Abstract The aim of this study is to determine, among young Black men who have sex with men (YBMSM), the 12-month efficacy of a single-session, clinic-based intervention promoting condom use to enhance sexual pleasure (purpose 1) and the use of condoms from the start-to-finish of anal sex (purpose 2). A pre-test, post-test randomized controlled trial was conducted, using a 12-month period of follow-up observation, in STI clinics. Data from 394 YBMSM completing baseline and 12-month follow-up assessments were analyzed. The experimental condition comprised a one-to-one, interactive program (Focus on the Future) designed for tailored delivery. Regarding study purpose 1, in an age-adjusted linear regression model for 277 HIV-uninfected men, there was a significant effect of the intervention (Beta=0.13, P =0.036) relative to more favorable sexual experiences when using condoms. Regarding study purpose 2, in an adjusted logistic regression model, for HIV-uninfected men, there was a significant effect of the intervention (AOR=0.54, P =0.048) relative to using condoms from start-to-finish of anal sex. Significant effects for HIV-infected men were not observed. A small, but non-significant, effect was observed relative to men’s self-report of always using condoms. This single-session program may be a valuable counseling tool for use in conjunction with pre-exposure prophylaxis-related care for HIV-uninfected YBMSM. Introduction Young Black men who have sex with men (YBMSM) have experienced a far more rapid escalation of the HIV/AIDS epidemic than MSM who identify as White or Latino or any other sub-population in the U.S. [1–4]. YBMSM have a one-in-four chance of becoming infected with HIV by the time they reach 25 years of age  and a one-in-two chance of becoming infected in their lifetime . Fortunately, the advent of pre-exposure prophylaxis (PrEP) holds great promise for reducing this disparity in HIV incidence among YBMSM. An often overlooked aspect of PrEP, however, is that guidelines from the United States Centers for Disease Control and Prevention (CDC) clearly recommend that persons receiving PrEP also receive ongoing counseling to promote the use of condoms . Despite this important opportunity, single-session, clinic-based counseling programs designed to promote condom use among YBMSM have not been tested. Largely disappointing findings from behavioral intervention studies of MSM (of multi-session interventions) [8–13] suggest that using only a single-session intervention may be inadequate to promote condom use among YBMSM over significant periods of time. Acknowledging this reality, a more realistic goal of brief interventions may be fostering positive condom use experiences among high-risk populations such as YBMSM. In turn, these positive experiences may favorably alter condom use norms and practices over time among program recipients and, possible, their peers who may learn from them. The purpose of this study was to test the efficacy of a single-session, clinic-based, behavioral intervention designed specifically to promote positive experiences with condom use among YBMSM residing in the southern U.S. This sex-positive intervention program was predicated on a CDC-classified Evidence-Based Intervention (EBI) known as Focus on the Future (FoF) [14–16]. This EBI was adapted for YBMSM using the ADAPT-ITT framework . Hypothesized outcomes 12 months after the single-session program included men’s reports that condom use added to sexual pleasure (purpose 1) and that condoms were used from the start to the finish of anal sex (purpose 2). As these occurrences would be expected to culminate in the consistent use of condoms, men’s self-report of always using condoms was additionally assessed as part of this second purpose. Finally, because it is vital to investigate these questions with both HIV-uninfected and HIV-infected YBMSM, sub-set analyses were conducted. Materials and methods Study sample This is a secondary analysis of data collected for a Phase III randomized controlled trial of a single-session, clinic-based condom use promotion program for YBMSM. Baseline data and data from the 12-month follow-up assessment were used for this study. A consecutive sample of 600 YBMSM was recruited from 2 sexually transmitted disease clinics located in Jackson, MS. One clinic was federally designated and the other was supported by the University of Mississippi Medical School. Both clinics received federal support for HIV/STD services, thus serving as ‘safety net’ clinics for persons without the options of seeing a private provider for suspected acquisition of HIV or other STIs. Inclusion criteria were (1) assigned male at birth; (2) self-identification as Black/African American; (3) 15–29 years of age; (4) attending the clinic to be tested for HIV or other STIs, (5) having engaged in anal sex with a male partner at least once in the past 6 months and (6) the ability to