HIV InfectionsT2NCT04067661
A Couples-based Intervention for Transgender Women and Their Partners
A study testing CHIP in people with HIV Infections and HIV Primary Infection, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, HIV Primary Infection
- What is being tested?
- CHIP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Currently psychotic, suicidal, or manic
- Either partner reports that participating in the study would cause them physical harm
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94158
About this study
Official title: A Couples-Based Approach to HIV Prevention for Transgender Women and Their Male Partners
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.
Read the 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.
- Conditions
- HIV Infections, HIV Primary Infection
- Being tested
- CHIP, Control
- Keywords
- HIV Prevention, Transgender Women, Intervention
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHIPBehavioural
Also called It Takes Two
The couples-based HIV prevention intervention consists of four couples counseling sessions focused on relationship skills to decrease HIV risk behaviors.
ControlBehavioural
Enhanced standard of care, which includes information and referrals on HIV risk and prevention.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants and their partners will complete four couples counseling sessions focused on developing and enhancing relationship skills to decrease HIV risk behaviors. Receives: Behavioral: CHIP |
| Control | Active comparator | Participants and their partners will receive information and referrals on HIV risk and prevention strategies. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Condomless Sex
Self-report condomless anal or vaginal sex with any partner in the past 3 months
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start1 Nov 2019
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Why it stopped: NIH terminated funding for this project stating "This award no longer effectuates agency priorities."
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, Emory University, Research Foundation for Mental Hygiene, Inc., National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Kristi Gamarel, University of Michigan
- Investigators
- Ellen Stein, Study director, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04067661
- Sponsor's protocol ID
- F050837
- Other IDs
- 5R01MH115765-05
- Acronym
- T2
- Status last verified
- Jul 2025
- First submitted
- 22 Aug 2019
- Last updated
- 6 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 30003506Sevelius 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.
PubMed 32415617Gamarel 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.
PubMed 33060086
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Couples-Based Approach to HIV Prevention for Transgender Women and Their Male Partners
- ClinicalTrials.gov ID
- NCT04067661
- Acronym / sponsor ID
- T2 / F050837
- Conditions
- HIV Infections, HIV Primary Infection
- Keywords
- HIV Prevention, Transgender Women, Intervention
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: NIH terminated funding for this project stating "This award no longer effectuates agency priorities."
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- University of California, San Francisco, Emory University, Research Foundation for Mental Hygiene, Inc., National Institute of Mental Health (NIMH)
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 26 Aug 2019 (actual)
- Results
- Posted 6 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study involved a randomized controlled trial comparing the couples-based HIV prevention to an enhanced standard of care control condition
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: CHIPParticipants and their partners will complete four couples counseling sessions focused on developing and enhancing relationship skills to decrease HIV risk behaviors. |
| Control | Active comparator | Behavioral: ControlParticipants and their partners will receive information and referrals on HIV risk and prevention strategies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Currently psychotic, suicidal, or manic
- Either partner reports that participating in the study would cause them physical harm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHIPAlso: It Takes TwoThe couples-based HIV prevention intervention consists of four couples counseling sessions focused on relationship skills to decrease HIV risk behaviors. | Behavioural | Intervention |
| ControlEnhanced standard of care, which includes information and referrals on HIV risk and prevention. | Behavioural | Control |
Primary outcome
Condomless Sex
Time frame: Changes in self-reported condomless anal or vaginal sex at 12-month follow-up
Self-report condomless anal or vaginal sex with any partner in the past 3 months
Composite HIV Risk
Time frame: 12 months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30003506Gamarel 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.
- Results publication: PubMed 32415617Sevelius 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.
- Results publication: PubMed 33060086Gamarel 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellen Stein study director
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHIP in people with HIV Infections and HIV Primary Infection, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Condomless Sex (time frame: Changes in self-reported condomless anal or vaginal sex at 12-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04067661, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.