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

Johns Hopkins University logo

Johns Hopkins University

Status and phase

Completed
Phase 2

Conditions

Substance Abuse, Intravenous
HIV

Treatments

Other: Prize bowl drawings
Behavioral: Contingency

Study type

Interventional

Funder types

Other

Identifiers

NCT01031745
R01-DA018577-S3

Details and patient eligibility

About

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.

Enrollment

120 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 2 patient groups

Contingency
Experimental group
Treatment:
Behavioral: Contingency
Control
Active Comparator group
Treatment:
Other: Prize bowl drawings

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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