Supporting Adolescent Adherence in Vietnam (SAAV)

Not Applicable

Completed

Interventions: Combination Product: Tailored realtime triggered reminder pkg

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Tailored realtime triggered reminder pkg	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.

Primary Outcome Measures

Name	Time	Method
Optimal on-time adherence	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 Outcome Measures

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