Trial record 2 of 11 for:    Open Studies | "Transgendered Persons"

TransPrEP: Social Network-Based PrEP Adherence for Transgender Women in Peru (TransPrEP)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2016 by University of California, Los Angeles
Sponsor:
Collaborators:
The Fenway Institute
Brown University
Asociacion Civil Impacta Salud y Educación
Information provided by (Responsible Party):
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT02710032
First received: March 8, 2016
Last updated: March 10, 2016
Last verified: March 2016
  Purpose
The investigators propose a social network-based PrEP adherence intervention as part of a comprehensive, context-specific approach to HIV prevention for TW in Lima, Peru. In order to be effective, PrEP-based prevention strategies need to address not only biological efficacy, but also individual behavioral decision-making processes, interpersonal partnership contexts of risk, peer norms of sexual behavior and PrEP adherence, and structural access to prevention technologies. Using a health promotion behavioral model that combines Social Action Theory with social network theories of information dissemination and collective behavior change, the investigators propose to develop and refine a network-based intervention that promotes PrEP adherence in the existing social networks of TW. Formative research will outline individual, partner-level, and network-based contexts of sexual risk behavior, patterns of social network interactions, anticipated adoption and use of new prevention technologies, and optimal content for a PrEP adherence intervention. Findings will be used to define the elements of a prevention intervention using social networks of TW and social media technologies to generate, implement, and reinforce social norms of PrEP adherence and risk behavior reduction for TW.

Condition Intervention
HIV Infection
Behavioral: Social Network-Based Adherence Intervention
Behavioral: Social Media Platform

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: TransPrEP: Social Network-Based PrEP Adherence for Transgender Women in Peru

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Serum Drug Level [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    Serum monitoring of Truvada drug level

  • Hair Sample Drug Level [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    Hair sample monitoring of Truvada drug level


Secondary Outcome Measures:
  • Self-reported Adherence [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    Self-reported adherence to Truvada


Estimated Enrollment: 105
Study Start Date: April 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
Social Network-Based Adherence Intervention
Behavioral: Social Network-Based Adherence Intervention
Participants in clusters randomized to the intervention arm will be asked to attend a series of weekly group workshops emphasizing a collective approach to HIV prevention and mutual support for PrEP adherence.
Behavioral: Social Media Platform
ii) Social Media Platform: The social media component of the intervention will include structured internet platforms designed to educate, motivate, and promote discussions of PrEP adherence within the participant network, unstructured participant-generated interactions to articulate and reinforce newly developed social norms within the network, and practical tools to support daily PrEP adherence.
No Intervention: Control
Control

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 18 years of age or older;
  2. Identify as male-to-female transgender (e.g., "trans," "transgender," "travesti");
  3. Report behavioral risk for HIV infection (UAI with at least one HIV-infected or unknown serostatus partner in the preceding 6 months);
  4. HIV-uninfected by rapid test.

Exclusion Criteria:

  1. Unable to provide informed consent, including people with severe mental illness requiring immediate treatment or with mental illness limiting their ability to participate (e.g., dementia);
  2. HIV infection (Rapid HIV assay positive);
  3. Active Hepatitis B infection (Hepatitis B Surface Antigen positive);
  4. Renal insufficiency (Creatinine Clearance <50).
  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: NCT02710032

Contacts
Contact: Jesse L Clark, MD, MSc 310 825 7225 jlclark@mednet.ucla.edu

Locations
Peru
Asociacion Civil Impacta Salud y Educacion
Lima, Peru
Sponsors and Collaborators
University of California, Los Angeles
The Fenway Institute
Brown University
Asociacion Civil Impacta Salud y Educación
Investigators
Principal Investigator: Jesse L Clark, MD, MSc UCLA Geffen School of Medicine
  More Information

Responsible Party: University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02710032     History of Changes
Other Study ID Numbers: R34MH104072 
Study First Received: March 8, 2016
Last Updated: March 10, 2016
Health Authority: United States: Institutional Review Board, United States
Peru: Instituto Nacional de Salud, Peru

Keywords provided by University of California, Los Angeles:
Transgender women
HIV Pre-Exposure Prophylaxis
Adherence
Peru
Social Networks

ClinicalTrials.gov processed this record on May 30, 2016