Finally, another limitation is use of self-reported contraceptive use instead of more objective indicators of unintended pregnancy, which is usual in this kind of studies.6 Despite these limitations, the multivariate findings indicate that a gender-sensitive and culturally tailored counselling intervention increased optimal contraception use by 14% among the population of a low-income neighbourhood with a high proportion of immigration. As far as we know, this could be the first RCT on brief contraceptive counselling in a low-income community setting with a high proportion of immigrants. According to the observed benefits in contraceptive use, our results provide a strong rationale for studies assessing the potential effects on unwanted pregnancy rates in the intervention neighbourhoods. In the future, extending this intervention could significantly reduce the rate of unintended pregnancy in low-income areas. Supplementary data Supplementary data are available at EURPUB online. Acknowledgements We would like to acknowledge Lluïsa Estruga, Silvia Martín and Anna Zaragoza for their role and contribution in the study’s implementation. Funding The trial was funded by the Spanish Science and Innovation Ministery (grant number FIS PI05/2727) with additional support from the Barcelona Public Health Agency. The funders had no further role in the design, collection, analysis and interpretation of data; the writing of the article or in the decision to submit the article for publication. Conflicts of interest: None declared. Key points Immigrants and native residents in disadvantaged neighbourhoods experience inequalities in reproductive health. Counselling has been recommended to promote informed choice of contraceptives, but there is a need for evaluative research focused on socially disadvantaged populations and ethnic groups. In Barcelona (Spain), a randomized controlled trial was developed in order to evaluate a community intervention of contraceptive counselling among men and women living in two disadvantaged neighbourhoods with a high proportion of migrants. This brief intervention increased by 14% the consistent use of effective contraceptive methods at 3 months. The strategy can contribute to prevent unwanted pregnancies in urban areas with similar characteristics. References 1 Starrs A. A Lancet Commission on sexual and reproductive health and rights: Going beyond the Sustainable Development Goals. Lancet  2015; 386: 1111– 2. Google Scholar CrossRef Search ADS PubMed  2 United Nations. United Nations Population Division | Department of Economic and Social Affairs. 2015. Available at: http://www.un.org/en/development/desa/population/events/other/10/index.shtml (22 April 2016, date last accessed). 3 Ruiz-Muñoz D, Pérez G, Garcia-Subirats I, Díez E. Social and economic inequalities in the use of contraception among women in Spain. J Women’s Heal  2011; 20: 403– 11. Google Scholar CrossRef Search ADS   4 National Institute for Health and Clinical Excellence. One to one interventions to reduce the transmission of sexually transmitted infections (STIs) including HIV, and to reduce the rate of under 18 conceptions, especially among vulnerable and at risk groups. NICE Public Heal Interv Guide 3 2007;1–50. Available at: www.nice.org.uk/PHI003. 5 Zapata LB, Tregear SJ, Curtis KM, et al.   Impact of contraceptive counseling in clinical settings: a systematic review. Am J Prev Med  2015; 49: S31– 45. Google Scholar CrossRef Search ADS PubMed  6 Lopez LM, Grey TW, Chen M, et al.   Theory-based interventions for contraception. Cochrane Database Syst Rev  2016; Issue Art: CD007249. 7 Blank L, Baxter SK, Payne N, et al.   Systematic review and narrative synthesis of the effectiveness of contraceptive service interventions for young people, delivered in health care settings. Health Educ Res  2012; 27: 1102– 19. Google Scholar CrossRef Search ADS PubMed  8 Agència de Salut Pública de Barcelona. La Salut a Barcelona en xifres. In: Bartoll X and García-Altés A. La Salut a Barcelona 2008. Barcelona: Agència de Salut Pública de Barcelona, 2009:88–9. 9 Departament d’Estudis i Programació (Ajuntament de Barcelona). Distribució Territorial de la Renda Familiar Disponible. Barcelona; 2014:24. Available at: http://barcelonaeconomia.bcn.cat/sites/default/files/RFD_2014_informe.pdf (15 June 2016, date last accessed). 10 Departament d’Estadística. La Poblacio Estrangera a Barcelona 2015. Barcelona; 2015:137. Available at: http://www.bcn.cat/estadistica/catala/dades/inf/pobest/pobest15/pobest15.pdf (22 April 2016, date last accessed). 11 Nebot L, Diez E, Martin S, et al.   Efectos de una intervencion de consejo anticonceptivo en adolescentes de barrios desfavorecidos con alta proporcion de inmigrantes. Gac Sanit  2016; 30: 43– 6. Google Scholar CrossRef Search ADS PubMed  12 Moher D, Hopewell S, Schulz KF, et al.   CONSORT 2010 explanation and elaboration: Updated guidelines for reporting parallel group randomised trials. Int J Surg  2012; 10: 28– 55. Google Scholar CrossRef Search ADS PubMed  13 Treasure T, MacRae KD. Minimisation: the platinum standard for trials? BMJ  1998; 317: 362– 3. Google Scholar CrossRef Search ADS PubMed  14 WHO. Brief Sexuality-Related Communication: Recommendations for a Public Health Approach, Vol. 70 . World Health Organization, 2015. Available at: http://www.who.int/reproductivehealth/publications/sexual_health/sexuality-related-communication/en/ (15 June 2016, date last accessed). 15 Jianzhong Z, Ma Y, Weihua L. Strategies for communicating contraceptive effectiveness. Public Health Nurs  2014; 31: 438– 40. Google Scholar CrossRef Search ADS PubMed  16 Lopez LM, Grey TW, Tolley EE, Chen M. Brief educational strategies for improving contraception use in young people. Cochrane Database Syst Rev  2016; 3: CD012025. Google Scholar PubMed  17 Wilson A, Nirantharakumar K, Truchanowicz EG, et al.   Motivational interviews to improve contraceptive use in populations at high risk of unintended pregnancy: a systematic review and meta-analysis. Eur J Obstet Gynecol Reprod Biol  2015; 191: 72– 9. Google Scholar CrossRef Search ADS PubMed  18 Díez E, Vadillo V, Cabanas M, Estruga L. Estudi qualitatiu dels determinants de la salut reproductiva en dones immigrades. In: García-Altés A, editor. La salut a Barcelona 2004 . Barcelona: Agència de Salut Pública de Barcelona, 2005. 19 Bartholomew LK, Parcel GS, Kok G. Intervention mapping: a process for developing theory- and evidence-based health education programs. Health Educ Behav  1998; 25: 545– 63. Google Scholar CrossRef Search ADS PubMed  20 Pérez A, Garcia-Continente X, Allué N, et al.   Informe FRESC 2012: 25 Anys d'Enquestes a Adolescents Escolaritzats de Barcelona. Barcelona, 2013: 1–64. Available at. http://www.aspb.cat/quefem/docs/Informe_FRESC_2012.pdf. (8 July 2016, date last acessed). 21 WHO. WHO | Family planning/Contraception. WHO 2016. Available at: http://www.who.int/mediacentre/factsheets/fs351/en/ (18 May 2016, date last acessed). 22 Committee for Medicinal Products for Human Use. EMA guideline on missing data in confirmatory clinical trials. Eur Med Agency 2010:12. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/09/WC500096793.pdf (18 May 2016, date last acessed). 23 Zou G. A Modified Poisson regression approach to prospective studies with binary data. Am J Epidemiol  2004; 159: 702– 6. Google Scholar CrossRef Search ADS PubMed  24 Lancet. Adolescent health: boys matter too. Lancet (London, England)  2015; 386: 2227. CrossRef Search ADS PubMed  25 Kabagenyi A, Ndugga P, Wandera SO, Kwagala B. Modern contraceptive use among sexually active men in Uganda: does discussion with a health worker matter?. BMC Public Health  2014; 14: 286. Google Scholar CrossRef Search ADS PubMed  26 Gonzalez EU, Sable MR, Campbell JD, Dannerbeck A. The influence of patriarchal behavior on birth control access and use among recent hispanic immigrants. J Immigr Minor Health  2010; 12: 551– 8. Google Scholar CrossRef Search ADS PubMed  27 Ross DA. Behavioural interventions to reduce HIV risk: what works?. AIDS  2010; 24(Suppl 4): S4– 14. Google Scholar CrossRef Search ADS PubMed  28 Crosby R, Salazar LF. Reduction of condom use errors from a brief, clinic-based intervention: a secondary analysis of data from a randomised, controlled trial of young black males. Sex Transm Infect  2015; 91: 111– 5. Google Scholar CrossRef Search ADS PubMed  29 Higgins JA, Wang Y. Which young adults are most likely to use withdrawal? The importance of pregnancy attitudes and sexual pleasure. Contraception  2015; 91: 320– 7. Google Scholar CrossRef Search ADS PubMed  30 Le Guen M, Ventola C, Bohet A, et al.   Men’s contraceptive practices in France: evidence of male involvement in family planning. Contraception  2015; 92: 46– 54. Google Scholar CrossRef Search ADS PubMed  31 Trussell J. Contraceptive failure in the United States. Contraception  2011; 83: 397– 404. Google Scholar CrossRef Search ADS PubMed  32 Halpern V, Lopez LM, Grimes DA, Gallo MF. Strategies to improve adherence and acceptability of hormonal methods of contraception. Cochrane Database Syst Rev  2011; CD004317. 33 Ceperich SD, Ingersoll KS. Motivational interviewing + feedback intervention to reduce alcohol-exposed pregnancy risk among college binge drinkers: determinants and patterns of response. J Behav Med  2011; 34: 381– 95. Google Scholar CrossRef Search ADS PubMed  34 Wellings K, Brima N, Sadler K, et al.   Stopping and switching contraceptive methods: findings from Contessa, a prospective longitudinal study of women of reproductive age in England. Contraception  2015; 91: 57– 66. Google Scholar CrossRef Search ADS PubMed  35 Sánchez J, De La Rosa M, Serna CA. Project Salud: Efficacy of a community-based HIV prevention intervention for Hispanic migrant workers in south Florida. AIDS Educ Prev  2013; 25: 363– 75. Google Scholar CrossRef Search ADS PubMed  36 Huang Y, Merkatz R, Zhu H, et al.   The free perinatal/postpartum contraceptive services project for migrant women in Shanghai: effects on the incidence of unintended pregnancy. Contraception  2014; 89: 521– 7. Google Scholar CrossRef Search ADS PubMed  37 Matsuda Y, McGrath JM, Knafl GJ, et al.   Examining relationship/family planning factors and sexual relationship power among immigrant Latino couples in the United States. Hisp Health Care Int  2014; 12: 161– 73. Google Scholar CrossRef Search ADS PubMed  38 Yore J, Dasgupta A, Ghule M, et al.   CHARM, a gender equity and family planning intervention for men and couples in rural India: protocol for the cluster randomized controlled trial evaluation. Reprod Health  2016; 13: 14. Google Scholar CrossRef Search ADS PubMed  39 Heil SH, Gaalema DE, Herrmann ES. Incentives to promote family planning. Prev Med (Baltim)  2012; 55: S106– 12. Google Scholar CrossRef Search ADS   40 Campbell JP, Maxey VA, Watson WA. Hawthorne effect: implications for prehospital research. Ann Emerg Med  1995; 26: 590– 4. Google Scholar CrossRef Search ADS PubMed  © The Author 2017. Published by Oxford University Press on behalf of the European Public Health Association. All rights reserved. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png The European Journal of Public Health Oxford University Press