speak and comprehend English. All age-eligible Black men were approached in the clinic waiting area and asked about their interest in volunteering for an HIV prevention study. Also, the opportunity to enroll in this study was promoted through announcements (via social media and print material posted in and near the clinics) directed specifically to patients of these clinics. In addition, project recruiters attended bars and nightclubs to make YBMSM aware of the study and encouraged these men to be tested for HIV/STIs at the either clinic and consider study enrollment at that time. Recruiters also ‘fielded’ inquiries made via social media from potential participants and used these as opportunities to encourage YBMSM to attend the clinic and possibly enroll in the study. Men expressing interest in study enrollment were screened for eligibility. A total of 881 were screened; of these, 621 were eligible. After being offered the opportunity to enroll, 21 declined, yielding an overall participation rate of 96.6%. Of the 600 enrolled, 394 completed the 12-month follow-up assessment (yielding a retention rate of 66%). All study procedures were approved by the Institutional Review Boards of the University of Mississippi Medical Center, the Mississippi State Department of Health and the University of Kentucky. A Data Safety and Monitoring Board was appointed according to NIH guidelines and held annual in-person meetings to review study progress and discuss any issues that had occurred. Before study enrollment began, the trial was registered (clinical.trials.gov #NCT01439503) Study procedures After providing written informed consent (or gaining parental consent for those under 18 years of age) participants completed an online questionnaire using Qualtrics (Provo, UT) in a private office not physically connected to the clinic. The self-administered questionnaire had an optional audio component in the event that men experienced literacy issues. The questionnaire collected information relative to sociodemographic characteristics, sexual risk and protective behaviors and a broad range of potential analytic covariates. Upon completing the online questionnaire, men were randomized to either the experimental or a standard-of-care control condition. Randomization was achieved by using a computer-generated algorithm. Two hundred ninety-nine men were assigned to the experimental condition and 301 were assigned to the control condition. Next, men who did not know their HIV-infection status were tested for HIV by using Clearview Complete HIV 1/2 (Alere) or by standard HIV test processed at the Mississippi State Department of Health Public Health Laboratory in blood specimens. Before ending the enrollment session, the project director interviewed each participant to gain his preferences for our planned contacts with him between quarterly follow-up visits occurring over the ensuing 12 months. These retention efforts included the use of private messaging on social media platforms, text messaging, phone-call reminders and e-mail reminders. Finally, men were compensated for their time in the amount of $50 and those randomized to the experimental condition were introduced to the project health educator. Retention efforts occurred in a manualized manner over the next 12 months. Experimental condition The experimental condition comprised a single-session, one-to-one, interactive program (FoF) designed for tailored delivery in a private, clinic-based, office space housing a computer with a 27-in. monitor (used for audio–visual teaching aids). The adopted FoF counseling program contained seven objectives that the health educator used as the basis for the tailored session. Tailoring is a technique that has been previously applied to HIV prevention programs [18–20] and involves content options for the educator to select from that will best meet the client’s prevention needs. In addition to tailoring, the adapted FoF program was designed with a ‘branching pattern’ to accommodate the needs of HIV-infected YBMSM. The basis of this program involves building rapport and trust with the client over his future goals and aspirations. That rapport/trust is then used to help personalize the education as a means to achieving freedom to pursue life goals in the absence of HIV acquisition risk (or transmission risk for those living with HIV). Clients also learn that HIV protective behaviors are a vital part of a ‘community response’ to the disproportionate burden of HIV experienced by YBMSM in the south. Men then learn skills need to enact consistent and correct condom use as part of satisfying and pleasurable sex with other men. As part of FoF, men were provided with a guided tour of a ‘condom and lube buffet.’ This buffet was extensive and occupied 60 ft2 of office space. It included a wide array of condom types, brands and sizes. The educator used this buffet as a ‘stand up’ teaching opportunity by having men physically move from bin-to-bin to examine condoms and open up any package that interested them. Men were encouraged to take a variety of condoms and lubricants in service of finding the ‘optimal fit and feel for you and your partner.’ This stand up segment of the program was structured to be a highly interactive learning experience. Men were told they may fill (and keep) a canvas ditty bag with as many condoms and lubricant vials as they choose (designed to hold about 30 selections of condoms/lubricants). Standard-of-care control condition All men receiving the intervention condition also received full standard-of-care as per established clinic protocols. Men randomized to the control condition received only this routine standard-of-care. Clinical standard of care included assessment for Chlamydia and gonorrhea, as well as assessments for syphilis and, for those who were not known to be HIV-infected, a serology-based screening test for HIV (also previously described). During the testing process all men were interviewed by the attending clinician relative to their sexual risk and protective behaviors. Although free condoms were provided within the clinic as part of this standard of care, men randomized to the control condition received an enhanced version of this service during the time spent with the study project director. Men were provided with access to the same condom and lube buffet that was offered to men randomized to the intervention condition; however, their access was not used as a teaching opportunity and thus it was not interactive. They did receive the same size canvas ditty bag and were encouraged to fill it with as many condoms and lubricants as possible. The rationale for including this feature in the control condition is that the efficacy trial was designed to test the value of the education session, rather than the value of providing ample access to high quality condoms and lubricants. By making this access universal for men in both study conditions, the only difference between the conditions was the education session. Outcome measures For the first purpose of the study (whether the intervention promoted enhanced sexual pleasure when using condoms), a 5-item scale was developed and administered at baseline and at the 12-month follow-up assessment. Items were (1) Condoms help me enjoy sex, (2) Condoms help me let go of my fears, (3) Condoms help me feel better about sex after it ends, (4) Condoms help me have better sex and (5) Condoms help me intensify orgasm. Response options were provided on a 5-point Likert scale ranging from (1) “strongly disagree” to (5) ‘strongly disagree.’ Inter-item reliability was excellent (Cronbach’s alpha = 0.84). For the second purpose of the study (whether the intervention promoted condom use from start to finish of anal sex), two items were administered at the 12-month assessment. Items were posed as ‘yes’ versus ‘no’: (1) Did you start having anal sex and then put the condom on later? and (2) Did you take the condom off before you had your nut? A dichotomous variable was formed to reflect reporting one or both of these issues versus reporting neither one. Finally, men responded to a single item asking if they had always used condoms in the past 3 months. Data analysis All analyses pertained to the analytic sample of 394 men. For the model pertaining to the first study purpose, differences scores between baseline and the 12-month assessment were calculated. An independent groups t test was then used to compare the means by study condition, stratified by HIV status. Next, a direct entry linear regression model was fitted for the difference scores. For the model pertaining to the second study purpose, logistic regression was used to determine intervention efficacy. Finally, both regression models were tested separately for HIV-infected men and HIV-uninfected men (using HIV infection status as assessed at baseline). SPSS (version 22.0) was used to analyze the data. Significance was defined by an alpha of 0.05. For the first model (i.e. the 5-item scale), because the outcome was a perception rather than a behavior, only men’s age was used as a logically plausible covariate. For the second model (i.e. the 2-item measure of complete condom use), because the outcome was behavioral, seven covariates were selected based on their plausible association with the outcome measure. These were: (1) age, (2) whether men were diagnosed with an STI at study enrollment, (3) whether men were employed, (4) highest level of education achieved, (5) monthly income, (6) whether men had male side partners in the 3 months preceding the 12-month assessment and (7) whether men were versatile (had both receptive and insertive anal sex). Results Description of the sample Mean age of the sample was 22.5 years (standard deviation = 3.2 years). Table I displays the remaining descriptive statistics for the retained sample of 394 YBMSM. An