Clinical trial NCT03213366: Social Media Based Peer-Led Intervention for HIV Prevention
Official title: Empowering With PrEP Cluster-Randomized Controlled Trial: A Social Media Based Peer-Led Intervention for HIV Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Prevention
PrEP Uptake
Keywords: PrEP
HIV prevention
Public Health Social Media Campaign
Peer Intervention
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Albert Einstein College of Medicine
name: National Institute of Mental Health (NIMH)
First posted: 2017-07-11
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There will be two groups of Peer Leaders recruited. One group of Peer Leaders will be randomized to deliver the E-PrEP intervention and the second group of peer leaders will be randomized to deliver a general health campaign (control).
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Number of Participants Intending to Start Using PrEP Over Time
timeFrame: baseline, 6 weeks, and 12 weeks
measure: Number of Participants Using PrEP Over Time
timeFrame: at baseline, 6 weeks, and 12 weeks
Secondary outcomes:
measure: Change in PrEP Knowledge
timeFrame: at baseline, 6 weeks, and 12 weeks
measure: PrEP Awareness
timeFrame: baseline, 6 weeks, 12 weeks
measure: PrEP Stigma
timeFrame: baseline, 6 weeks, 12 weeks
measure: Communication About PrEP
timeFrame: baseline, 6 weeks, 12 weeks
measure: PrEP Barriers
timeFrame: baseline, 6 weeks, 12 weeks
measure: Self-efficacy About Using PrEP
timeFrame: at baseline, 6 weeks, and 12 weeks
Other outcomes:
measure: Number of Participants With Self-reported HIV Testing
timeFrame: at baseline, 6 weeks, and 12 weeks
measure: Number of Participants With Self-reported Linkage-to-Care
timeFrame: at baseline, 6 weeks, and 12 weeks
measure: Trust in the Peer by Participant
timeFrame: at baseline and 6 weeks
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Viraj Patel, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Patel VV, Ginsburg Z, Golub SA, Horvath KJ, Rios N, Mayer KH, Kim RS, Arnsten JH. Empowering With PrEP (E-PrEP), a Peer-Led Social Media-Based Intervention to Facilitate HIV Preexposure Prophylaxis Adoption Among Young Black and Latinx Gay and Bisexual Men: Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2018 Aug 28;7(8):e11375. doi: 10.2196/11375.