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

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

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).

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Behavioral: Intervention

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 Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Alabama CRS
  • Georgia
    • Atlanta, Georgia, United States, 30308-2012
      • Ponce de Leon CRS
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Baltimore CRS
  • Massachusetts
    • Boston, Massachusetts, United States, 02215-4302
      • Fenway Health CRS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Standard of care
Experimental: 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.	Behavioral: 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.; Other Names: Case Management

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health care utilization at baseline and 24 months	computer assisted self interview	Up to 24 months
Stigma at baseline and 24 months	computer assisted self interview	Up to 24 months
Number of contacts (text message, email, phone, in person) for each participant randomized to the CM intervention arm over follow-up	clinical contact	Up to 24 months
Open-ended questions for process evaluation	Open ended qualitative data compiled and coded	Up to 12 months
The phylogenetic relationship between HIV sequences	HIV genetic sequencing	Up to 24 months
Syphilis positive or negative at baseline	STI description at baseline	Up to 24 months

Collaborators and Investigators

• Sponsor: HIV Prevention Trials Network
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Study Chair: Chris Beyrer, MD/MPH, Johns Hopkins University; Study Chair: Robert H Remien, PhD, Columbia University

Publications and helpful links

General Publications

• KM Mitchell, B Hoots, D Dimitrov, et al. Potential Impact on HIV Incidence of Increasing Viral Suppression among HIV- positive MSM in Baltimore: Mathematical Modelling for HPTN 078. HIV Research for Prevention (HIVR4P 2016). Chicago, October 17-21, 2016. Abstract OA10.04

Helpful Links

• Potential Impact on HIV Incidence of Increasing Viral Suppression among HIV- positive MSM in Baltimore: Mathematical Modelling for HPTN 078

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2016
• Primary Completion (Actual): February 8, 2019
• Study Completion (Actual): February 8, 2019

Study Registration Dates

• First Submitted: January 13, 2016
• First Submitted That Met QC Criteria: January 21, 2016
• First Posted (Estimated): January 26, 2016

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 20, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: MSM; RDS; ART; CCM; PAF; PEP; DAIDS; HPTN; ACA
• Other Study ID Numbers: HPTN 078; 11995 (Other Identifier: DAIDS); UM1AI068619 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No