important entry in this table is men’s HIV infection status at study enrollment. As shown, 28.2% (n = 111) were HIV-infected. Table I. Baseline demographic characteristics of the retained sample Characteristic % Enrolled in school/college 47.5 Employed 58.4 Depend on sex partners for transportation, etc. 15.5 Missed meals due to a lack of money (past 12 months) 23.9 In a relationship with a ‘main’ male sex partner 57.0 Recent penile–vaginal sex (past 90 days) with a female 17.4 HIV-infected at baseline 28.2 Assigned to intervention condition 50.2 Characteristic % Enrolled in school/college 47.5 Employed 58.4 Depend on sex partners for transportation, etc. 15.5 Missed meals due to a lack of money (past 12 months) 23.9 In a relationship with a ‘main’ male sex partner 57.0 Recent penile–vaginal sex (past 90 days) with a female 17.4 HIV-infected at baseline 28.2 Assigned to intervention condition 50.2 Table I. Baseline demographic characteristics of the retained sample Characteristic % Enrolled in school/college 47.5 Employed 58.4 Depend on sex partners for transportation, etc. 15.5 Missed meals due to a lack of money (past 12 months) 23.9 In a relationship with a ‘main’ male sex partner 57.0 Recent penile–vaginal sex (past 90 days) with a female 17.4 HIV-infected at baseline 28.2 Assigned to intervention condition 50.2 Characteristic % Enrolled in school/college 47.5 Employed 58.4 Depend on sex partners for transportation, etc. 15.5 Missed meals due to a lack of money (past 12 months) 23.9 In a relationship with a ‘main’ male sex partner 57.0 Recent penile–vaginal sex (past 90 days) with a female 17.4 HIV-infected at baseline 28.2 Assigned to intervention condition 50.2 Findings: study purpose 1 (does condom use add to sexual pleasure) The baseline scale yielded a mean of 18.0 (SD = 5.1) and the same measure at the 12-month assessment yielded a mean of 18.5 (SD = 5.6). The mean of the difference score (12-month minus baseline) was 0.56 (SD = 6.4). The overall mean difference score was greater (more favorable) for men randomized to the intervention condition (1.37) compared to those in the control condition (−0.28). This difference was significant (t = 2.57, df = 386, P = 0.01). The intervention effect, however, only applied to HIV-uninfected men (mean difference of intervention condition = 1.16 versus −0.51 in the control condition; t = 2.15, df = 276, P = 0.03). For HIV-infected men the mean difference scores did not vary by condition (mean difference of intervention condition = 1.83 versus 0.40 in the control condition; t = 1.27, df = 108, P = 0.21). In the age-adjusted linear regression model for 277 HIV-uninfected men, there was a significant effect of the intervention (Beta = 0.13, P = 0.036) on sexual pleasure when using condoms. Age had a non-significant Beta of 0.04 (P = 0.48). In the age-adjusted linear regression model for 109 HIV-infected men, there was not a significant effect of the intervention (Beta = 0.12, P = 0.22). Age had a non-significant Beta of 0.02 (P = 0.81). Findings: study purpose 2 Eighty-two (20.8%) of the 394 men were classified as not always using condoms from the start-to-finish of anal sex. Table II displays the adjusted odds ratios and their 95% confidence intervals relative to the intervention effects for men, stratified by HIV status. As shown, men randomized to the intervention condition were significantly less likely (by about 46%) to report not using condoms from start-to-finish of anal sex. Table II. Logistic regression findings for the two-item measure of using condoms from start to finish of anal sex Variable HIV-uninfected (n = 255) HIV-infected (n = 99) AOR 95% CI P AOR 95% CI P Assigned to intervention 0.54 0.29–0.99 0.048 64 23–1.76 0.37 Age 1.05 0.94–1.17 0.42 1.09 0.91–1.32 0.33 STI diagnosed at enrollment 0.83 0.29–2.31 0.72 1.30 0.29–5.85 0.73 Employed 0.79 0.40–1.55 0.49 2.53 0.75–8.45 0.13 Highest level of education 0.90 0.61–1.33 0.60 0.85 0.46–1.158 0.62 Had side male sex partners 1.90 0.92-3.93 . 0.08 0.91 0.62-1.34 0.63 Versatile (top and bottom) 0.58 0.28–1.23 0.16 2.52 0.81–7.84 0.11 Variable HIV-uninfected (n = 255) HIV-infected (n = 99) AOR 95% CI P AOR 95% CI P Assigned to intervention 0.54 0.29–0.99 0.048 64 23–1.76 0.37 Age 1.05 0.94–1.17 0.42 1.09 0.91–1.32 0.33 STI diagnosed at enrollment 0.83 0.29–2.31 0.72 1.30 0.29–5.85 0.73 Employed 0.79 0.40–1.55 0.49 2.53 0.75–8.45 0.13 Highest level of education 0.90 0.61–1.33 0.60 0.85 0.46–1.158 0.62 Had side male sex partners 1.90 0.92-3.93 . 0.08 0.91 0.62-1.34 0.63 Versatile (top and bottom) 0.58 0.28–1.23 0.16 2.52 0.81–7.84 0.11 Table II. Logistic regression findings for the two-item measure of using condoms from start to finish of anal sex Variable HIV-uninfected (n = 255) HIV-infected (n = 99) AOR 95% CI P AOR 95% CI P Assigned to intervention 0.54 0.29–0.99 0.048 64 23–1.76 0.37 Age 1.05 0.94–1.17 0.42 1.09 0.91–1.32 0.33 STI diagnosed at enrollment 0.83 0.29–2.31 0.72 1.30 0.29–5.85 0.73 Employed 0.79 0.40–1.55 0.49 2.53 0.75–8.45 0.13 Highest level of education 0.90 0.61–1.33 0.60 0.85 0.46–1.158 0.62 Had side male sex partners 1.90 0.92-3.93 . 