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

October 19, 2023 updated by: Yale University
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
227

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
PrEP uptake
Time Frame: PrEP uptake at baseline
Actual PrEP uptake: participants self report if they use prep (Yes/No)
PrEP uptake at baseline
PrEP uptake
Time Frame: PrEP uptake (Yes/No) at 24-weeks
Actual PrEP uptake: participants self report if they use prep (Yes/No)
PrEP uptake (Yes/No) at 24-weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
HIV testing
Time Frame: baseline
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
Time Frame: 24-weeks
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
Time Frame: PrEP use intention at baseline
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
Time Frame: PrEP use intention at 24-weeks
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
Time Frame: PrEP knowledge at baseline
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
Time Frame: PrEP knowledge at 24-weeks
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
Time Frame: self efficacy to use PrEP at baseline
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
Time Frame: self efficacy to use PrEP at 24-weeks
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
Time Frame: motivation to use PrEP at baseline
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
Time Frame: motivation to use PrEP at 24-weeks
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
Time Frame: PrEP stigma at baseline
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
Time Frame: PrEP stigma at 24-weeks
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
Time Frame: Social support for PrEP use at baseline
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
Time Frame: Social support for PrEP use at 24-weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Substance Abuse and Mental Health Services Administration (SAMHSA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Frederick Altice, M.D., M.A., Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 5, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 23, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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