HIV InfectionsTERANCT03292432
Triggered Escalating Real-time Adherence (TERA) Intervention
A study testing TERA Intervention (TERA) in people with HIV Infections, run by University of North Carolina, Chapel Hill at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- TERA Intervention (TERA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 8 sitesUnited States
- Study dates
- 12 Apr 2018to 12 Oct 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 13 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Confirmation of HIV-1 Infection as documented in the participant's medical record by at least two of the following criteria:
- Reactive HIV screening test result with an HIV antibody or HIV antibody/antigen-based, Food and Drug Administration (FDA)-licensed assay followed by a positive supplemental assay (e.g., HIV-1 Western Blot, HIV-1 indirect immunofluorescence, HIV-1/HIV-2 discriminatory immunoassay);
- Plasma HIV-1 quantitative ribonucleic acid (RNA) assay >1,000 copies/mL;
- Positive HIV-1 deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assay; or
- Positive plasma HIV-1 RNA qualitative assay
- Participant aware of his or her HIV infection, as determined by site staff
Show all 13Show fewer
- Documented plasma HIV-1 RNA plasma ≥200 copies/mL within 45 days of the date of the enrollment visit
- Prescribed antiretroviral therapy for at least 24 weeks or more prior to documented plasma HIV-1 RNA plasma ≥200 copies/mL.
- Prescribed a once-daily (one or more pills once a day) ART regimen with at least two active agents (per clinician judgment or genotype evidence) at enrollment
- Able to communicate in spoken and written English
- Currently has a cellular phone that is also able to send and receive text messages
- Willing and able to provide at least one additional contact phone number (preferably two) to contact participant
- Able and willing to provide written informed assent/consent and able to obtain written parental or guardian permission (if required as specified by the site, by state law, and/or Institutional Review Board policy, and detailed in each site's Protocol Implementation Plans) to be screened for and to enroll in this study
Who cannot join
- Gross cognitive limitations, acute emotional instability, or medical or mental health illness that in the opinion of site personnel would impair the individual's ability to provide informed consent and/or interfere with the protocol's objectives
- Concurrent participation in interventional studies addressing adherence unless approved in advance by study team
- Positive pregnancy test at the time of enrollment. If participant becomes pregnant while on study, they may continue on study
- Currently using or planning to use an electronic dose monitoring and reminder device outside of the study
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Emory University School of Medicine
Atlanta, Georgia, 30322
University of Colorado Denver Children's Hospital Colorado
Aurora, Colorado, 80045
Johns Hopkins University
Baltimore, Maryland, 21287
Wayne State University School of Medicine
Detroit, Michigan, 48201
Broward Health Childrens Diagnostic and Treatment Center (CDTC)
Fort Lauderdale, Florida, 33316
University of Florida Center for HIV/AIDS, Research, Education & Service
Jacksonville, Florida, 32209
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Bronx-Lebanon Hospital Center
The Bronx, New York, 10457
About this study
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
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 open/close 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.
Read the 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 copies/ml 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:
- To address lower than anticipated enrollment, the requirement that participants be failing first line ART was dropped in Protocol Version 2.0 (May 9, 2018).
- Accrual was closed before reaching the target enrollment of 120 participants on the recommendation of the Study Monitoring Committee (September 30, 2019).
- 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 3.1. The LOA detailed three modifications due to COVID-19 study visit suspension, but did not affect the existing protocol:
- 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.
- 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.
- Virtual/remote 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.
- Conditions
- HIV Infections
- Being tested
- TERA Intervention (TERA), Standard of Care (SOC)
- Keywords
- Adherence, Medication
- Medical subject headings
- HIV Infections, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TERA Intervention (TERA)Behavioural
A sequence of adherence support strategies implemented at care visits and as needed on the basis of EDM data. Components include: (1) remote education/preparation with an adherence coach conducted with VSee software (video conferencing) at site at baseline, week 4 and week 12; (2) one-way text alert at dose time when bottle has not yet been opened for that dosing window (users can disable this on request); (3) missed dose two-way outreach text asking "What's the plan?" which gets sent to both the participant's phone and a study phone; and (4) implementation of the coach-outreach (phone, text, remote counseling) triggered by missed doses or as a check-in to inquire about the well-being of the youth (once per week when no other contact with coach occurred the week prior).
