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

HIV Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01031745
• Other study ID #: R01-DA018577-S3
• Status: Completed
• Phase: Phase 2
• First received: December 12, 2009
• Last updated: November 1, 2016
• Start date: May 2011
• Est. completion date: November 2011

Study information

• Verified date: November 2016
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardIndia: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• HIV
• Substance Abuse, Intravenous
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
India	YR Gaitonde Centre for Substance Abuse-Related Research (YRGCSAR)	Chennai	Tamil Nadu

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	YR Gaitonde Centre for AIDS Research and Education

Country where clinical trial is conducted

India, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to initiation of HAART		12 months	No
Secondary	Attendance at HIV treatment visits		12-months	No
Secondary	HAART possession ratio (a surrogate of medication adherence based on pharmacy fill data)		12-months	No
Secondary	Proportion with HIV RNA < 400 copies/mL at 6- and 12-months		12-month	No
Secondary	Changes in absolute CD4 count from baseline at 6- and 12-months		12-months	No