Effects of a counselling intervention to improve contraception in deprived neighbourhoods: a randomized controlled trial

Loading next page...
 
/lp/ou_press/effects-of-a-counselling-intervention-to-improve-contraception-in-NcD0EP9djL
Publisher
Oxford University Press
Copyright
© The Author 2017. Published by Oxford University Press on behalf of the European Public Health Association. All rights reserved.
ISSN
1101-1262
eISSN
1464-360X
D.O.I.
10.1093/eurpub/ckx046
Publisher site
See Article on Publisher Site

Abstract

Abstract Background This study aims to evaluate the effects of a community-based counselling intervention to improve contraception use among immigrant and native residents in deprived neighbourhoods. Methods Randomized controlled trial. Women aged 14–49 years and men aged 14–39 years from two low-income neighbourhoods with high proportion of immigration in Barcelona (Catalonia, Spain) who had not undergone irreversible contraception and were not planning a pregnancy were recruited (2011–13). A culturally developed and theoretically based brief counselling intervention was delivered in community settings. The primary outcome was the consistent use of effective contraceptive methods (optimal use). Secondary outcomes were the incorrect use of effective methods and the use of less effective methods stratified by sex and migrant status. Differences within subgroups from baseline to the 3-month follow-up were analysed by intention to treat and per protocol. The effects were assessed with adjusted robust Poisson regressions. Results The study enrolled and randomized 746 eligible participants. There were no differences between the intervention and control groups in demographic characteristics. Optimal use significantly increased in men, women, immigrants and natives in the intervention group, with no changes in the control group. In the intervention group, inconsistent use of effective methods decreased by 54.9% and that of less effective methods by 47.2%. The overall adjusted prevalence ratio of optimal use in the intervention group versus the control group was 1.138 (95% CI: 1.010–1.284). Conclusion This brief counselling intervention increased the consistent use of effective contraception in low-income neighbourhoods with a high proportion of immigration. Introduction Birth control is crucial for the healthy development of countries.1 Although unintended pregnancy rates have progressively decreased worldwide in the last 50 years, inequalities in reproductive health persist both within and between countries.2 They are associated with determinants such as migrant status and income.3 Increasing the uptake of highly effective contraceptive methods and improving contraceptive use are important strategies to decrease unintended pregnancy. Contraceptive counselling based on theory and behavioural methods has been recommended to promote informed contraceptive choice, but there is a need for evaluative research on brief interventions for improving contraceptive use in socially disadvantaged groups, distinct ethnic groups and low resources settings.4–7 Spain is among the countries with the lowest fertility rates in the world.2 In the first decade of the 21st century, it experienced an unprecedented influx of economic migrants from poorer countries, especially to major cities. This was associated with increased fertility and teenage pregnancy rates in Barcelona. Abortion rates among immigrants were three times the native rates.8 In this context, public health services of Barcelona were commissioned to set up and evaluate a pilot intervention the aim of which was to lower these inequalities as well as to assess the intervention extension for the future. As economic immigrants tend to live in less affluent areas, where housing is more affordable, we developed a counselling intervention (SIRIAN programme) and tested it in deprived areas with a high proportion of the newly arrived. The objective of this study was to evaluate whether a community brief intervention improved optimal contraceptive use at 3 months, by sex and migration status (immigrants or natives) among residents living in two deprived neighbourhoods. Methods Study aims, setting and participants A randomized, controlled, parallel-group trial was conducted over 36 months, from October 2011 to September 2014, in two neighbourhoods in the lowest quintile of available family income of Barcelona (Bon Pastor and Baró de Viver) and with a high proportion of immigrants.9,10 The trial protocol was approved by the institutional ethics committee, and was conducted in accordance with the principles of the Declaration of Helsinki. All participants provided signed informed consent. Participants were recruited for the study from residents in the selected neighbourhoods by flyers and posters in the streets and referrals from civic, community and primary health centres. The participants were asked to invite neighbours, relatives and friends, with a view to generating a snowball recruiting strategy. Eligible participants were women aged 14–49 years and men aged 14–39 years, regardless of their partnership status. Adolescents and young adult men were included because previous investigations had shown that they had limited knowledge about contraceptive methods and could be receptive to changing their sexual behaviour.6,11 We excluded those who had undergone an irreversible contraceptive method and those who desired a pregnancy. Randomization Stratified blocked randomization by country of origin was performed with a web-based system for the first 10 cases of every country in a 1:1 ratio. The following cases were assigned by minimisation to balance recruitment12,13 (Supplementary Material S1). Participants were assigned to either a group receiving a counselling intervention on contraceptive methods or to a control group without intervention. Both groups completed a questionnaire at baseline and 3 months later. Accepting an alpha risk 0.05 and a beta risk below 0.2 in a bilateral contrast, we estimated that a sample size of 250 participants assigned to receive the contraceptive counselling and 250 in the control group would allow an 80% power to detect a between-group difference of 12.5% in the primary end point of the trial with a baseline proportion of use of effective methods of 55%.3 The participants underwent an initial screening for eligibility and a study counsellor obtained informed consent. Then, the counsellor opened a randomization list and administered the questionnaire or the counselling intervention. By telephone, interviews were arranged to take place 3 months after baseline at a time convenient to the participant (Supplementary