By InvitationNot Applicable

Getting to Zero Among HHI MSM in the American South

United States2,700 participantsStarted 2025-12-10

Plain-language summary

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.

Who can participate

Age range

15 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 inter…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To evaluate whether the HPTN 096 integrated strategy increases the number of HHI MSM clients at PHASE healthcare facilities.

Timeframe: Month 12

To evaluate whether the HPTN 096 integrated strategy increases retention in care among HHI MSM living with HIV at PHASE healthcare facilities.

Timeframe: Month 12

To evaluate whether the HPTN 096 integrated strategy increases PrEP prescriptions for HHI MSM not living with HIV at PHASE healthcare facilities.

Timeframe: Month 12

Trial details

NCT IDNCT05075967

SponsorHIV Prevention Trials Network

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2028-12-31

View on ClinicalTrials.gov More HIV Infections trials

Plain-language summary

Who can participate

Age range

15 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

To evaluate whether the HPTN 096 integrated strategy increases the number of HHI MSM clients at PHASE healthcare facilities.

Timeframe: Month 12

To evaluate whether the HPTN 096 integrated strategy increases retention in care among HHI MSM living with HIV at PHASE healthcare facilities.

Timeframe: Month 12

To evaluate whether the HPTN 096 integrated strategy increases PrEP prescriptions for HHI MSM not living with HIV at PHASE healthcare facilities.

Timeframe: Month 12