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

December 12, 2009
February 22, 2012
May 2011
November 2011   (final data collection date for primary outcome measure)
Time to initiation of HAART [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Time to initiation of HAART [ Time Frame: End of study ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01031745 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Attendance at HIV treatment visits [ Time Frame: End of study (12-month) ] [ Designated as safety issue: No ]
  • HAART possession ratio (a surrogate of medication adherence based on pharmacy fill data) [ Time Frame: End of study (12-month) ] [ Designated as safety issue: No ]
  • Proportion with HIV RNA < 400 copies/mL at 6- and 12-months [ Time Frame: End of study (12-month) ] [ Designated as safety issue: No ]
  • Changes in absolute CD4 count from baseline at 6- and 12-months [ Time Frame: End of study (12-month) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Contingency Management in the Delivery of HAART to Drug Users in Chennai, India
Not Provided

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV
  • Substance Abuse, Intravenous
  • 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
  • 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.
  • Experimental: Contingency
    Intervention: Behavioral: Contingency
  • Active Comparator: Control
    Intervention: Other: Prize bowl drawings
Solomon SS, Srikrishnan AK, Vasudevan CK, Anand S, Kumar MS, Balakrishnan P, Mehta SH, Solomon S, Lucas GM. Voucher incentives improve linkage to and retention in care among HIV-infected drug users in Chennai, India. Clin Infect Dis. 2014 Aug 15;59(4):589-95. doi: 10.1093/cid/ciu324. Epub 2014 May 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
November 2011
November 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01031745
R01-DA018577-S3
No
Gregory M Lucas, Johns Hopkins University School of Medicine
Johns Hopkins University
YR Gaitonde Centre for AIDS Research and Education
Not Provided
Johns Hopkins University
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP