Clinical trial NCT01488942: Use of Incentives to Retain Drug Users in HIV Therapy
Official title: A Randomized Clinical Trial Evaluating the Role of Contingent Reinforcement in the Engagement of and Retention of Drug Users in HAART Programs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infection
Keywords: HIV
reinforcement
medication adherence
patient compliance
antiretroviral therapy, highly active
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2011-12-08
Enrollment: 139
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Once HAART has been initiated, participants will be expected to be assessed at weeks 1,2,3,4,6,8,10,12,14, and 16. Detailed adherence and dispensing records for all antiretroviral medications for each participant will be maintained. Adherence will be assessed primarily on the basis of pharmacy refill records, as well as self-report. Subsequently participants will attend monthly clinical follow-up visits at weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52. Standard laboratory monitoring will be performed at that time, and will include complete blood count (CBC), differential, basic chemistry, liver and kidney profile, as well as CD4 cell count and plasma HIV-1-RNA level, consistent with current care guidelines. All patients will also undergo urine toxicology screens at baseline and quarterly (weeks 12, 24, 36, and 52) in order to assess any effects of engaging in HAART programs on substance use. Follow-up will also include an adverse events assessment (ADE) from a standardized list of signs and symptoms noted by either the patient or practitioner or identified through laboratory testing. At baseline and each quarterly visit, participants will complete the Center for Epidemiologic Studies Depression Scale (CES-D) where a score of 16 correlates with risk of depression. This tool has been validated in our population in a prior study. Participants will also complete the Addiction Severity Index questionnaire, a validated instrument used to examine severity of psychosocial problems in seven domains including drug and alcohol use . Composite scores are derived, and higher scores reflect greater problems. Past 3-month versions of the HIV Risk Behavior Scale will also be administered at baseline and at quarterly visits. This scale assesses injection drug use and sexual behaviors, and responses are coded on a 6-point scale with higher values indicating higher risk.

Participants who are randomized to receive a reinforcer for clinic follow-up will receive the reinforcer at the end of each clinic visit. When the reinforcer is linked to plasma viral load, subjects in the reinforcer arm will be notified within a week of the plasma viral load result, and of any reinforcement earned. Subjects can elect to come in at any time to receive the reinforcement, or they can wait until their next monthly appointment and receive the earnings at that time.

For participants who do not present for laboratory and clinical follow-up within two weeks on either side of their scheduled quarterly visit, an extensive investigation into the client's whereabouts through street outreach as well as a search of hospital records for hospitalization and the provincial vital statistics database for possible deaths will be prompted. Those who discontinue therapy or who are lost to follow-up at or before 52 weeks will be considered therapy failures in the analyses.

A final visit 24 weeks after the week 52 visit will be performed. This will involve the same procedures as the quarterly study visits during the first year, including standard laboratory tests and urine toxicology, ADE assessments, and CES-D, Addiction Severity Index and HIV Risk Behavior Scale questionnaires. Participants who fail to present for laboratory and clinical follow-up within 2 weeks of the expected date of this visit will be sought as described above.

Eligibility criteria: Inclusion Criteria:

1. Adults at least 19 years of age.
2. 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.
3. 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)

Exclusion Criteria:

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

Primary outcomes:
measure: proportion of subjects achieving virologic suppression (plasma viral load less than or equal to 100 copies/mL) at 52 weeks after HAART initiation.
timeFrame: 52 weeks after HAART initiation.
Secondary outcomes:
measure: duration of sustained virologic suppression during the first 52 weeks after HAART initiation.
timeFrame: during the first 52 weeks after HAART initiation.
measure: proportion of subjects achieving virologic suppression (plasma viral load less than or equal to 100 copies/mL) at 72 weeks after HAART initiation.
timeFrame: 72 weeks after HAART initiation.
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St. Paul's Hospital, VIDUS and Incentives study office site, 611 Powell St.
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Mark Hull, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Julio SG Montaner, MD
role: PRINCIPAL_INVESTIGATOR
References: