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A couple-based HIV prevention intervention for Latino men who have sex with men: study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Latino men who have sex with men (MSM) experienced a 13% increase in HIV diagnoses from 2010 to 2014, more than any other racial/ethnic subgroup of MSM in the United States. If current HIV diagnoses rates persist, about one in four Latino MSM in the United States will be diagnosed with HIV during their lifetime. Although some efficacious HIV prevention interventions for Latino MSM exist, none have focused on couples. This paper describes the protocol of a randomized controlled trial (RCT) to test the preliminary efficacy of a couple-based HIV prevention intervention that is culturally tailored for Latino men and their same-sex partners. METHODS:The RCT will determine the preliminary efficacy of Connecting Latinos en Pareja (CLP) to increase the proportion of anal sex acts that are HIV protected (i.e., anal sex acts in which condoms, pre-exposure prophylaxis (PrEP), treatment as prevention (TasP), or a combination thereof, are used to reduce risk of HIV transmission). CLP builds upon previous couple-based interventions with white and black MSM by incorporating biomedical prevention techniques, such as PrEP and TasP, implementing a framework responsive to the couple's serostatus, and addressing the socio-cultural factors that influence HIV risk among Latino MSM. We also include input from community stakeholders, members of the target population, and a community advisory board as part of intervention development. Assessments will be conducted at baseline, and 3- and 6-months post-intervention to examine the intervention effects on outcomes (HIV-protected sex acts), and factors potentially mediating or moderating intervention effects. DISCUSSION:This paper describes an innovative RCT that incorporates multiple HIV prevention techniques for Latino MSM in couples, regardless of serostatus. The ongoing involvement of community stakeholders, members of the target population, and a community advisory board is emphasized, and plans for widespread dissemination and application of findings into practice are discussed. TRIAL REGISTRATION:Trial registration: NCT03048838 . Registered on 3 February 2017.

SUBMITTER: Martinez O

PROVIDER: S-EPMC5887179 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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A couple-based HIV prevention intervention for Latino men who have sex with men: study protocol for a randomized controlled trial.

Martinez Omar O Isabel Fernandez M M Wu Elwin E Carballo-Diéguez Alex A Prado Guillermo G Davey Adam A Levine Ethan E Mattera Brian B Lopez Nikki N Valentin Omar O Murray Ashley A Sutton Madeline M

Trials 20180405 1

<h4>Background</h4>Latino men who have sex with men (MSM) experienced a 13% increase in HIV diagnoses from 2010 to 2014, more than any other racial/ethnic subgroup of MSM in the United States. If current HIV diagnoses rates persist, about one in four Latino MSM in the United States will be diagnosed with HIV during their lifetime. Although some efficacious HIV prevention interventions for Latino MSM exist, none have focused on couples. This paper describes the protocol of a randomized controlled ...[more]

