HIV/AIDS and InfectionsNCT03198663
POSSE Project: A Community-Level Intervention for Black YMSM
A study testing POSSE in people with HIV/AIDS and Infections, run by Cook County Health at 2 sites in United States.
Trial summary
Black young men who have sex with men (BYMSM) are at high risk for contracting and transmitting HIV, and represent a priority population for developing effective interventions. Within the House Ball community (HBC), a clandestine subculture of the Black gay community, HIV is highly stigmatized. Read more about this study
- Who is it for?
- Ages 15 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS and Infections
- What is being tested?
- POSSE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,037 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jun 2016to 1 Apr 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 15 to 25 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- self-identified as Black,
- between the ages of 15 - 24 (inclusive), and
- in attendance at a HBC event at the time of the assessment.
Who cannot join
- intoxicated or otherwise unable to consent at time of enrollment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Chicago, Illinois
Study site
Philadelphia, Pennsylvania
About this study
Black young men who have sex with men (BYMSM) are at high risk for contracting and transmitting HIV, and represent a priority population for developing effective interventions. Within the House Ball community (HBC), a clandestine subculture of the Black gay community, HIV is highly stigmatized. This stigma, coupled with high HIV prevalence rates and elevated levels of undiagnosed/untreated HIV infection, places BYMSM in HBCs at incredible risk for HIV infection. Community-level interventions that target social norms, behavior, and stigma in the HBC are sorely needed in order to make a broader impact among BYMSM. Building on prior work in the community, this study proposes to launch an innovative Effectiveness-Implementation Hybrid Type 2 trial to examine the effectiveness and implementation of a community-level HIV prevention intervention (called POSSE) based on popular opinion leader (POL) models across two cities with similar HBCs, Chicago and Philadelphia. The proposed study has two specific aims: 1) To determine the effectiveness of a POL intervention, POSSE, to decrease sexual risk behavior (UAI), STIs and HIV stigma among BYMSM in the HBC; and 2) To evaluate the processes, strategies, barriers and facilitators for the implementation of POSSE delivered across two distinct metropolitan areas with high HIV prevalence among BYMSM and similar House Ball Communities. To examine these aims, the investigators will first use social network strategies to identify, screen, and recruit POLs (n=75) from the Philadelphia HBC. The investigators will then gather baseline behavioral and biological (HIV/STI testing) data in both Chicago and Philadelphia (n=100 BYMSM per city) and train the Philadelphia POLs to implement the POSSE intervention. The investigators will conduct an implementation-focused process evaluation to assess fidelity to the POSSE intervention; number, content, spread, and acceptability of risk reduction messages; age appropriateness of the messages; acceptability of the overall intervention; and barriers/facilitators to implementation. Next, the investigators will complete follow-up assessments every 6 months post- intervention in both cities (n=100 BYMSM per city at each assessment point). The investigators will also assess behavior change in those delivering the intervention (POLs) at each assessment point. The investigators will conduct implementation-focused qualitative interviews with POLs (n=15) and community participants (n=30) from Philadelphia. Last, the investigators will implement POSSE in Chicago by repeating the steps outlined above, continuing assessments in both cities, and conducting qualitative interviews in Chicago.
- Conditions
- HIV/AIDS and Infections
- Being tested
- POSSE
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POSSEBehavioural
Popular-opinion leader
| Study group | Role | What they receive |
|---|---|---|
| POSSE Intervention | Experimental | Not described Receives: Behavioral: POSSE |
| Control | Other | Delayed intervention Receives: Behavioral: POSSE |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV incidence
Measured: 24 months
Secondary outcomes (1)
STI incidence
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start1 Jun 2016
- Primary completion1 Mar 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDS and InfectionsStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,037 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook County Health
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sybil Hosek, Cook County Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198663
- Sponsor's protocol ID
- R01MH104106
- Status last verified
- Jun 2023
- First submitted
- 7 Mar 2017
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POSSE Project: A Community-Level Intervention for Black YMSM
- ClinicalTrials.gov ID
- NCT03198663
- Acronym / sponsor ID
- R01MH104106
- Conditions
- HIV/AIDS and Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,037 participants (actual)
- Lead sponsor
- Cook County HealthOther government
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 26 Jun 2017 (actual)
- 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.
Black young men who have sex with men (BYMSM) are at high risk for contracting and transmitting HIV, and represent a priority population for developing effective interventions. Within the House Ball community (HBC), a clandestine subculture of the Black gay community, HIV is highly stigmatized. This stigma, coupled with high HIV prevalence rates and elevated levels of undiagnosed/untreated HIV infection, places BYMSM in HBCs at incredible risk for HIV infection. Community-level interventions that target social norms, behavior, and stigma in the HBC are sorely needed in order to make a broader impact among BYMSM. Building on prior work in the community, this study proposes to launch an innovative Effectiveness-Implementation Hybrid Type 2 trial to examine the effectiveness and implementation of a community-level HIV prevention intervention (called POSSE) based on popular opinion leader (POL) models across two cities with similar HBCs, Chicago and Philadelphia. The proposed study has two specific aims: 1) To determine the effectiveness of a POL intervention, POSSE, to decrease sexual risk behavior (UAI), STIs and HIV stigma among BYMSM in the HBC; and 2) To evaluate the processes, strategies, barriers and facilitators for the implementation of POSSE delivered across two distinct metropolitan areas with high HIV prevalence among BYMSM and similar House Ball Communities. To examine these aims, the investigators will first use social network strategies to identify, screen, and recruit POLs (n=75) from the Philadelphia HBC. The investigators will then gather baseline behavioral and biological (HIV/STI testing) data in both Chicago and Philadelphia (n=100 BYMSM per city) and train the Philadelphia POLs to implement the POSSE intervention. The investigators will conduct an implementation-focused process evaluation to assess fidelity to the POSSE intervention; number, content, spread, and acceptability of risk reduction messages; age appropriateness of the messages; acceptability of the overall intervention; and barriers/facilitators to implementation. Next, the investigators will complete follow-up assessments every 6 months post- intervention in both cities (n=100 BYMSM per city at each assessment point). The investigators will also assess behavior change in those delivering the intervention (POLs) at each assessment point. The investigators will conduct implementation-focused qualitative interviews with POLs (n=15) and community participants (n=30) from Philadelphia. Last, the investigators will implement POSSE in Chicago by repeating the steps outlined above, continuing assessments in both cities, and conducting qualitative interviews in Chicago.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POSSE Intervention | Experimental | Behavioral: POSSE |
| Control | Other | Behavioral: POSSEDelayed intervention |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- self-identified as Black,
- between the ages of 15 - 24 (inclusive), and
- in attendance at a HBC event at the time of the assessment.
Key exclusion criteria (1 listed)
- intoxicated or otherwise unable to consent at time of enrollment
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 |
|---|---|---|
| POSSEPopular-opinion leader | Behavioural | Control, POSSE Intervention |
Primary outcome
HIV incidence
Time frame: 24 months
1 secondary outcome
STI incidence
Time frame: 24 months
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 29 Jun 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POSSE in people with HIV/AIDS and Infections, run by Cook County Health at 2 sites in United States.
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 3 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 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
HIV incidence (time frame: 24 months). 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 29 Jun 2023.