Ignite Creation Date:
2024-05-06 @ 10:34 AM
Last Modification Date:
2024-10-26 @ 12:32 PM
Study NCT ID:
NCT03292432
Status:
COMPLETED
Last Update Posted:
2021-03-11
First Post:
2017-09-20
Brief Title:
Triggered Escalating Real-time Adherence TERA Intervention
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Triggered Escalating Real-time Adherence Intervention to Promote Rapid HIV Viral Suppression Among Youth Living With HIV Failing Antiretroviral Therapy The TERA Study
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TERA
Brief Summary:
Youth Living with HIV YLWH often face unique challenges achieving high and sustained rates of adherence to their antiretroviral therapy ART Poor adherence can lead to unsuppressed virus more advanced HIV disease and poorer health outcomes eventually exhausting treatment options To date however there are few demonstrated interventions for youth failing first line therapy This study evaluated a novel intervention that used remote coaching through video enabled counseling sessions an Electronic Dose Monitoring EDM pill bottle that notified an adherence coach when youth failed to openclose the device around dose time and problem solving outreach by the coach in response to not dosing from the EDM This intensive boot camp strategy was implemented for 12 weeks followed by observation through 48 weeks
Detailed Description:
This was a Phase II two-arm randomized open-label study Eligible participants had failed ART therapy defined as having a detectable plasma Human Immunodeficiency Virus - Type 1 Ribonucleic Acid HIV-1 RNA 200 copiesml within 45 days of enrollment despite having been prescribed ART for at least 24 weeks They could continue the same ART regimen or start a new once daily regimen Participants were stratified by age 18 vs 18 years of age and randomized in equal proportions to receive the study intervention TERA or standard of care SOC with no enrollment limits in each stratum Target accrual was 120 participants to be enrolled over one year
TERA was a time-limited 12 weeks intervention approach that a used wireless electronic dose monitoring EDM to identify dose-times passing with no bottle opening b sent a text asking about the delay c evaluated response to the text and d initiated follow-up by an adherence coach depending on the response and if the bottle remained unopened for a designated period post dosing Phone based outreach used problem solving discussion with an adherence coach who could use an agreed-upon contact tree to reach the youth through other individuals This boot camp strategy was used to unsettle or disrupt established non-adherence behaviors and factors promoting ongoing non-adherence
Participants were followed for 48 weeks with clinic visits at entry and weeks 4 12 24 36 and 48 Audio computer assisted self-interviews ACASI were conducted every 12 weeks to collect information on adherence motivation and skills social support mental and physical health functioning Viral loads medication and medical histories were also collected at each study visit
The primary objective of the study was to compare HIV-virologic suppression VLS rates at 12 weeks Secondary objectives included comparing VLS rates and EDM rates of ART adherence at 24 36 and 48 weeks as well as patterns of adherence over time
Major changes after the start of enrollment
1 To address lower than anticipated enrollment the requirement that participants be failing first line ART was dropped in Protocol Version 20 May 9 2018
2 Accrual was closed before reaching the target enrollment of 120 participants on the recommendation of the Study Monitoring Committee September 30 2019
3 Coronavirus disease of 2019 COVID-19 Updates On March 20 2020 the TERA study suspended all study activities due to COVID-19 On May 5 2020 sites were allowed to resume TERA study activities whenever their institution allowed human subjects research to resume Participants were encouraged to return for their final Week 48 clinic visits
At the time of the study pause data collection for the Primary Outcome Measures was complete so the analyses proposed in the original Statistical Analysis Plan were not affected Follow-up for the Secondary Outcome Measures involving HIV-1 RNA measurements and adherence was incomplete with 33 of participants still on study Because of the possibility that participant behavior and adherence to ART would differ pre- and post-pandemic and it would not be possible to collect HIV-1 RNA measurements within the required visit windows sites were actively trying to keep patients from coming into care unless urgently needed the Study Team decided to base analyses on data collected prior to the COVID-19 study pause In addition because the secondary virologic outcome measures were a combination of HIV-1 RNA levels and data completeness classifying participants with no HIV-1 RNA measurement within the allowed visit window as virologic failures the analysis population for these outcome measures only included participants with sufficient time on study to reach each study visit
These changes were implemented on June 2 2020 in a Letter of Amendment LOA to TERA Protocol Version 31 The LOA detailed three modifications due to COVID-19 study visit suspension but did not affect the existing protocol
