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A Couples-based Intervention for Transgender Women and Their Partners (It Takes Two)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04067661
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : January 9, 2020
Sponsor:
Collaborators:
University of California, San Francisco
Brown University
Information provided by (Responsible Party):
Kristi Gamarel, University of Michigan

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 100 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.

Condition or disease Intervention/treatment Phase
HIV Infections HIV Primary Infection Behavioral: CHIP Behavioral: Control Not Applicable

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.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:

  1. Assess the effect of CHIP on theory-based mediators (i.e., communication, joint problem-solving).
  2. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
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)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
Participants and their partners will complete four couples counseling sessions focused on developing and enhancing relationship skills to decrease HIV risk behaviors.
Behavioral: CHIP
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.
Behavioral: Control
Enhanced standard of care, which includes information and referrals on HIV risk and prevention.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  • At least one partner is HIV-negative
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04067661


Contacts
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Contact: Kristine E Gamarel, PhD 734-647-3178 kgamarel@umich.edu
Contact: Jeanne M Sevelius, PhD 415-476-6358 j.sevelius@ucsf.edu

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94158
Contact: Jeanne M Sevelius, PhD    415-476-6358    j.sevelius@ucsf.edu   
Sponsors and Collaborators
University of Michigan
University of California, San Francisco
Brown University
Investigators
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Study Director: Ellen Stein University of California, San Francisco
Publications of Results:
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Responsible Party: Kristi Gamarel, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT04067661    
Other Study ID Numbers: F050837
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We will compile structured de-identified datasets and can make them available for additional/secondary data analyses. For data sharing, the research team will follow the "standards for privacy of individually identifiable health information." Participants' records and results will not be identified. No contact information will be included in any archived datasets.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kristi Gamarel, University of Michigan:
HIV Prevention
Transgender Women
Intervention
Additional relevant MeSH terms:
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Infection
Communicable Diseases