HIV
Conditions
Keywords
MSM, ART, CCM, DAIDS, HPTN, ACA, PAF, PEP, RDS
Brief 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).
Detailed description
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.
Interventions
BEHAVIORALIntervention
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.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
HIV Prevention Trials Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HIV status at screening for each MSM recruited | At Baseline | HIV status |
| HIV viral load at month 24 of participants randomized | 24 months | time driven HIV viral load |
| HIV viral load at screening for each MSM recruited | 12 months | HIV viral load |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HIV viral load of those randomized | HIV viral load at Months 3, 6, 9, 12 | HIV viral load |
| Number of all care visits from randomization through the end of 12 months follow up | Over 12 months | clinical care uptake |
| Baseline Demographics | At Baseline | Participant-administered questionnaire |
| CD4 status at baseline | At Baseline | CD4 cell count |
| HIV viral load status at baseline | At Baseline | HIV viral load |
| Syphilis status at baseline | At Baseline | Syphilis status |
| Self-reported sexual risk behavior of unprotected anal intercourse, characteristics of 3 most recent partners) at baseline and 24 months | 12 months | participant-administered questionnaire |
| Time of all care visits from randomization through the end of 12 months follow up | Over 12 months | clinical care uptake |
| HCV status at baseline | At Baseline | HCV status |
| Date of recruitment for each man recruited by DC-RDS | During recruitment period | recruitment timeline |
| Wave of recruitment for each man recruited by DC-RDS | During recruitment period | recruitment timeline |
Other
| Measure | Time frame | Description |
|---|---|---|
| The phylogenetic relationship between HIV sequences | Up to 24 months | HIV genetic sequencing |
| Syphilis positive or negative at baseline | Up to 24 months | STI description at baseline |
| Health care utilization at baseline and 24 months | Up to 24 months | computer assisted self interview |
| Open-ended questions for process evaluation | Up to 12 months | Open ended qualitative data compiled and coded |
| Number of contacts (text message, email, phone, in person) for each participant randomized to the CM intervention arm over follow-up | Up to 24 months | clinical contact |
| Stigma at baseline and 24 months | Up to 24 months | computer assisted self interview |
Countries
United States
Outcome results
None listed