Evaluating Rewards-Based Adherence and Electronic Medication Monitoring in HIV-Positive Adolescents

Completed

• Conditions: Human Immunodeficiency Virus (HIV); Acquired Immunodeficiency Syndrome (AIDS)
• Interventions: Other: Questionnaire

• Registration Number: NCT01849393
• Lead Sponsor: St. Jude Children's Research Hospital

Brief Summary

The primary objective of this project is to assess the study population's acceptance of two medication adherence support strategies: incentive-based programs and electronic medication monitoring. The study population is adolescents (ages 16 - 24) positive for human immunodeficiency virus (HIV) currently undergoing treatment with antiretrovirals at St. Jude's HIV clinic. Participation in the study will involve completion of a survey: an Audio Computer Assisted Self Interview (ACASI). The duration of the survey is anticipated to be 10-20 minutes. Patient identifiers will not be attached the survey.

Detailed Description

Whether or not patients take their medications is one of the most noticeable and important predictors of treatment success or failure for HIV infection. Ways to improve compliance, specifically rewards-based programs and electronic medication monitoring, have shown some success in limited clinical research studies focused on adult subjects. Because the social and developmental factors in adolescents are different from adults, adolescents may not respond to these interventions in the same way as adults. This study will investigate adolescent acceptance and the effectiveness of these programs.

Study Timeline

• Study First Submitted: 2013-05-06
• Study First Submitted QC: 2013-05-06
• Study First Posted: 2013-05-08
• Study Start: 2013-06
• Status Verified: 2013-12
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Last Update Submitted: 2013-12-12
• Last Update Posted: 2013-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• HIV positive
• Ages 16-24 years.
• Participants must understand written or spoken English, because the ACASI used in the study can only be administered in English.

Exclusion Criteria

• Adolescents with a documented diagnosis of mental retardation or a significant motor or sensory impairment that would preclude participation in the study survey.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study Population	Questionnaire	Participants must meet the eligibility requirements will complete a questionnaire on the computer.

Primary Outcome Measures

Name	Time	Method
Reported perceptions about incentive-based adherence programs and electronic medication monitoring	Once, at enrollment	Participants will complete a survey/questionnaire on the computer describing their disease state, the frequency and amount of medication taken daily, and how well they comply with taking their medications and attending their clinic appointments. They will also note their perceptions about how incentive-based adherence programs and electronic medication monitoring. Descriptive statistics will be prepared from survey results.

Trial Locations

Locations (1)

St. Jude Children's Research Hospital; 🇺🇸 Memphis, Tennessee, United States