Trial record 9 of 1425 for:    HIV | Open Studies

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2013 by Columbia University
Sponsor:
Collaborators:
University of Puerto Rico
Iniciativa Comunitaria de Investigacion
Puerto Rico Department of Health
University of Miami
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Lisa Metsch, Columbia University
ClinicalTrials.gov Identifier:
NCT01792752
First received: February 8, 2013
Last updated: February 13, 2013
Last verified: February 2013
  Purpose

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. We will also evaluate the implementation process and cost of the enhanced care approach including implications for cost-effectiveness, feasibility of expansion, and sustainability.


Condition Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Enhanced Access to HIV Care for Drug Users in San Juan, Puerto Rico

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • HIV Virologic Suppression [ Time Frame: Every 6 months for up to 36 months ] [ Designated as safety issue: No ]
    Assessment of success of the intervention will be measured by testing whether there is a significant change in virologic suppression associated with the intervention.


Secondary Outcome Measures:
  • Increasing HIV care visit attendance [ Time Frame: Every 6 months for up to 36 months ] [ Designated as safety issue: No ]
  • Uptake of antiretroviral therapy [ Time Frame: Every 6 months for up to 36 months ] [ Designated as safety issue: No ]
  • Adherence to HIV treatment regimens [ Time Frame: Every 6 months for up to 36 months ] [ Designated as safety issue: No ]
  • Decreasing substance use [ Time Frame: Every 6 months for up to 36 months ] [ Designated as safety issue: No ]
  • Consistency of enrollment in the intervention and receipt of intervention services across neighborhoods over time [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Cost of delivering the intervention and of other medical services received [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: August 2013
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

Study Design

The overall goal of this project is to implement and evaluate a community-level, structured approach, the "Enhanced HIV Care Access and Retention Intervention" for drug users in San Juan, Puerto Rico. It will bring HIV care directly to five San Juan neighborhoods in which a high proportion of HIV-positive injection drug users (IDUs) reside. The enhanced care intervention is comprised of 4 components: A) a neighborhood-level HIV Testing Campaign to identify HIV-positive drug users who are not aware of their HIV status, B) a Treatment Re-engagement Campaign using patient navigators for out-of-care HIV-positive IDUs, C) a Patient Navigator Linkage to Care and Substance Abuse Treatment team for both newly diagnosed and out of care HIV-positive IDUs and D) a Mobile HIV Care Clinic staffed by HIV clinicians to facilitate linkage into and retention in care. The intervention will be evaluated using a randomized roll-out design, a refinement of the stepped-wedge design.

The intervention will be rolled-out at 6-month intervals in each of the five neighborhoods. The order in which neighborhoods will receive the intervention will be determined randomly. Once a neighborhood begins to receive the intervention, it will continue receiving the intervention throughout the remaining period of the study. The number of individuals served by the intervention who enter into care, their appointment adherence, viral loads and health service and substance abuse treatment utilization will be documented. The success of the intervention will be determined by examining the proportion of virologic suppression over time in an independent assessment cohort of approximately 400 HIV-positive drug-using individuals drawn from the five neighborhoods included in the intervention. The primary evaluation outcomes of this study are to see whether the intense saturation of our intervention results in persons in the assessment cohort being offered and receiving intervention services and the impact on their viral load.

Assessment Cohort

Exposure to the intervention will be evaluated by the assessment cohort as the intervention strategy is rolled out in each of the 5 intervention neighborhoods. Eligible participants (defined below) will be scheduled for a baseline appointment, and asked to bring documentation of their HIV status if available. At the baseline visit, participants will: 1) review and sign the consent form; 2) complete a rapid HIV test; 3) provide blood to assess CBC (including CD4 and plasma HIV RNA; and 4) complete a behavioral assessment using an audio computer assisted interview (ACASI). Participants recruited into the assessment cohort will be counseled on the importance of HIV care and risk reduction practices following existing standards within Puerto Rico. At the end of the baseline visit, participants will be compensated for their time and travel costs and reminded about the next scheduled visit in six month's time. Participants will then be followed at six month intervals for a period of 30 months (and 36 months for neighborhood 5). At each assessment points they will be asked to complete the behavioral assessment using an ACASI and to have their blood drawn for CD4 and viral load.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

HIV Testing Campaign

Inclusion Criteria:

  1. be 18 years of age or older
  2. report having injected drugs (opioid or stimulants) at least once in the past 30 days
  3. provide written informed consent

HIV Care Cohort

Inclusion Criteria:

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

Assessment Cohort

Inclusion Criteria:

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

Exclusion Criteria (for all study components mentioned above):

  1. do not meet any one or more of the above-described inclusion criteria
  2. have significant cognitive or developmental impairment to the extent that they are unable to provide informed consent
  3. are terminated via Site PI decision
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01792752

Contacts
Contact: Paco C. Castellon, M.P.H. 305-243-8419 pc2594@columbia.edu

Locations
Puerto Rico
Iniciativa Comunitaria de Investigacion, Inc. Not yet recruiting
Hato Rey, Puerto Rico, 00918
Contact: Glenda Davila Torres, M.D.    787-250-8629    gdavila@iniciativacomunitaria.org   
Principal Investigator: Jose Vargas Vidot, M.D.         
Puerto Rico Department of Health Not yet recruiting
Rio Piedras, Puerto Rico, 00922
Contact: Sandra Miranda De Leon, M.P.H.    787-763-0240    smiranda@salud.gov.pr   
Principal Investigator: Sandra Miranda De Leon, M.P.H.         
Sponsors and Collaborators
Columbia University
University of Puerto Rico
Iniciativa Comunitaria de Investigacion
Puerto Rico Department of Health
University of Miami
Weill Medical College of Cornell University
Investigators
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: Jose Vargas Vidot, M.D. Iniciativa Comunitaria de Investigacion, Inc.
Study Director: Paco C. Castellon, M.P.H. Columbia University
  More Information

No publications provided

Responsible Party: Lisa Metsch, Stephen Smith Professor and Chair of Sociomedical Sciences Department, Columbia University
ClinicalTrials.gov Identifier: NCT01792752     History of Changes
Other Study ID Numbers: AAAK8805, 1R01DA035280-01
Study First Received: February 8, 2013
Last Updated: February 13, 2013
Health Authority: United States: Institutional Review Board
United States: Data and Safety Monitoring Board

Keywords provided by Columbia University:
HIV/AIDS
Drug Users
Puerto Rico

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
HIV Antibodies
Substance-Related Disorders
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Chemically-Induced Disorders
Mental Disorders
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014