Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Enhanced HIV Care Access and Retention Intervention

+ HIV Testing Campaign

+ Treatment Re-engagement Campaign

Behavioral
Who is being recruted

Blood-Borne Infections+17

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: December 2013
See protocol details

Summary

Principal SponsorColumbia University
Last updated: March 28, 2022
Sourced from a government-validated database.Claim as a partner

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.

NCT01792752
Principal SponsorColumbia University
Last updated: March 28, 2022
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

2082 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesMental DisordersCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralHIV InfectionsLentivirus InfectionsChemically-Induced DisordersDrug MisuseAcquired Immunodeficiency SyndromeSubstance-Related Disorders

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.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Group II

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.

Study 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 Maps

Iniciativa Comunitaria de Investigacion, Inc.

San Juan, Puerto Rico
Completed2 Study Centers