CTN 248: Incentives to Stop AIDS and HIV in Drug Users

About The Study

This randomized trial will measure the effectiveness of providing incentives as a strategy for increasing the frequency of desired behaviors such as adherence to medications to achieve long-term behavior change in the form of sustained virologic suppression. This study is aimed at finding novel and effective means of diagnosing HIV in people with substance use issues and improving antiretroviral uptake and adherence in hard-to-reach populations.

About The Disease

Illicit drug users represent extremely vulnerable populations and include a disproportionate number of women, sex trade workers, ethnic minorities, street involved persons and the homeless. Recent research suggests that the rate of HIV prevalence in BC’s lower mainland drug using population ranges from 25% to 30%. Illicit drug users often face challenging circumstances that present serious barriers to seeking out and receiving adequate health care. The study researchers consider it critical to focus on HIV care for drug users and other hard-to-reach populations, to both reduce rates of HIV related deaths and to decrease HIV transmission.

Study Approach

The study has two stages. Participants in first stage of the study are not required to take any medications and will only be asked to take an HIV test and related blood tests and complete a questionnaire. Researchers will collect clinical, socio-demographic and behavioural data. Half of the participants in this stage will be randomly selected to receive $10 for taking the tests and $15 for returning to get the results to evaluate whether testing behaviour can be altered by providing associated incentives.

The next stage of the study will be open to HIV positive drug users considered ready for antiretroviral therapy. Participants will be randomly assigned to one of two groups. Both groups will receive the same standard health care and basic compensation for participation, however one group will receive additional incentives linked to achieving clinical outcomes. The incentive schedule will escalate up to $25 linked initially to clinic visits and subsequently linked to treatment results, with the opportunity for additional incentives, if participants are able to effectively suppress HIV viral load.

Participants will be asked to complete interviews, questionnaires, urine and blood tests. For the first visit, before antiretroviral therapy is started, a urine test and 70mL of blood will be drawn. Once HIV treatment has started, blood samples will be collected every four weeks for standard laboratory tests including HIV viral load (the amount of virus in the blood), CD4 cell counts (white blood cells that are affected by HIV), and a complete blood count (liver and kidney functions). The amount of blood drawn at each visit (after the first visit) will be about 20mL. Participants will also be asked to provide urine samples every three months to check kidney functions and drug use.