Use of Incentives to Retain Drug Users in HIV Therapy

NCT01488942 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 139

Last updated 2019-07-15

No results posted yet for this study

Summary

In many urban centres including Vancouver's Downtown Eastside, there is a high rate of HIV infection among users of illicit drugs. Among drug users who present to care and start highly active antiretroviral therapy (HAART), retention in care and adherence to their treatment regimen may be less than optimal. Given the known benefits of HAART on both the individual and populational levels, new strategies are required to help retain HIV-infected drug users on HAART.

Contingency management (CM) is a strategy to affect behaviour by providing a reward (e.g. money) to reinforce the desired behaviour. CM has been used with success in other areas of medicine (e.g. smoking cessation, weight loss) and in the drug using population, but has not been established as a means to improve retention in HAART programs.

The proposed research primarily seeks to assess the effectiveness of monetary-based CM in retaining HIV-infected drug users in HAART programs. 240 HAART-eligible subjects will be randomized in a 2:1 ratio to either receive (n=160) the reinforcer or to a control arm (n=80). All subjects will receive HAART and standard care, and those randomized to the reinforcer arm will receive escalating reinforcement initially for attendance at each clinic visit (until month 6 after starting HAART) and subsequently (until month 12 after starting HAART) will receive an escalating variable reinforcer for each month in which a plasma viral load less than or equal to 100 copies/mL is maintained.

Our hypotheses are that drug users initiating HAART and randomly selected to receive a reinforcer for attending clinic visits then maintaining monthly virologic suppression during the first 52 weeks after HAART initiation will be significantly more likely to achieve virologic suppression at 52 weeks, will have a significantly longer duration of sustained virologic suppression during the first 52 weeks, and will be significantly more likely to maintain virologic suppression at 72 weeks after HAART initiation, than those not offered a reinforcer.

Conditions

  • HIV Infection

Interventions

OTHER

monetary reinforcer

The protocol will follow an escalating schedule of reinforcements tied to clinic visit attendance for the first 24 weeks, after which the reinforcers will take the form of an escalating variable reinforcement schedule in the form of fishbowl prize draws linked to maintenance of suppressed viral load for the remainder of the 52-week study period. In addition, a reset function will be incorporated by which the reinforcer will be rolled back to an initial lower value if clinic visits or viral load targets are not met. This will be rapidly scaled up again once targets are met.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH
  • University of British Columbia

    lead OTHER

Principal Investigators

  • Mark Hull, MD · University of British Columbia

  • Julio SG Montaner, MD · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2018-03-31
Completion
2018-03-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01488942 on ClinicalTrials.gov