Supporting Adolescent Adherence in Vietnam (SAAV) (SAAV)
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03031197|
Recruitment Status : Completed
First Posted : January 25, 2017
Last Update Posted : April 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Adolescents HIV/AIDS Patient Adherence||Combination Product: Tailored realtime triggered reminder pkg||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||81 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|
|Actual Study Start Date :||May 15, 2017|
|Actual Primary Completion Date :||May 25, 2018|
|Actual Study Completion Date :||May 25, 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.
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03031197
|Institute for Population Health and Development|
|Principal Investigator:||Mary DeSilva, ScD||University of New England|