Contingency Management in the Delivery of HAART to Drug Users in Chennai, India
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ClinicalTrials.gov Identifier: NCT01031745 |
Recruitment Status
:
Completed
First Posted
: December 15, 2009
Last Update Posted
: November 2, 2016
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Condition or disease | Intervention/treatment | Phase |
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HIV Substance Abuse, Intravenous | Behavioral: Contingency Other: Prize bowl drawings | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Study Start Date : | May 2011 |
Actual Primary Completion Date : | November 2011 |
Actual Study Completion Date : | November 2011 |
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
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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.
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- Time to initiation of HAART [ Time Frame: 12 months ]
- Attendance at HIV treatment visits [ Time Frame: 12-months ]
- HAART possession ratio (a surrogate of medication adherence based on pharmacy fill data) [ Time Frame: 12-months ]
- Proportion with HIV RNA < 400 copies/mL at 6- and 12-months [ Time Frame: 12-month ]
- Changes in absolute CD4 count from baseline at 6- and 12-months [ Time Frame: 12-months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
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)
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01031745
India | |
YR Gaitonde Centre for Substance Abuse-Related Research (YRGCSAR) | |
Chennai, Tamil Nadu, India, 600113 |
Publications of Results:
Responsible Party: | Gregory M. Lucas, Professor of Medicine, Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT01031745 History of Changes |
Other Study ID Numbers: |
R01-DA018577-S3 |
First Posted: | December 15, 2009 Key Record Dates |
Last Update Posted: | November 2, 2016 |
Last Verified: | November 2016 |
Keywords provided by Gregory M. Lucas, Johns Hopkins University:
Complementary Therapies Drug Users |
Additional relevant MeSH terms:
Substance-Related Disorders Substance Abuse, Intravenous Chemically-Induced Disorders Mental Disorders |