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

NCT ID: NCT01031745

Last Updated: 2016-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2011-11-30

Brief Summary

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.

Conditions

HIV; Substance Abuse, Intravenous

Keywords

Complementary Therapies; Drug Users

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Contingency

Group Type: EXPERIMENTAL

Contingency

Intervention Type: 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

Control

Group Type: ACTIVE_COMPARATOR

Prize bowl drawings

Intervention Type: 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.

Interventions

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

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

YR Gaitonde Centre for AIDS Research and Education

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Gregory M. Lucas

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Chennai, Tamil Nadu, India

Countries

India

References

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.

Reference Type: RESULT

PMID: 24803381 (View on PubMed)

Other Identifiers

R01DA018577

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01-DA018577-S3

Identifier Type: -

Identifier Source: org_study_id