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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Enhancing Recruitment, Linkage to Care and Treatment for HIV-Infected Men Who Have Sex With Men (MSM) in the United States

Conditions
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HIV

Intervention / Treatment
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* Behavioral: Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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. | Behavioral: Intervention<br>* 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.<br>* Other names: Case Management;|
| No Intervention: Control<br>Standard of care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV status at screening for each MSM recruited | HIV status | At Baseline | 
| HIV viral load at screening for each MSM recruited | HIV viral load | 12 months | 
| HIV viral load at month 24 of participants randomized | time driven HIV viral load | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Date of recruitment for each man recruited by DC-RDS | recruitment timeline | During recruitment period | 
| Wave of recruitment for each man recruited by DC-RDS | recruitment timeline | During recruitment period | 
| HIV viral load of those randomized | HIV viral load | HIV viral load at Months 3, 6, 9, 12 | 
| Number of all care visits from randomization through the end of 12 months follow up | clinical care uptake | Over 12 months | 
| Time of all care visits from randomization through the end of 12 months follow up | clinical care uptake | Over 12 months | 
| HCV status at baseline | HCV status | At Baseline | 
| Baseline Demographics | Participant-administered questionnaire | At Baseline | 
| CD4 status at baseline | CD4 cell count | At Baseline | 
| HIV viral load status at baseline | HIV viral load | At Baseline | 
| Syphilis status at baseline | Syphilis status | At Baseline | 
| Self-reported sexual risk behavior of unprotected anal intercourse, characteristics of 3 most recent partners) at baseline and 24 months | participant-administered questionnaire | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MSM, ART, CCM, DAIDS, HPTN, ACA, PAF, PEP, RDS