HIVNCT02918799
Pilot of Mpowerment for Young Men Who Have Sex With Men (YMSM) in Beirut
A study testing Mpowerment in people with HIV, run by RAND.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 29 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Mpowerment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- men aged 18-29, who have had anal sex with men in the past 6 months
Who cannot join
- not residing in Lebanon
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV
- Being tested
- Mpowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MpowermentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Community cohort | Other | 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. Receives: Behavioral: Mpowerment |
What is being measured
The primary outcome is the main question the study is designed to answer.
condomless anal sex
condomless anal sex with HIV+ or unknown status partners in past 3 months will be assessed via questionnaire
Measured: past 3 months
HIV testing
Variable will be assessed via questionnaire
Measured: past 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionJan 2020
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Intervention will be evaluated with community cohort and use of pre- post-intervention analysis plan
- Masking
- None (open label)
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Collaborators
- Lebanese AIDS Society, Arab Foundation for Freedom and Equality, University of California, San Francisco, AIDS Project Los Angeles
- Responsible party
- Sponsor
- Investigators
- Glenn Wagner, PhD, Principal investigator, RAND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02918799
- Sponsor's protocol ID
- 2014-0992
- Status last verified
- Oct 2020
- First submitted
- 16 Sep 2016
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot of Culturally Tailored Mpowerment for HIV Prevention Among YMSM in Beirut
- ClinicalTrials.gov ID
- NCT02918799
- Acronym / sponsor ID
- 2014-0992
- Conditions
- HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- RANDUniversity, hospital or other
- Collaborators
- Lebanese AIDS Society, Arab Foundation for Freedom and Equality, University of California, San Francisco, AIDS Project Los Angeles
- Study start
- Aug 2016 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 29 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intervention will be evaluated with community cohort and use of pre- post-intervention analysis plan
| Arm | Type | Receives |
|---|---|---|
| Community cohort | Other | Behavioral: MpowermentBeirut 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. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- men aged 18-29, who have had anal sex with men in the past 6 months
Key exclusion criteria (1 listed)
- not residing in Lebanon
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MpowermentMP 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. | Behavioural | Community cohort |
Primary outcome
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
HIV testing
Time frame: past 6 months
Variable will be assessed via questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glenn Wagner, PhD principal investigator
RAND
Questions about this trial
What is this clinical trial studying?
A study testing Mpowerment in people with HIV, run by RAND.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
condomless anal sex (time frame: past 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2020.