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

NCT02710032 | Completed

• 1 other identifier: R34MH104072
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Infection

Keywords

Transgender women; HIV Pre-Exposure Prophylaxis; Adherence; Peru; Social Networks

Outcome Measures

Primary Outcomes (1)

• Serum Drug Level

  Serum monitoring of Truvada drug level

  6 Months

Secondary Outcomes (2)

• Self-reported Adherence

  6 Months

• Hair Sample Drug Level

  6 Months

Study Arms (2)

Intervention

EXPERIMENTAL

Social Network-Based Adherence Intervention

Behavioral: Social Network-Based Adherence Intervention; Behavioral: Social Media Platform

Control

NO INTERVENTION

Control

Interventions

Social Network-Based Adherence Intervention BEHAVIORAL

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.

Intervention

Social Media Platform BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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);
• HIV infection (Rapid HIV assay positive);
• Active Hepatitis B infection (Hepatitis B Surface Antigen positive);
• Renal insufficiency (Creatinine Clearance \<50).

Sponsors & Collaborators

• University of California, Los Angeles: lead
• The Fenway Institute: collaborator
• Brown University: collaborator
• Asociación Civil Impacta Salud y Educación, Peru: collaborator

Study Sites (1)

Asociacion Civil Impacta Salud y Educacion

Lima, Peru

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

• Jesse L Clark, MD, MSc

  UCLA Geffen School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 8, 2016
• First Posted: March 16, 2016
• Study Start: July 1, 2017
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: August 7, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

PE (1)