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

HIV Prevention Trials Network144 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

144

Conditions

HIV

Interventions

InterventionBEHAVIORAL

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.

Eligibility

Sex: MALEMin age: 16 Years

Medical Language ↔ Plain English

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

Locations (4)

Alabama CRS

Birmingham, Alabama, United States

Ponce de Leon CRS

Atlanta, Georgia, United States

Johns Hopkins Baltimore CRS

Baltimore, Maryland, United States

Fenway Health CRS

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

HIV status at screening for each MSM recruited

HIV status

Time frame: At Baseline

HIV viral load at screening for each MSM recruited

HIV viral load

Time frame: 12 months

HIV viral load at month 24 of participants randomized

time driven HIV viral load

Time frame: 24 months

Secondary Outcomes

Date of recruitment for each man recruited by DC-RDS

recruitment timeline

Time frame: During recruitment period

Wave of recruitment for each man recruited by DC-RDS

recruitment timeline

Time frame: During recruitment period

HIV viral load of those randomized

HIV viral load

Time frame: 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

Time frame: Over 12 months

Time of all care visits from randomization through the end of 12 months follow up

clinical care uptake

Time frame: Over 12 months

HCV status at baseline

HCV status

Data from ClinicalTrials.gov

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