Supporting Adolescent Adherence in Vietnam (SAAV) (SAAV)
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|ClinicalTrials.gov Identifier: NCT03031197|
Recruitment Status : Not yet recruiting
First Posted : January 25, 2017
Last Update Posted : April 26, 2017
University of New England
Institute of Population, Health and Development, Vietnam
Information provided by (Responsible Party):
Mary DeSilva, University of New England
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 or disease||Intervention/treatment||Phase|
|Adolescents HIV/AIDS Patient Adherence||Combination Product: Tailored realtime triggered reminder pkg||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|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|
|Estimated Study Start Date :||May 15, 2017|
|Estimated Primary Completion Date :||February 2018|
|Estimated Study Completion Date :||February 2018|
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.
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
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