Material S2). For ethical reasons, the control group underwent the intervention after the follow-up assessment. The community counselling intervention The counselling sessions lasted up to 45 min, depending on individual need.4,14 The interview was based on World Health Organization guidelines and communication tools.14,15 They were structured on the basis of social cognitive theory, addressing factors that could help reduce risk-taking and improve self-efficacy and motivation, and in motivational interviewing, with active listening and a non-judgemental attitude.16,17 The intervention was culturally adapted in line with the results of formative investigation.18 Given the limited information on the reproductive health needs of immigrant women, we conducted a qualitative study prior to the development of the programme. The study populations were prioritized according to the classification of non-EU citizen’s residents, abortion rates and the opinion of experts. We studied communities from Latin America, Morocco, Romania, Senegal, Pakistan, China and the Philippines. We conducted interviews with key informants and 15 focus groups in which 108 women participated. We explored their views on motherhood, the importance of having children, relationships and sexuality, contraception, teenage pregnancy, abortion and social and religious norms. The sample was intentional. In light of these results the research group structured the intervention. According to the psychosocial determinants emerged in the qualitative study, materials were prepared for each community, which were refined with pre-test interviews. The development and implementation of the intervention followed the Intervention Mapping planning model, which relies on theoretical and logic models.19 All counselling was specifically tailored to individual needs. Throughout the interview, topics were proposed using materials written to discuss the main benefits of contraception from the perspective of the immigrant communities. These included guided discussions on family planning during the life course, the amount of time required to care for children, the economic resources required for newborns and children, along with an assessment of knowledge on contraceptive methods, and of their actual use (whether optimal or not). Samples of contraceptive methods were presented and abortion and emergency contraception were addressed. Knowledge on access to primary health care centres and sexual and reproductive health clinics was reinforced. Participants were given condoms, the leaflet, and a 10-trip urban travel card, as an incentive. Counselling was provided mainly (92%) by two public health nurses and one health psychologist, and the rest was provided by physicians, all of them with specific training. Fidelity to the protocol was assessed in the training sessions. The satisfaction of participants was very high. All interviews were performed in community facilities (public library, community centres…) or in a separate facility within the primary health care centre. The questionnaire was developed according to the results of a formative investigation and was adapted from the Barcelona Health Survey questionnaire and other studies assessing contraceptive use and knowledge in the city.11,20 It covered demographic variables (sex, age, country of birth, educational attainment, occupational situation, partner relationships and parity with categories as described in table 1). Use of methods was assessed by asking which form or forms of contraception (if any) were they currently using (oral contraception, male condoms, ring, implant, patches, intrauterine device, injections, female condoms, female sterilization, vasectomy and tubal occlusion, withdrawal and periodic abstinence) and how these methods were used. The questionnaire was administered by the counsellors within the counselling in the intervention group, and in an interview in the control group. Table 1 Characteristics of participants at baseline   Intervention (n = 293) %  Control (n = 278) %  P  Sex            Female  73.4  75.9  0.502  Age group (years)            14–19  24.9  20.5  0.360      20–29  23.5  24.1        30–39  32.4  30.9        40–49  19.1  24.5    Median (IQR)  30 (18.5)  31 (19)    Birth country            Spain  61.8  57.2  0.177      Morocco  12.6  10.4        Ecuador  9.9  11.2        Other countries  15.7  21.2    Educational level            Less than primary  4.9  7.9  0.496      Primary  31.7  31.4        Secondary  58.1  53.7        University  5.3  6.9    Occupational situation            Housework  17.7  16.9  0.812      Student  22.9  21.2        Worker  23.2  27.7        Unemployed  28.7  26.6        Other  7.5  7.6    Partner relationship            Yes  72.7  72.3  0.926  Parity            0  49.8  41.7  0.112      1  17.7  17.6        2  18.4  26.3        3 or more  14.0  14.4      Intervention (n = 293) %  Control (n = 278) %  P  Sex            Female  73.4  75.9  0.502  Age group (years)            14–19  24.9  20.5  0.360      20–29  23.5  24.1        30–39  32.4  30.9        40–49  19.1  24.5    Median (IQR)  30 (18.5)  31 (19)    Birth country            Spain  61.8  57.2  0.177      Morocco  12.6  10.4        Ecuador  9.9  11.2        Other countries  15.7  21.2    Educational level            Less than primary  4.9  7.9  0.496      Primary  31.7  31.4        Secondary  58.1  53.7        University  5.3  6.9    Occupational situation            Housework  17.7  16.9  0.812      Student  22.9  21.2        Worker  23.2  27.7        Unemployed  28.7  26.6        Other  7.5  7.6    Partner relationship            Yes  72.7  72.3  0.926  Parity            0  49.8  41.7  0.112      1  17.7  17.6        2  18.4  26.3        3 or more  14.0  14.4    SIRIAN randomized controlled trial Outcomes and statistics The primary outcome was the consistent use of effective methods. Such methods included oral contraception, male condoms, ring, implant, patches, intrauterine device, injections, female condoms, female sterilization, vasectomy and tubal occlusion.21 Secondary outcomes were: (i) Inconsistent use of effective methods (common examples are condoms used in some intercourse episodes and not in others, or condoms used improperly, or taking birth control pills but missing too many doses for pregnancy prevention), and (ii) Use of less effective methods (withdrawal and periodic abstinence).21 Practices such as douching were not considered a contraceptive method. We used two analysis strategies. Changes in the primary outcome were analysed by using data from the full-analysis set, which included all participants who underwent randomization (intention to treat). In