Supporting Adolescent Adherence in Vietnam (SAAV) (SAAV)

April 2, 2020 updated by: Mary DeSilva, University of New England

The Supporting Adolescent Adherence in Vietnam (SAAV) Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Hanoi, Vietnam
        • Institute for Population Health and Development

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Other Names:
  • wireless monitoring/feedback, counseling, dose histories
No Intervention: Control
Comparison subjects will receive usual care and an offer of counseling at monthly clinic visits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
End of intervention period (month 7)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of New England

Collaborators

Boston University
Institute of Population, Health and Development, Vietnam

Investigators

  • Principal Investigator: Mary DeSilva, ScD, University of New England

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2017

Primary Completion (Actual)

May 25, 2018

Study Completion (Actual)

May 25, 2018

Study Registration Dates

First Submitted

January 21, 2017

First Submitted That Met QC Criteria

January 21, 2017

First Posted (Estimate)

January 25, 2017

Study Record Updates

Last Update Posted (Actual)

April 8, 2020

Last Update Submitted That Met QC Criteria

April 2, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R21MH109381-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Undecided.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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