0.08 0.91 0.62-1.34 0.63 Versatile (top and bottom) 0.58 0.28–1.23 0.16 2.52 0.81–7.84 0.11 Variable HIV-uninfected (n = 255) HIV-infected (n = 99) AOR 95% CI P AOR 95% CI P Assigned to intervention 0.54 0.29–0.99 0.048 64 23–1.76 0.37 Age 1.05 0.94–1.17 0.42 1.09 0.91–1.32 0.33 STI diagnosed at enrollment 0.83 0.29–2.31 0.72 1.30 0.29–5.85 0.73 Employed 0.79 0.40–1.55 0.49 2.53 0.75–8.45 0.13 Highest level of education 0.90 0.61–1.33 0.60 0.85 0.46–1.158 0.62 Had side male sex partners 1.90 0.92-3.93 . 0.08 0.91 0.62-1.34 0.63 Versatile (top and bottom) 0.58 0.28–1.23 0.16 2.52 0.81–7.84 0.11 For the analysis of a possible intervention effect on men always using condoms, 47.5% of men in control condition reported always using condoms (in the 3 months preceding the 12-month assessment) and 51.5% of the men randomized to the intervention condition reported always using condoms. This difference was not significant (P = 0.42). Further, although favoring the intervention condition for HIV-uninfected men, the differences were also not significant when the analysis was stratified by HIV status. Among HIV-uninfected men in the control condition 46.0% always used condoms versus 52.5% in the intervention condition (P = 0.59). Among HIV-infected men in the control condition 49.5% always used condoms versus 47.4% in the intervention condition (P = 0.50). Finally, because condom use with main partners versus ‘side’ partners are very different behaviors, whether having side anal sex partners in the past 3 months moderated the intervention effect on always using condoms was tested. Among 96 men indicated recent sex with side partners, 45 were in the control condition and 51 were assigned to the intervention condition. Although not significant (P = 0.25) a modest effect size was observed that favored the intervention condition. Just over one-third (35.6%) of men in the control condition always used condoms, compared to nearly one-half (47.1%) of those in the intervention condition. This represents a risk ratio of 0.76, indicating a modest level of protection conferred by the intervention even 1 year after men received the 1-h session. Discussion In the era of PrEP, this is the first efficacy trial to demonstrate that a 1-h, clinic-based session can promote changes that favor overall more positive experiences using condoms 12 months after receiving this counseling. Even more importantly, this demonstration of efficacy occurred among YBMSM residing in a southern U.S. city experiencing extremely high rates of HIV incidence thereby suggesting the utility of this approach to HIV prevention in prioritized populations. That intervention effects were found for the HIV-uninfected men further support the potential value of this single-session intervention as a counseling program for YBMSM considering or being prescribed PrEP. The enduring intervention effects observed in this study suggest that a 1-h session can create positive changes in how YBMSM experience condom use for anal sex thereby pre-disposing them to ongoing use regardless of whether they use PrEP. A primary tenet of social cognitive theory provides an explanatory framework for the supposition that the observed effects may represent long-term behavior change. That tenet is the construct of response–efficacy. Response efficacy is the learned belief that effort expended will produce desirable results. The intent of the intervention was to create conditions for men that allowed their subsequent use of condoms to be sexually satisfying. The program emphasized the concept of having ‘better sex with latex’ and provided men with various skills (including the selection of best-fitting condoms and best-feeling lubricants) needed to achieve this goal. In a high HIV-incidence city such as Jackson, MS, these positive condom use experiences may have helped men to find that condom-protected sex can be highly pleasurable given that worry and fear of HIV acquisition may be dismissed during anal sex. This may also explain why the intervention effect was only observed for those men who HIV-uninfected. The intervention program also emphasized teaching men to apply condoms (to themselves or their top partner) after erection but before they become so aroused that they would easily forget that ‘dipping’ (the practice of starting sex without a condom and then putting one on before ejaculation) is a risky practice. The program also taught men about pre-ejaculate and about the risk of trying to anticipate ejaculation and using that as a guide for a time to apply condoms. The concept of risk was cast in the form of ‘odds’ with visuals showing men their elevated odds of HIV/STI acquisition (or just STI acquisition for HIV-infected men) based on their