Comparing Repeated (Annual) Couples HIV Testing and Counseling to Individual HIV Testing and Counseling Among Male Couples at High Risk of HIV Infection: Protocol for a Randomized Control Trial.

BACKGROUND: Couples HIV testing and counseling (CHTC) is now a standard of care prevention strategy recommended by the Centers for Disease Control and Prevention for sexual minority men (SMM) in relationships. Despite standard recommendations that couples complete CHTC every 6-12 months, no study has empirically evaluated the effects associated with CHTC retesting. OBJECTIVE: This study aims to understand the benefits associated with continued dyadic engagement in the HIV prevention continuum through routine CHTC retesting, which is of particular importance for emerging-adult SMM in relationships who use drugs. METHODS: Eligible couples for this CHTC retesting trial must already be enrolled in the 4Us trial, where they completed a CHTC session after their baseline survey. The purpose of the original 4Us trial was to test the efficacy of 2 intervention components for CHTC: a communication skills training video and a substance use module. Couples were eligible for the original 4Us trial if they identified as cisgender male, were in a relationship for 3 months or longer, were aged 17 years or older, and communicated in English. At least 1 partner had to be aged 17-29 years, report HIV negative or unknown serostatus, report use of at least 1 drug (cannabis, cocaine or crack, crystal methamphetamine, ketamine, gamma-hydroxybuterate [GHB], psychedelics, ecstasy, prescription medication misuse, opiates, and nitrates) use, and engage in condomless anal sex (CAS) acts with a casual partner or have a main partner who is nonmonogamous or serodiscordant. Those who complete the 4Us 12-month follow-up and remain in a relationship with the partner they participated in 4Us with are offered the opportunity to participate in this CHTC retesting trial. Those consenting are randomized to either CHTC retesting or individual HIV testing. Follow-up assessments are conducted 3 and 6 months after randomization to evaluate the effects of repeat CHTC on 2 primary outcomes: (1) CAS with a casual partner in the absence of preexposure prophylaxis (PrEP), and (2) CAS with a serodiscordant main partner who is not virally suppressed or concurrent CAS between main and casual partners in the absence of PrEP. RESULTS: The CHTC retesting trial launched in January 2023, and enrollment is ongoing. As of February 2024, the study had enrolled 106 eligible participants (n=53 couples). CONCLUSIONS: Findings from this CHTC retesting study will contribute to knowledge about the benefits associated with regular (repeated) CHTC testing versus routine individual HIV testing for SMM in relationships. The results of this trial will inform CHTC retesting guidance. TRIAL REGISTRATION: ClinicalTrials.gov NCT05833074; htps://www.clinicaltrials.gov/study/NCT05833074. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/53023.

Pilot Randomized Controlled Trial of Motivational Interviewing with Sexual Minority Male Couples to Reduce Drug Use and Sexual Risk: The Couples Health Project.

A randomized controlled trial evaluated the preliminary efficacy of a dyadically-delivered motivational interviewing (MI) intervention to reduce drug use and sexual risk in a sample of 50 sexual minority (cis)male (SMM) couples. In each couple, at least one partner was aged 18-29; reported drug use and sexual HIV transmission risk; and was HIV-negative. Couples were randomized to either the three-session MI intervention or an attention-matched control, with follow-up surveys completed at 3- and 6-months post-baseline. Between-group differences for all outcomes were non-significant in the overall sample. Subsequent moderation analyses indicated the intervention significantly reduced illicit drug use (excluding marijuana) at 3-month follow-up when either respondents (B = - 1.96; interval rate ratio-IRR 0.02-1.22; p = .001), their partners (B = - 2.60; IRR 0.01-0.64; p = .004), or both (B = - 2.38; IRR 0.01-0.80; p = .001) reported high levels of baseline use. The intervention also reduced condomless anal sex (CAS) with casual partners when both partners reported high frequency baseline CAS (B = - 2.54; IRR 0.01-0.83; p = .047). Findings provide initial evidence of the potential for MI to address drug use and sexual risk-taking among SMM couples at highest risk.Trial Registration ClinicalTrials.gov (NIH U.S. National Library of Medicine) Identifier: #NCT03386110.

A full-factorial randomized controlled trial of adjunct couples HIV testing and counseling components addressing drug use and communication skills among sexual minority male couples.

BACKGROUND: The past decade has seen increasing attention directed to the development of HIV prevention interventions for male couples, driven by epidemiological data indicating that main or primary - rather than causal - partnerships account for a substantial number of HIV infections in this population. Couples HIV testing and counseling (CHTC) has emerged as a standard of care in the US. This protocol describes a study that aims to evaluate the efficacy of two adjunct components to CHTC - communication training (CT) videos and a substance use module (SUM) - to reduce drug use and sexual HIV transmission risk behavior. METHODS: Eligible couples must include one participant who is aged 17-29, HIV-negative, and reports recent drug use. Both partners must be aged 17 or older, identify as cismale (assigned male sex at birth and currently identify as male gender), and communicate in English. Couples are randomized post-baseline to one of four conditions (CHTC as usual, CHTC plus CT video; CHTC + SUM and CHTC + CT video + SUM) in a full-factorial design. Follow up assessments are completed at 3-, 6-, 9- and 12-months post baseline. DISCUSSION: Results of this trial will enhance the application of CHTC. If found effective, adjunct components would comprise a brief and scalable drug use intervention that could be readily integrated into existing HIV testing settings. TRIAL REGISTRATION: ClinicalTrials.gov Protocol Registration; NCT05000866 ; completed August 3, 2021; https://register.clinicaltrials.gov/ Protocol version 1.0; September 1, 2021.

Day-level associations between drug use and sexual behavior in male couples: Actor partner interdependence modeling of timeline follow-back data.

BACKGROUND: Both marijuana and other illicit drugs (e.g., cocaine/crack, methamphetamines, ecstasy, gamma-hydroxybuterate, and ketamine) have been linked to the occurrence of condomless anal sex (CAS) with casual partners among sexual minority men (SMM) and these associations largely generalize to partnered SMM. Software advances now permit testing the day-level correspondence between participants' sexual behavior and their own drug use (actor effects) as well as their partners' (partner-effects). METHODS: Participants comprised 50 couples (100 individuals) recruited in the New York City metro area. All were 18 or older and identified as cis male. In each couple, at least one partner was 18-29 years old, HIV-negative, reported recent (past 30 day) drug use and recent (past 30 day) CAS with a casual partner or CAS with a non-monogamous or sero-discordant main partner at screening. RESULTS: Marijuana was associated with CAS between main partners on days both partners reported its use. A similar pattern was observed for other illicit drugs. Respondents were more likely to report CAS with casual partners on days CAS between main partners occurred. Both marijuana and other illicit drugs were associated with increased likelihood of CAS with casual partners on days a main partner did not use drugs. These associations were attenuated on days where partners reported the use of different drugs. CONCLUSIONS: The co-occurrence of CAS with main and casual partners maximizes shared sexual risk. Results support the continued emphasis on dyadic HIV prevention interventions and the development of theoretically-based interventions that may address drug use by both partners in the relationship.

Testing the drug use and condomless anal sex link among sexual minority men: The predictive utility of marijuana and interactions with relationship status.

BACKGROUND: The association between drug use and condomless anal sex (CAS) is well documented among sexual minority men (SMM). Less is known about whether this association generalizes to marijuana and across relationship status and sexual agreements groups (single, partnered monogamous, partnered open -outside partners permitted, and partnered monogamish -outside partners permitted when main partners are together). METHODS: A nationwide sample of SMM (N = 65,707) were recruited through a geosocial networking app between November 2017 and November 2019. Participants reported on drug use and instances of CAS with casual partners in the previous 30 days. RESULTS: Both marijuana and club drug use were associated with the occurrence of CAS with casual partners among single men. Only club drug use was associated with CAS frequency in this group. The association between marijuana and the occurrence of CAS did not differ significantly among monogamous men, while the associations between club drug use and the occurrence as well as frequency of CAS were significantly weaker. Meanwhile, the associations between club drug use and the occurrence as well as frequency of CAS did not differ significantly between single and non-monogamous (open and monogamish) subgroups; however, the association between marijuana and the occurrence of CAS was significantly weaker. CONCLUSIONS: Findings largely replicated the robust association between club drug use and CAS with casual partners. They support the assertion that marijuana use predicts sexual risk for some SMM subgroups. Finally, they illustrate the potential for relationship status - and sexual agreements - to contextualize associations between drug use and CAS.