- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02918799
Pilot of Mpowerment for Young Men Who Have Sex With Men (YMSM) in Beirut
October 5, 2020 updated by: RAND
Pilot of Culturally Tailored Mpowerment for HIV Prevention Among YMSM in Beirut
This project will adapt and pilot a multi-level, community-based intervention to promote HIV prevention and sexual health among young men who have sex with men in Beirut.
Study Overview
Detailed Description
Mpowerment (MP) is an evidence-based community-level, structural, social and behavioral intervention for HIV prevention developed for YMSM that targets individual and community empowerment and mobilization, self-affirmation, sexual self-knowledge, and creation of a supportive social environment.
MP has been widely used in the U.S., but not in a mostly Muslim setting.
This project will adapt and pilot MP for the sociocultural issues facing YMSM (age 18-29) in Beirut.
There will be a 2-year pilot implementation of MP, with longitudinal cohorts of YMSM in Beirut and Jounieh, the latter being the control community.
Primary outcomes will be unprotected anal sex and HIV testing, with secondary outcomes being engagement in peer outreach, and perceived peer norms related to condom use and HIV testing.
Study Type
Interventional
Enrollment (Actual)
226
Phase
- Not Applicable
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
Ages Eligible for Study
14 years to 25 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- men aged 18-29, who have had anal sex with men in the past 6 months
Exclusion Criteria:
- not residing in Lebanon
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Community cohort
Beirut community will receive the multi-component intervention Mpowerment; the community cohort of YMSM will be used to evaluate the effects of the intervention on the community, as the cohort participants may or may not have participated in the intervention.
|
MP is a multi-level intervention that reaches out to all YMSM in a community by mobilizing men to encourage their friends to reduce risk behavior and join the program (informal outreach), along with holding social activities that promote safe sex (formal outreach).
MP provides YMSM with skills, support and confidence to find solutions within themselves for sexual health, and seeks to affirm the validity and rights of same-sex behavior and identities.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
condomless anal sex
Time Frame: past 3 months
|
condomless anal sex with HIV+ or unknown status partners in past 3 months will be assessed via questionnaire
|
past 3 months
|
|
HIV testing
Time Frame: past 6 months
|
Variable will be assessed via questionnaire
|
past 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Glenn Wagner, PhD, RAND
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)
August 1, 2016
Primary Completion (Actual)
January 1, 2020
Study Completion (Actual)
March 1, 2020
Study Registration Dates
First Submitted
September 16, 2016
First Submitted That Met QC Criteria
September 27, 2016
First Posted (Estimate)
September 29, 2016
Study Record Updates
Last Update Posted (Actual)
October 6, 2020
Last Update Submitted That Met QC Criteria
October 5, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 2014-0992
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.