Proyecto PACTo: Enhanced HIV Care Access and Retention for Drug Users in San Juan, Puerto Rico, 2013-2014 (ICPSR 39791)
Version Date: Apr 22, 2026 View help for published
Principal Investigator(s): View help for Principal Investigator(s)
Jorge Santana-Bagur, University of Puerto Rico;
Lisa R. Metsch, Columbia University;
Daniel J. Feaster, University of Miami;
Sandra Miranda de Leon, Puerto Rico. Department of Health;
Bruce R. Schackman, Cornell University. Weill Cornell Medical College
Series:
https://doi.org/10.3886/ICPSR39791.v1
Version V1
Alternate Title View help for Alternate Title
Summary View help for Summary
This study evaluates the effectiveness of the Enhanced HIV Care Access and Retention Intervention in achieving HIV virologic suppression among HIV-infected substance users in San Juan, Puerto Rico. The implementation process and cost of the enhanced care approach, including implications for cost effectiveness, feasibility of expansion, and sustainability are also included in the evaluation process. This study consists of two multi-component phases: a pre-trial phase and a trial phase. The pre-trial phase consists of ethnographic and pre-implementation interviews, HIV provider surveys and a survey of employees within a community-based agency that is an integral part of trial implementation. Ethnographic and pre-implementation qualitative interviews were conducted prior to implementation of the trial to inform the development of assessment tools and the intervention, and to inform the selection of the appropriate neighborhoods/areas from which to recruit HIV-infected substance users. Employees of Iniciativa Comunitaria de Investigacion, Inc. (ICI), an existing community-based, non-profit organization that is responsible for conducting HIV testing, recruitment and outreach for the study, were invited to complete a survey to assess organizational readiness for change at ICI. HIV providers in major cities in Puerto Rico will be invited to complete a survey to assess their treatment practices and other issues pertaining to HIV care. The trial phase consists of an Assessment Cohort, a multicomponent Enhanced HIV Care Access and Retention Intervention, and an HIV Care Cohort.
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Subject Terms View help for Subject Terms
Geographic Coverage View help for Geographic Coverage
Smallest Geographic Unit View help for Smallest Geographic Unit
City of San Juan, Puerto Rico
Restrictions View help for Restrictions
Users are reminded that these data are to be used solely for statistical analysis and reporting of aggregated information, and not for the investigation of specific individuals or organizations. Access to the data is restricted. Users interested in obtaining these data must complete a Restricted Data Use Agreement. Data are provided via ICPSR's Virtual Data Enclave (VDE). Apply for access to these data through the ICPSR VDE portal. Information and instructions are available within the data portal. For further assistance please reference the VDE Guide to learn about the application process, about using the VDE, and how to request disclosure review of VDE output.
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Date of Collection View help for Date of Collection
Data Collection Notes View help for Data Collection Notes
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This is a Fast Track Release. Users should consult the principal investigator(s) if further information is needed.
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This study includes data files from 6-month, 12-month, and final data collection periods. It also includes a study summary, study questionnaires, and supplemental study data documentation.
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Some documentation and data content in this study are written in Spanish.
Study Purpose View help for Study Purpose
The Enhanced HIV Care Access and Retention Intervention evaluates the effectiveness of the Enhanced HIV Care Access and Retention Intervention in achieving HIV virologic suppression among HIV-infected substance users in San Juan, Puerto Rico. It includes evaluation of the implementation process and cost of the enhanced care approach, including implications for cost-effectiveness, feasibility of expansion, and sustainability. This study has multiple campaigns, with the following goals:
- Saturate the five areas/zones with HIV testing, linkage/reengagement, HIV medical treatment, and retention support services;
- Identify drug users living with HIV who either do not know their HIV status and/or are not engaged in HIV care;
- Provide direct HIV care services through a mobile health clinic;
- Support identified HIV-infected drug users with patient navigators (PNs) to enhance their ability to engage in HIV care, to initiate antiretroviral therapy, and maintain adherence to their treatment regimens;
- Provide linkages to substance use treatment, screening and access to treatment for other physical and mental comorbidities, general primary health care, and social/psychosocial services addressing unstable housing, food insecurity, interpersonal violence, and legal issues.
