Social Media Based Peer-Led Intervention for HIV Prevention

HIV Prevention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03213366
• Other study ID #: 2016-7263
• Secondary ID: 5K23MH102118-04
• Status: Completed
• Phase: N/A
• Start date: June 16, 2017
• Est. completion date: November 1, 2017

Study information

• Verified date: October 2019
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: November 1, 2017
• Est. primary completion date: November 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 29 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• 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.
• 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.

Locations

Country	Name	City	State
United States	Albert Einstein College of Medicine	Bronx	New York

Sponsors (4)

Lead Sponsor	Collaborator
Montefiore Medical Center	Albert Einstein College of Medicine, National Institute of Mental Health (NIMH), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Self-reported HIV Testing	Self-reported HIV testing at baseline, 6 weeks, and 12 weeks.	at baseline, 6 weeks, and 12 weeks
Other	Number of Participants With Self-reported Linkage-to-Care	Self-reported information about health care access (i.e. going to a medical appointment).	at baseline, 6 weeks, and 12 weeks
Other	Trust in the Peer by Participant	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.	at baseline and 6 weeks
Primary	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
Primary	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	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.	at baseline, 6 weeks, and 12 weeks
Secondary	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.	baseline, 6 weeks, 12 weeks
Secondary	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.	baseline, 6 weeks, 12 weeks
Secondary	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).	baseline, 6 weeks, 12 weeks
Secondary	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.	baseline, 6 weeks, 12 weeks
Secondary	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.	at baseline, 6 weeks, and 12 weeks