Social Media Based Peer-Led Intervention for HIV Prevention

• ClinicalTrials.gov Identifier: NCT03213366
• Recruitment Status: Completed
• First Posted: July 11, 2017
• Results First Posted: September 6, 2019
• Last Update Posted: November 6, 2019
• Sponsor: Montefiore Medical Center
• Collaborators: National Institutes of Health (NIH); Albert Einstein College of Medicine; National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Viraj V. Patel, Montefiore Medical Center

Tracking Information

• First Submitted Date: March 28, 2017
• First Posted Date: July 11, 2017
• Results First Submitted Date: April 25, 2019
• Results First Posted Date: September 6, 2019
• Last Update Posted Date: November 6, 2019
• Actual Study Start Date: June 16, 2017
• Actual Primary Completion Date: November 1, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 12, 2019)

• 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).

Original Primary Outcome Measures (submitted: July 7, 2017)

Change in Intention to use PrEP over time. [ Time Frame: baseline, 6 weeks, and 12 weeks ]

The primary outcome will be change in intention to use PrEP from baseline to 6 weeks and 12 weeks, and measured using a PrEP motivational scale. This outcome will inform sample size calculations for a subsequent fully powered trial.

Current Secondary Outcome Measures (submitted: October 25, 2019)

• Change in PrEP Knowledge [ Time Frame: at baseline, 6 weeks, and 12 weeks ]
  Self-reported PrEP related knowledge. Participants were asked two questions about PrEP knowledge. For each question, they got one point if the answer was correct. Scale range from 0-2. The score were added and the average of the sum was reported. The higher the score, the higher the knowledge of PrEP.
• PrEP Awareness [ Time Frame: baseline, 6 weeks, 12 weeks ]
  Awareness about PrEP. PrEP awareness was measured with one question, scored 1 to 5. The mean for each arm was calculated at each time point. The higher the score, the higher the level of awareness about PrEP.
• PrEP Stigma [ Time Frame: baseline, 6 weeks, 12 weeks ]
  Any stigma the participant might have about PrEP or those who use PrEP To measure PrEP Stigma we asked 3 questions, using a Likert scale (from 1-4; 1= Strongly Disagree, 4=Strongly Agree). The scores were summed for each participant. The scores range from 1-12, with higher scores indicating higher levels of PrEP Stigma. The higher the score, the higher the level of PrEP stigma.
• Communication About PrEP [ Time Frame: baseline, 6 weeks, 12 weeks ]
  Discussion of PrEP with friends, partners, or family. Communication about PrEP was measured with 2 questions, using a Likert scale ( from 1-5;1=Not at all, 5= Extremely). The scores of the 2 questions were summed for each participant. The scores range from 1-10, with higher the score indicating higher the level of communication about PrEP (i.e. higher scores indicates participants communicating more about PrEP).
• PrEP Barriers [ Time Frame: baseline, 6 weeks, 12 weeks ]
  Any Barriers to PrEP uptake. To measure barriers to PrEP uptake, 7 items were used. Each item was measured using a likert scale ( from 1-4; 1=Strongly Disagree, 4= Strongly Agree). The scores of each question were summed for each participant (scale scores ranged 1-28, with higher scores indicating higher levels of PrEP Barriers). The higher the score, the higher the number of PrEP Barriers.
• Self-efficacy About Using PrEP [ Time Frame: at baseline, 6 weeks, and 12 weeks ]
  Self-reported answer to questions about self-efficacy of using PrEP. There were two questions to measure self-efficacy of PrEP using a Likert scale (ranging from 1-5; 1=Not at all, 5=Extremely). The scores from both questions were summed for each participant. The scale range from 1-10 with higher scores indicating higher the levels of PrEP self-efficacy.

Original Secondary Outcome Measures (submitted: July 7, 2017)

• Change in PrEP use [ Time Frame: at baseline, 6 weeks, and 12 weeks ]
  Self-reported PrEP use
• Change in PrEP Knowledge [ Time Frame: at baseline, 6 weeks, and 12 weeks ]
  Self-reported PrEP related knowledge
• Changes in Perceptions about PrEP [ Time Frame: at baseline, 6 weeks, and 12 weeks ]
  Self-reported questions about views about efficacy, side effects, etc of PrEP
• Changes in HIV testing and sexual behaviors [ Time Frame: at baseline, 6 weeks, and 12 weeks ]
  Self-reported HIV testing and sexual behaviors
• Changes in Linkage-to-Care [ Time Frame: at baseline, 6 weeks, and 12 weeks ]
  Self-reported information about health care access

Current Other Pre-specified Outcome Measures (submitted: October 25, 2019)

• Number of Participants With Self-reported HIV Testing [ Time Frame: at baseline, 6 weeks, and 12 weeks ]
  Self-reported HIV testing at baseline, 6 weeks, and 12 weeks.
• Number of Participants With Self-reported Linkage-to-Care [ Time Frame: at baseline, 6 weeks, and 12 weeks ]
  Self-reported information about health care access (i.e. going to a medical appointment).
• Trust in the Peer by Participant [ Time Frame: at baseline and 6 weeks ]
  The scale measure the level of trust the Participant had on the Peer's online post. Trust in the Peer Leader was measured using 4 questions, each scored from 1-7 (1=Strongly Disagree, 7=Strongly Agree). The score for the 4 questions was summed for each participant. The score ranged from 1-28 with higher scores indicating a higher level of trust the participant had in their Peer Leader.

Original Other Pre-specified Outcome Measures (submitted: July 7, 2017)

• Changes in Social Networks [ Time Frame: at baseline and 6 weeks ]
  To understand potential influence of social network changes on PrEP uptake
• Peer Relationship [ Time Frame: at baseline and 6 weeks ]
  Measure tie-strength and PL-Participant relationship to understand influence of a social media intervention on peer influence

Descriptive Information

• Brief Title: 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
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).

Masking: Double (Participant, Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Prevention

Condition

• HIV Prevention
• PrEP Uptake

Intervention

• Behavioral: E-PrEP- Peer-Led Intervention about PrEP
  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.
• Behavioral: BxNow - General Health Campaign
  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.

Study Arms

• Experimental: E-PrEP- Peer-Led Intervention about PrEP
  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.
  Intervention: Behavioral: E-PrEP- Peer-Led Intervention about PrEP
• Active Comparator: BxNow - General Health Campaign
  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.
  Intervention: Behavioral: BxNow - General Health Campaign

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 16, 2018): 152
• Original Estimated Enrollment (submitted: July 7, 2017): 240
• Actual Study Completion Date: November 1, 2017
• Actual Primary Completion Date: November 1, 2017 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Including participants who self-identify as male or transgender individual and also have sex with men.

• Ages: 18 Years to 29 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03213366
• Other Study ID Numbers: 2016-7263; 5K23MH102118-04 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Viraj V. Patel, Montefiore Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Montefiore Medical Center
• Original Study Sponsor: Same as current

Collaborators

• National Institutes of Health (NIH)
• Albert Einstein College of Medicine
• National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Viraj Patel, MD, MPH; Montefiore Medical Center

• PRS Account: Montefiore Medical Center
• Verification Date: October 2019