Supporting Adolescent Adherence in Vietnam (SAAV)

HIV/AIDS Clinical Trial

— SAAV  

Official title:

The Supporting Adolescent Adherence in Vietnam (SAAV) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03031197
• Other study ID #: 1R21MH109381-01
• Status: Completed
• Phase: N/A
• Start date: May 15, 2017
• Est. completion date: May 25, 2018

Study information

• Verified date: April 2020
• Source: University of New England
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: May 25, 2018
• Est. primary completion date: May 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

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

Related Conditions & MeSH terms

• Adolescents
• HIV/AIDS
• Patient Adherence

Intervention

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.

Locations

Country	Name	City	State
Vietnam	Institute for Population Health and Development	Hanoi

Sponsors (3)

Lead Sponsor	Collaborator
University of New England	Boston University, Institute of Population, Health and Development, Vietnam

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	CD4 count	Mean change in CD4 count in each study arm	Pre-intervention month (month 1) vs. last intervention month (month 7)
Secondary	Viral load	Percent of patients with undetectable viral load (UDVL) in each study arm	End of intervention period (month 7)