Use of Incentives to Retain Drug Users in HIV Therapy

NCT01488942 | Completed DMC

• 2 other identifiers: H11-005141R01DA031043-01
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

HIV; reinforcement; medication adherence; patient compliance; antiretroviral therapy, highly active

Outcome Measures

Primary Outcomes (1)

• proportion of subjects achieving virologic suppression (plasma viral load less than or equal to 100 copies/mL) at 52 weeks after HAART initiation.

  52 weeks after HAART initiation.

Secondary Outcomes (2)

• duration of sustained virologic suppression during the first 52 weeks after HAART initiation.

  during the first 52 weeks after HAART initiation.

• proportion of subjects achieving virologic suppression (plasma viral load less than or equal to 100 copies/mL) at 72 weeks after HAART initiation.

  72 weeks after HAART initiation.

Study Arms (2)

monetary reinforcer

EXPERIMENTAL

Subjects randomized to this arm will receive an escalating reinforcer 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 viral load at or below 100 copies/mL is maintained

Other: monetary reinforcer

no reinforcer

NO INTERVENTION

All subjects will receive HAART and standard medical care, but subjects in the control arm will not receive monetary reinforcers.

Interventions

monetary reinforcer OTHER

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.

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:

• Adults at least 19 years of age.
• Have used illicit drugs (heroin, cocaine, cocaine/heroin combinations, methamphetamines, injectable morphine and codeine, but excluding isolated marijuana use) at least once in the past three months.
• Eligible for, and willing to initiate HAART. To be eligible for HAART, participants must have CD4 count at or below 350 cells/mm3 at the HAART eligibility screening visit and/or significant co-morbidities identified in current international guidelines (hepatitis B/C co-infection, HIV associated nephropathy, high risk for cardiovascular disease)

You may not qualify if:

• No history of active drug use as defined above.
• Pregnant women.
• Receipt of HAART for more than 6 months within the preceding 12 months.
• Persons in recovery from gambling addiction (due to the element of chance in the CM intervention).
• Persons acutely intoxicated at time of consent.

Sponsors & Collaborators

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

Study Sites (1)

St. Paul's Hospital, VIDUS and Incentives study office site, 611 Powell St.

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

HIV Infections; Medication Adherence; Patient Compliance

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; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

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: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: December 6, 2011
• First Posted: December 8, 2011
• Study Start: December 1, 2012
• Primary Completion: March 31, 2018
• Study Completion: March 31, 2018
• Last Updated: July 15, 2019

Record last verified: 2019-07

Locations

CA (1)