Peer-led Social Media Intervention to Prevent HIV Among Young Men Who Have Sex With Men (YMSM)

The aim of this study is to examine the effect of social media intervention on the use of pre-exposure prophylaxis (PrEP) by young men who have sex with men (YMSM) in the greater New Haven area.

Study Overview

• Status: Completed
• Conditions: Hiv; Pre-Exposure Prophylaxis; Men
• Intervention / Treatment: Behavioral: PrEP messages; Behavioral: Heath messages

Detailed Description

There are three specific aims of this study. In the first specific aim, two focus group discussions (FGDs) of YMSM will be conducted to assess the feasibility and acceptability of social media intervention. In the second specific aim of the study, a quasi-pre-post experimental study will be conducted to examine the effect of social media intervention on PrEP uptake (primary outcome) and PrEP use intention, HIV testing, PrEP knowledge, self-efficacy and social support (secondary outcome). In the third specific aim of the study, the most important topics around PrEP will be assessed on the Facebook page of the intervention group by conducting a content analysis.

• Study Type: Interventional
• Enrollment (Actual): 227
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University
    • New Haven, Connecticut, United States, 06510
      • APNH: A Place to Nourish your Health (APNH)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 29 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Biologically male or transgender man
• Self-identification as gay or bi-sexual
• Resident of greater New Haven area
• Willing and able to use Facebook during the span of the study

Exclusion Criteria:

• • Women will not be included in the study

  • Under the age of 18 and over the age of 29
  • Unable to provide informed consent
  • Verbally or physically threatening to research staff

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PrEP Messages; The peer leaders and the study staff will post PrEP related health messages	Behavioral: PrEP messages; The peer leaders and the study staff will post PrEP related health messages
Active Comparator: Health messages; The peer leaders and study staff will post general health messages that are not related to sexual health.	Behavioral: Heath messages; The peer leaders and study staff will post general health messages that are not related to sexual health

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PrEP uptake	Actual PrEP uptake: participants self report if they use prep (Yes/No)	PrEP uptake at baseline
PrEP uptake	Actual PrEP uptake: participants self report if they use prep (Yes/No)	PrEP uptake (Yes/No) at 24-weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV testing	Date of the last HIV test: participants self report the date of their last HIV test as a function of time in days.	baseline
HIV testing	Date of the last HIV test: participants self report the date of their last HIV test as a function of time in days.	24-weeks
PrEP use intention	Willingness to use/likelihood of using PrEP in the next 6 months : self reported assessment to measure participants' willingness to use prep in the next 6 month s on a single question using Likert scale from 1(very unlikely) to 7 (very likely)	PrEP use intention at baseline
PrEP use intention	Willingness to use/likelihood of using PrEP in the next 6 months : self reported assessment to measure participants' willingness to use prep in the next 6 month s on a single question using Likert scale from 1(very unlikely) to 7 (very likely)	PrEP use intention at 24-weeks
PrEP knowledge	Knowledge of PrEP for HIV prevention: self reported assessment to measure participants' knowledge on PrEP on a set of True or False questions	PrEP knowledge at baseline
PrEP knowledge	Knowledge of PrEP for HIV prevention: self reported assessment to measure participants' knowledge on PrEP on a set of True or False questions	PrEP knowledge at 24-weeks
self efficacy to use PrEP	Beliefs in his/her ability of using PrEP: participants self report their level of confidence in taking PrEP on a set of items using Likert scales from 1 (Not at all confident) to 5 (completely confident)	self efficacy to use PrEP at baseline
self efficacy to use PrEP	Beliefs in his/her ability of using PrEP: participants self report their level of confidence in taking PrEP on a set of items using Likert scales from 1 (Not at all confident) to 5 (completely confident)	self efficacy to use PrEP at 24-weeks
motivation to use PrEP	How motivated s/he is to use PrEP and what motivates s/he to use PrEP: self reported assessment to measure participants' different types of motivation to use PrEP on a set of items using Likert scales from 1(strongly disagree) to 7 (strongly agree)	motivation to use PrEP at baseline
motivation to use PrEP	How motivated s/he is to use PrEP and what motivates s/he to use PrEP: self reported assessment to measure participants' different types of motivation to use PrEP on a set of items using Likert scales from 1(strongly disagree) to 7 (strongly agree)	motivation to use PrEP at 24-weeks
PrEP stigma	Perceived stigma related to PrEP use: self reported assessment to measure perception of stigma related to PrEP use on a set of items using Likert scales from 1(strongly disagree) to 7 (strongly agree)	PrEP stigma at baseline
PrEP stigma	Perceived stigma related to PrEP use: self reported assessment to measure perception of stigma related to PrEP use on a set of items using Likert scales from 1(strongly disagree) to 7 (strongly agree)	PrEP stigma at 24-weeks
Social support for PrEP use	Help and support that individuals receive that can facilitate PrEP uptake: Perceived stigma related to PrEP use: self reported assessment to measure perception of social support related to PrEP use on a set of items using Likert scales from 1(strongly disagree) to 7 (strongly agree)	Social support for PrEP use at baseline
Social support for PrEP use	Help and support that individuals receive that can facilitate PrEP uptake: Perceived stigma related to PrEP use: self reported assessment to measure perception of social support related to PrEP use on a set of items using Likert scales from 1(strongly disagree) to 7 (strongly agree)	Social support for PrEP use at 24-weeks

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: Substance Abuse and Mental Health Services Administration (SAMHSA)
• Investigators: Principal Investigator: Frederick Altice, M.D., M.A., Yale University

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2018
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): April 1, 2023

Study Registration Dates

• First Submitted: June 2, 2020
• First Submitted That Met QC Criteria: June 2, 2020
• First Posted (Actual): June 5, 2020

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: pre-exposure prophylaxis (PrEP); social media intervention
• Other Study ID Numbers: 2000022728; 1H79TI080736 (Other Grant/Funding Number: Substance Abuse and Mental Health Services Administration)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All data will be kept confidential.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No