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 range16 Years
SexMALE
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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
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