Enhanced Access to HIV Care for Drug Users in San Juan, Puerto Rico

Summary

The overall goal of this project is to implement and evaluate a community-level, structured approach to enhance HIV care access and retention for drug users in San Juan, Puerto Rico. The "Enhanced HIV Care Access and Retention Intervention" will: 1) identify drug users living with HIV who either do not know their HIV status and/or are not engaged in HIV care; 2) provide direct HIV care services through a mobile health van; and 3) support identified HIV-infected drug users with patient navigators to enhance their ability to engage in HIV care and substance abuse treatment, to initiate antiretroviral therapy, and maintain adherence to their treatment regimens. The structural enhanced care approach will be evaluated through a randomized roll-out design, a refinement of the stepped-wedge design. The community-level success of the intervention will be assessed by evaluating virologic suppression (primary biological outcome), increased attendance to HIV care visits, uptake of antiretroviral therapy, adherence to HIV treatment regimens, and decreased substance use (as secondary behavioral outcomes) in an independent cohort of HIV-positive individuals drawn from each of the neighborhoods included in the intervention. The investigators will also evaluate the implementation process and cost of the enhanced care approach including implications for cost-effectiveness, feasibility of expansion, and sustainability.

Conditions

• HIV
• AIDS
• Substance Abuse

Interventions

BEHAVIORAL

Enhanced HIV Care Access and Retention Intervention

Through the Enhanced HIV Care Access and Retention Intervention, the five neighborhoods will receive the 4 components of the intervention: 1) HIV Testing Campaign; 2) Treatment Re-engagement Campaign; 3) Patient Navigator Linkage to Care and Substance Abuse Treatment Team; and 4) Mobile Care Clinic. In addition to these intervention components, study participants will receive screening and access to treatment for other physical and mental co-morbidities, general primary health care, and social/psychosocial services addressing unstable housing, food insecurity, interpersonal violence, legal issues. All HIV-positive IDUs identified either through the HIV Testing Campaign or the Treatment Re-engagement Campaign will be enrolled in the HIV Care Cohort. The HIV Care Cohort will be comprised of the HIV-positive injectors who are receiving direct services in the Mobile Care Clinic. The 4 intervention components are detailed below:

BEHAVIORAL

HIV Testing Campaign

When the intervention is initiated in a neighborhood, HIV rapid testing will begin and continue in a particular neighborhood from the time that the neighborhood's intervention begins until the end of the study period. Anyone testing HIV positive will be seen and counseled by a member of the Patient Navigator Team.

BEHAVIORAL

Treatment Re-engagement Campaign

Simultaneously with the introduction of the HIV Testing Campaign, a patient navigator team will approach HIV-positive IDUs identified as not having seen their HIV care provider in the last 6 months. In addition, known HIV-positive IDUs within the designated neighborhoods will be approached for service enrollment and meet with a patient navigator.

BEHAVIORAL

Patient Navigator Linkage to Care and Substance Abuse Treatment Team

The patient navigator team will provide informational support to the HIV-positive injectors, motivate them to attend HIV care visits and engage in substance abuse treatment, encourage their use of and adherence to antiretroviral therapies, and work with them to overcome any barriers to attendance at HIV care visits and substance abuse treatment. All clients of the patient navigator will become part of the HIV Care Cohort; they will have been identified either in the HIV Testing Campaign or the Treatment Re-Engagement Campaign.

BEHAVIORAL

Mobile Care Clinic

Participants who choose to receive services in the study mobile HIV care clinic will receive an initial appointment and the patient navigator will ensure that the client attends it. At the initial visit, clients will have a medical history taken, be examined and have blood drawn to measure CD4 and viral load. The mobile care clinic doctor will also prescribe medications for the client at the subsequent visit which will be scheduled as soon as lab results are available and interpreted, approximately one week later. The mobile HIV care clinic van will provide health services to the general IDU population within each intervention neighborhood to avoid any stigmatization of the HIV positive clients.

Sponsors & Collaborators

• University of Puerto Rico

  collaborator OTHER

• Iniciativa Comunitaria de Investigacion

  collaborator UNKNOWN

• Puerto Rico Department of Health

  collaborator UNKNOWN

• University of Miami

  collaborator OTHER

• Weill Medical College of Cornell University

  collaborator OTHER

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• Columbia University

  lead OTHER

Principal Investigators

• Lisa Metsch, Ph.D. · Columbia University

• Jorge Santana, M.D. · University of Puerto Rico Medical Sciences Campus

• Sandra Miranda De Leon, M.P.H. · Puerto Rico Department of Health

• Daniel Feaster, Ph.D. · University of Miami

• Bruce Schackman, Ph.D. · Joan & Sanford I. Weill Medical College of Cornell University

• Glenda Davila, M.D. · Iniciativa Comunitaria de Investigacion, Inc.

• Lauren K. Gooden, Ph.D · Columbia University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-12-20

Primary Completion

2020-08-31

Completion

2021-07-31

Countries

• Puerto Rico

Study Locations