AdolescentsSAAVNCT03031197
Supporting Adolescent Adherence in Vietnam (SAAV)
A study testing Tailored realtime triggered reminder pkg in people with Adolescents and HIV/AIDS, run by University of New England at 1 site in Vietnam.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Adolescents, HIV/AIDS, Patient Adherence
- What is being tested?
- Tailored realtime triggered reminder pkg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteVietnam
- Study dates
- 15 May 2017to 25 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Adolescents, HIV/AIDS, Patient Adherence
- Being tested
- Tailored realtime triggered reminder pkg
- Keywords
- adherence, adolescent, HIV/AIDS, Vietnam
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored realtime triggered reminder pkgCombination product
Also called wireless monitoring/feedback, counseling, dose histories
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.
| Study group | Role | What they receive |
|---|---|---|
| Tailored realtime triggered reminder pkg | Experimental | 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. Receives: Combination Product: Tailored realtime triggered reminder pkg |
| Control | No intervention | Comparison subjects will receive usual care and an offer of counseling at monthly clinic visits. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal on-time adherence
Proportion of patients with ≥95% on-time adherence at end of 6-month intervention period in each study arm
Measured: End of intervention period (month 7)
Secondary outcomes (2)
CD4 count
Mean change in CD4 count in each study arm
Measured: Pre-intervention month (month 1) vs. last intervention month (month 7)
Viral load
Percent of patients with undetectable viral load (UDVL) in each study arm
Measured: End of intervention period (month 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study start15 May 2017
- Primary completion25 May 2018
- Study completion25 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AdolescentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New England
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Population, Health and Development, Vietnam, Boston University
- Responsible party
- Principal investigator, Mary DeSilva, University of New England
- Investigators
- Mary DeSilva, ScD, Principal investigator, University of New England
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03031197
- Sponsor's protocol ID
- 1R21MH109381-01
- Acronym
- SAAV
- Status last verified
- Apr 2020
- First submitted
- 21 Jan 2017
- Last updated
- 8 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Undecided.
Publications
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.
PubMed 30819228
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Supporting Adolescent Adherence in Vietnam (SAAV) Study
- ClinicalTrials.gov ID
- NCT03031197
- Acronym / sponsor ID
- SAAV / 1R21MH109381-01
- Conditions
- Adolescents, HIV/AIDS, Patient Adherence
- Keywords
- adherence, adolescent, HIV/AIDS, Vietnam
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University of New EnglandUniversity, hospital or other
- Collaborators
- Institute of Population, Health and Development, Vietnam, Boston University
- Study start
- 15 May 2017 (actual)
- Primary completion
- 25 May 2018 (actual)
- Study completion
- 25 May 2018 (actual)
- First posted
- 25 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tailored realtime triggered reminder pkg | Experimental | Combination Product: Tailored realtime triggered reminder pkgThe 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. |
| Control | No intervention | –Comparison subjects will receive usual care and an offer of counseling at monthly clinic visits. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored realtime triggered reminder pkgAlso: wireless monitoring/feedback, counseling, dose historiesCore 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. | Combination product | Tailored realtime triggered reminder pkg |
Primary outcome
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
2 secondary outcomes
CD4 count
Time frame: Pre-intervention month (month 1) vs. last intervention month (month 7)
Viral load
Time frame: End of intervention period (month 7)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2020.
- Derived from this study: PubMed 30819228DeSilva 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.
- Individual participant dataSharing planned: Undecided. Undecided.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary DeSilva, ScD principal investigator
University of New England
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored realtime triggered reminder pkg in people with Adolescents and HIV/AIDS, run by University of New England at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimal on-time adherence (time frame: End of intervention period (month 7)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03031197, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2020.