- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03465852
HIV Prevention Among Latina Transgender Women Who Have Sex With Men: Evaluation of a Locally Developed Intervention
Study Overview
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:
- 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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lilli K Mann-Jackson
- Phone Number: 336-716-6441
- Email: lmann@wakehealth.edu
Study Locations
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27157-1063
- Wake Forest University Health Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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. . |
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 compared to baseline assessed 6 months after completion of the intervention.
|
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
|
Uptake compared to baseline assessed 6 months after completion of the intervention.
|
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
|
Uptake compared to baseline assessed 6 months after completion of the intervention.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Scott D Rhodes, PhD, Wake Forest University Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00040441
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
A plan agreed to by the Principal Investigator and the Centers for Disease Control and Prevention (CDC) will make, after approval by the CDC, the following study data available to applicants who provide detailed information on their reasons for requesting the data and plans analysis and use of the data:
- Quantitative data from structured surveys for baseline and 6-month follow-up assessments;
- Qualitative data from in-depth interviews with selected study participants to elucidate factors that contribute to or impede participant reports of engaging in the expected intervention outcomes following completion of the intervention (consistent condom use and use of PrEP and medically-supervised hormone therapy):
- medical record abstractions, and data from biological markers including PrEP and HIV test results. None of the data described here will contain personal identifying information from study participants.
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV Infections
-
University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
-
University of California, San DiegoUniversity of California, Los Angeles; University of Southern California; California... and other collaboratorsCompleted
-
Gérond'ifRecruiting
-
University of California, DavisCompleted
-
University of California, San DiegoNational Center for Complementary and Integrative Health (NCCIH)CompletedHIV PositiveUnited States
-
University of ChicagoUniversity of Athens; National Development and Research Institutes, Inc.Completed
-
HIV Prevention Trials NetworkNational Institute on Drug Abuse (NIDA); National Institute of Allergy and...CompletedHIV PositiveIndonesia, Ukraine, Vietnam
-
University of ZimbabweCompleted
-
Florida International UniversityCompleted
-
Boston Children's HospitalNational Institute on Minority Health and Health Disparities (NIMHD)Completed