NCT05075967Enrolling by invitation
Getting to Zero Among HHI MSM in the American South
Getting to Zero Among Highest HIV Incidence (HHI) Men Who Have Sex With Men (MSM) in the American South: Testing an Integrated Strategy
Source: ClinicalTrials.gov · Last updated 13 Mar 2026
Brief summary (registry, in English)
This study will evaluate a status-neutral integrated strategy to improve access to and uptake of HIV prevention and treatment services for the highest HIV incidence (HHI) men who have sex with men (MSM) in participating communities. The ultimate goal is to establish a strategy to reduce HIV incidence among HHI MSM in the southern United States (US) by increasing the number of HHI MSM accessing prevention and treatment services, increasing uptake and use of pre-exposure prophylaxis (PrEP) among those living without HIV and increasing retention in care, and thus viral suppression, among those living with HIV.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 2700 (estimated)
- First submitted
- 19 Aug 2021
- Start date
- 10 Dec 2025
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- HIV Prevention Trials Network
- Diseases
- HIV
- NCT number
- NCT05075967
What you commit to
- Study type: Interventional
- Planned participants: 2700
- From 10 Dec 2025 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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.
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- 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.
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- 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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Age in the registry: 15 years to - · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| FHI 360 Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.