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.
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
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