PMID: 29622045

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Project description:BACKGROUND:Men who have sex with men (MSM) continue to be the predominately impacted risk group in the United States HIV epidemic and are a priority group for risk reduction in national strategic goals for HIV prevention. Modeling studies have demonstrated that a comprehensive package of status-tailored HIV prevention and care interventions have the potential to substantially reduce new infections among MSM. However, uptake of basic prevention services, including HIV testing, sexually transmitted infection (STI) testing, condom distribution, condom-compatible lubricant distribution, and preexposure prophylaxis (PrEP), is suboptimal. Further, stronger public health strategies are needed to promote engagement in HIV care and viral load suppression among MSM living with HIV. Mobile health (mHealth) tools can help inform and encourage MSM regarding HIV prevention, care, and treatment, especially among men who lack access to conventional medical services. This protocol details the design and procedures of a randomized controlled trial (RCT) of a novel mHealth intervention that comprises a comprehensive HIV prevention app and brief, tailored text- and video-based messages that are systematically presented to participants based on the participants' HIV status and level of HIV acquisition risk. OBJECTIVE:The objective of the RCT was to test the efficacy of the Mobile Messaging for Men (M-Cubed, or M3) app among at least 1200 MSM in Atlanta, Detroit, and New York. The goal was to determine its ability to increase HIV testing (HIV-negative men), STI testing (all men), condom use for anal sex (all men), evaluation for PrEP eligibility, uptake of PrEP (higher risk HIV-negative men), engagement in HIV care (men living with HIV), and uptake of and adherence to antiretroviral medications (men living with HIV). A unique benefit of this approach is the HIV serostatus-inclusiveness of the intervention, which includes both HIV-negative and HIV-positive MSM. METHODS:MSM were recruited through online and venue-based approaches in Atlanta, Detroit, and New York City. Men who were eligible and consented were randomized to the intervention (immediate access to the M3 app for a period of three months) or to the waitlist-control (delayed access) group. Outcomes were evaluated immediately postintervention or control period, and again three and six months after the intervention period. Main outcomes will be reported as period prevalence ratios or hazards, depending on the outcome. Where appropriate, serostatus/risk-specific outcomes will be evaluated in relevant subgroups. Men randomized to the control condition were offered the opportunity to use (and evaluate) the M3 app for a three-month period after the final RCT outcome assessment. RESULTS:M3 enrollment began in January 2018 and concluded in November 2018. A total of 1229 MSM were enrolled. Data collection was completed in September 2019. CONCLUSIONS:This RCT of the M3 mobile app seeks to determine the effects of an HIV serostatus-inclusive intervention on the use of multiple HIV prevention and care-related outcomes among MSM. A strength of the design is that it incorporates a large sample and broad range of MSM with differing prevention needs in three cities with high prevalence of HIV among MSM. TRIAL REGISTRATION:ClinicalTrials.gov NCT03666247; https://clinicaltrials.gov/ct2/show/NCT03666247. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/16439.

Project description:BackgroundDigital HIV interventions (DHI) have been efficacious in reducing sexual risk behaviors among sexual minority populations, yet challenges in promoting and sustaining users' engagement in DHI persist. Understanding the correlates of DHI engagement and their impact on HIV-related outcomes remains a priority. This study used data from a DHI (myDEx) designed to promote HIV prevention behaviors among single young men who have sex with men (YMSM; ages 18-24 years) seeking partners online.ObjectiveThe goal of this study is to conduct a secondary analysis of the myDex project data to examine whether YMSM's online behaviors (eg, online partner-seeking behaviors and motivations) are linked to participants' engagement (ie, the number of log-ins and the number of sessions viewed).MethodsWe recruited 180 YMSM who were randomized into either myDEx arm or attention-control arm using a stratified 2:1 block randomization. In the myDEx arm, we had 120 YMSM who had access to the 6-session intervention content over a 3-month period. We used Poisson regressions to assess the association between YMSM's baseline characteristics on their DHI engagement. We then examined the association between the participants' engagement and their self-reported changes in HIV-related outcomes at the 3-month follow-up.ResultsThe mean number of log-ins was 5.44 (range 2-14), and the number of sessions viewed was 6.93 (range 0-22) across the 3-month trial period. In multivariable models, the number of log-ins was positively associated with high education attainment (estimated Poisson regression coefficient [β]=.22; P=.045). The number of sessions viewed was associated with several baseline characteristics, including the greater number of sessions viewed among non-Hispanic YMSM (β=.27; P=.002), higher education attainment (β=.22; P=.003), higher perceived usefulness of online dating for hookups (β=.13; P=.002) and perceived loneliness (β=.06; P=.004), as well as lower experienced online discrimination (β=-.01; P=.007) and limerence (β=-.02; P=.004). The number of sessions viewed was negatively associated with changes in internalized homophobia (β=-.06; P<.001) and with changes in perceived usefulness of online dating for hookups (β=-.20; P<.001). There were no significant associations between the number of log-ins and changes in the participants' behaviors at the 90-day follow-up.ConclusionsDHI engagement is linked to participants' sociodemographic and online behaviors. Given the importance of intervention engagement in the intervention's effectiveness, DHIs with personalized intervention components that consider the individuals' differences could increase the overall engagement and efficacy of DHIs.Trial registrationClinicalTrials.gov NCT02842060; https://clinicaltrials.gov/ct2/show/NCT02842060.

