Enhancing Recruitment, Linkage to Care and Treatment for HIV-Infected MSM in the United States

This study will use deep-chain respondent driven sampling (DC-RDS) and direct recruitment (DR) to identify and recruit HIV-infected MSM who are not virally suppressed. A subset of these men will be enrolled into one of two study arms. The intervention arm will provide a Case Manager (CM) intervention package designed to enhance linkage to care, antiretroviral treatment (ART) initiation, treatment adherence and retention in care. The control arm will provide the standard of care (SOC) for linkage to care, initiation of ART, treatment adherence and retention in care. The primary outcome of the study is viral suppression 12 months after enrollment. Phylogenetic methods will be used to evaluate the relationship between viruses in study participants. Mathematical modeling will be performed using demographic, behavioral, and clinical data generated from this study and other sources to estimate the population-level impact of the CM intervention on HIV incidence and to estimate the level of identification, linkage, ART coverage and viral suppression that would be required to achieve a substantial reduction in HIV incidence among MSM in the US settings where the study is conducted.

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