We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Supporting Adolescent Adherence in Vietnam (SAAV) (SAAV)

This study is not yet open for participant recruitment.
Verified April 2017 by Mary DeSilva, University of New England
Sponsor:
ClinicalTrials.gov Identifier:
NCT03031197
First Posted: January 25, 2017
Last Update Posted: April 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Institute of Population, Health and Development, Vietnam
Boston University
Information provided by (Responsible Party):
Mary DeSilva, University of New England
  Purpose
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.

Condition Intervention
Adolescents HIV/AIDS Patient Adherence Combination Product: Tailored realtime triggered reminder pkg

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description:
Open Label
Primary Purpose: Supportive Care
Official Title: The Supporting Adolescent Adherence in Vietnam (SAAV) Study

Further study details as provided by Mary DeSilva, University of New England:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • CD4 count [ Time Frame: Pre-intervention month (month 1) vs. last intervention month (month 7) ]
    Mean change in CD4 count in each study arm

  • Viral load [ Time Frame: End of intervention period (month 7) ]
    Percent of patients with undetectable viral load (UDVL) in each study arm


Estimated Enrollment: 80
Anticipated Study Start Date: May 15, 2017
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: wireless monitoring/feedback, counseling, dose histories
No Intervention: Control
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Mary DeSilva, Assistant Research Professor, University of New England
ClinicalTrials.gov Identifier: NCT03031197     History of Changes
Other Study ID Numbers: 1R21MH109381-01 ( U.S. NIH Grant/Contract )
First Submitted: January 21, 2017
First Posted: January 25, 2017
Last Update Posted: April 26, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Mary DeSilva, University of New England:
adherence
adolescent
HIV/AIDS
Vietnam