Can community coalitions slash HIV rates in the south?
NCT ID NCT05075967
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a community-based approach to lower HIV rates among men who have sex with men (MSM) at highest risk in the southern United States. The strategy uses local coalitions to reduce barriers, promote testing, increase PrEP use, and improve care for those living with HIV. About 2,700 participants will be involved, and the goal is to see if this integrated plan boosts access to prevention and treatment services.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Health Access Coalitions (community coalition program)
- What this could lead to
- If successful, this could provide a proven community-led model to reduce new HIV infections among the most at-risk men in the American South.
- What could go wrong
- This is a large but early-stage behavioral study without a control group, so it's hard to know if changes are due to the strategy or other factors. Results may not apply to other regions or populations.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 2,700 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A research network
The lead sponsor is a research network or cooperative group.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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15 years and older
- Sex
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Male participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Cross-Sectional HHI MSM Client Assessment Inclusion Criteria * At least 18 years of age * Man * Self-reports a lifetime history of anal sex with another man (i.e., at any time in their life) * Determined to be HHI within the study community per Centers for Disease Control and Prevention surveillance data * Willing and able to provide consent to participate in the study * Have a medical visit scheduled during the designated sampling period at a PHASE treatment or prevention healthcare facility Cross-Sectional HHI MSM Client Assessment Exclusion Criteria Individuals who have any condition that, in the opinion of the Investigator of Record (IoR) or designee, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives, will be excluded from the cross-sectional assessment. There are no co-enrollment restrictions for participation in this assessment. \---------------------------------------- HHI MSM Clients In-depth Interviews (IDIs) Inclusion Criteria * Met inclusion criteria for the cross-sectional HHI MSM client assessment * Completed the cross-sectional HHI MSM client assessment * Willing and able to provide assent/consent HHI MSM Clients IDIs Exclusion Criteria Individuals who have any condition that, in the opinion of the Investigator of Record (IoR) or designee, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives, will be excluded from the qualitative interview. There are no co-enrollment restrictions for these interviews. \---------------------------------------- PHASE HCF Staff IDIs Inclusion Criteria * Is a staff member at a participating PHASE facility * Participated in at least one PHASE activity (e.g., attended a PHASE Foundation training, participated in Extension of Community Healthcare Outcomes training, member of PHASE quality improvement team) * Willing and able to provide consent PHASE HCF Staff IDIs Exclusion Criteria Individuals who have any condition that, in the opinion of the Investigator of Record (IoR) or designee, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives, will be excluded from the qualitative interview. There are no co-enrollment restrictions for these interviews \----------------------------------------
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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FHI 360
Durham, North Carolina, 27701, United States
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Other studies related to the condition(s) this trial covers.
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- New injectable HIV prevention drug tested in healthy volunteers