intention-to-treat analyses, the only imputation performed on the missing values was last-data-carried-forward,22 in this case, the baseline data. The secondary outcomes were analysed among participants assessed after baseline (per protocol). We calculated within-group participant changes in the outcome measures between baseline and follow-up with McNemar tests on dichotomous variables of the primary endpoint and the secondary endpoints. Then, a per protocol analysis was performed to estimate relative risks and the prevalence ratio derived from robust variance Poisson regression models.23 The models included the intervention group, with the baseline value of the relevant variable as a covariate, and were adjusted by sex, age, migration status, ethnicity, educational attainment and partner status. Finally, in the intention-to-treat strategy, the latter models were repeated for the whole randomized sample. Results Participant flow is presented in figure 1. Of 838 individuals screened, 80 did not meet the eligibility criteria, 12 didn’t want to participate and 746 were enrolled and randomized. Table 1 characterizes the total samples by the assigned condition and analysis strategy. There were no significant differences between the intervention and control groups in any demographic characteristics or between those followed-up and those lost to follow-up. Figure 1 View largeDownload slide Participant enrollment and follow-up. SIRIAN randomized controlled trial of community contraceptive counselling. Barcelona 2013 Figure 1 View largeDownload slide Participant enrollment and follow-up. SIRIAN randomized controlled trial of community contraceptive counselling. Barcelona 2013 Table 2 shows the baseline and 3-month follow-up percentages of participants incorrectly using an effective contraceptive method, those using less effective methods and those employing optimal contraception. At follow-up, the overall percentage of participants in the intervention group who had been inconsistently using effective methods was reduced by 54.9%, those using less effective methods decreased by 47.2% and optimal use increased by 22.2% in the intervention group (P < 0.001) and 10.4% in the control group (P = 0.036). Optimal use significantly increased in men, women, immigrants and natives in the intervention group, with no changes in those in the control group. Table 2 Inconsistent use of effective contraception, use of less effective methods and optimal use of contraception at baseline and month 3 by intervention group, stratified by sex and migrant status   Intervention  Control    Pre  Post  Varb  P  Pre  Post  Varb  P    %  %  %    %  %  %      Inconsistent use of effective methodsa  Menc  19.2  3.8  −80.2  0.004  20.9  17.9  −14.4  0.754  Womend  8.4  5.6  −33.3  0.286  9.0  6.2  −31.1  0.238  Migrantse  8.9  5.4  −39.3  0.424  10.1  12.6  24.8  0.508  Nativesf  12.7  5.7  −55.1  0.007  13.2  6.3  −52.3  0.013  Allg  11.3  5.1  −54.9  0.005  11.9  9.0  −24.4  0.185    Use of less effective methodsh  Menc  14.1  3.8  −73.0  0.008  13.4  14.9  11.2  1.000  Womend  11.6  7.4  −36.2  0.064  15.6  12.3  −21.2  0.167  Migrantse  10.7  4.5  −57.9  0.039  17.6  16.0  −9.1  0.774  Nativesf  13.3  7.7  −42.1  0.031  13.2  10.7  −18.9  0.424  Allg  12.3  6.5  −47.2  0.002  15.1  12.9  −14.6  0.327    Optimal usei  Menc  57.7  78.2  35.5  0.002  50.7  56.7  11.8  0.454  Womend  54.4  63.7  17.1  0.012  51.7  57.3  10.8  0.065  Migrantse  60.7  71.4  17.6  0.036  57.1  60.5  6.0  0.503  Nativesf  51.9  65.2  25.6  0.001  47.2  54.7  15.9  0.050  Allg  55.3  67.6  22.2  0.000  51.8  57.2  10.4  0.036    Intervention  Control    Pre  Post  Varb  P  Pre  Post  Varb  P    %  %  %    %  %  %      Inconsistent use of effective methodsa  Menc  19.2  3.8  −80.2  0.004  20.9  17.9  −14.4  0.754  Womend  8.4  5.6  −33.3  0.286  9.0  6.2  −31.1  0.238  Migrantse  8.9  5.4  −39.3  0.424  10.1  12.6  24.8  0.508  Nativesf  12.7  5.7  −55.1  0.007  13.2  6.3  −52.3  0.013  Allg  11.3  5.1  −54.9  0.005  11.9  9.0  −24.4  0.185    Use of less effective methodsh  Menc  14.1  3.8  −73.0  0.008  13.4  14.9  11.2  1.000  Womend  11.6  7.4  −36.2  0.064  15.6  12.3  −21.2  0.167  Migrantse  10.7  4.5  −57.9  0.039  17.6  16.0  −9.1  0.774  Nativesf  13.3  7.7  −42.1  0.031  13.2  10.7  −18.9  0.424  Allg  12.3  6.5  −47.2  0.002  15.1  12.9  −14.6  0.327    Optimal usei  Menc  57.7  78.2  35.5  0.002  50.7  56.7  11.8  0.454  Womend  54.4  63.7  17.1  0.012  51.7  57.3  10.8  0.065  Migrantse  60.7  71.4  17.6  0.036  57.1  60.5  6.0  0.503  Nativesf  51.9  65.2  25.6  0.001  47.2  54.7  15.9  0.050  Allg  55.3  67.6  22.2  0.000  51.8  57.2  10.4  0.036  a Inconsistent use of effective methods: Inconsistent use of oral contraception, male condoms, ring, implant, injection, patches, intrauterine device, female condoms, female sterilization, vasectomy or tubal occlusion. b Var, percentage of variation = [(%Post − %Pre)/%Pre]. c Men (n = 145): intervention (n = 78), control (n = 67). d Women (n = 426): intervention (n = 215), control (n = 211). e Migrants (n = 231): intervention (n = 112), control (n = 119). f Natives (n = 340): intervention (n = 181), control (n = 159). g All (n = 571): intervention (n = 293), control (n = 278). h Use of less effective methods: Withdrawal or periodic abstinence. i Optimal use: consistent use of at least one effective contraceptive method (oral contraception, male condoms, ring, implant, injection, patches, intrauterine device, female condoms, female sterilization, vasectomy or tubal occlusion). Table 3 shows that, in the per-protocol analysis, optimal use increased with the intervention among men [aPR: 1.402 (1.092–1.799)] and in the whole sample [aPR: 1.184 (1.040–1.349)]. By intention to treat, these effects remained significant [aPR: 1.344 (1.053–1.716)] [aPR: 1.138 (1.010–1.284)]. Table 3 Prevalence ratios of optimal contraceptive usea in the intervention group versus the control group at 3 months stratified by sex and migrant status   Per protocol (n = 571)  Intention to treat (n = 746)    RR (95% CI)b  aPR (95% CIc  aPR (95% CIc  Women  1.306 (0.885 − 1.929)  1.111 (0.953 − 1.296)  1.075 (0.935 − 1.236)  Men  2.738 (1.329 − 5.642)  1.402 (1.092 − 1.799)  1.344 (1.053 − 1.716)  Migrants  1.632 (0.941 − 2.830)  1.187 (0.984 − 1.432)  1.120 (0.939 − 1.336)  Natives  1.550 (1.001 − 2.400)  1.191 (0.196 − 1.424)  1.158 (0.983 − 1.363)  All  1.560 (1.109 − 2.194)  1.184 (1.040 − 1.349)  1.138 (1.010 − 1.284)    Per protocol (n = 571)  Intention to treat (n = 746)    RR (95% CI)b  aPR (95% CIc  aPR (95% CIc  Women  1.306 (0.885 − 1.929)  1.111 (0.953 − 1.296)  1.075 (0.935 − 1.236)  Men  2.738 (1.329 − 