Project description:BackgroundYoung men who have sex with men (YMSM) and transgender people in the Detroit Metro Area are the only risk group for whom the incidence of HIV and sexually transmitted infections (STI) has increased since 2000, with HIV incidence nearly doubling among youth. Substance use (including alcohol), which is relatively frequent among YMSM and transgender people, creates barriers to the optimal delivery of HIV prevention and care services. Standard HIV counseling, testing, and referral (CTR) is limited in providing strategies to identify and address substance use. Hence, in its current form, CTR may not be serving the prevention needs of substance-using YMSM and transgender people. Brief counseling interventions, grounded in principles of motivational interviewing, may offer a mechanism to meet the HIV prevention and care needs of substance-using YMSM and transgender people.ObjectiveThis prospective, 4-arm, factorial randomized controlled trial aims to examine the efficacy of an motivational interviewing-based substance use brief intervention (SUBI) on participants' substance use and engagement in HIV prevention.MethodsThe research implements a prospective randomized controlled trial (Project Swerve) of 600 YMSM and transgender people recruited both online and in person. Eligibility criteria include participants who (1) are between the ages of 15 to 29 years, (2) live in the Detroit Metro Area, (3) self-identify as a man or transgender man or woman, (4) have had sexual contact with a man in the 6 months before enrollment, (5) self-report binge drinking or any substance use in the 3 months before enrollment, and (6) self-report an unknown or negative HIV status upon enrollment. Participants are randomized to receive, 3-months apart starting at baseline, 2 individual sessions. Sessions are CTR-only, SUBI-only, CTR followed by SUBI, or SUBI followed by CTR.ResultsProject Swerve was launched in April 2017 and enrollment is ongoing.ConclusionsIncorporating a SUBI that utilizes the principles of motivational interviewing into HIV CTR provides an opportunity to tailor counseling services for YMSM and transgender people to address additional client barriers to HIV and STI testing.Trial registrationClinicalTrials.gov NCT02945436; http://clinicaltrials.gov/ct2/show/NCT02945436 (Archived by WebCite at http://www.webcitation.org/6yFyOK57w).

Project description:BackgroundeHealth interventions based on risk stratification have not been extensively applied for HIV behavioral interventions among HIV-negative men who have sex with men (MSM).ObjectiveThis study aimed to evaluate the efficacy of a mobile phone intervention based on an HIV risk prediction tool in promoting HIV testing and reducing high-risk behavior among HIV-negative MSM in China.MethodsWe performed a mobile phone-based randomized controlled clinical trial for 12 weeks. A comprehensive intervention package deployed on Jinshuju-an online survey platform-was developed and consisted of 4 components: (1) a validated HIV risk prediction tool that provides information on personalized risk reduction interventions; (2) a map of individualized HIV testing facilities based on their geographic location; (3) a QR code for free resources on HIV prevention, including condoms and HIV self-testing kits; and (4) general resources for HIV health education. MSM participants recruited from WeChat/QQ groups were randomly assigned to the intervention or control group at a 1:1 ratio. The staff sent the QR code for the comprehensive intervention package to MSM in the intervention group over WeChat and sent the QR code only for the resources on HIV health education to those in the control group. At baseline and 12-week follow-up, data on HIV-related risk behavior and HIV testing behavior were collected through the Jinshuju online survey platform.ResultsIn total, 192 MSM were recruited and assigned to the intervention or control group (n=96 each). At week 12, the total clinical trial retention rate was 87.5%. The number of male sexual partners of the MSM in the past 3 months was significantly lower in the intervention group than in the control group (3.51, SD 4.1 vs 6.01, SD 11.4, respectively; mean difference -2.5; 95% CI -5.12 to 0.12; P=.05); the rate of condom use with casual sexual partners was higher in the intervention group than in the control group (87%, n=66/76 vs 70%, n=54/77 respectively; odds ratio 2.81, 95% CI 1.23-6.39; P=.01). The proportion of individuals intending to undergo HIV testing after in the following 30 days was marginally higher in the intervention group than in the control group (90%, n=77/86 vs 79%, n=65/82 respectively; odds ratio 2.20, 95% CI 0.90-5.35; P=.07). The incremental cost-effectiveness ratio of eHealth intervention was US $131.60 on reducing 1 sexual partner and US $19.70 for a 1% increment in condom usage with casual partners.ConclusionsA comprehensive intervention based on an HIV risk prediction tool can reduce the number of male sexual partners among MSM and increase the rate of condom use with casual partners. Hence, this intervention is a very promising preventive strategy for HIV among MSM, especially in areas with a prominent HIV epidemic.Trial registrationChinese Clinical Trial Registry ChiCTR1800017268; http://www.chictr.org.cn/showprojen.aspx?proj=29271.

