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

NCT03465852 | Completed DMC

• 1 other identifier: IRB00040441
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (2)

Intervention arm

EXPERIMENTAL

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

Wait list comparison (control) arm

OTHER

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

Interventions

ChiCAS BEHAVIORAL

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.

Intervention arm; Wait list comparison (control) arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Persons who self-identify as male-to-female transgender or report having been born male and identifying as female.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• (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;

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157-1063, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Scott D Rhodes, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Study participants will be randomly assigned to the intervention or the wait list comparison arm
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: The intervention study uses an intervention arm and a wait list comparison (control) arm

Study Record Dates

• First Submitted: March 8, 2018
• First Posted: March 14, 2018
• Study Start: July 15, 2019
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: February 28, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Wake Forest University will make study data from which all personal identifying information has been removed, available to CDC for potential release at the termination of the study. It is anticipated that the complete dataset will be made available to CDC about April 2023, after the grantee, its partners, and CDC have agreed that all key study analyses have been completed and cleared by CDC for publication. All data will be retained until analysis is complete and for up to three years following study closure by the Wake Forest Institutional Review Board (IRB). At that time, users must delete all data stored on their servers. CDC will store complete de-identified data on a secure server that is accessible through the Division of HIV Prevention, Prevention Research Branch for an indefinite period.
• Access Criteria: Persons who request data will be required to provide an approved copy of the Publication Guidelines Concept Proposal and a signed copy of the Data Sharing Agreement before data will be provided to them. The data sharing agreement must list and be signed by all individuals who will have access to the data or participate in preparing materials for publication before engaging in research and analysis activities with these data.

Locations

US (1)