Supporting Adolescent Adherence in Vietnam (SAAV)

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Supporting Adolescent Adherence in Vietnam (SAAV) Study

Conditions
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Adolescents, HIV/AIDS, Patient Adherence

Intervention / Treatment
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* Combination Product: Tailored realtime triggered reminder pkg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tailored realtime triggered reminder pkg<br>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. | Combination Product: Tailored realtime triggered reminder pkg<br>* 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.<br>* Other names: wireless monitoring/feedback, counseling, dose histories;|
| No Intervention: Control<br>Comparison subjects will receive usual care and an offer of counseling at monthly clinic visits. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optimal on-time adherence | Proportion of patients with ≥95% on-time adherence at end of 6-month intervention period in each study arm | End of intervention period (month 7) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD4 count | Mean change in CD4 count in each study arm | Pre-intervention month (month 1) vs. last intervention month (month 7) | 
| Viral load | Percent of patients with undetectable viral load (UDVL) in each study arm | End of intervention period (month 7) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vietnam, adherence, adolescent, HIV/AIDS