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

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01031745
• Collaborator: YR Gaitonde Centre for AIDS Research and Education (Other)
• Enrollment: 120
• Location: 1
• Arms: 2
• Duration (Months): 6
• Patients Per Site Per Month: 19.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV; Substance Abuse, Intravenous	Behavioral: Contingency; Other: Prize bowl drawings	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: May 1, 2011
• Actual Primary Completion Date: Nov 1, 2011
• Actual Study Completion Date: Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Contingency	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
Active Comparator: Control	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.

Outcome Measures

Primary Outcome Measures

1. Time to initiation of HAART [12 months]

Secondary Outcome Measures

1. Attendance at HIV treatment visits [12-months]

2. HAART possession ratio (a surrogate of medication adherence based on pharmacy fill data) [12-months]

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

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	YR Gaitonde Centre for Substance Abuse-Related Research (YRGCSAR)	Chennai	Tamil Nadu	India	600113

Sponsors and Collaborators

• Johns Hopkins University
• YR Gaitonde Centre for AIDS Research and Education

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gregory M. Lucas, Professor of Medicine, Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT01031745
• Other Study ID Numbers: R01-DA018577-S3
• First Posted: Dec 15, 2009
• Last Update Posted: Nov 2, 2016
• Last Verified: Nov 1, 2016

• Keywords provided by Gregory M. Lucas, Professor of Medicine, Johns Hopkins University: Complementary Therapies; Drug Users
• Additional relevant MeSH terms: Substance-Related Disorders; Substance Abuse, Intravenous

Study Results

No Results Posted as of Nov 2, 2016