Study Design View help for Study Design
The trial phase consists of an Assessment Cohort, a multicomponent Enhanced HIV Care Access and Retention Intervention, and an HIV Care Cohort. The trial evaluates the intervention through a randomized roll-out design, a refinement of the stepped wedge design. The community-level success of the intervention is assessed by evaluating virologic suppression (primary biological outcome), increased attendance to HIV care visits, increased uptake of antiretroviral therapy, increased adherence to HIV treatment regimens, and decreased substance use (as secondary behavioral outcomes) in the Assessment Cohort. All participants in the Assessment Cohort provided informed consent and complete a baseline CAPI (focusing on drug use, mental health, demographics and socio-demographic factors, HIV care and drug treatment history) and blood draws for viral load and CD4 count. Follow-up assessments consisting of CAPI and blood draws were conducted approximately every 6 months post-baseline. Individuals recruited from areas/zones 1-4 have 5 follow-up assessments and those from area/zone 5 have 6 follow-up assessments. Individuals that reside in area/zone 5 have 1 additional assessment period because the intervention was implemented last in that neighborhood and for 1 year. Medical records were reviewed to document use of HIV care and drug treatment during the study period. The intervention consists of an 1) HIV Testing Campaign, 2) Patient Navigation Linkage to HIV Care and Substance Abuse Treatment Team, 3) Treatment Re-engagement Campaign, and a 4) Mobile Care Clinic. All HIV-infected substance users who are identified through the HIV Testing Campaign, the Treatment Re-engagement/Patient Navigator Team or through the Mobile Care Clinic were enrolled in the HIV Care Cohort. This HIV Care Cohort is comprised of the HIV-positive substance users who are receiving direct services; they may or may not be part of the Assessment Cohort. It is appropriate and expected that there is overlap between persons in the two cohorts as it is expected that saturation by the intervention team results in persons in the Assessment Cohort being exposed to the intervention.
Sample View help for Sample
The recruitment and sampling method consists of obtaining study participants (in the assessment cohort) who are:
- Recruited from neighborhoods (within the 5 San Juan areas/zones targeted for intervention) with high rates of HIV and substance abuse; and
- Referred to the study team from community agencies, clinics/medical facilities and treatment programs/centers.
The randomization method is as follows: As part of this study's randomized roll-out design, each area/zone was randomly assigned to a specific time at which the study intervention activities commenced. All areas/zones received the intervention at various times throughout the trial. The implementation continued for the duration of the trial. While there was no control group per se, each area/zone served as its own control in that each area/zone experienced a period of time (prior to intervention commencement) in which no study intervention took place.
Time Method View help for Time Method
Universe View help for Universe
HIV-infected substance users in San Juan, Puerto Rico
Unit(s) of Observation View help for Unit(s) of Observation
Data Source View help for Data Source
Computer assisted personal interviews (CAPIs), medical record abstraction, and blood draws (labs) from HIV-infected substance users in San Juan, Puerto Rico.
Data Type(s) View help for Data Type(s)
Mode of Data Collection View help for Mode of Data Collection
Description of Variables View help for Description of Variables
Variable content covers the topics of HIV-related health records, medical history, and treatment behavior. It also includes content about mental health, substance use, demographic information, and social behavior. Data also includes results from blood draws (laboratory tests).
HideOriginal Release Date View help for Original Release Date
2026-04-22
Version History View help for Version History
2026-04-22 ICPSR data undergo a confidentiality review and are altered when necessary to limit the risk of disclosure. ICPSR also routinely creates ready-to-go data files along with setups in the major statistical software formats as well as standard codebooks to accompany the data. In addition to these procedures, ICPSR performed the following processing steps for this data collection:
- Performed consistency checks.
- Performed recodes and/or calculated derived variables.
Notes
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One or more files in this data collection have special restrictions. Restricted data files are not available for direct download from the website; click on the Restricted Data button to learn more.