Enhanced Access to HIV Care for Drug Users in San Juan, Puerto Rico (Proyecto PACTo)
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|ClinicalTrials.gov Identifier: NCT01792752|
Recruitment Status : Recruiting
First Posted : February 15, 2013
Last Update Posted : August 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|HIV AIDS Substance Abuse||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||Not Applicable|
Recent scientific advances demonstrate that for people living with HIV, antiretroviral therapy (ART) is the most effective strategy to improve immune function, reduce morbidity, improve quality of life, prolong survival, and prevent HIV transmission. Translating this knowledge into practice, however, requires prompt diagnosis and linkage to care, entry into care with timely ART initiation, and engagement in care, support for ART adherence, and retention to promote durable viral suppression. Addressing failures in this cascade of care, often referred to as the "Seek, Test, Treat, and Retain (STTR)" paradigm, has become a major part of the National HIV/AIDS strategy in the United States. To date, much of the research and discussion surrounding this strategy has focused on expanding HIV testing to improve the early identification of new cases. There has been less attention focused on linkage to, engagement in, and retention in care. Specifically, little attention has focused on identifying HIV-positive individuals who, despite being aware of their diagnosis, have never been in HIV care, are intermittent users of care, or have dropped out of care.
HIV-infected injection drug users (IDUs) are a particularly difficult subpopulation to link to and retain in HIV care. They face a myriad of challenges that can impede retention in care including substance use disorders (both alcohol and drugs), mental health problems and poverty-related issues such as unstable housing and food insecurity. If IDUs adhere to their treatment regimens, however, studies have demonstrated they realize similar survival benefits from antiretroviral therapy as persons without a history of injection drug use. In contrast to the majority of communities in the U.S., in Puerto Rico, drug use, particularly injection drug use, continues to fuel a fast-growing HIV epidemic. Puerto Rico has an estimated incidence rate of 45 HIV cases per 100,000 population, twice the rate for the 50 U.S. states, and almost 40% of new infections are associated with injection drug use. In contrast, only 12% of new infections in the 50 U.S. states are among IDUs.
The overall goal of this project is to implement and evaluate a community-level, structured enhanced approach, the Enhanced HIV Care Access and Retention Intervention, for substance users in San Juan, Puerto Rico. It will bring HIV care directly to five San Juan zones in which a high proportion of HIV-infected substance users reside. The significance of the study is threefold.f care, or have dropped out of care.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||4110 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Enhanced Access to HIV Care for Drug Users in San Juan, Puerto Rico|
|Actual Study Start Date :||December 20, 2013|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||August 2020|
Experimental: 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. 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
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.
No Intervention: Control / Neighborhood(s) not receiving the 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.
- HIV Virologic Suppression [ Time Frame: Every 6 months for up to 36 months ]Assessment of success of the intervention will be measured by testing whether there is a significant change in virologic suppression associated with the intervention.
- Increasing HIV care visit attendance [ Time Frame: Every 6 months for up to 36 months ]
- Uptake of antiretroviral therapy [ Time Frame: Every 6 months for up to 36 months ]
- Adherence to HIV treatment regimens [ Time Frame: Every 6 months for up to 36 months ]
- Decreasing substance use [ Time Frame: Every 6 months for up to 36 months ]
- Consistency of enrollment in the intervention and receipt of intervention services across neighborhoods over time [ Time Frame: 36 months ]
- Cost of delivering the intervention and of other medical services received [ Time Frame: 36 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01792752
|Contact: Iveth G. Yanez, M.P.Aemail@example.com|
|Puerto Rico Department of Health||Recruiting|
|Rio Piedras, Puerto Rico, 00922|
|Contact: Jose Juan Bertran, M.D. 787-763-0240 firstname.lastname@example.org|
|Principal Investigator: Sandra Miranda De Leon, M.P.H.|
|Iniciativa Comunitaria de Investigacion, Inc.||Recruiting|
|San Juan, Puerto Rico, 00918|
|Contact: Wilmarie Calderon, M.P.H. 787-338-8383 email@example.com|
|Principal Investigator: Glenda Davila, M.D.|
|Principal Investigator:||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.|
|Study Director:||Lauren K. Gooden, Ph.D||Columbia University|