Clinical trial NCT03031197: Supporting Adolescent Adherence in Vietnam (SAAV)
Official title: The Supporting Adolescent Adherence in Vietnam (SAAV) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescents
HIV/AIDS
Patient Adherence
Keywords: adherence
adolescent
HIV/AIDS
Vietnam
Lead sponsor: University of New England
Sponsor class: OTHER
Collaborators: name: Institute of Population, Health and Development, Vietnam
name: Boston University
First posted: 2017-01-25
Enrollment: 81
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Optimal on-time adherence
timeFrame: End of intervention period (month 7)
Secondary outcomes:
measure: CD4 count
timeFrame: Pre-intervention month (month 1) vs. last intervention month (month 7)
measure: Viral load
timeFrame: End of intervention period (month 7)
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Institute for Population Health and Development
Study officials:
affiliation: University of New England
name: Mary DeSilva, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: DeSilva M, Vu CN, Bonawitz R, Hai LT, Van Lam N, Yen LT, Gifford AL, Haberer J, Linh DT, Sabin L. The Supporting Adolescent Adherence in Vietnam (SAAV) study: study protocol for a randomized controlled trial assessing an mHealth approach to improving adherence for adolescents living with HIV in Vietnam. Trials. 2019 Feb 28;20(1):150. doi: 10.1186/s13063-019-3239-1.