Project description:BACKGROUND:Young sexual minority men in the United States have a high incidence rate of HIV infection. Early intervention among this group, that is timed to precede or coincide with sexual initiation, is of critical importance to prevent HIV infection. Despite this, there are very few published randomized controlled efficacy trials testing interventions to reduce sexual vulnerability for HIV acquisition among racially/ethnically diverse, very young, sexual minority men (aged ≤18 years). This paper describes the design of a mobile app-based intervention trial to reduce sexual risk for HIV acquisition and promote health protection in this group. METHODS:This study is a randomized controlled trial of an mHealth-based HIV prevention intervention, MyPEEPS Mobile, among diverse sexual minority cisgender young men, aged 13-18 years. The mobile intervention was adapted from a prior group-based intervention curriculum with evidence of efficacy, designed to be specific to the risk contexts and realities of young sexual minority men, and to include psychoeducational and skill-building components with interactive games and activities. Participants are recruited locally within four regional hubs (Birmingham, AL, Chicago, IL, New York City, NY, Seattle, WA) and nationwide via the Internet, enrolled in-person or remotely (via videoconference), and randomized (1:1) to either the MyPEEPS Mobile intervention or delayed intervention condition. Post-hoc stratification by age, race/ethnicity, and urban/suburban vs. rural statuses is used to ensure diversity in the sample. The primary outcomes are number of male anal sex partners and frequency of sexual acts with male partners (with and without condoms), sex under the influence of substances, and uptake of pre-and post-exposure prophylaxis, as well as testing for HIV and other sexually transmitted infections at 3-, 6- and 9-month follow-up. DISCUSSION:Behavioral interventions for very young sexual minority men are needed to prevent sexual risk early in their sexual development and maturation. This study will provide evidence to determine feasibility and efficacy of a mobile app-based HIV prevention intervention to reduce sexual risk among this very young group. TRIAL REGISTRATION:ClinicalTrials.gov number, NCT03167606, registered May 30, 2017.