1 Extension of Week 48 visit window through the end of data collection October 12 2020 for participants on-study as of March 20 2020 due to COVID-19 study suspension
2 Changed all secondary outcome measures to apply only to data collected prior to COVID-19 study suspension on March 20 2020 Only participants who had been on study long enough to reach the Week 24 36 or 48 study visits were included in the analyses
3 Virtualremote site monitoring was implemented for all remaining site monitoring visits
On September 24 2020 the Study Team released a memo to the sites extending the date for the Week 48 study visit to October 12 2020
Results for secondary outcome measures 3 to 8 are based on the pre COVID-19 study pause database as of March 20 2020
Results for secondary outcome measures 9 and 10 are based on the complete study database as of October 12 2020
TERA was a time-limited 12 weeks intervention approach that a used wireless electronic dose monitoring EDM to identify dose-times passing with no bottle opening b sent a text asking about the delay c evaluated response to the text and d initiated follow-up by an adherence coach depending on the response and if the bottle remained unopened for a designated period post dosing Phone based outreach used problem solving discussion with an adherence coach who could use an agreed-upon contact tree to reach the youth through other individuals This boot camp strategy was used to unsettle or disrupt established non-adherence behaviors and factors promoting ongoing non-adherence
Participants were followed for 48 weeks with clinic visits at entry and weeks 4 12 24 36 and 48 Audio computer assisted self-interviews ACASI were conducted every 12 weeks to collect information on adherence motivation and skills social support mental and physical health functioning Viral loads medication and medical histories were also collected at each study visit
The primary objective of the study was to compare HIV-virologic suppression VLS rates at 12 weeks Secondary objectives included comparing VLS rates and EDM rates of ART adherence at 24 36 and 48 weeks as well as patterns of adherence over time
Major changes after the start of enrollment
1 To address lower than anticipated enrollment the requirement that participants be failing first line ART was dropped in Protocol Version 20 May 9 2018
2 Accrual was closed before reaching the target enrollment of 120 participants on the recommendation of the Study Monitoring Committee September 30 2019
3 Coronavirus disease of 2019 COVID-19 Updates On March 20 2020 the TERA study suspended all study activities due to COVID-19 On May 5 2020 sites were allowed to resume TERA study activities whenever their institution allowed human subjects research to resume Participants were encouraged to return for their final Week 48 clinic visits
At the time of the study pause data collection for the Primary Outcome Measures was complete so the analyses proposed in the original Statistical Analysis Plan were not affected Follow-up for the Secondary Outcome Measures involving HIV-1 RNA measurements and adherence was incomplete with 33 of participants still on study Because of the possibility that participant behavior and adherence to ART would differ pre- and post-pandemic and it would not be possible to collect HIV-1 RNA measurements within the required visit windows sites were actively trying to keep patients from coming into care unless urgently needed the Study Team decided to base analyses on data collected prior to the COVID-19 study pause In addition because the secondary virologic outcome measures were a combination of HIV-1 RNA levels and data completeness classifying participants with no HIV-1 RNA measurement within the allowed visit window as virologic failures the analysis population for these outcome measures only included participants with sufficient time on study to reach each study visit
These changes were implemented on June 2 2020 in a Letter of Amendment LOA to TERA Protocol Version 31 The LOA detailed three modifications due to COVID-19 study visit suspension but did not affect the existing protocol
1 Extension of Week 48 visit window through the end of data collection October 12 2020 for participants on-study as of March 20 2020 due to COVID-19 study suspension
2 Changed all secondary outcome measures to apply only to data collected prior to COVID-19 study suspension on March 20 2020 Only participants who had been on study long enough to reach the Week 24 36 or 48 study visits were included in the analyses
3 Virtualremote site monitoring was implemented for all remaining site monitoring visits
On September 24 2020 the Study Team released a memo to the sites extending the date for the Week 48 study visit to October 12 2020
Results for secondary outcome measures 3 to 8 are based on the pre COVID-19 study pause database as of March 20 2020
Results for secondary outcome measures 9 and 10 are based on the complete study database as of October 12 2020
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5U24HD089880-02 | NIH | None | httpsreporternihgovquickSearch5U24HD089880-02 |