Supporting Adolescent Adherence in Vietnam (SAAV)

NCT03031197 | Completed FDA Device

• 1 other identifier: 1R21MH109381-01
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Adolescents; HIV/AIDS; Patient Adherence

Keywords

adherence; adolescent; HIV/AIDS; Vietnam

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• CD4 count

  Pre-intervention month (month 1) vs. last intervention month (month 7)

• Viral load

  End of intervention period (month 7)

Study Arms (2)

Tailored realtime triggered reminder pkg

EXPERIMENTAL

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

Control

NO INTERVENTION

Comparison subjects will receive usual care and an offer of counseling at monthly clinic visits.

Interventions

Tailored realtime triggered reminder pkg COMBINATION_PRODUCT

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.

Also known as: wireless monitoring/feedback, counseling, dose histories

Tailored realtime triggered reminder pkg

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of New England: lead
• Institute of Population, Health and Development, Vietnam: collaborator
• Boston University: collaborator

Study Sites (1)

Institute for Population Health and Development

Hanoi, Vietnam

Location

Related Publications (1)

• 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.

  PMID: 30819228 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Patient Compliance

Interventions

Counseling

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Mary DeSilva, ScD

  University of New England

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Research Professor

Study Record Dates

• First Submitted: January 21, 2017
• First Posted: January 25, 2017
• Study Start: May 15, 2017
• Primary Completion: May 25, 2018
• Study Completion: May 25, 2018
• Last Updated: April 8, 2020

Record last verified: 2020-04

Locations

VN (1)