5.642)  1.402 (1.092 − 1.799)  1.344 (1.053 − 1.716)  Migrants  1.632 (0.941 − 2.830)  1.187 (0.984 − 1.432)  1.120 (0.939 − 1.336)  Natives  1.550 (1.001 − 2.400)  1.191 (0.196 − 1.424)  1.158 (0.983 − 1.363)  All  1.560 (1.109 − 2.194)  1.184 (1.040 − 1.349)  1.138 (1.010 − 1.284)  a Consistent use of at least one effective contraceptive method: oral contraception, male condoms, ring, implant, injection, patches, intrauterine device, female condoms, female sterilization, vasectomy or tubal occlusion. b Relative risk. c Adjusted prevalence ratio derived from robust variance Poisson regression models adjusted by sex, age, migration status, ethnicity, educational attainment and partner status. Discussion This study demonstrates that a brief theory-based counselling intervention can lead to an improvement in the reported use of effective contraception by residents in deprived urban neighbourhoods with a high proportion of immigrants. Among men, optimal contraceptive use rose by 35%. Counselling was associated with an 80.2% decrease in inconsistent use of effective methods and a 73% reduction in the use of less effective methods. These results highlight the importance of gender-inclusive approaches in reducing unmet need for family planning.24 Most interventions on sexual health among men aim to reduce sexually transmitted diseases and HIV infections through condom use, which prevents unintended pregnancy, but not as a primary goal. Low involvement among men has been related to the following issues: gender roles in sexual, family and reproductive health, leading to the perception that reproductive health is a woman’s domain; poor knowledge of contraception and the misconception that contraceptive methods disrupt sexual activity; the limited choice of available male contraceptives, mainly restricted to the condom, including fears about vasectomy; the preference for large families and concerns that women’s use of contraceptives will lead to extramarital sexual relations in rural and traditional settings; clinical settings perceived as unfriendly by men, and educational status.3,25,26 The decrease in the proportion of inconsistent contraceptive use among men was of the utmost importance. In our study, the only inconsistently used methods reported by men were condoms (data not shown). Our results are consistent with the few interventions aiming to reduce condom use errors among males, proven to be quite effective.27 A brief, single-session programme, similar to ours, though performed in a clinical setting, modestly reduced the rate of condom use errors in a sample of young black men.28 Most men in the study used effective contraception, but 14% reported using less effective methods (all used withdrawal), a similar proportion to that reported in many developed countries.2 Withdrawal use has been associated with the perception by men that condoms are likely to diminish sexual pleasure,29 and is more likely to be used by men with low incomes or lower educational levels.30 In our intervention, men’s use of withdrawal was substantially reduced in the intervention group. Consistent optimal use of contraception is the primary determinant of its effectiveness.31 Worldwide, hormonal contraceptives are among the most popular reversible methods. Despite their high theoretical effectiveness, typical use results in much lower effectiveness. This disparity largely reflects difficulties in adherence to the contraceptive regimen and low rates of long-term continuation.32 Even when effective contraceptives are readily available, behavioural practices such as switching and discontinuation of contraceptive methods may have a detrimental effect on the efficacy of contraception. Among women, optimal contraceptive use rose with the intervention but this increase lost significance in the multivariate analysis; a similar randomized controlled trial (RCT) reported a lower use of ineffective contraception at 4 months (OR 0.56; 95% CI 0.31–0.98).33 In contrast to the results for men, women in the specific behaviour analysis did not report changes in less effective or inconsistent contraception use, and change concentrated on greater use of effective contraception. In our study, women’s inconsistent use was much lower than men’s and remained unchanged, as in other strategies to aid women’s contraceptive adherence which have proved elusive.32,34 Migrants, even within the same country, may be at a greater risk for poor health due to circumstances which include their economic transition, decreased access to health services, the complications of the host health systems and, usually, a kind of ethnic and racial intolerance and hostility in the host community.35 Being an immigrant can also be a risk factor for unmet family planning needs.3,4,7,36 In this study, use of less effective methods decreased by 57.9% and optimal use increased by 17.6% among migrants in the intervention group. However, these increases did not remain significant in the adjusted models. Most immigrant participants were from Latin America, the most populous community in Spain. Studies in countries hosting Latin community immigrants have documented gaps in reproductive health and contraception knowledge, gendered attitudes about condoms and contraception and associations between family planning and power relationships in couples.37 This pattern may be changing in recent times, as a qualitative study observed no patriarchal ideology supporting women’s subordination to men or cultural influences discouraging access to and use of birth control in the Hispanic community.26 Our results are consistent with this finding, as immigrants were open to participating in this study and in discussing and changing sexual behaviours, as in other culturally tailored interventions.35,38 Strengths and limitations This study has several strengths. First, the internal validity of the findings was reinforced by the randomized trial design, the small percentage of losses to follow-up (24%),6 and the lack of differences in losses to follow-up between the groups. Regarding external validity, the results of this RCT could easily be replicated in other neighbourhoods in Barcelona and cities with similar contexts. Furthermore, a large proportion of the target populations were reached. A total of 15.2% (571/3751) of residents in the targeted age group participated in the study (12.7% of men, 11.8% of women, 23.4% of immigrants and 12.3% of natives). This may be due to the overall planning of the intervention,19 to the outreach approach4,7 and to our taking advantage of community-based infrastructures, enhancing accessibility and word-of-mouth dynamics, a most powerful communicator. In