Clinical trial NCT03465852: HIV Prevention Among Latina Transgender Women Who Have Sex With Men: Evaluation of a Locally Developed Intervention
Official title: HIV Prevention Among Latina Transgender Women Who Have Sex With Men: Evaluation of a Locally Developed Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
First posted: 2018-03-14
Enrollment: 144
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention study uses an intervention arm and a wait list comparison (control) arm
Primary purpose: PREVENTION

Brief summary: 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: 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:

1. 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);
2. 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
3. Participants with mixed results (n=10).

Eligibility criteria: Inclusion Criteria:

1. Self-identify as male-to-female transgender or report having been born male and identifying as female;
2. Self-identify as Hispanic or Latina;
3. Are ≥ 18 years of age;
4. Report sex with at least 1 man in the past 6 months;
5. Are HIV negative (based on self-report and verification by HIV testing);
6. Are fluent in Spanish; and
7. 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;

Primary outcomes:
measure: Uptake of PrEP
timeFrame: Uptake compared to baseline assessed 6 months after completion of the intervention.
measure: Uptake of medically supervised hormone therapy
timeFrame: Uptake compared to baseline assessed 6 months after completion of the intervention.
measure: Consistent condom use
timeFrame: Uptake compared to baseline assessed 6 months after completion of the intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Scott D Rhodes, PhD
role: PRINCIPAL_INVESTIGATOR
References: