A Couples-based Intervention for Transgender Women and Their Partners (It Takes Two)
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|ClinicalTrials.gov Identifier: NCT04067661|
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : January 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections HIV Primary Infection||Behavioral: CHIP Behavioral: Control||Not Applicable|
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.5
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 100 trans women and their partners (200 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:
1. 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.
The secondary aims are to:
- Assess the effect of CHIP on theory-based mediators (i.e., communication, joint problem-solving).
- Explore partner gender (trans woman vs. male partner and couple HIV status (seroconcordant negative vs. serodiscordant) as potential moderators of the effect of CHIP on CR-HIV.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The study involved a randomized controlled trial comparing the couples-based HIV prevention to an enhanced standard of care control condition|
|Masking:||None (Open Label)|
|Official Title:||A Couples-Based Approach to HIV Prevention for Transgender Women and Their Male Partners|
|Actual Study Start Date :||November 1, 2019|
|Estimated Primary Completion Date :||April 30, 2023|
|Estimated Study Completion Date :||April 30, 2023|
Participants and their partners will complete four couples counseling sessions focused on developing and enhancing relationship skills to decrease HIV risk behaviors.
The couples-based HIV prevention intervention consists of four couples counseling sessions focused on relationship skills to decrease HIV risk behaviors.
Other Name: It Takes Two
Active Comparator: Control
Participants and their partners will receive information and referrals on HIV risk and prevention strategies.
Enhanced standard of care, which includes information and referrals on HIV risk and prevention.
- Composite Risk for HIV [ Time Frame: Changes in CR-HIV at 12-month follow-up ]CR-HIV is a couple-level binary indicator of any HIV risk (e.g., yes=1 vs. no=0), which is an algorithm based on whether one or both partners report condomless anal or vaginal sex with a HIV serodiscordant or status-unknown primary or other partner in the past 3 months. If one or both partners in the dyad report condomless sex with a serodiscordant or status-unknown primary or other partner, then the couple is coded as 1 if (i) the HIV-negative participant is not adherent to PrEP and/or (ii) the HIV-positive participant is not virally suppressed.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04067661
|Contact: Kristine E Gamarel, PhDemail@example.com|
|Contact: Jeanne M Sevelius, PhDfirstname.lastname@example.org|
|United States, California|
|University of California, San Francisco||Recruiting|
|San Francisco, California, United States, 94158|
|Contact: Jeanne M Sevelius, PhD 415-476-6358 email@example.com|
|Study Director:||Ellen Stein||University of California, San Francisco|