Incentives to Promote Medication Adherence Among HIV-Infected Youth

PRIMARY OBJECTIVE:

• To describe the effects of a novel incentive intervention model on HIV-infected youths' patterns of antiretroviral medication adherence.

SECONDARY OBJECTIVES:

• To evaluate the feasibility of an outpatient incentive intervention model.
• To assess participant satisfaction with the incentive intervention model.
• To evaluate the effect of an outpatient incentive intervention model on targeted health behaviors (numbers of missed appointments and STI diagnoses).
• To measure the effect of the incentive intervention on HIV viral load and CD4+ count.
• To determine the overall and per patient cost of the incentive intervention model.
• To describe associations between adherence measures: real-time medication monitor data, pharmacy pill count, pharmacy prescription pick-up data, medication possession ratio, and self-report.

Upon enrollment, participants will receive education and a real-time medication monitor. Participants will be followed monthly in the clinic and will be prescribed thirty-day supplies of medication. During weeks 1-4 participants will establish a baseline with the real-time medication monitor. During weeks 5-28, participants will receive remote incentives based on their level of medication adherence as measured by the real-time medication monitor. Additional lottery-style incentives will occur at regular follow-up visits. No incentives will be applied during weeks 29-48. Participants will complete the protocol at the week 48 visit.

Inclusion criteria

• ≥16 and ≤ 24 years old
• Documented diagnosis of HIV
• Adolescent is aware of his/her HIV diagnosis
• Adolescent understands either written or spoken English.
• Adolescent is willing and able to provide informed consent or assent.
• Adolescent has access to a phone and the internet at the time of enrollment.
• Adolescent meets the definition of inadequate ARV adherence, which is any of the following in the previous 12 months:

• < 80% adherent to any ARV by pharmacy pill count
• ≥ 7 days delay in scheduled ARV prescription pick-up
• Detectable viral load after being on ARVs for at least 12 weeks

Exclusion criteria

• Adolescent has a documented diagnosis of mental retardation or a significant motor or sensory impairment that would preclude participation.
• Adolescent has a documented acute psychiatric illness, including suicidal ideation, homicidal ideation or active psychosis.
• Adolescent was diagnosed with HIV in the previous 6 months.
• Adolescent has a planned transition to alternative care setting prior to study completion (e.g. relocation, pregnancy or planned pregnancy, transition to adult care).
• Concurrent enrollment on a research study with an intervention targeted at increasing adherence to antiretroviral regimens.