Standard of Care (SOC)Behavioural
Cell-phone reminders, patient-education, adherence planning (medication management), and checking-in on adherence at clinical care visits, as well as Viral load (VL) monitoring with patient feedback on VL, are used at sites. Less common, but available as a general service at some sites, on several websites, and at many pharmacies, youth may also receive text messages at dose times, for appointment reminders, and for refill reminders.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (SOC) | Active comparator | Standard of Care for adherence support at Site Receives: Behavioral: Standard of Care (SOC) |
| TERA Intervention (TERA) | Experimental | Triggered, escalating, real-time adherence (TERA) intervention for 12 weeks. Receives: Behavioral: TERA Intervention (TERA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Plasma Human Immunodeficiency Virus - Type I Ribonucleic Acid (HIV-1 RNA) Levels Less Than (<) 50 Copies/mL at Week 12
Participants with HIV-1 RNA < 50 copies/mL within the week 12 window (+/- 14 days) are classified as successes. Participants with HIV-1 RNA >= 50 copies/mL or with no HIV-1 RNA measurement within the week 12 window are classified as failures.
Measured: 12 weeks post enrollment
Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Week 12
Participants with HIV-1 RNA < 200 copies/mL within the week 12 window (+/- 14 days) are classified as successes. Participants with HIV-1 RNA >= 200 copies/mL or with no HIV-1 RNA measurement within the week 12 window are classified as failures.
Measured: 12 weeks post enrollment
Secondary outcomes (6)
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 24, 36 and 48
Participants with HIV-1 RNA < 50 copies/mL within each week window (+/- 28 days) are classified as successes. Participants with HIV-1 RNA >= 50 copies/mL or who had the opportunity to reach the study visit week and with no HIV-1 RNA measurement within the week window are classified as failures.
Measured: 24, 36 and 48 weeks post enrollment
Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Weeks 24, 36 and 48
Participants with HIV-1 RNA < 200 copies/mL within each week window (+/- 28 days) are classified as successes. Participants with HIV-1 RNA >= 200 copies/mL or who had the opportunity to reach the study visit week and with no HIV-1 RNA measurement within the week window are classified as failures.
Measured: 24, 36 and 48 weeks post enrollment
Percentage of Participants With HIV-1 RNA < 200 Copies/mL at 12 Weeks and Maintained Through 48 Weeks
Participants are classified as successes if both the week 12 (+/- 14 days) and week 48 (+/- 28 days) HIV-1 RNA measurements are < 200 copies/mL and at least one of the week 24 (+/- 28 days) or week 36 (+/- 28 days) HIV-1 RNA measurements is < 200 copies/mL. Otherwise, the participant is classified as a failure.
Measured: 48 weeks post enrollment
Percentage of Days With Dose Taken From Weeks 0-12, >12-24, >24-36 and >36-48
For each participant and each 12-week period, the percentage is calculated as the number of days with dose taken divided by the number of days with data reported in the Electronic Monitoring Device (EDM).
Measured: Enrollment through 48 weeks
Percentage of Days With Dose Taken Within Defined Acceptable Window (+/- 4 Hours) From Weeks 0-12, >12-24, >24-36 and >36-48
For each participant and each 12-week period, the percentage is calculated as the number of days with dose taken within acceptable window divided by the number of days with data reported in the EDM.
Measured: Enrollment through 48 weeks
Incidence Rate of 7-day Gaps Between Dosing for Weeks 0-12, >12-24, >24-36 and >36-48
For each participant, the incidence rate during each 12 week interval is calculated as the ratio of the number of 7-day gaps between doses relative to the number of weeks with data reported, times 12. Consecutive gaps of more than 7 days increase the gap count by one, e.g., missing 20 days counts as 2 gaps.
Measured: Enrollment through 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start12 Apr 2018
- Primary completion6 Jan 2020
- Study completion12 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies 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
- Model description
- This is a Phase II, two-arm, randomized, open-label study.
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH), National Institute on Drug Abuse (NIDA), National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- K. Rivet Amico, PhD, Principal investigator, University of Michigan School of Public HealthMichael Hudgens, PhD, Study director, University of North Carolina, Chapel HillAditya H Gaur, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03292432
- Sponsor's protocol ID
- ATN 152
- Other IDs
- 5U24HD089880-02
- Acronym
- TERA
- Status last verified
- Oct 2020
- First submitted
- 20 Sep 2017
- Last updated
- 11 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Amico KR, Dunlap A, Dallas R, Lindsey J, Heckman B, Flynn P, Lee S, Horvath K, West Goolsby R, Hudgens M, Filipowicz T, Polier M, Hill E, Mueller Johnson M, Miller J, Neilan A, Ciaranello A, Gaur A. Triggered Escalating Real-Time Adherence Intervention to Promote Rapid HIV Viral Suppression Among Youth Living With HIV Failing Antiretroviral Therapy: Protocol for a Triggered Escalating Real-Time Adherence Intervention. JMIR Res Protoc. 2019 Mar 18;8(3):e11416. doi: 10.2196/11416.
