Enhancing Recruitment, Linkage to Care and Treatment for HIV-Infected MSM in the United States (NCT02663219) | Clinical Trial Compass
CompletedNot Applicable
Enhancing Recruitment, Linkage to Care and Treatment for HIV-Infected MSM in the United States
United States144 participantsStarted 2016-06-06
Plain-language summary
The purpose of this study is to develop and assess the efficacy of an integrated strategy that includes feasible and scalable interventions to identify, recruit, link to care, retain in care, attain, and maintain viral suppression among HIV-infected men who have sex with men (MSM) in the United States (US).
Who can participate
Age range
16 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.
Inclusion Criteria:
Individuals who meet all of the following criteria are eligible for study screening:
* Biological male (at birth)
* Self-report of history of anal intercourse with another man
* 16 years or older
Individuals who are eligible for screening and who meet all of the following criteria are eligible for enrollment into the CM intervention and SOC control arms:
* HIV-infected, as defined in the HPTN 078 Study-Specific Procedures (SSP) Manual
* Not virally suppressed (defined as HIV VL ≥ 1000 copies/ml)
* Can receive HIV care at one of the participating clinics (as chosen by each site)
* No current plan to relocate in the 24 months following enrollment
Exclusion Criteria:
Individuals who meet any of the following criteria will be excluded from study screening:
* Unable or unwilling to provide consent/assent for study participation.
* Active or previous participation in an HIV vaccine trial.
* Any condition that, in the opinion of the Investigator of Record (IoR), would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Individuals who are eligible for screening, but who meet the following criteria are excluded from enrollment into the CM intervention and SOC control arms:
• Current participation in a linkage or ART adherence study
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.
1This trial focused on recruiting HIV-positive men who have sex with men and then linking them to care — since it's now completed, can you tell me whether there are published results showing whether the approach actually helped people get into treatment and lower their viral loads over the 24 months?
2The trial measured HIV viral load at both the start and again at 24 months — what does a change in viral load over that timeframe actually mean for someone's long-term health, and how does that compare to what I might expect from starting standard care today?
3Since this study was about improving how people get connected to HIV care rather than testing a specific drug, does that mean participants were still receiving standard HIV treatment throughout, and would enrolling in something like this have affected my access to other treatment options?
4This trial is listed as 'Phase NA,' which suggests it was more of a behavioral or systems-level intervention than a drug trial — can you help me understand what that means for how much is known about the risks and benefits compared to a traditional Phase 2 or Phase 3 drug study?
5Given that this trial is now completed, are there similar ongoing studies or care-linkage programs based on its findings that might be relevant to my situation, or would jumping straight into standard HIV treatment be the more practical path for me right now?
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
1
HIV status at screening for each MSM recruited
Timeframe: At Baseline
2
HIV viral load at screening for each MSM recruited
Timeframe: 12 months
3
HIV viral load at month 24 of participants randomized