Clinical Trials

MainTitle

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

This study is currently recruiting participants. (see Contacts and Locations)

Verified July 2019 by Centers for Disease Control and Prevention

Sponsor
Centers for Disease Control and Prevention


Information provided by (Responsible Party)
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier
NCT03465852

First received: March 8, 2018
Last updated: July 24, 2019
Last Verified: July 2019
History of Changes
Purpose

Purpose

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.

Condition Intervention
HIV Infections

Behavioral : ChiCAS

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The intervention study uses an intervention arm and a wait list comparison (control) arm
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: HIV Prevention Among Latina Transgender Women Who Have Sex With Men: Evaluation of a Locally Developed Intervention

Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures

  • Uptake of PrEP [ Time Frame: Uptake compared to baseline assessed 6 months after completion of the intervention. ]
    Increased uptake of PrEP relative to baseline measures of use
  • Uptake of medically supervised hormone therapy [ Time Frame: Uptake compared to baseline assessed 6 months after completion of the intervention. ]
    Increased uptake of medically supervised hormone therapy relative to baseline use measures
  • Consistent condom use [ Time Frame: Uptake compared to baseline assessed 6 months after completion of the intervention. ]
    Increased consistent condom relative to baseline use measures

Estimated Enrollment: 140
Study Start Date: July 15, 2019
Estimated Study Completion Date: October 15, 2020
Estimated Primary Completion Date: October 15, 2020 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Intervention arm
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

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.

Other: Wait list comparison (control) arm
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

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.

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
ipants with mixed results (n=10).

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: Male  
Accepts Healthy Volunteers: Yes  

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;

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03465852

Contacts

Contact:   Scott D Rhodes, PhD 336-713-5080 srhodes@wakehealth.edu
Contact:   Lilli K Mann-Jackson 336-716-6441 lmann@wakehealth.edu

Locations

United States, North Carolina
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157-1063
Contact: Scott D Rhodes, PhD    336-713-5080    srhodes@wakehealth.edu
Contact: Lilli K Mann-Jackson, MPh    336-716-6441    lmann@wakehealth.edu
Principal Investigator: Scott D Rhodes, PhD

Sponsors and Collaborators

Centers for Disease Control and Prevention

Investigators

Principal Investigator: Scott D Rhodes, PhD Wake Forest University Health Sciences
More Information

More Information


Responsible Party: Centers for Disease Control and Prevention  
ClinicalTrials.gov Identifier: NCT03465852   History of Changes  
Other Study ID Numbers: IRB00040441  
Study First Received: March 8, 2018  
Last Updated: July 24, 2019  
Individual Participant Data    
Plan to Share IPD: Yes  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

Additional relevant MeSH terms:
HIV Infections

ClinicalTrials.gov processed this data on May 24, 2020
This information is provided by ClinicalTrials.gov.