Social Media Based Peer-Led Intervention for HIV Prevention

NCT03213366 | Completed Results

• 2 other identifiers: 2016-72635K23MH102118-04
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Prevention; PrEP Uptake

Keywords

PrEP; HIV prevention; Public Health Social Media Campaign; Peer Intervention

Outcome Measures

Primary Outcomes (2)

• Number of Participants Intending to Start Using PrEP Over Time

  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.

  baseline, 6 weeks, and 12 weeks

• Number of Participants Using PrEP Over Time

  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).

  at baseline, 6 weeks, and 12 weeks

Secondary Outcomes (6)

• 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

• Communication About PrEP

  baseline, 6 weeks, 12 weeks

• PrEP Barriers

  baseline, 6 weeks, 12 weeks

Other Outcomes (3)

• Number of Participants With Self-reported HIV Testing

  at baseline, 6 weeks, and 12 weeks

• Number of Participants With Self-reported Linkage-to-Care

  at baseline, 6 weeks, and 12 weeks

• Trust in the Peer by Participant

  at baseline and 6 weeks

Study Arms (2)

E-PrEP- Peer-Led Intervention about PrEP

EXPERIMENTAL

8 Peer Leaders (PLs) will be randomly assigned to the E-PrEP arm. Each of the PLs will recruit at least 15 participants into a private social media group on one of several social media platforms. PLs will then deliver a behavioral intervention over a 6 week period, posting information and engaging participants in a discussion about PrEP, PrEP access, and other related health issues. All contents will be formatted to be both mobile device accessible.

Behavioral: E-PrEP- Peer-Led Intervention about PrEP

BxNow - General Health Campaign

ACTIVE COMPARATOR

BxNow is an attention-matched control. Eight of the 16 PLs will be randomly assigned to the BxNow arm. The BxNow campaign will be a 6-week long social media intervention about general health wellness topics chosen and administered by the PLs assigned into this arm. Similarly to the intervention group, PLs in the BxNow arm will create private social media groups and recruit participants into these private groups. General health information in the BxNow arm will be posted with the same frequency as in the intervention arm.

Behavioral: BxNow - General Health Campaign

Interventions

E-PrEP- Peer-Led Intervention about PrEP BEHAVIORAL

Intervention contents and targets were informed by a systematic review of PrEP barriers and facilitators, a locally conducted qualitative study, and key informant and peer leader inputs. The contents were developed or adapted by study staff and peer leaders. Components and associated text have been designed to engage participants in online discussions about PrEP and related health and social topics. Posts will also include information about linkage-to-care, and insurance access. New contents will be posted almost daily.

E-PrEP- Peer-Led Intervention about PrEP

BxNow - General Health Campaign BEHAVIORAL

BxNow will focus on general health topics unrelated to HIV or sexual health (i.e. fitness, nutrition, smoking), as chosen by PLs. Contents will be developed or adapted by PLs and posted almost daily. Posts will also include information about linkage-to-care and insurance access. At the end of the intervention, BxNow participants will be exposed to E-PrEP components at the end of the trial.

BxNow - General Health Campaign

Eligibility Criteria

• Age: 18 Years - 29 Years
• Gender Eligibility Details: Including participants who self-identify as male or transgender individual and also have sex with men.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Montefiore Medical Center: lead
• National Institutes of Health (NIH): collaborator
• Albert Einstein College of Medicine: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Albert Einstein College of Medicine

The Bronx, New York, 10467, United States

Location

Related Publications (1)

• 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.

  PMID: 30154071 DERIVED

Results Point of Contact

• Title: Dr. Viraj V Patel
• Organization: Albert Einstein College of Medicine

vpatel@montefiore.org

718.920-7102

Study Officials

• Viraj Patel, MD, MPH

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Both Peer Leaders and participants will be masked to the group randomized to. The statistician, who will be analyzing the data, will also be masked to group assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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).

Study Record Dates

• First Submitted: March 28, 2017
• First Posted: July 11, 2017
• Study Start: June 16, 2017
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: November 6, 2019
• Results First Posted: September 6, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)