Clinical trial NCT02663219: Enhancing Recruitment, Linkage to Care and Treatment for HIV-Infected MSM in the United States
Official title: Enhancing Recruitment, Linkage to Care and Treatment for HIV-Infected Men Who Have Sex With Men (MSM) in the United States
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: MSM
ART
CCM
DAIDS
HPTN
ACA
PAF
PEP
RDS
Lead sponsor: HIV Prevention Trials Network
Sponsor class: NETWORK
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2016-01-26
Enrollment: 144
Sex: MALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: HIV status at screening for each MSM recruited
timeFrame: At Baseline
measure: HIV viral load at screening for each MSM recruited
timeFrame: 12 months
measure: HIV viral load at month 24 of participants randomized
timeFrame: 24 months
Secondary outcomes:
measure: Date of recruitment for each man recruited by DC-RDS
timeFrame: During recruitment period
measure: Wave of recruitment for each man recruited by DC-RDS
timeFrame: During recruitment period
measure: HIV viral load of those randomized
timeFrame: HIV viral load at Months 3, 6, 9, 12
measure: Number of all care visits from randomization through the end of 12 months follow up
timeFrame: Over 12 months
measure: Time of all care visits from randomization through the end of 12 months follow up
timeFrame: Over 12 months
measure: HCV status at baseline
timeFrame: At Baseline
measure: Baseline Demographics
timeFrame: At Baseline
measure: CD4 status at baseline
timeFrame: At Baseline
measure: HIV viral load status at baseline
timeFrame: At Baseline
measure: Syphilis status at baseline
timeFrame: At Baseline
measure: Self-reported sexual risk behavior of unprotected anal intercourse, characteristics of 3 most recent partners) at baseline and 24 months
timeFrame: 12 months
Other outcomes:
measure: Health care utilization at baseline and 24 months
timeFrame: Up to 24 months
measure: Stigma at baseline and 24 months
timeFrame: Up to 24 months
measure: Number of contacts (text message, email, phone, in person) for each participant randomized to the CM intervention arm over follow-up
timeFrame: Up to 24 months
measure: Open-ended questions for process evaluation
timeFrame: Up to 12 months
measure: The phylogenetic relationship between HIV sequences
timeFrame: Up to 24 months
measure: Syphilis positive or negative at baseline
timeFrame: Up to 24 months
Locations:
city: Birmingham
country: United States
facility: Alabama CRS
state: Alabama
city: Atlanta
country: United States
facility: Ponce de Leon CRS
state: Georgia
city: Baltimore
country: United States
facility: Johns Hopkins Baltimore CRS
state: Maryland
city: Boston
country: United States
facility: Fenway Health CRS
state: Massachusetts
Study officials:
affiliation: Johns Hopkins University
name: Chris Beyrer, MD/MPH
role: STUDY_CHAIR
affiliation: Columbia University
name: Robert H Remien, PhD
role: STUDY_CHAIR
References:
citation: 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