HIV Infections, HIV Primary Infection
Conditions
Keywords
HIV Prevention, Transgender Women, Intervention
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 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.
Interventions
BEHAVIORALCHIP
The couples-based HIV prevention intervention consists of four couples counseling sessions focused on relationship skills to decrease HIV risk behaviors.
BEHAVIORALControl
Enhanced standard of care, which includes information and referrals on HIV risk and prevention.
Sponsors
University of California, San Francisco
Emory University
Research Foundation for Mental Hygiene, Inc.
National Institute of Mental Health (NIMH)
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
The study involved a randomized controlled trial comparing the couples-based HIV prevention to an enhanced standard of care control condition
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Condomless Sex | 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 | 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. |
Countries
United States
Participant flow
Pre-assignment details
104 individuals (52 couples) were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 52 |
| 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. | 52 |
| Total | 104 |
Baseline characteristics
| Characteristic | Intervention | Control | Total |
|---|---|---|---|
| Age, Continuous | 36.5 years STANDARD_DEVIATION 1.8 | 35.5 years STANDARD_DEVIATION 2.1 | 36.0 years STANDARD_DEVIATION 1.1 |
| Condomless sex | 52 Participants | 52 Participants | 104 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 6 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 37 Participants | 45 Participants | 82 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 7 Participants | 14 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 9 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 7 Participants | 12 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 4 Participants | 9 Participants |
| Race (NIH/OMB) White | 29 Participants | 24 Participants | 53 Participants |
| Region of Enrollment United States | 52 participants | 52 participants | 104 participants |
| Sex: Female, Male Female | 38 Participants | 36 Participants | 74 Participants |
| Sex: Female, Male Male | 14 Participants | 16 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 52 |
| other Total, other adverse events | 0 / 52 | 0 / 52 |
| serious Total, serious adverse events | 0 / 52 | 0 / 52 |
Outcome results
Primary
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
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Composite HIV Risk | 17 Participants |
| Control | Composite HIV Risk | 28 Participants |
Primary
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Condomless Sex | 20 participants |
| Control | Condomless Sex | 31 participants |