Proyecto PACToEnhanced Access to HIV Care for Drug Users in San Juan, Puerto Rico
Enhanced HIV Care Access and Retention Intervention
+ HIV Testing Campaign
+ Treatment Re-engagement Campaign
Blood-Borne Infections+17
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
Study start date: December 20, 2013
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.2082 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
HIV Testing Campaign Inclusion Criteria: 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 Inclusion Criteria: 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 Inclusion Criteria: 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 Exclusion Criteria (for all study components mentioned above): do not meet any one or more of the above-described inclusion criteria have significant cognitive or developmental impairment to the extent that they are unable to provide informed consent are terminated via Site PI decision
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
No InterventionStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Puerto Rico Department of Health
Rio Piedras, Puerto RicoOpen Puerto Rico Department of Health in Google MapsIniciativa Comunitaria de Investigacion, Inc.
San Juan, Puerto Rico