PubMed 30882360Lindsey JC, Hudgens M, Gaur AH, Horvath KJ, Dallas R, Heckman B, Mueller Johnson M, Amico KR. Electronic Dose Monitoring Device Patterns in Youth Living With HIV Enrolled in an Adherence Intervention Clinical Trial. J Acquir Immune Defic Syndr. 2023 Mar 1;92(3):231-241. doi: 10.1097/QAI.0000000000003126.
PubMed 36730762Amico KR, Crawford J, Ubong I, Lindsey JC, Gaur AH, Horvath K, Goolsby R, Mueller Johnson M, Dallas R, Heckman B, Filipowicz T, Polier M, Rupp BM, Hudgens M. Correlates of High HIV Viral Load and Antiretroviral Therapy Adherence Among Viremic Youth in the United States Enrolled in an Adherence Improvement Intervention. AIDS Patient Care STDS. 2021 May;35(5):145-157. doi: 10.1089/apc.2021.0005.
PubMed 33960843
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03292432
- Acronym / sponsor ID
- TERA / ATN 152
- Conditions
- HIV Infections
- Keywords
- Adherence, Medication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH), National Institute on Drug Abuse (NIDA), National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 12 Apr 2018 (actual)
- Primary completion
- 6 Jan 2020 (actual)
- Study completion
- 12 Oct 2020 (actual)
- First posted
- 25 Sep 2017 (actual)
- Results
- Posted 8 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 open/close 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 copies/ml 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:
- To address lower than anticipated enrollment, the requirement that participants be failing first line ART was dropped in Protocol Version 2.0 (May 9, 2018).
- Accrual was closed before reaching the target enrollment of 120 participants on the recommendation of the Study Monitoring Committee (September 30, 2019).
- 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 3.1. The LOA detailed three modifications due to COVID-19 study visit suspension, but did not affect the existing protocol:
- 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.
- 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.
- Virtual/remote 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a Phase II, two-arm, randomized, open-label study.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (SOC) | Active comparator | Behavioral: Standard of Care (SOC)Standard of Care for adherence support at Site |
| TERA Intervention (TERA) | Experimental | Behavioral: TERA Intervention (TERA)Triggered, escalating, real-time adherence (TERA) intervention for 12 weeks. |
Who may qualify
- Ages
- 13 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- Confirmation of HIV-1 Infection as documented in the participant's medical record by at least two of the following criteria:
- Participant aware of his or her HIV infection, as determined by site staff
- Documented plasma HIV-1 RNA plasma ≥200 copies/mL within 45 days of the date of the enrollment visit
- Prescribed antiretroviral therapy for at least 24 weeks or more prior to documented plasma HIV-1 RNA plasma ≥200 copies/mL.
- Prescribed a once-daily (one or more pills once a day) ART regimen with at least two active agents (per clinician judgment or genotype evidence) at enrollment
Key exclusion criteria (4 listed)
- Gross cognitive limitations, acute emotional instability, or medical or mental health illness that in the opinion of site personnel would impair the individual's ability to provide informed consent and/or interfere with the protocol's objectives
- Concurrent participation in interventional studies addressing adherence unless approved in advance by study team
- Positive pregnancy test at the time of enrollment. If participant becomes pregnant while on study, they may continue on study
- Currently using or planning to use an electronic dose monitoring and reminder device outside of the study
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 |
|---|---|---|
| TERA Intervention (TERA)A sequence of adherence support strategies implemented at care visits and as needed on the basis of EDM data. Components include: (1) remote education/preparation with an adherence coach conducted with VSee software (video conferencing) at site at baseline, week 4 and week 12; (2) one-way text alert at dose time when bottle has not yet been opened for that dosing window (users can disable this on request); (3) missed dose two-way outreach text asking "What's the plan?" which gets sent to both the participant's phone and a study phone; and (4) implementation of the coach-outreach (phone, text, remote counseling) triggered by missed doses or as a check-in to inquire about the well-being of the youth (once per week when no other contact with coach occurred the week prior). | Behavioural | TERA Intervention (TERA) |
| Standard of Care (SOC)Cell-phone reminders, patient-education, adherence planning (medication management), and checking-in on adherence at clinical care visits, as well as Viral load (VL) monitoring with patient feedback on VL, are used at sites. Less common, but available as a general service at some sites, on several websites, and at many pharmacies, youth may also receive text messages at dose times, for appointment reminders, and for refill reminders. | Behavioural | Standard of Care (SOC) |
Primary outcome
Percentage of Participants With Plasma Human Immunodeficiency Virus - Type I Ribonucleic Acid (HIV-1 RNA) Levels Less Than (<) 50 Copies/mL at Week 12
Time frame: 12 weeks post enrollment
Participants with HIV-1 RNA < 50 copies/mL within the week 12 window (+/- 14 days) are classified as successes. Participants with HIV-1 RNA >= 50 copies/mL or with no HIV-1 RNA measurement within the week 12 window are classified as failures.
Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Week 12
Time frame: 12 weeks post enrollment
Participants with HIV-1 RNA < 200 copies/mL within the week 12 window (+/- 14 days) are classified as successes. Participants with HIV-1 RNA >= 200 copies/mL or with no HIV-1 RNA measurement within the week 12 window are classified as failures.
6 secondary outcomes
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 24, 36 and 48
Time frame: 24, 36 and 48 weeks post enrollment
Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Weeks 24, 36 and 48
Time frame: 24, 36 and 48 weeks post enrollment
Percentage of Participants With HIV-1 RNA < 200 Copies/mL at 12 Weeks and Maintained Through 48 Weeks
Time frame: 48 weeks post enrollment
Percentage of Days With Dose Taken From Weeks 0-12, >12-24, >24-36 and >36-48
Time frame: Enrollment through 48 weeks
Percentage of Days With Dose Taken Within Defined Acceptable Window (+/- 4 Hours) From Weeks 0-12, >12-24, >24-36 and >36-48
Time frame: Enrollment through 48 weeks
Incidence Rate of 7-day Gaps Between Dosing for Weeks 0-12, >12-24, >24-36 and >36-48
Time frame: Enrollment through 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30882360Amico KR, Dunlap A, Dallas R, Lindsey J, Heckman B, Flynn P, Lee S, Horvath K, West Goolsby R, Hudgens M, Filipowicz T, Polier M, Hill E, Mueller Johnson M, Miller J, Neilan A, Ciaranello A, Gaur A. Triggered Escalating Real-Time Adherence Intervention to Promote Rapid HIV Viral Suppression Among Youth Living With HIV Failing Antiretroviral Therapy: Protocol for a Triggered Escalating Real-Time Adherence Intervention. JMIR Res Protoc. 2019 Mar 18;8(3):e11416. doi: 10.2196/11416.
- Derived from this study: PubMed 36730762Lindsey JC, Hudgens M, Gaur AH, Horvath KJ, Dallas R, Heckman B, Mueller Johnson M, Amico KR. Electronic Dose Monitoring Device Patterns in Youth Living With HIV Enrolled in an Adherence Intervention Clinical Trial. J Acquir Immune Defic Syndr. 2023 Mar 1;92(3):231-241. doi: 10.1097/QAI.0000000000003126.
- Derived from this study: PubMed 33960843Amico KR, Crawford J, Ubong I, Lindsey JC, Gaur AH, Horvath K, Goolsby R, Mueller Johnson M, Dallas R, Heckman B, Filipowicz T, Polier M, Rupp BM, Hudgens M. Correlates of High HIV Viral Load and Antiretroviral Therapy Adherence Among Viremic Youth in the United States Enrolled in an Adherence Improvement Intervention. AIDS Patient Care STDS. 2021 May;35(5):145-157. doi: 10.1089/apc.2021.0005.
- Individual participant dataSharing planned: No
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HIV, HIV - Human Immunodeficiency Virus
RecruitingPhase 1
AMC 120, Glofitamab Plus Chemoimmunotherapy in Newly Diagnosed HIV-Associated Large B-Cell Lymphoma (The "Glofit-RCHOP Study")
AIDS-Related Diffuse Large B-cell Lymphoma, Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
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.
K. Rivet Amico, PhD principal investigator
University of Michigan School of Public Health
Michael Hudgens, PhD study director
University of North Carolina, Chapel Hill
Aditya H Gaur, MD principal investigator
St. Jude Children's Research Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TERA Intervention (TERA) in people with HIV Infections, run by University of North Carolina, Chapel Hill at 8 sites in United States.
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 13 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 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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?
Yes. Results are posted in the registry (first posted 8 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With Plasma Human Immunodeficiency Virus - Type I Ribonucleic Acid (HIV-1 RNA) Levels Less Than (<) 50 Copies/mL at Week 12 (time frame: 12 weeks post enrollment). The study lists 2 primary outcomes in all. 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 NCT03292432, which also lists 3 linked publications.
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 11 Mar 2021.