addition, the 10-trip urban transport card (costing about 10€) offered in each interview probably acted as a selective incentive, enhancing motivation for participation and adherence among those experiencing greatest economic hardship. Like other behaviours, family planning behaviours are sensitive to incentives.39 Finally, another strength of the study is that the overall analyses were carried out on an intention-to-treat basis, even though the sample size limited the statistical power of the subgroups analysis. Thus, behaviours were analysed per protocol, allowing a better understanding of the intervention effects among those actually receiving the intervention. Admittedly, this study also has a few limitations. One is that, since the intervention involved behavioural change, participants could not be blinded to their treatment allocation. However, blinding is often not feasible for participants or providers in educational interventions. Another limitation is the use of self-report measures on protected sex, which has the potential for several biases. Although self-report measures are standard in contraceptive research, they have been shown to overestimate contraceptive use because of social desirability and other types of information bias. However, this bias probably acts in both measures of each arm and may therefore be less important in terms of evaluating the counselling effects. Effects in the control group are not unusual in this kind of intervention, and this could have occurred in our study, reducing the evidence of its true effectiveness. Three factors might have been in play: the attention received in the control group may have been sufficiently powerful to facilitate a change because all participants had access to clinical care; Hawthorne effects (changes in behaviour resulting from awareness of being observed);40 and contamination, especially in the community setting, as participants in the intervention arms may have passed on the information to participants in the control arm. A further limitation is that this study did not measure long-term effects. Few studies have examined contraceptive use after a short intervention for an extended period, and have not shown consistent results.16 Finally, another limitation is use of self-reported contraceptive use instead of more objective indicators of unintended pregnancy, which is usual in this kind of studies.6 Despite these limitations, the multivariate findings indicate that a gender-sensitive and culturally tailored counselling intervention increased optimal contraception use by 14% among the population of a low-income neighbourhood with a high proportion of immigration. As far as we know, this could be the first RCT on brief contraceptive counselling in a low-income community setting with a high proportion of immigrants. According to the observed benefits in contraceptive use, our results provide a strong rationale for studies assessing the potential effects on unwanted pregnancy rates in the intervention neighbourhoods. In the future, extending this intervention could significantly reduce the rate of unintended pregnancy in low-income areas. Supplementary data Supplementary data are available at EURPUB online. Acknowledgements We would like to acknowledge Lluïsa Estruga, Silvia Martín and Anna Zaragoza for their role and contribution in the study’s implementation. Funding The trial was funded by the Spanish Science and Innovation Ministery (grant number FIS PI05/2727) with additional support from the Barcelona Public Health Agency. The funders had no further role in the design, collection, analysis and interpretation of data; the writing of the article or in the decision to submit the article for publication. Conflicts of interest: None declared. Key points Immigrants and native residents in disadvantaged neighbourhoods experience inequalities in reproductive health. Counselling has been recommended to promote informed choice of contraceptives, but there is a need for evaluative research focused on socially disadvantaged populations and ethnic groups. In Barcelona (Spain), a randomized controlled trial was developed in order to evaluate a community intervention of contraceptive counselling among men and women living in two disadvantaged neighbourhoods with a high proportion of migrants. This brief intervention increased by 14% the consistent use of effective contraceptive methods at 3 months. The strategy can contribute to prevent unwanted pregnancies in urban areas with similar characteristics. References 1 Starrs A. A Lancet Commission on sexual and reproductive health and rights: Going beyond the Sustainable Development Goals. Lancet  2015; 386: 1111– 2. Google Scholar CrossRef Search ADS PubMed  2 United Nations. United Nations Population Division | Department of Economic and Social Affairs. 2015. Available at: http://www.un.org/en/development/desa/population/events/other/10/index.shtml (22 April 2016, date last accessed). 3 Ruiz-Muñoz D, Pérez G, Garcia-Subirats I, Díez E. Social and economic inequalities in the use of contraception among women in Spain. J Women’s Heal  2011; 20: 403– 11. Google Scholar CrossRef Search ADS   4 National Institute for Health and Clinical Excellence. One to one interventions to reduce the transmission of sexually transmitted infections (STIs) including HIV, and to reduce the rate of under 18 conceptions, especially among vulnerable and at risk groups. NICE Public Heal Interv Guide 3 2007;1–50. Available at: www.nice.org.uk/PHI003. 5 Zapata LB, Tregear SJ, Curtis KM, et al.   Impact of contraceptive counseling in clinical settings: a systematic review. Am J Prev Med  2015; 49: S31– 45. Google Scholar CrossRef Search ADS PubMed  6 Lopez LM, Grey TW, Chen M, et al.   Theory-based interventions for contraception. Cochrane Database Syst Rev  2016; Issue Art: CD007249. 7 Blank L, Baxter SK, Payne N, et al.   Systematic review and narrative synthesis of the effectiveness of contraceptive service interventions for young people, delivered in health care settings. Health Educ Res  2012; 27: 1102– 19. Google Scholar CrossRef Search ADS PubMed  8 Agència de Salut Pública de Barcelona. La Salut a Barcelona en xifres. In: Bartoll X and García-Altés A. La Salut a Barcelona 2008. Barcelona: Agència de Salut Pública de Barcelona, 2009:88–9. 9 Departament d’Estudis i Programació (Ajuntament de Barcelona). Distribució Territorial de la Renda Familiar Disponible. Barcelona; 2014:24. Available at: http://barcelonaeconomia.bcn.cat/sites/default/files/RFD_2014_informe.pdf (15 June 2016, date last accessed). 