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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02663219
• Other study ID #: HPTN 078
• Secondary ID: UM1AI06861911995
• Status: Completed
• Phase: N/A
• Start date: June 6, 2016
• Est. completion date: February 8, 2019

Study information

• Verified date: August 2022
• Source: HIV Prevention Trials Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: February 8, 2019
• Est. primary completion date: February 8, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV

Intervention

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.

Locations

Country	Name	City	State
United States	Ponce de Leon CRS	Atlanta	Georgia
United States	Johns Hopkins Baltimore CRS	Baltimore	Maryland
United States	Alabama CRS	Birmingham	Alabama
United States	Fenway Health CRS	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
HIV Prevention Trials Network	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health care utilization at baseline and 24 months	computer assisted self interview	Up to 24 months
Other	Stigma at baseline and 24 months	computer assisted self interview	Up to 24 months
Other	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
Other	Open-ended questions for process evaluation	Open ended qualitative data compiled and coded	Up to 12 months
Other	The phylogenetic relationship between HIV sequences	HIV genetic sequencing	Up to 24 months
Other	Syphilis positive or negative at baseline	STI description at baseline	Up to 24 months
Primary	HIV status at screening for each MSM recruited	HIV status	At Baseline
Primary	HIV viral load at screening for each MSM recruited	HIV viral load	12 months
Primary	HIV viral load at month 24 of participants randomized	time driven HIV viral load	24 months
Secondary	Date of recruitment for each man recruited by DC-RDS	recruitment timeline	During recruitment period
Secondary	Wave of recruitment for each man recruited by DC-RDS	recruitment timeline	During recruitment period
Secondary	HIV viral load of those randomized	HIV viral load	HIV viral load at Months 3, 6, 9, 12
Secondary	Number of all care visits from randomization through the end of 12 months follow up	clinical care uptake	Over 12 months
Secondary	Time of all care visits from randomization through the end of 12 months follow up	clinical care uptake	Over 12 months
Secondary	HCV status at baseline	HCV status	At Baseline
Secondary	Baseline Demographics	Participant-administered questionnaire	At Baseline
Secondary	CD4 status at baseline	CD4 cell count	At Baseline
Secondary	HIV viral load status at baseline	HIV viral load	At Baseline
Secondary	Syphilis status at baseline	Syphilis status	At Baseline
Secondary	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

External Links

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