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HIV InfectionTransPrEPNCT02710032

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

A study testing Social Network-Based Adherence Intervention and Social Media Platform in people with HIV Infection, run by University of California, Los Angeles at 1 site in Peru.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
HIV Infection
What is being tested?
Social Network-Based Adherence Intervention and Social Media Platform
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 sitePeru
Study dates
1 Jul 2017to 31 Jul 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 18 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Peru1 site
  • Asociacion Civil Impacta Salud y Educacion

    Lima

Other trials in Peru

About this study

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.

Read the detailed description

Pre-Exposure Prophylaxis (PrEP) has biological efficacy in reducing risk for HIV acquisition but its clinical effectiveness is strongly influenced by patient adherence, which is in turn influenced by social and behavioral factors. Trials conducted among serodiscordant heterosexual African couples who were engaged in supportive romantic partnerships found PrEP to be highly effective for HIV prevention. In contrast, studies with socially marginalized populations in Latin America without strong interpersonal support networks, such as transgender women (TW), found substantially lower levels of adherence and, as a result, effectiveness. We believe that new, social network-based strategies to promote PrEP adherence, coupled with behavioral interventions to minimize risk compensation, will be critical to controlling the spread of HIV among TW in Latin America.

TW in Peru are at high risk for HIV infection (30-33% HIV prevalence) and in urgent need of new approaches to prevention that adequately address HIV risk as part of their life contexts. Due to their social and economic marginalization and lack of support from traditional neighborhood and family networks, TW frequently neglect traditional approaches to HIV/STI prevention that have been developed for men who have sex with men (MSM), and report high rates of compensated sex, unprotected intercourse, and sexually transmitted infection (STI) co-infections. Despite their socially marginalized status, communities of TW in Lima are frequently connected through dense social and geographic networks that provide support outside of traditional community systems, disseminate new information and ideas, and define and maintain standards of behavior. While these social networks provide a critical framework for the dissemination and maintenance of TW community norms, they have not previously been used as a framework for HIV prevention.

We 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, we 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.

Aim 1. To conduct an open evaluation of a social network-based PrEP adherence intervention for TW in Peru. The intervention will be piloted with a group of 10-15 TW recruited from a social network within a single geographic area. Using a dynamic process of implementation, refinement, and re-implementation over a 6-month period, we will assess acceptability and feasibility of specific intervention and evaluation components. Data will be used to finalize the study design, intervention manual, and quantitative assessment tools for the pilot randomized controlled trial.

Aim 2. To conduct a pilot RCT of a social network-based PrEP adherence intervention for TW in Peru. The investigators plan to enroll 6 social network clusters of TW (3 clusters per arm, recruited from 2 seeds matched from 3 geographical areas in Lima, Peru) (total N=90 TW enrolled [15 TW per cluster] to achieve at least N=60 TW completers [10 TW per cluster]) that will be randomized to participate in either the network-based PrEP adherence intervention or a control intervention. The primary outcome will be adherence to PrEP (measured via laboratory analysis of presence of detectable drug in serum, laboratory analysis of presence of detectable drug in hair, and participant self-report). The major secondary outcome will be behavioral risk compensation, specifically the degree to which participants in the two arms do or do not modify HIV risk behaviors while taking PrEP. Behavioral and biological assessments will be conducted at Baseline, 3-month, and 6-month intervals.

Conditions
HIV Infection
Being tested
Social Network-Based Adherence Intervention, Social Media Platform
Keywords
Transgender women, HIV Pre-Exposure Prophylaxis, Adherence, Peru, Social Networks
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Social Network-Based Adherence InterventionBehavioural

    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.

  • Social Media PlatformBehavioural

    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.

Study groups in NCT02710032
Study groupRoleWhat they receive
InterventionExperimentalSocial Network-Based Adherence Intervention
Receives: Behavioral: Social Network-Based Adherence Intervention; Behavioral: Social Media Platform
ControlNo interventionControl

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum Drug Level

    Serum monitoring of Truvada drug level

    Measured: 6 Months

Secondary outcomes (2)
  1. Self-reported Adherence

    Self-reported adherence to Truvada

    Measured: 6 Months

  2. Hair Sample Drug Level

    Hair sample monitoring of Truvada drug level

    Measured: 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2016 (estimated)
  2. Study start1 Jul 2017
  3. Primary completion31 Jul 2018
  4. Study completion31 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02710032
Sponsor's protocol ID
R34MH104072
Acronym
TransPrEP
Status last verified
Aug 2018
First submitted
8 Mar 2016
Last updated
7 Aug 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Social Network-Based Adherence Intervention and Social Media Platform in people with HIV Infection, run by University of California, Los Angeles at 1 site in Peru.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum Drug Level (time frame: 6 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2018.

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