HIV Prevention Among Latina Transgender Women Who Have Sex With Men: Evaluation of a Locally Developed Intervention

Study Overview
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Brief Summary
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Wake Forest University and its partners, Triad Health Project, and the University of North Carolina, Greensboro, will be evaluating the effectiveness of ChiCAS (Chicas Creando Acceso a la Salud or Girls Creating Access to Health), a locally developed, Spanish language small group behavioral intervention that promotes access to and participation by Hispanic/Latina transgender women who are HIV negative and who have sex with men in pre-exposure prophylaxis (PrEP), medically supervised hormone therapy, and consistent condom use.

Detailed Description
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ChiCAS will be delivered as two 4-hour group sessions over a period of two weeks to groups of about 10 participants at seven community-based organizations (CBOs) in five metropolitan locations in North Carolina (Asheville, Charlotte, Greensboro/Winston-Salem, Raleigh/Durham and Wilmington). The intervention will be evaluated by comparing women randomized to the ChiCAS intervention group to those randomized to the delayed-intervention (waitlist) comparison group. As many as 140 participants (as many 70 participants per arm) in total will be recruited to the study. All participants will complete identical quantitative assessments at baseline and 6-month follow up. Baseline and 6-month follow-up data collection will include the following measures: Outcome variables: Use of PrEP and medically supervised hormone therapy and consistent condom use. Demographics: Age, current living situation, marital/partner status, education, country and region of origin, ethnicity/race, work and work patterns and history, financial status (including income, numbers of persons income supports), number of children and adults living in household, gender identity; time in the US and NC; Spanish-language literacy; English-language skills; health insurance; documentation status. Mediating variables: Knowledge about HIV and STDs: types of diseases, modes of transmission, signs, symptoms, prevention strategies, and their magnitude within communities; condom use-related attitudes, skills, self-efficacy, and intentions; adherence to traditional Latino values of masculinity and fatalism; transphobia; ethnic group pride; knowledge of available transition-related services, how to access, what to expect, and eligibility; barriers to seeking healthcare services, for HIV testing, PrEP, or transition-related services; perceived access to health care; social support; substance use; substance use during sex; communication skills with partners and providers; provider trust. Other variables: Religiosity; mental health, perceived discrimination; community attachment; foregoing unsafe sex/episodic abstinence HIV and sexually transmitted disease (STD) history; victimization; sexual compulsivity; sex for money, drugs or shelter, self-reported health status, acculturation, community attachment, technology use, HIV and STD history A qualitative interview will be administered to 30 randomly selected participants after they complete the 6-month follow-up assessments. Three groups of ten participants each will be interviewed to identify factors associated with each of the following outcome patterns: Participants who reported an increase in at least one HIV prevention behavioral outcome (PrEP or condom use) and who reported an increase in the use of medically supervised hormone therapy (n=10); Participants who did not report an increase in at least one HIV prevention behavioral outcome (PrEP or condom use) and did not report an increase in the use of medically supervised hormone therapy (n=10), and Participants with mixed results (n=10).

Official Title
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HIV Prevention Among Latina Transgender Women Who Have Sex With Men: Evaluation of a Locally Developed Intervention

Conditions
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HIV Infections

Intervention / Treatment
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* Behavioral: ChiCAS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Self-identify as male-to-female transgender or report having been born male and identifying as female; Self-identify as Hispanic or Latina; Are ≥ 18 years of age; Report sex with at least 1 man in the past 6 months; Are HIV negative (based on self-report and verification by HIV testing); Are fluent in Spanish; and Provide informed consent. Exclusion Criteria: (a) Having participated in any HIV prevention intervention within the past 12 months, including Chicas or other interventions co-developed by Wake Gorest University (HOLA en Grupos or HOLA). Are ≥ 18 years of age;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The intervention study uses an intervention arm and a wait list comparison (control) arm
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>Persons randomized to this arm will have completed the study consent process (including being tested with the INSTI rapid HIV test to verify their self-reported HIV negative status and their eligibility to participate in the study) and the baseline survey, and will receive the Spanish language ChiCAS intervention shortly after being randomized and will complete a follow-up assessment 6 months after completing the intervention. . | Behavioral: ChiCAS<br>* Promotes access to and participation by HIV negative Hispanic/Latina transgender women who have sex with men in PrEP, medically supervised hormone therapy, and consistent condom use.<br>|
| Other: Wait list comparison (control) arm<br>Persons randomized to this arm will have completed the study consent process (including being tested with the INSTI rapid HIV test to verify their self-reported HIV negative status and their eligibility to participate in the study) and the baseline survey, but will not receive the Spanish language ChiCAS intervention until they complete a follow-up assessment 6 months after completing the baseline assessment. | Behavioral: ChiCAS<br>* Promotes access to and participation by HIV negative Hispanic/Latina transgender women who have sex with men in PrEP, medically supervised hormone therapy, and consistent condom use.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uptake of PrEP | Increased uptake of PrEP relative to baseline measures of use | Uptake compared to baseline assessed 6 months after completion of the intervention. | 
| Uptake of medically supervised hormone therapy | Increased uptake of medically supervised hormone therapy relative to baseline use measures | Uptake compared to baseline assessed 6 months after completion of the intervention. | 
| Consistent condom use | Increased consistent condom relative to baseline use measures | Uptake compared to baseline assessed 6 months after completion of the intervention. |