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Completed

NCT Number: NCT03031197

Supporting Adolescent Adherence in Vietnam (SAAV)

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.

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Key information

Conditions

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

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute for Population Health and Development

Hanoi, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: wireless monitoring/feedback, counseling, dose histories

Primary outcomes

  1. Optimal on-time adherence

    Time frame: 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 outcomes

  1. CD4 count

    Time frame: Pre-intervention month (month 1) vs. last intervention month (month 7)

    Mean change in CD4 count in each study arm

  2. Viral load

    Time frame: End of intervention period (month 7)

    Percent of patients with undetectable viral load (UDVL) in each study arm

Sponsors and collaborators

Lead sponsor

University of New England

Other

Collaborators

  • Boston University
  • Institute of Population, Health and Development, Vietnam

Registry information

Official study title

The Supporting Adolescent Adherence in Vietnam (SAAV) Study

Acronym: SAAV

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 25, 2017
Registry last updated
Apr 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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