Supporting Adolescent Adherence in Vietnam (SAAV)

NCT ID: NCT03031197

Last Updated: 2020-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-15

Study Completion Date

2018-05-25

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Adolescents HIV/AIDS Patient Adherence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Open Label

Study Groups

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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.

Group Type EXPERIMENTAL

Tailored realtime triggered reminder pkg

Intervention Type 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.

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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wireless monitoring/feedback, counseling, dose histories

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Population, Health and Development, Vietnam

OTHER

Sponsor Role collaborator

Boston University

OTHER

Sponsor Role collaborator

University of New England

OTHER

Sponsor Role lead

Responsible Party

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Mary DeSilva

Assistant Research Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mary DeSilva, ScD

Role: PRINCIPAL_INVESTIGATOR

University of New England

Locations

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Institute for Population Health and Development

Hanoi, , Vietnam

Site Status

Countries

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Vietnam

References

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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.

Reference Type DERIVED
PMID: 30819228 (View on PubMed)

Other Identifiers

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1R21MH109381-01

Identifier Type: NIH

Identifier Source: org_study_id

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