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

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ClinicalTrials.gov Identifier: NCT02710032
Recruitment Status : Completed
First Posted : March 16, 2016
Last Update Posted : August 7, 2018
Sponsor:
Collaborators:
The Fenway Institute
Brown University
Asociación Civil Impacta Salud y Educación, Peru
Information provided by (Responsible Party):
Jesse Clark, University of California, Los Angeles

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.

Condition or disease Intervention/treatment Phase
HIV Infection Behavioral: Social Network-Based Adherence Intervention Behavioral: Social Media Platform Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: TransPrEP: Social Network-Based PrEP Adherence for Transgender Women in Peru
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : July 31, 2018
Actual Study Completion Date : July 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Serum Drug Level [ Time Frame: 6 Months ]
    Serum monitoring of Truvada drug level


Secondary Outcome Measures :
  1. Self-reported Adherence [ Time Frame: 6 Months ]
    Self-reported adherence to Truvada

  2. Hair Sample Drug Level [ Time Frame: 6 Months ]
    Hair sample monitoring of Truvada drug level



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02710032


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

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Responsible Party: Jesse Clark, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02710032     History of Changes
Other Study ID Numbers: R34MH104072 ( U.S. NIH Grant/Contract )
First Posted: March 16, 2016    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Due to restrictions on sharing of human subjects data, other researchers' requests for access to data will be reviewed and subject to approval by the relevant IRBs.

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

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

Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases