NCT02206906

Incentives to Promote Medication Adherence Among HIV-Infected Youth

Investigation of Incentives to Promote Medication Adherence Among HIV-Infected Youth on Antiretroviral Therapy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 25 (actual)
• Sponsor: St. Jude Children's Research Hospital · Academic / Other
• Sex: All
• Age: 16 Years – 24 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• HIV

Interventions

Type	Name	Description
BEHAVIORAL	Incentive intervention model	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.

Timeline

• Start date: 2014-07-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2014-08-01
• Last updated: 2016-06-21

Locations

1 site across 1 country: United States