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

NCT01792752 | Completed

• 2 other identifiers: AAAK88051R01DA035280-01
• Study Type: interventional
• Target: 2,082
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

HIV/AIDS; Drug Users; Puerto Rico

Outcome Measures

Primary Outcomes (1)

• HIV Virologic Suppression

  Assessment of success of the intervention will be measured by testing whether there is a significant change in virologic suppression associated with the intervention.

  Every 6 months for up to 36 months

Secondary Outcomes (6)

• Increasing HIV care visit attendance

  Every 6 months for up to 36 months

• Uptake of antiretroviral therapy

  Every 6 months for up to 36 months

• Adherence to HIV treatment regimens

  Every 6 months for up to 36 months

• Decreasing substance use

  Every 6 months for up to 36 months

• Consistency of enrollment in the intervention and receipt of intervention services across neighborhoods over time

  36 months

Study Arms (2)

Enhanced HIV Care Access and Retention Intervention

EXPERIMENTAL

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. The neighborhoods will receive the intervention at different times throughout the study period, but once the intervention is initiated in a neighborhood it will continue being implemented in that neighborhood until the end of the study period.

Behavioral: Enhanced HIV Care Access and Retention Intervention; Behavioral: HIV Testing Campaign; Behavioral: Treatment Re-engagement Campaign; Behavioral: Patient Navigator Linkage to Care and Substance Abuse Treatment Team; Behavioral: Mobile Care Clinic

Control / Neighborhood(s) not receiving the intervention

NO INTERVENTION

The neighborhood(s) not receiving the intervention will act as a control while the intervention is initiated and implemented in other neighborhoods. All neighborhoods will receive the intervention but at different times throughout the study period. Once the intervention is initiated in a neighborhood, that neighborhood will continue receiving the intervention until the end of the study period.

Interventions

Enhanced HIV Care Access and Retention Intervention BEHAVIORAL

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:

Enhanced HIV Care Access and Retention Intervention

HIV Testing Campaign BEHAVIORAL

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.

Enhanced HIV Care Access and Retention Intervention

Treatment Re-engagement Campaign BEHAVIORAL

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.

Enhanced HIV Care Access and Retention Intervention

Patient Navigator Linkage to Care and Substance Abuse Treatment Team BEHAVIORAL

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.

Enhanced HIV Care Access and Retention Intervention

Mobile Care Clinic BEHAVIORAL

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.

Enhanced HIV Care Access and Retention Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• be 18 years of age or older
• report having injected drugs (opioid or stimulants) at least once in the past 30 days
• provide written informed consent
• HIV Care Cohort
• be 18 years of age or older
• test HIV-seropositive through rapid testing (confirmed with Western Blot or immunofluorescence assay)
• report having injected drugs more than once per week for the past 30 days
• self-report that they have not been in HIV care for the past 6 months
• agree to have their blood drawn for CD4 and HIV plasma RNA testing
• live in one of the San Juan neighborhoods targeted for intervention
• provide basic contact information for follow-up
• sign a HIPAA Authorization/medical record release form
• provide written informed consent
• Assessment Cohort
• be 18 years of age or older

You may not qualify if:

• have significant cognitive or developmental impairment to the extent that they are unable to provide informed consent
• are terminated via Site PI decision

Sponsors & Collaborators

• Columbia University: lead
• University of Puerto Rico: collaborator
• Iniciativa Comunitaria de Investigacion: collaborator
• Puerto Rico Department of Health: collaborator
• University of Miami: collaborator
• Weill Medical College of Cornell University: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

Puerto Rico Department of Health

Rio Piedras, 00922, Puerto Rico

Location

Iniciativa Comunitaria de Investigacion, Inc.

San Juan, 00918, Puerto Rico

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Substance-Related Disorders; Drug Misuse

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Lisa Metsch, Ph.D.

  Columbia University

  PRINCIPAL INVESTIGATOR

• Jorge Santana, M.D.

  University of Puerto Rico Medical Sciences Campus

  PRINCIPAL INVESTIGATOR

• Sandra Miranda De Leon, M.P.H.

  Puerto Rico Department of Health

  PRINCIPAL INVESTIGATOR

• Daniel Feaster, Ph.D.

  University of Miami

  PRINCIPAL INVESTIGATOR

• Bruce Schackman, Ph.D.

  Joan & Sanford I. Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

• Glenda Davila, M.D.

  Iniciativa Comunitaria de Investigacion, Inc.

  PRINCIPAL INVESTIGATOR

• Lauren K. Gooden, Ph.D

  Columbia University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Stephen Smith Professor and Chair of Sociomedical Sciences Department

Study Record Dates

• First Submitted: February 8, 2013
• First Posted: February 15, 2013
• Study Start: December 20, 2013
• Primary Completion: August 1, 2020
• Study Completion: July 1, 2021
• Last Updated: March 28, 2022

Record last verified: 2022-03

Locations

PR (2)