Project description:BackgroundAs HIV infection continues unabated, there is a need for effective interventions targeting at-risk men who have sex with men (MSM). Engaging MSM online where they meet sexual partners is critical for HIV prevention efforts.MethodsA randomized controlled trial (RCT) conducted online among U.S. MSM recruited from several gay sexual networking websites assessed the impact of 2 HIV prevention videos and an HIV prevention webpage compared to a control condition for the study outcomes HIV testing, serostatus disclosure, and unprotected anal intercourse (UAI) at 60-day follow-up. Video conditions were pooled due to reduced power from low retention (53%, n = 1,631). No participant incentives were provided.Principal findingsFollow-up was completed by 1,631 (53%) of 3,092 eligible men. In the 60 days after the intervention, men in the pooled video condition were significantly more likely than men in the control to report full serostatus disclosure ('asked and told') with their last sexual partner (OR 1.32, 95% CI 1.01-1.74). Comparing baseline to follow-up, HIV-negative men in the pooled video (OR 0.70, 95% CI 0.54-0.91) and webpage condition (OR 0.43, 95% CI 0.25-0.72) significantly reduced UAI at follow-up. HIV-positive men in the pooled video condition significantly reduced UAI (OR 0.38, 95% CI 0.20-0.67) and serodiscordant UAI (OR 0.53, 95% CI 0.28-0.96) at follow-up.Conclusions/significanceFindings from this online RCT of MSM recruited from sexual networking websites suggest that a low cost, brief digital media intervention designed to engage critical thinking can increase HIV disclosure to sexual partners and decrease sexual risk. Effective, brief HIV prevention interventions featuring digital media that are made widely available may serve as a complementary part of an overall behavioral and biomedical strategy for reducing sexual risk by addressing the specific needs and circumstances of the target population, and by changing individual knowledge, motivations, and community norms.Trial registrationClinicalTrials.gov NCT00649701.

Project description:BACKGROUND:In the recent years, the Internet has been used as a medium to find sexual partners and engage in risky sexual behavior. This has changed the way in which men having have sex with men (MSM) seek sexual partners and has increased the number of high-risk sexual encounters. Therefore, developers of human immunodeficiency virus (HIV)-prevention interventions have also started using the Internet as a viable medium to promote safe sexual behaviors. However, much of the efforts thus far have been aimed at HIV-negative rather than HIV-positive MSM. HIV-positive individuals continue to engage in risky sexual behaviors and thus constitute an important group in which HIV prevention strategies need to be addressed. Therefore, HIV prevention in HIV-positive MSM is a critical issue. OBJECTIVE:Condom-Him, an Internet-based intervention tailored to increase condom use among HIV-positive MSM, was developed with the aim of improving condom use, self-efficacy, and intentions to use condoms among these individuals. The acceptability and feasibility of this Internet-based intervention will be examined in a pilot study. METHODS:We will perform a randomized controlled parallel-group superiority trial. HIV-positive MSM who currently engage in unprotected anal sex will be recruited for the study. Participants will be randomly assigned using a one-to-one allocation ratio generated by the computer program. The researchers will be blinded to participant's group assignment. Participants will be assigned either to use the Condom-Him intervention (experimental arm) or to view a list of websites containing HIV/AIDS related information (control arm). Self-administered questionnaires will be provided online before randomization (baseline) and two weeks after intervention (post-test). RESULTS:The study will include a total of 60 participants with 30 in each group. The results from this pilot study will provide further evidence for a larger study to examine the effectiveness of this intervention and will provide a cost-effective and widely accessible approach to HIV prevention for HIV-positive MSM. CONCLUSIONS:Internet-based interventions for HIV-positive MSM, a population that has been under-represented in the efforts for positive prevention of HIV within Canada, have the potential to provide a cost-effective strategy, which influences the way in which information is accessed and provided to high-risk individuals. The advantages of an Internet-based intervention include the potential to provide consistency in the delivery of an intervention and the ability to disseminate the intervention to a wider population. Internet-based interventions are perceived as vital tools in combating HIV infection within the realm of social media. Therefore, it is important to determine the feasibility and acceptability of these interventions before implementing them. TRIAL REGISTRATION:Clinicaltrials.gov: NCT01726153; http://clinicaltrials.gov/ct2/show/NCT01726153 (Archived by WebCite at http://www.webcitation.org/6Jljzip8B).

Dataset Information

A couple-based HIV prevention intervention for Latino men who have sex with men: study protocol for a randomized controlled trial.

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A couple-based HIV prevention intervention for Latino men who have sex with men: study protocol for a randomized controlled trial.

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