Contingency Management in the Delivery of HAART to Drug Users in Chennai, India

This study has been completed.
Sponsor:
Collaborator:
YR Gaitonde Centre for AIDS Research and Education
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01031745
First received: December 12, 2009
Last updated: February 22, 2012
Last verified: February 2012
  Purpose

Drug use (DU) is a major risk factor for HIV infection in many regions of the world. However, as highly active antiretroviral therapy (HAART) has been rolled out in South and South East Asia, less than 2% of individuals initiated on HAART were drug users (DUs) or former DUs, despite the fact that approximately 20% of HIV infections in the region are ascribed to DU. India is home to about 2.4 million HIV-infected individuals. Though, injection drug users contribute to only about 3% of all HIV infections in India; it is estimated that there are between 168,000 and 1.1 million DUs in India with HIV prevalence about 30%. Novel approaches are needed to engage disenfranchised populations in HIV care in lower and middle income countries, where the burden of HIV disease is growing. Incentive-based strategies (or contingency management) have been shown to be effective in reducing illicit drug use, smoking cessation, and weight loss. Short-term pilot studies have also shown that incentive-based strategies can improve electronically-monitored rates of adherence to HAART in the US, and a recent study in Africa showed that a small incentive approximately doubled the rate that individuals returned to learn the results of their HIV test. However, to date there is no experience with the use of incentive-based interventions to improve engagement into care and risk-reduction among out-of-care HIV-infected DUs in developing world settings. The investigators propose to conduct pilot randomized trial comparing a voucher incentive strategy to a control condition to improve engagement in HIV care and HIV treatment outcomes among out-of-care, treatment-eligible, HIV-infected DUs in Chennai, India. Subjects in the incentive arm will be eligible to earn incentive vouchers for 1) initiating HAART at a government-sanctioned HIV treatment clinic, 2) adherence to scheduled follow-up visits at the HIV clinic, and 3) achieving suppression of HIV RNA. Subjects will be enrolled from a mature research venue in Chennai, YR Gaitonde Centre for Substance Abuse-related Research (YRGCSAR), which focuses the epidemiology and natural history of HIV in DUs. Preliminary data from this pilot study will be used to inform the design of a phase-III study.


Condition Intervention Phase
HIV
Substance Abuse, Intravenous
Behavioral: Contingency
Other: Prize bowl drawings
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Time to initiation of HAART [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Attendance at HIV treatment visits [ Time Frame: 12-months ] [ Designated as safety issue: No ]
  • HAART possession ratio (a surrogate of medication adherence based on pharmacy fill data) [ Time Frame: 12-months ] [ Designated as safety issue: No ]
  • Proportion with HIV RNA < 400 copies/mL at 6- and 12-months [ Time Frame: 12-month ] [ Designated as safety issue: No ]
  • Changes in absolute CD4 count from baseline at 6- and 12-months [ Time Frame: 12-months ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: May 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Contingency Behavioral: Contingency
Participants are provided a non-monetary incentive for achieving particular tasks between study visits. Tasks include initiation of HAART, timely refill of medications from the government ART centers, suppression of HIV RNA
Active Comparator: Control Other: Prize bowl drawings
Control participants receive counseling and referral, but no incentives for engagement in HIV care. At study visits they are eligible to receive "bonuses" through prizebowl drawings to offset the inability to earn incentives.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Provide written informed consent
  • Provide a history of injection or non-injection drug use in prior 30 days
  • Documented evidence of HIV infection
  • Be ART naïve (by self-report)
  • Satisfy Indian National Guidelines for initiation of HAART (any of the following)

    • Absolute CD4+ count < 200 cells/ µl
    • AIDS-defining illness with any CD4+ count
    • Absolute CD4+ count between 200 - 350 cell/ µl with HIV-related symptoms

Exclusion Criteria:

  • Indicates an intention to migrate in the next 12 months
  • Any medical or psychiatric condition that the study physician believes to be a contraindication to study participation.
  • Enrolled in another HIV treatment program
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01031745

Locations
India
YR Gaitonde Centre for Substance Abuse-Related Research (YRGCSAR)
Chennai, Tamil Nadu, India, 600113
Sponsors and Collaborators
Johns Hopkins University
YR Gaitonde Centre for AIDS Research and Education
  More Information

No publications provided by Johns Hopkins University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gregory M Lucas, Johns Hopkins University School of Medicine
ClinicalTrials.gov Identifier: NCT01031745     History of Changes
Other Study ID Numbers: R01-DA018577-S3
Study First Received: December 12, 2009
Last Updated: February 22, 2012
Health Authority: United States: Institutional Review Board
India: Institutional Review Board

Keywords provided by Johns Hopkins University:
Complementary Therapies
Drug Users

Additional relevant MeSH terms:
Substance Abuse, Intravenous
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 16, 2014