The Supporting Adolescent Adherence in Vietnam (SAAV) Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of New England
- Enrollment
- 81
- Locations
- 1
- Primary Endpoint
- Optimal on-time adherence
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Masking Description
Open Label
Eligibility Criteria
- Ages
- 12 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •currently a patient at the Infectious Disease (ID) clinic at National Hospital for Pediatrics (NHP) in Hanoi, Vietnam
- •between 12 and 17 years old of age AND
- •expected to remain in care at the NHP for 7 months minimum
- •currently on ART
- •live in the clinic catchment area
- •willing to provide informed assent, caregiver willing to provide consent
- •identified ás having adherence challenges (CD4, detectable VL, and/or clinician suggestion)
Exclusion Criteria
- •below the age of 12 years or above the age of 18
- •not currently on ART
- •live outside the clinic catchment area
- •not willing to provide informed assent, caregiver not willing to provide consent
Arms & Interventions
Tailored realtime triggered reminder pkg
The core intervention will utilize innovative wireless technology to provide patients with 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. The core intervention will be personalized by each intervention arm patient, who may choose features to suit their preferences.
Intervention: Tailored realtime triggered reminder pkg (Combination Product)
Control
Comparison subjects will receive usual care and an offer of counseling at monthly clinic visits.
Outcomes
Primary Outcomes
Optimal on-time adherence
Time Frame: End of intervention period (month 7)
Proportion of patients with ≥95% on-time adherence at end of 6-month intervention period in each study arm
Secondary Outcomes
- CD4 count(Pre-intervention month (month 1) vs. last intervention month (month 7))
- Viral load(End of intervention period (month 7))
Investigators
Mary DeSilva
Assistant Research Professor
University of New England