Use of Incentives to Engage Drug Users in HIV Therapy

NCT01526421 | Completed DMC

• 2 other identifiers: H11-005921R01DA031043-01
• Study Type: interventional
• Target: 301
• Locations: 1 country
• Sites: 1

Brief Summary

Highly active antiretroviral therapy (HAART), the current standard of care for treatment of HIV infection, is highly effective when taken appropriately. Before starting this treatment, a person must be aware of their HIV status and present to a clinic for medical care. They then undergo screening procedures (medical assessment and laboratory tests) to determine whether they are eligible to receive HAART, i.e. whether HIV treatment is necessary and safe for them. In many urban centres including Vancouver's Downtown Eastside, there is a high rate of HIV infection among users of illicit drugs. However, HIV-infected drug users often do not present to the medical system and complete the process necessary to start HAART. Given the known benefits of HAART, new strategies are required to increase rates of HAART initiation in this group. 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 HAART uptake. The proposed research primarily seeks to assess the effectiveness of monetary-based CM in engaging HIV-infected drug users in HAART programs. Drug users identified through outreach will be randomized in a 1:1 ratio to one of two arms; participants in one arm will be offered a monetary-based reinforcer to participate (n=150) and participants in the second arm will be offered no reinforcer (n=150). Participation involves reporting to the study site for formal study of eligibility screening, consisting of clinical evaluation, medical history and laboratory testing required to determine eligibility to receive HAART. Participants randomized to the reinforcer arm will receive gift cards at the completion of screening procedures. Our hypothesis is that drug users offered a monetary-based reinforcer will be significantly more likely to complete HAART eligibility screening than those not offered a reinforcer.

Conditions

HIV Infection

Keywords

HIV; Antiretroviral therapy, highly active

Outcome Measures

Primary Outcomes (1)

• the proportion of drug users undertaking clinical and laboratory screening to determine eligibility for highly active antiretroviral therapy (HAART).

  HAART eligibility screening entails presenting to the study site within 2 weeks of pre-screening, undergoing laboratory testing and providing a medical history, and returning for results within the subsequent four weeks.

  6 weeks

Study Arms (2)

monetary reinforcer

EXPERIMENTAL

Other: monetary reinforcer

no reinforcer

NO INTERVENTION

Interventions

monetary reinforcer OTHER

Participants randomized to the reinforcer arm will receive gift cards at the completion of screening procedures.

Also known as: contingency management

monetary reinforcer

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 19 years or older
• Self-reports as having used illicit drugs within last 3 months
• Self-reports known or at-risk for HIV infection.

You may not qualify if:

• Unable to provide informed consent due to severe mental or physical illness, or substance intoxication at the time of interview
• Has lived in the greater Vancouver area for three months or less (as a means to enhance participant retention)
• Pregnancy
• Receipt of antiretroviral therapy within the last 12 months
• Known history of gambling addiction.

Sponsors & Collaborators

• University of British Columbia: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

St. Paul's Hospital, VIDUS study office site, 342 East Hastings

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Mark Hull, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Julio SG Montaner, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2012
• First Posted: February 3, 2012
• Study Start: February 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: December 20, 2012

Record last verified: 2012-12

Locations

CA (1)