city of residence and the overwhelming disparities in HIV acquisition for YBMSM. That an intervention effect relative to using condoms from start-to-finish of anal sex was observed 12 months after the single session is a finding not previously reported in the HIV prevention literature; however, similar effects lasting for 6 months have been reported for young Black men having sex with females . Overall, the findings suggest that a single-session counseling program could be effectively delivered as part of clinical care offered to YBMSM receiving sexual health services. Given the great potential of PrEP to greatly reduce HIV incidence among YBMSM [22–27], a clear need now exists to promote condom use as STI-preventive measure that complements PrEP use [28–30]. That a single-session, clinic-based intervention can promote positive condom use experiences among HIV-uninfected YBMSM is an encouraging ‘first step’ in the development of other single-session counseling programs that can be delivered as an accompanying service to YBMSM taking PrEP. Without question, the multiple and interlocking influences that determine condom use behaviors of YBMSM cannot easily be altered. These include whether sex occurs in the context of a relationship, and if so the nature of the relationship and the power dynamics at play. These also include affective states at the time of sex, being intoxicated/high, the availability of condoms, and various aspects of the immediate sociosexual environment that may influence condom use. Thus, the use of a single-session counseling program in conjunction with the recommended 3-month interval testing/counseling visits of men taking PrEP is a potentially wise clinical practice. Limitations Findings are limited by several issues. First, the loss of one-third of the sample creates a potential for attrition bias and results in a loss of statistical power stemming from a reduced sample size. Second, the potential for demand effects (i.e. the tendency of people assigned to the intervention condition to provide answers to interview questions that are thought to ‘please’ the investigator) is always an issue when using self-reported outcome measures in tests of behavioral interventions. Third, other forms of positive condom use experiences were not assessed and thus the potential for other related-findings (significant and non-significant) remains. Fourth, it is possible that the simple distribution of specialty condoms (otherwise typically unaffordable for many YBMSM enrolled in the study) and lubricants may have been a strong intervention in its own right, thereby creating change among men randomized to the control condition and diminishing the effect sizes obtained relative to reports of always using condoms. Whether this loss of no-cost access after the study ended led to decay of the observed behaviors changes is a concern. Fifth, the sample size of 394 men limited statistical power when analyses were based on sub-groups (i.e. HIV-infected versus HIV-uninfected men, men with and without side partners). Sixth, the outcome measure assessing sexual pleasure experienced during condom use has not been previously validated. Finally, given the intent of the adapted FoF program to complement PrEP-associated counseling efforts, basing the trial on a convenience sample of YBMSM attending sexual health clinics is a strength of the study as opposed to a limitation. Indeed, testing this program in the context of its intended practice setting (i.e. sexually transmitted disease clinics) adds to the external validity of the findings. Conclusion This analysis of data from a Phase III RCT suggests that effects of a single-session, clinic-based behavioral intervention include enhanced positive experiences using condoms for anal sex among HIV-uninfected YBMSM. This evidence lays an initial foundation for guiding clinical efforts to promote the dual use of PrEP and condoms to produce an ultimately greater protective bio-behavioral response to the threat of HIV and STI acquisition among YBMSM residing in the southern U.S. Because it can be integrated with clinical care routines, the single-session program known as FoF may be a valuable counseling program for use in conjunction with the initial administration of PrEP to YBMSM and during recommended 3-month follow-up visits for YBMSM taking PrEP. Funding This study was funded by a grant from the National Institute of Mental Health to the first author, R01MH092226. Conflict of interest statement None declared. References 1 National HIV/AIDS Strategy for the United States: Updated to 2020. Office of National AIDS Policy 2015 : 1 – 65 . 2 Centers of Disease Control and Prevention . DHAP annual report 2011: Accelerating progress, investing for impact. 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Health Education Research – Oxford University Press
Published: Mar 9, 2018
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