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

Not Applicable

Completed

• Conditions: HIV
• Interventions: Behavioral: Intervention

• Registration Number: NCT02663219
• Lead Sponsor: HIV Prevention Trials Network

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.

Study Timeline

• Study First Submitted: 2016-01-13
• Study First Submitted QC: 2016-01-21
• Study First Posted: 2016-01-26
• Study Start: 2016-06-06
• Primary Completion: 2019-02-08
• Study Completion: 2019-02-08
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-20
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 144

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Intervention	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Baseline Demographics	At Baseline	Participant-administered questionnaire
Wave of recruitment for each man recruited by DC-RDS	During recruitment period	recruitment timeline
Number of all care visits from randomization through the end of 12 months follow up	Over 12 months	clinical care uptake
Date of recruitment for each man recruited by DC-RDS	During recruitment period	recruitment timeline
HIV viral load of those randomized	HIV viral load at Months 3, 6, 9, 12	HIV viral load
HIV viral load status at baseline	At Baseline	HIV viral load
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
CD4 status at baseline	At Baseline	CD4 cell count
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

Trial Locations

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