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

NCT02663219 | Completed DMC

• 3 other identifiers: HPTN 078UM1AI06861911995
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 4

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).

Conditions

HIV

Keywords

MSM; ART; CCM; DAIDS; HPTN; ACA; PAF; PEP; RDS

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (11)

• Date of recruitment for each man recruited by DC-RDS

  During recruitment period

• Wave of recruitment for each man recruited by DC-RDS

  During recruitment period

• HIV viral load of those randomized

  HIV viral load at Months 3, 6, 9, 12

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

  Over 12 months

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

  Over 12 months

Other Outcomes (6)

• Health care utilization at baseline and 24 months

  Up to 24 months

• Stigma at baseline and 24 months

  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

  Up to 24 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

Standard of care

Interventions

Intervention BEHAVIORAL

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.

Also known as: Case Management

Intervention

Eligibility Criteria

• Age: 16 Years+
• Gender Eligibility Details: biologically male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HIV Prevention Trials Network: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (4)

Alabama CRS

Birmingham, Alabama, 35294, United States

Location

Ponce de Leon CRS

Atlanta, Georgia, 30308-2012, United States

Location

Johns Hopkins Baltimore CRS

Baltimore, Maryland, 21287, United States

Location

Fenway Health CRS

Boston, Massachusetts, 02215-4302, United States

Location

Related Publications (2)

• 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

  BACKGROUND

• Maragh-Bass AC, Hucks-Ortiz C, Beyrer C, Remien RH, Mayer K, Del Rio C, Batey DS, Farley JE, Gamble T, Tolley EE. Multilevel Stigma and Its Associations with Medical Care Ratings Among Men Who Have Sex With Men in HPTN 078. J Prim Care Community Health. 2023 Jan-Dec;14:21501319231175362. doi: 10.1177/21501319231175362.

  PMID: 37243342 DERIVED

Related Links

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

MeSH Terms

Interventions

Methods; Case Management

Intervention Hierarchy (Ancestors)

Investigative Techniques; Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Chris Beyrer, MD/MPH

  Johns Hopkins University

  STUDY CHAIR

• Robert H Remien, PhD

  Columbia University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2016
• First Posted: January 26, 2016
• Study Start: June 6, 2016
• Primary Completion: February 8, 2019
• Study Completion: February 8, 2019
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)