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

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

BackgroundCouples 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. ObjectiveThis 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. MethodsEligible 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. ResultsThe 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). ConclusionsFindings 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 RegistrationClinicalTrials.gov NCT05833074; htps://www.clinicaltrials.gov/study/NCT05833074 International Registered Report Identifier (IRRID)DERR1-10.2196/5302

Comparing Social Media and In-Person Recruitment: Lessons Learned From Recruiting Substance-Using, Sexual and Gender Minority Adolescents and Young Adults for a Randomized Control Trial

BackgroundRecruiting large samples of diverse sexual and gender minority adolescent and young adults (AYAs) into HIV intervention research is critical to the development and later dissemination of interventions that address the risk factors for HIV transmission among substance-using, sexual and gender minority AYAs. ObjectiveThis paper aimed to describe the characteristics of the samples recruited via social media and in-person methods and makes recommendations for strategies to recruit substance-using, sexual and gender minority AYAs, a hardly reached population that is a priority for HIV prevention research. MethodsUsing data from a randomized control trial of an HIV and substance use intervention with sexual and gender minority AYAs, aged 15 to 29 years in southeastern Michigan (n=414), we examined demographic and behavioral characteristics associated with successful recruitment from a range of virtual and physical venues. ResultsWe found that paid advertisements on Facebook, Instagram, and Grindr offered the largest quantity of eligible participants willing to enroll in the trial. Instagram offered the largest proportion of transgender masculine participants, and Grindr offered the largest proportion of Black/African American individuals. Although we attempted venue-based recruitment at clubs, bars, community centers, and AIDS service organizations, we found it to be unsuccessful for this specific hardly reached population. Social media and geobased dating applications offered the largest pool of eligible participants. ConclusionsUnderstanding factors associated with successful recruitment has the potential to inform effective and efficient strategies for HIV prevention research with substance-using, sexual and gender AYAs. Trial RegistrationClinicalTrials.gov NCT02945436; https://clinicaltrials.gov/ct2/show/NCT02945436 International Registered Report Identifier (IRRID)RR2-10.2196/resprot.941

HIV and Sexually Transmitted Infection Testing Among Substance-Using Sexual and Gender Minority Adolescents and Young Adults: Baseline Survey of a Randomized Controlled Trial (Preprint)

BACKGROUND Gay, bisexual, and other men who have sex with men and transgender individuals are more heavily affected by HIV and other sexually transmitted infections (STIs) than their cisgender, heterosexual peers. In addition, sexual and gender minorities who use substances are often at a further increased risk of HIV and other STIs. Increasing testing for HIV and other STIs allows this hardly reached population to receive early intervention, prevention, and education. OBJECTIVE We explored HIV and STI testing patterns among 414 sexual and gender minority adolescents and young adults aged 15 to 29 years who self-reported substance use and lived in southeastern Michigan. METHODS We analyzed data from the baseline survey of a 4-arm randomized controlled trial that aimed to examine the efficacy of a brief substance use intervention for creating gains in engagement in HIV prevention. We fit multinomial logistic regression models to 2 categorical HIV and STI testing variables (lifetime and previous 12 months) based on self-reports of testing (never, STIs only, HIV only, or both). In addition, we compared HIV and STI testing behaviors across demographic characteristics, structural factors, psychosocial barriers, substance use, and sexual behaviors. RESULTS Our findings showed that 35.5% (147/414) of adolescents and young adults reported not being tested for either HIV or STIs in the previous year, and less than half (168/414, 40.6%) of the sample achieved the Centers for Disease Control and Prevention recommendation of HIV and STI testing once per year. We observed HIV and STI testing disparities across sociodemographic (eg, sexual identity, education, and income) and health (eg, substance use) correlates. Specifically, cisgender gay men who have sex with men were more likely to report being tested for HIV compared with bisexual men and transgender individuals, who were more likely to be tested for STIs. CONCLUSIONS This study illustrates the results of an HIV prevention intervention in southeastern Michigan showing the need for HIV prevention interventions that leverage structural factors, psychosocial barriers, and substance use as key drivers to achieve HIV and STI testing rates to meet the Centers for Disease Control and Prevention guidelines. CLINICALTRIAL ClinicalTrials.gov NCT02945436; http://clinicaltrials.gov/ct2/show/NCT02945436 INTERNATIONAL REGISTERED REPORT RR2-10.2196/resprot.9414 </sec

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

Abstract 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.http://deepblue.lib.umich.edu/bitstream/2027.42/173508/1/12889_2021_Article_12208.pd