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Clinical Trials/NCT03213366
NCT03213366
Completed
N/A

Empowering With PrEP Cluster-Randomized Controlled Trial: A Social Media Based Peer-Led Intervention for HIV Prevention

Montefiore Medical Center1 site in 1 country152 target enrollmentJune 16, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
HIV Prevention
Sponsor
Montefiore Medical Center
Enrollment
152
Locations
1
Primary Endpoint
Number of Participants Intending to Start Using PrEP Over Time
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The purpose of this study is to test the feasibility, acceptability, and preliminary efficacy of E-PrEP on reaching young men of color who have sex with men (YMCSM) at high-risk of HIV infection to reduce HIV acquisition. E-PrEP is a peer-designed social media-based health intervention to increase PrEP awareness, knowledge, and motivation as a tool for HIV prevention and to increase linkage to primary care.

Detailed Description

This study examines a social media based peer-led and delivered intervention focused on increasing PrEP adoption in young men of color who have sex with men (YMCSM). While prior efficacy trials have included YMCSM 18-29, we will focus on PrEP in YMCSM outside clinical trial settings. Rather than an alternative medium for implementation of existing interventions designed for in-person contact, social media may be a true 'game changer' to engage hard to reach individuals. While many online behavioral interventions exist, including some that use social media, this will be one of the few studies to use and test social media to facilitate uptake of a biomedical intervention. E-PrEP will connect the target population (YMCSM) to a new prevention tool (PrEP) through rapid linkage to medical care, accelerating diffusion of PrEP. Given the paucity of data regarding social media-based interventions to change health-related behavior, E-PrEP may have a marked impact on future bio-behavioral interventions, especially those that include diffusion of innovation. Social media offers the power of scale and efficiency for large potential impact, even with relatively low-intensity interventions. Similarly, PrEP, if widely adopted in high-risk populations and offered with behavioral interventions, could markedly decrease HIV infection rates. Social media-based, peer-led approaches like E-PrEP could be used to enhance efforts by community-based and other organizations that employ internet-assisted or peer-outreach strategies to improve health. Primary Aim: To test the feasibility and preliminary efficacy of E-PrEP for increasing PrEP adoption in a cluster-randomized controlled trial.

Registry
clinicaltrials.gov
Start Date
June 16, 2017
End Date
November 1, 2017
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Viraj V. Patel

Assistant Professor

Montefiore Medical Center

Eligibility Criteria

Inclusion Criteria

  • Male or Transgender individual; Ages 18-29; Have had unprotected anal sex with a male partner in the prior 12 months; Fluent in English or Spanish; Are HIV-negative or unknown status (self-report); Identify as Black and/or Latino

Exclusion Criteria

  • YMCSM who do not consent/assent to study; not currently using at least one of 2 social media sites that will be used for the E-PrEP intervention (not using Facebook, or Instagram), and do not live in New York City.

Outcomes

Primary Outcomes

Number of Participants Intending to Start Using PrEP Over Time

Time Frame: baseline, 6 weeks, and 12 weeks

This primary outcome is intention to use PrEP in the next month measured at baseline, 6 weeks, and 12 weeks. This was assessed with a yes/no question (dichotomous variable). However, this variable does not include anyone who reported PrEP use at either 6 or 12 weeks. This outcome will inform sample size calculations for a subsequent fully powered trial.

Number of Participants Using PrEP Over Time

Time Frame: at baseline, 6 weeks, and 12 weeks

This outcome is the number of participants who self-report using PrEP at baseline, 6 weeks, or 12 weeks. This was measure by a yes/no question asking if the participant currently uses PrEP (dichotomous variable).

Secondary Outcomes

  • Self-efficacy About Using PrEP(at baseline, 6 weeks, and 12 weeks)
  • PrEP Barriers(baseline, 6 weeks, 12 weeks)
  • Communication About PrEP(baseline, 6 weeks, 12 weeks)
  • Change in PrEP Knowledge(at baseline, 6 weeks, and 12 weeks)
  • PrEP Awareness(baseline, 6 weeks, 12 weeks)
  • PrEP Stigma(baseline, 6 weeks, 12 weeks)

Study Sites (1)

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