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Trial Outcomes & Findings for A Couples-based Intervention for Transgender Women and Their Partners (NCT NCT04067661)

NCT ID: NCT04067661

Last Updated: 2025-08-06

Results Overview

Self-report condomless anal or vaginal sex with any partner in the past 3 months

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

104 participants

Primary outcome timeframe

Changes in self-reported condomless anal or vaginal sex at 12-month follow-up

Results posted on

2025-08-06

Participant Flow

104 individuals (52 couples) were enrolled in the study.

Participant milestones

Participant milestones
Measure
Intervention
Participants and their partners will complete four couples counseling sessions focused on developing and enhancing relationship skills to decrease HIV risk behaviors. CHIP: The couples-based HIV prevention intervention consists of four couples counseling sessions focused on relationship skills to decrease HIV risk behaviors.
Control
Participants and their partners will receive information and referrals on HIV risk and prevention strategies. Control: Enhanced standard of care, which includes information and referrals on HIV risk and prevention.
Overall Study
STARTED
52
52
Overall Study
COMPLETED
42
50
Overall Study
NOT COMPLETED
10
2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Couples-based Intervention for Transgender Women and Their Partners

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Intervention
n=52 Participants
Participants and their partners will complete four couples counseling sessions focused on developing and enhancing relationship skills to decrease HIV risk behaviors. CHIP: The couples-based HIV prevention intervention consists of four couples counseling sessions focused on relationship skills to decrease HIV risk behaviors.
Control
n=52 Participants
Participants and their partners will receive information and referrals on HIV risk and prevention strategies. Control: Enhanced standard of care, which includes information and referrals on HIV risk and prevention.
Total
n=104 Participants
Total of all reporting groups
Age, Continuous
36.5 years
STANDARD_DEVIATION 1.8 • n=99 Participants
35.5 years
STANDARD_DEVIATION 2.1 • n=107 Participants
36.0 years
STANDARD_DEVIATION 1.1 • n=206 Participants
Sex: Female, Male
Female
38 Participants
n=99 Participants
36 Participants
n=107 Participants
74 Participants
n=206 Participants
Sex: Female, Male
Male
14 Participants
n=99 Participants
16 Participants
n=107 Participants
30 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
14 Participants
n=99 Participants
6 Participants
n=107 Participants
20 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
37 Participants
n=99 Participants
45 Participants
n=107 Participants
82 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
n=99 Participants
1 Participants
n=107 Participants
2 Participants
n=206 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=99 Participants
1 Participants
n=107 Participants
2 Participants
n=206 Participants
Race (NIH/OMB)
Asian
7 Participants
n=99 Participants
7 Participants
n=107 Participants
14 Participants
n=206 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Black or African American
5 Participants
n=99 Participants
9 Participants
n=107 Participants
14 Participants
n=206 Participants
Race (NIH/OMB)
White
29 Participants
n=99 Participants
24 Participants
n=107 Participants
53 Participants
n=206 Participants
Race (NIH/OMB)
More than one race
5 Participants
n=99 Participants
7 Participants
n=107 Participants
12 Participants
n=206 Participants
Race (NIH/OMB)
Unknown or Not Reported
5 Participants
n=99 Participants
4 Participants
n=107 Participants
9 Participants
n=206 Participants
Region of Enrollment
United States
52 participants
n=99 Participants
52 participants
n=107 Participants
104 participants
n=206 Participants
Condomless sex
52 Participants
n=99 Participants
52 Participants
n=107 Participants
104 Participants
n=206 Participants

PRIMARY outcome

Timeframe: Changes in self-reported condomless anal or vaginal sex at 12-month follow-up

Population: We analyzed data at the individual level. The number presented represents that participants who competed their 12-month follow-up. Since participants were recruited as dyads, tests for differences in outcomes between intervention and control conditions were adjusted for non-independence in the data due to clustering at the couple level.

Self-report condomless anal or vaginal sex with any partner in the past 3 months

Outcome measures

Outcome measures
Measure
Intervention
n=42 Participants
Participants and their partners will complete four couples counseling sessions focused on developing and enhancing relationship skills to decrease HIV risk behaviors. CHIP: The couples-based HIV prevention intervention consists of four couples counseling sessions focused on relationship skills to decrease HIV risk behaviors.
Control
n=50 Participants
Participants and their partners will receive information and referrals on HIV risk and prevention strategies. Control: Enhanced standard of care, which includes information and referrals on HIV risk and prevention.
Condomless Sex
20 participants
31 participants

PRIMARY outcome

Timeframe: 12 months

Population: We analyzed data at the individual level. The number presented represents that participants who competed their 12-month follow-up. Since participants were recruited as dyads, tests for differences in outcomes between intervention and control conditions were adjusted for non-independence in the data due to clustering at the couple level.

We created a composite measure incorporating self-reported condomless sex, PrEP adherence, and viral suppression, resulting in a binary HIV risk outcome (1=yes, 0=no). Participants reporting condomless sex in the past 30 days, along with either lack of viral suppression or non-adherence to PrEP, were categorized as at HIV risk. Conversely, those who did not report condomless sex, were virally suppressed, or were adherent to PrEP were placed in the not at HIV risk group. The variable was constructed such that 1= HIV Risk versus 0 = No HIV Risk. The results below represent the number of participants who were categorized as 1 = HIV risk at the 12-month follow up.

Outcome measures

Outcome measures
Measure
Intervention
n=42 Participants
Participants and their partners will complete four couples counseling sessions focused on developing and enhancing relationship skills to decrease HIV risk behaviors. CHIP: The couples-based HIV prevention intervention consists of four couples counseling sessions focused on relationship skills to decrease HIV risk behaviors.
Control
n=50 Participants
Participants and their partners will receive information and referrals on HIV risk and prevention strategies. Control: Enhanced standard of care, which includes information and referrals on HIV risk and prevention.
Composite HIV Risk
17 Participants
28 Participants

Adverse Events

Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kristi Gamarel

University of Michigan

Phone: 7346473178

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place