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Social Media Based Peer-Led Intervention for HIV Prevention

Primary Purpose

HIV Prevention, PrEP Uptake

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
E-PrEP- Peer-Led Intervention about PrEP
BxNow - General Health Campaign
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Prevention focused on measuring PrEP, HIV prevention, Public Health Social Media Campaign, Peer Intervention

Eligibility Criteria

18 Years - 29 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Albert Einstein College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

E-PrEP- Peer-Led Intervention about PrEP

BxNow - General Health Campaign

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

Change in PrEP Knowledge
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
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
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
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
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
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.

Full Information

First Posted
March 28, 2017
Last Updated
October 25, 2019
Sponsor
Montefiore Medical Center
Collaborators
National Institutes of Health (NIH), Albert Einstein College of Medicine, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT03213366
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
June 16, 2017 (Actual)
Primary Completion Date
November 1, 2017 (Actual)
Study Completion Date
November 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montefiore Medical Center
Collaborators
National Institutes of Health (NIH), Albert Einstein College of Medicine, National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Prevention, PrEP Uptake
Keywords
PrEP, HIV prevention, Public Health Social Media Campaign, Peer Intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
152 (Actual)

8. Arms, Groups, and Interventions

Arm Title
E-PrEP- Peer-Led Intervention about PrEP
Arm Type
Experimental
Arm Description
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.
Arm Title
BxNow - General Health Campaign
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
E-PrEP- Peer-Led Intervention about PrEP
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
BxNow - General Health Campaign
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants Intending to Start Using PrEP Over Time
Description
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.
Time Frame
baseline, 6 weeks, and 12 weeks
Title
Number of Participants Using PrEP Over Time
Description
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).
Time Frame
at baseline, 6 weeks, and 12 weeks
Secondary Outcome Measure Information:
Title
Change in PrEP Knowledge
Description
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.
Time Frame
at baseline, 6 weeks, and 12 weeks
Title
PrEP Awareness
Description
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.
Time Frame
baseline, 6 weeks, 12 weeks
Title
PrEP Stigma
Description
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.
Time Frame
baseline, 6 weeks, 12 weeks
Title
Communication About PrEP
Description
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).
Time Frame
baseline, 6 weeks, 12 weeks
Title
PrEP Barriers
Description
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.
Time Frame
baseline, 6 weeks, 12 weeks
Title
Self-efficacy About Using PrEP
Description
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.
Time Frame
at baseline, 6 weeks, and 12 weeks
Other Pre-specified Outcome Measures:
Title
Number of Participants With Self-reported HIV Testing
Description
Self-reported HIV testing at baseline, 6 weeks, and 12 weeks.
Time Frame
at baseline, 6 weeks, and 12 weeks
Title
Number of Participants With Self-reported Linkage-to-Care
Description
Self-reported information about health care access (i.e. going to a medical appointment).
Time Frame
at baseline, 6 weeks, and 12 weeks
Title
Trust in the Peer by Participant
Description
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.
Time Frame
at baseline and 6 weeks

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Including participants who self-identify as male or transgender individual and also have sex with men.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Viraj Patel, MD, MPH
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30154071
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.
Results Reference
derived

Learn more about this trial

Social Media Based Peer-Led Intervention for HIV Prevention

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