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

NCT01031745 | Completed Phase 2

• 2 other identifiers: R01-DA018577-S3R01DA018577
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Time to initiation of HAART

  12 months

Secondary Outcomes (4)

• Attendance at HIV treatment visits

  12-months

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

  12-months

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

  12-month

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

  12-months

Study Arms (2)

Contingency

EXPERIMENTAL

Behavioral: Contingency

Control

ACTIVE COMPARATOR

Other: Prize bowl drawings

Interventions

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

Contingency

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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

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

Chennai, Tamil Nadu, 600113, India

Location

Related 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):589-95. doi: 10.1093/cid/ciu324. Epub 2014 May 6.

  PMID: 24803381 RESULT

MeSH Terms

Conditions

Substance Abuse, Intravenous; Drug Misuse

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: December 12, 2009
• First Posted: December 15, 2009
• Study Start: May 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

IN (1)