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Completed

NCT Number: NCT01031745

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

YR Gaitonde Centre for Substance Abuse-Related Research (YRGCSAR)

Chennai, Tamil Nadu, 600113, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Contingency

Behavioral

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

Prize bowl drawings

Other

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.

Primary outcomes

  1. Time to initiation of HAART

    Time frame: 12 months

Secondary outcomes

  1. Attendance at HIV treatment visits

    Time frame: 12-months

  2. HAART possession ratio (a surrogate of medication adherence based on pharmacy fill data)

    Time frame: 12-months

  3. Proportion with HIV RNA < 400 copies/mL at 6- and 12-months

    Time frame: 12-month

  4. Changes in absolute CD4 count from baseline at 6- and 12-months

    Time frame: 12-months

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • YR Gaitonde Centre for AIDS Research and Education

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Dec 15, 2009
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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