10 Departament d’Estadística. La Poblacio Estrangera a Barcelona 2015. Barcelona; 2015:137. Available at: http://www.bcn.cat/estadistica/catala/dades/inf/pobest/pobest15/pobest15.pdf (22 April 2016, date last accessed). 11 Nebot L, Diez E, Martin S, et al.   Efectos de una intervencion de consejo anticonceptivo en adolescentes de barrios desfavorecidos con alta proporcion de inmigrantes. Gac Sanit  2016; 30: 43– 6. Google Scholar CrossRef Search ADS PubMed  12 Moher D, Hopewell S, Schulz KF, et al.   CONSORT 2010 explanation and elaboration: Updated guidelines for reporting parallel group randomised trials. Int J Surg  2012; 10: 28– 55. Google Scholar CrossRef Search ADS PubMed  13 Treasure T, MacRae KD. Minimisation: the platinum standard for trials? BMJ  1998; 317: 362– 3. Google Scholar CrossRef Search ADS PubMed  14 WHO. Brief Sexuality-Related Communication: Recommendations for a Public Health Approach, Vol. 70 . World Health Organization, 2015. Available at: http://www.who.int/reproductivehealth/publications/sexual_health/sexuality-related-communication/en/ (15 June 2016, date last accessed). 15 Jianzhong Z, Ma Y, Weihua L. Strategies for communicating contraceptive effectiveness. Public Health Nurs  2014; 31: 438– 40. Google Scholar CrossRef Search ADS PubMed  16 Lopez LM, Grey TW, Tolley EE, Chen M. Brief educational strategies for improving contraception use in young people. Cochrane Database Syst Rev  2016; 3: CD012025. Google Scholar PubMed  17 Wilson A, Nirantharakumar K, Truchanowicz EG, et al.   Motivational interviews to improve contraceptive use in populations at high risk of unintended pregnancy: a systematic review and meta-analysis. Eur J Obstet Gynecol Reprod Biol  2015; 191: 72– 9. Google Scholar CrossRef Search ADS PubMed  18 Díez E, Vadillo V, Cabanas M, Estruga L. Estudi qualitatiu dels determinants de la salut reproductiva en dones immigrades. In: García-Altés A, editor. La salut a Barcelona 2004 . Barcelona: Agència de Salut Pública de Barcelona, 2005. 19 Bartholomew LK, Parcel GS, Kok G. Intervention mapping: a process for developing theory- and evidence-based health education programs. Health Educ Behav  1998; 25: 545– 63. Google Scholar CrossRef Search ADS PubMed  20 Pérez A, Garcia-Continente X, Allué N, et al.   Informe FRESC 2012: 25 Anys d'Enquestes a Adolescents Escolaritzats de Barcelona. Barcelona, 2013: 1–64. Available at. http://www.aspb.cat/quefem/docs/Informe_FRESC_2012.pdf. (8 July 2016, date last acessed). 21 WHO. WHO | Family planning/Contraception. WHO 2016. Available at: http://www.who.int/mediacentre/factsheets/fs351/en/ (18 May 2016, date last acessed). 22 Committee for Medicinal Products for Human Use. EMA guideline on missing data in confirmatory clinical trials. Eur Med Agency 2010:12. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/09/WC500096793.pdf (18 May 2016, date last acessed). 23 Zou G. A Modified Poisson regression approach to prospective studies with binary data. Am J Epidemiol  2004; 159: 702– 6. Google Scholar CrossRef Search ADS PubMed  24 Lancet. Adolescent health: boys matter too. Lancet (London, England)  2015; 386: 2227. CrossRef Search ADS PubMed  25 Kabagenyi A, Ndugga P, Wandera SO, Kwagala B. Modern contraceptive use among sexually active men in Uganda: does discussion with a health worker matter?. BMC Public Health  2014; 14: 286. Google Scholar CrossRef Search ADS PubMed  26 Gonzalez EU, Sable MR, Campbell JD, Dannerbeck A. The influence of patriarchal behavior on birth control access and use among recent hispanic immigrants. J Immigr Minor Health  2010; 12: 551– 8. Google Scholar CrossRef Search ADS PubMed  27 Ross DA. Behavioural interventions to reduce HIV risk: what works?. AIDS  2010; 24(Suppl 4): S4– 14. Google Scholar CrossRef Search ADS PubMed  28 Crosby R, Salazar LF. Reduction of condom use errors from a brief, clinic-based intervention: a secondary analysis of data from a randomised, controlled trial of young black males. Sex Transm Infect  2015; 91: 111– 5. Google Scholar CrossRef Search ADS PubMed  29 Higgins JA, Wang Y. Which young adults are most likely to use withdrawal? The importance of pregnancy attitudes and sexual pleasure. Contraception  2015; 91: 320– 7. Google Scholar CrossRef Search ADS PubMed  30 Le Guen M, Ventola C, Bohet A, et al.   Men’s contraceptive practices in France: evidence of male involvement in family planning. Contraception  2015; 92: 46– 54. Google Scholar CrossRef Search ADS PubMed  31 Trussell J. Contraceptive failure in the United States. Contraception  2011; 83: 397– 404. Google Scholar CrossRef Search ADS PubMed  32 Halpern V, Lopez LM, Grimes DA, Gallo MF. Strategies to improve adherence and acceptability of hormonal methods of contraception. Cochrane Database Syst Rev  2011; CD004317. 33 Ceperich SD, Ingersoll KS. Motivational interviewing + feedback intervention to reduce alcohol-exposed pregnancy risk among college binge drinkers: determinants and patterns of response. J Behav Med  2011; 34: 381– 95. Google Scholar CrossRef Search ADS PubMed  34 Wellings K, Brima N, Sadler K, et al.   Stopping and switching contraceptive methods: findings from Contessa, a prospective longitudinal study of women of reproductive age in England. Contraception  2015; 91: 57– 66. Google Scholar CrossRef Search ADS PubMed  35 Sánchez J, De La Rosa M, Serna CA. Project Salud: Efficacy of a community-based HIV prevention intervention for Hispanic migrant workers in south Florida. AIDS Educ Prev  2013; 25: 363– 75. Google Scholar CrossRef Search ADS PubMed  36 Huang Y, Merkatz R, Zhu H, et al.   The free perinatal/postpartum contraceptive services project for migrant women in Shanghai: effects on the incidence of unintended pregnancy. Contraception  2014; 89: 521– 7. Google Scholar CrossRef Search ADS PubMed  37 Matsuda Y, McGrath JM, Knafl GJ, et al.   Examining relationship/family planning factors and sexual relationship power among immigrant Latino couples in the United States. Hisp Health Care Int  2014; 12: 161– 73. Google Scholar CrossRef Search ADS PubMed  38 Yore J, Dasgupta A, Ghule M, et al.   CHARM, a gender equity and family planning intervention for men and couples in rural India: protocol for the cluster randomized controlled trial evaluation. Reprod Health  2016; 13: 14. Google Scholar CrossRef Search ADS PubMed  39 Heil SH, Gaalema DE, Herrmann ES. Incentives to promote family planning. Prev Med (Baltim)  2012; 55: S106– 12. Google Scholar CrossRef Search ADS   40 Campbell JP, Maxey VA, Watson WA. Hawthorne effect: implications for prehospital research. Ann Emerg Med  1995; 26: 590– 4. Google Scholar CrossRef Search ADS PubMed  © The Author 2017. Published by Oxford University Press on behalf of the European Public Health Association. All rights reserved.

Journal

The European Journal of Public HealthOxford University Press

Published: Feb 1, 2018

There are no references for this article.

You’re reading a free preview. Subscribe to read the entire article.


DeepDyve is your
personal research library

It’s your single place to instantly
discover and read the research
that matters to you.

Enjoy affordable access to
over 12 million articles from more than
10,000 peer-reviewed journals.

All for just $49/month

Explore the DeepDyve Library

Unlimited reading

Read as many articles as you need. Full articles with original layout, charts and figures. Read online, from anywhere.

Stay up to date

Keep up with your field with Personalized Recommendations and Follow Journals to get automatic updates.

Organize your research

It’s easy to organize your research with our built-in tools.

Your journals are on DeepDyve

Read from thousands of the leading scholarly journals from SpringerNature, Elsevier, Wiley-Blackwell, Oxford University Press and more.

All the latest content is available, no embargo periods.

See the journals in your area

Monthly Plan

  • Read unlimited articles
  • Personalized recommendations
  • No expiration
  • Print 20 pages per month
  • 20% off on PDF purchases
  • Organize your research
  • Get updates on your journals and topic searches

$49/month

Start Free Trial

14-day Free Trial

Best Deal — 39% off

Annual Plan

  • All the features of the Professional Plan, but for 39% off!
  • Billed annually
  • No expiration
  • For the normal price of 10 articles elsewhere, you get one full year of unlimited access to articles.

$588

$360/year

billed annually
Start Free Trial

14-day Free Trial