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

• ClinicalTrials.gov Identifier: NCT02663219
• Recruitment Status: Unknown
• First Posted: January 26, 2016
• Last Update Posted: January 10, 2018
• Sponsor: HIV Prevention Trials Network
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Information provided by (Responsible Party): HIV Prevention Trials Network

Study Description

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).

Condition or disease	Intervention/treatment	Phase
HIV	Behavioral: Intervention	Not Applicable

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 24 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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 356 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Enhancing Recruitment, Linkage to Care and Treatment for HIV-Infected Men Who Have Sex With Men (MSM) in the United States
• Actual Study Start Date: June 6, 2016
• Estimated Primary Completion Date: February 2019
• Estimated Study Completion Date: February 2019

Arms and Interventions

Arm	Intervention/treatment
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 Name: Case Management
No Intervention: Control; Standard of care

Outcome Measures

Primary Outcome Measures :

1. HIV status at screening for each MSM recruited [ Time Frame: UP to 24 months ]
2. HIV viral load at screening for each MSM recruited [ Time Frame: Up to 24 months ]

Secondary Outcome Measures :

1. HIV prevalence [ Time Frame: Up to 24 months ]
   comparison between those who enrolled
2. HIV viral load after enrollment [ Time Frame: Up to 24 months measured at months 3, 6, 9, 12, 18 and 24 ]
3. Number of times participants are linked to care [ Time Frame: Up to 24 months ]
4. HCV status at baseline [ Time Frame: Up to 24 months ]
5. HIV viral load at end of study [ Time Frame: Up to 24 months ]
6. Baseline Demographics [ Time Frame: Up to 24 months ]
   participant-administered questionnaire
7. CD4 status at baseline [ Time Frame: Up to 24 months ]
8. Self-reported sexual risk behavior of unprotected anal intercourse, characteristics of 3 most recent partners) at baseline and 24 months [ Time Frame: Up to 24 months ]
   participant-administered questionnaire
9. Antiretroviral adherence at 24 months [ Time Frame: Up to 24 months ]
   viral load and cd4 are the biomarkers for adherence

Other Outcome Measures:

1. Health care utilization at baseline and 24 months [ Time Frame: Up to 24 months ]
   computer assisted self interview
2. Stigma at baseline and 24 months [ Time Frame: Up to 24 months ]
   computer assisted self interview
3. Number of contacts (text message, email, phone, in person) for each participant randomized to the CM intervention arm over follow-up [ Time Frame: Up to 24 months ]
4. Satisfaction with the CM intervention components, as measured on a Likert scale during a standardized exit interview [ Time Frame: Up to 24 months ]
5. Usefulness of the CM intervention components, as measured on a Likert scale during a standardized exit interview [ Time Frame: Up to 24 months ]
6. Open-ended questions regarding linkage to HIV care [ Time Frame: Up to 24 months ]
   open ended qualitative data compiled and coded
7. The phylogenetic relationship between HIV sequences [ Time Frame: Up to 24 months ]
   relationship between HIV strains in different men
8. HIV viral load at baseline [ Time Frame: Up to 24 months ]
9. Syphilis positive or negative at baseline [ Time Frame: Up to 24 months ]
10. HIV viral suppression [ Time Frame: Up to 24 months ]

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Alabama

Alabama CRS

Birmingham, Alabama, United States, 35294

United States, Georgia

Ponce de Leon CRS

Atlanta, Georgia, United States, 30308-2012

United States, Maryland

Johns Hopkins Baltimore CRS

Baltimore, Maryland, United States, 21287

United States, Massachusetts

Fenway Health CRS

Boston, Massachusetts, United States, 02215-4302

Sponsors and Collaborators

HIV Prevention Trials Network

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

More Information

Additional Information:

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

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

• Responsible Party: HIV Prevention Trials Network
• ClinicalTrials.gov Identifier: NCT02663219
• Other Study ID Numbers: HPTN 078; UM1AI068619 ( U.S. NIH Grant/Contract ); 11995 ( Other Identifier: DAIDS )
• First Posted: January 26, 2016
• Last Update Posted: January 10, 2018
• Last Verified: January 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by HIV Prevention Trials Network:

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