An interventional study of CHIP and Control in HIV Infections and HIV Primary Infection, sponsored by University of Michigan. Terminated at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-06.
Sponsored by University of Michigan · Not applicable, Interventional, and Prevention
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.
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.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 104 is above the median of 83 across 3,251 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
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Exclusion Criteria:
Participants and their partners will complete four couples counseling sessions focused on developing and enhancing relationship skills to decrease HIV risk behaviors.
Behavioral: CHIP
Participants and their partners will receive information and referrals on HIV risk and prevention strategies.
Behavioral: Control
The couples-based HIV prevention intervention consists of four couples counseling sessions focused on relationship skills to decrease HIV risk behaviors.
Also known as: It Takes Two
Enhanced standard of care, which includes information and referrals on HIV risk and prevention.
Condomless Sex
Self-report condomless anal or vaginal sex with any partner in the past 3 months
Time frame: Changes in self-reported condomless anal or vaginal sex at 12-month follow-up
Composite HIV Risk
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.
Time frame: 12 months
| Milestone | Intervention | Control |
|---|---|---|
| Started | 52 | 52 |
| Completed | 42 | 50 |
| Not completed | 10 | 2 |
Self-report condomless anal or vaginal sex with any partner in the past 3 months
| participants | Intervention | Control |
|---|---|---|
| Condomless Sex | 20 | 31 |
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.
| Participants | Intervention | Control |
|---|---|---|
| Composite HIV Risk | 17 | 28 |
Collected over One year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | 0/52 (0%) | 0/52 (0%) | 0/52 (0%) |
| Control | 0/52 (0%) | 0/52 (0%) | 0/52 (0%) |
104 individuals (52 couples) were enrolled; the results are presented at the individual-level. Since participants were recruited as dyads, tests for differences in baseline characteristics between intervention and control conditions were adjusted for non-independence in the data due to clustering at the couple level.
| Age, Continuous(years) | Intervention | Control | Total |
|---|---|---|---|
| Mean | 36.5 ± 1.8 | 35.5 ± 2.1 | 36.0 ± 1.1 |
| Sex: Female, Male(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Female | 38 | 36 | 74 |
| Male | 14 | 16 | 30 |
| Ethnicity (NIH/OMB)(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Hispanic or Latino | 14 | 6 | 20 |
| Not Hispanic or Latino | 37 | 45 | 82 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Race (NIH/OMB)(Participants) | Intervention | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 1 | 2 |
| Asian | 7 | 7 | 14 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 5 | 9 | 14 |
| White | 29 | 24 | 53 |
| More than one race | 5 | 7 | 12 |
| Unknown or Not Reported | 5 | 4 | 9 |
| Region of Enrollment(participants) | Intervention | Control | Total |
|---|---|---|---|
| United States | 52 | 52 | 104 |
| Condomless sex(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Count of participants | 52 | 52 | 104 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — 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.
This study is terminated, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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