NCT03031197

Supporting Adolescent Adherence in Vietnam (SAAV)

The Supporting Adolescent Adherence in Vietnam (SAAV) Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: University of New England · Academic / Other
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The small RCT will assess feasibility, acceptability, and impact of a real-time intervention on ART adherence and clinical outcomes for HIV-positive adolescents. All subjects will use a wireless pill container (WPC) to monitor adherence. Intervention subjects will receive a personalized triggered reminder (cellphone message/call or bottle-based flash/alarm) when they miss a dose, and engage in monthly counseling sessions informed by their adherence data. Comparison subjects will receive usual care and an offer of counseling at monthly clinic visits.

Detailed description

A major priority in HIV care and treatment is identifying effective interventions for adolescent patients, including those that make use of new technologies, to help them achieve and maintain high levels of adherence to antiretroviral treatment (ART), particularly as they take responsibility for their own medication-taking in the transition to adult care. The research planned here will contribute to the scientific evidence base on approaches to support ART adherence effectively among youth by 1) conducting formative research on adherence challenges among adolescents and refining options for a personalized adherence intervention package; and 2) implementing a small randomized controlled trial (RCT) to assess the feasibility, acceptability, and efficacy of a novel real-time feedback intervention that permits adolescent patients to tailor intervention features to suit their individual preferences.

Conditions

• Adolescents
• HIV/AIDS
• Patient Adherence

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Tailored realtime triggered reminder pkg	Core intervention: 1) real time, personalized wireless reminder messages when ART doses are not taken on time, and 2) 'feedback' on adherence behavior via monthly interactive counseling sessions informed by summaries of their previous month's behavior. Personalized features of the intervention will be selected by each patient and may include 1) reminders sent to the WPC (light or chimes) or to patient's or caregiver's cell phone if dose is late; 2) content of text messages from a menu of options; 3) use of "youth-friendly" WPC adherence reports for interactive counseling sessions; 4) additional counseling by clinic staff; 5) a "buddy" system, by choosing someone to review the adherence report with him/her; and 6) a "reward message" after a pre-selected time period of excellent adherence.

Timeline

• Start date: 2017-05-15
• Primary completion: 2018-05-25
• Completion: 2018-05-25
• First posted: 2017-01-25
• Last updated: 2020-04-08

Locations

1 site across 1 country: Vietnam

Regulatory

• FDA-regulated device study