Incentives to Promote Medication Adherence Among HIV-Infected Youth

N/ACompletedNCT02206906

St. Jude Children's Research Hospital25 enrolled

Overview

Medication adherence is one of the most salient predictors of patient outcomes in the era following development of effective treatment for HIV infection. Evolving strategies to improve adherence, specifically incentive interventions and real-time medication monitoring, have shown some success in limited studies. Further investigation into incentive interventions for HIV-infected adolescents with poor medication adherence is necessary.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

HIV

Interventions

Incentive intervention modelBEHAVIORAL

All participants will receive a real-time electronic medication monitor to monitor daily pill-taking behavior. Participants with qualifying levels of adherence will receive a weekly incentive during the intervention period. At all clinic visits participants will participate in a lottery incentive to reinforce clinic attendance and negative STI screening tests.

Eligibility

Sex: ALLMin age: 16 YearsMax age: 24 Years

Medical Language ↔ Plain English

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.

Locations (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Outcomes

Primary Outcomes

Percentage of dosages taken within 2 hours of prescribed time per month

Data collected by a real-time medication monitor that records pillbox opening times.

Time frame: Monthly through week 48

Pharmacy pill count

Pharmacy pill count data is collected at each participant encounter, approximately once per month.

Time frame: Monthly from 6 months prior to study start through week 48