Clinical trial NCT04067661: A Couples-based Intervention for Transgender Women and Their Partners
Official title: A Couples-Based Approach to HIV Prevention for Transgender Women and Their Male Partners
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: HIV Infections
HIV Primary Infection
Keywords: HIV Prevention
Transgender Women
Intervention
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: Emory University
name: Research Foundation for Mental Hygiene, Inc.
First posted: 2019-08-26
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study involved a randomized controlled trial comparing the couples-based HIV prevention to an enhanced standard of care control condition
Primary purpose: PREVENTION

Brief summary: This project seeks to test the efficacy of a couples-based HIV prevention program in large-scale randomized controlled trial (RCT) to reduce HIV risk among transgender woman and their partners. This project involves enrolling a racially diverse sample of transgender women and their partners and randomizing 50 couples to either the couples-based HIV prevention intervention or an enhanced standard of care (SOC) control condition. Couples will be followed quarterly over 12-months. Analysis of study outcomes will utilize both individual- and dyadic-level data. The primary outcome is a composite measure of risk for HIV transmission which encompasses validated behavioral indicators of HIV risk as well as biomedical confirmation of viral suppression and PrEP adherence.

Detailed description: Transgender women (trans women; individuals with a feminine and/or female gender identity who were assigned male at birth) are disproportionately affected by HIV. One of the most consistently reported contexts for HIV transmission among trans women is within a primary partnership. In this partnership context, trans women report low condom use, difficulty disclosing their HIV status and negotiating HIV prevention strategies, poor communication about whether they permit sex outside of the relationship, and low rates of routine HIV testing. Likewise, research among males who have sex with trans women has found high HIV prevalence, inconsistent condom use with trans women, and low engagement with HIV prevention services.

For the past 10 years the investigators have conducted research to identify intervention targets for reducing HIV transmission in trans women and their partner using qualitative, survey, and intervention adaptation methodologies. Based on these conceptual and empirical understandings of HIV transmission in these dyads, the investigative team developed and pilot tested the first known couples-based HIV prevention program for trans women and primary partners (called "Couples HIV Intervention Program" or CHIP). CHIP was feasible, acceptable, and produced significant reductions in condomless sex acts with primary and casual partners and in number of casual partners at 3-month follow-up compared to a control group.

The project seeks to test the efficacy of the CHIP intervention on reductions in a Composite Risk for HIV (CR-HIV) outcome. CR-HIV is a binary indicator of couple HIV risk using validated measures of sexual behavior (defined as condomless anal or vaginal sex with a serodiscordant or unknown HIV status primary or outside partner), as well as PrEP use among HIV-negative participants and viral suppression among HIV-positive partners. The study involves two-arm prospective RCT in which 50 trans women and their partners (100 participants) will complete a Baseline assessment and then complete assessments every 3 months for 12 months. Recruitment and study activities will occur in San Francisco, California.

The primary specific aim is to evaluate the efficacy of CHIP on CR-HIV compared to an enhanced standard of care control condition. Hypothesis: It is hypothesize that couples in the CHIP condition will have lower CR-HIV at 12-month follow-up compared to couples in the control.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Self-report that they are in emotional and/or sexual relationship for at least three months
* One partner must identify as a trans women (assigned the male gender at birth but identify as female or as a trans woman)
* Both partners must have engaged in condomless sex within the past 6 months with any partner
* Able to provide informed consent
* Speak and read English

Exclusion Criteria:

* Currently psychotic, suicidal, or manic
* Either partner reports that participating in the study would cause them physical harm

Primary outcomes:
measure: Composite Risk for HIV
timeFrame: Changes in CR-HIV at 12-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Ellen Stein
role: STUDY_DIRECTOR
References:
citation: Gamarel KE, Chakravarty D, Neilands TB, Hoff CC, Lykens J, Darbes LA. Composite Risk for HIV: A New Approach Towards Integrating Biomedical and Behavioral Strategies in Couples-Based HIV Prevention Research. AIDS Behav. 2019 Jan;23(1):283-288. doi: 10.1007/s10461-018-2229-8.
citation: Sevelius JM, Gutierrez-Mock L, Zamudio-Haas S, McCree B, Ngo A, Jackson A, Clynes C, Venegas L, Salinas A, Herrera C, Stein E, Operario D, Gamarel K. Research with Marginalized Communities: Challenges to Continuity During the COVID-19 Pandemic. AIDS Behav. 2020 Jul;24(7):2009-2012. doi: 10.1007/s10461-020-02920-3. No abstract available.
citation: Gamarel KE, Sevelius JM, Neilands TB, Kaplan RL, Johnson MO, Nemoto T, Darbes LA, Operario D. Couples-based approach to HIV prevention for transgender women and their partners: study protocol for a randomised controlled trial testing the efficacy of the 'It Takes Two' intervention. BMJ Open. 2020 Oct 15;10(10):e038723. doi: 10.1136/bmjopen-2020-038723.