Trial Outcomes & Findings for Triggered Escalating Real-time Adherence (TERA) Intervention (NCT NCT03292432)

Last Updated: 2021-03-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

89 participants

Primary outcome timeframe

12 weeks post enrollment

Results posted on

2021-03-11

Participant Flow

Participants were enrolled at 10 sites in the United States between April 12, 2018 and September 30, 2019.

Participants were stratified by age (\< 18 years vs. \>= 18 years) and randomized equally to the TERA intervention and Standard of Care. One participant was randomized but never started a behavioral intervention as site closed before any data collected.

Participant milestones

Participant milestones
Measure	Standard of Care (SOC) Standard of care for adherence support at site	TERA Intervention (TERA) Triggered, escalating, real-time adherence (TERA) intervention for 12 weeks
Overall Study STARTED	46	43
Overall Study Started Study Intervention	45	43
Overall Study COMPLETED	31	32
Overall Study NOT COMPLETED	15	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Standard of Care (SOC) Standard of care for adherence support at site	TERA Intervention (TERA) Triggered, escalating, real-time adherence (TERA) intervention for 12 weeks
Overall Study Lost to Follow-up	11	8
Overall Study Death	2	1
Overall Study Withdrawal by Subject	1	2
Overall Study Site closed before any data collected	1	0

Baseline Characteristics

Triggered Escalating Real-time Adherence (TERA) Intervention

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard of Care (SOC) n=45 Participants Standard of care for adherence support at site	TERA Intervention (TERA) n=43 Participants Triggered, escalating, real-time adherence (TERA) intervention for 12 weeks	Total n=88 Participants Total of all reporting groups
Age, Continuous	22.1 years n=5 Participants	22.3 years n=7 Participants	22.2 years n=5 Participants
Age, Customized 13 - 17 years	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Age, Customized 18 - 21 years	16 Participants n=5 Participants	13 Participants n=7 Participants	29 Participants n=5 Participants
Age, Customized 22 - 25 years	24 Participants n=5 Participants	26 Participants n=7 Participants	50 Participants n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	21 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	22 Participants n=7 Participants	48 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	41 Participants n=5 Participants	34 Participants n=7 Participants	75 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	40 Participants n=5 Participants	34 Participants n=7 Participants	74 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment United States	45 Participants n=5 Participants	43 Participants n=7 Participants	88 Participants n=5 Participants
Mode of transmission Horizontal transmission	24 Participants n=5 Participants	25 Participants n=7 Participants	49 Participants n=5 Participants
Mode of transmission Vertical transmission	21 Participants n=5 Participants	18 Participants n=7 Participants	39 Participants n=5 Participants
Plasma Human Immunodeficiency Virus - Type 1 Ribonucleic Acid (HIV-1 RNA) 200 - <400 copies/mL	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Plasma Human Immunodeficiency Virus - Type 1 Ribonucleic Acid (HIV-1 RNA) 400 - <10,000 copies/mL	25 Participants n=5 Participants	21 Participants n=7 Participants	46 Participants n=5 Participants
Plasma Human Immunodeficiency Virus - Type 1 Ribonucleic Acid (HIV-1 RNA) 10,000 - <50,000 copies/mL	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
Plasma Human Immunodeficiency Virus - Type 1 Ribonucleic Acid (HIV-1 RNA) >= 50,000 copies/mL	7 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants
Cluster of differentiation 4 (CD4) cell count < 200 cells/mm^3	4 Participants n=5 Participants	11 Participants n=7 Participants	15 Participants n=5 Participants
Cluster of differentiation 4 (CD4) cell count 200 - < 500 cells/mm^3	16 Participants n=5 Participants	13 Participants n=7 Participants	29 Participants n=5 Participants
Cluster of differentiation 4 (CD4) cell count 500 - < 1000 cells/mm^3	22 Participants n=5 Participants	17 Participants n=7 Participants	39 Participants n=5 Participants
Cluster of differentiation 4 (CD4) cell count >= 1000 cells/mm^3	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Cluster of differentiation 4 (CD4) cell count Missing	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks post enrollment

Population: Includes participants who started study intervention

Outcome measures

Outcome measures
Measure	Standard of Care (SOC) n=45 Participants Standard of care for adherence support at site	TERA Intervention (TERA) n=43 Participants Triggered, escalating, real-time adherence (TERA) intervention for 12 weeks
Percentage of Participants With Plasma Human Immunodeficiency Virus - Type I Ribonucleic Acid (HIV-1 RNA) Levels Less Than (<) 50 Copies/mL at Week 12	24.4 Percentage of participants	20.9 Percentage of participants

PRIMARY outcome

Timeframe: 12 weeks post enrollment

Population: Includes participants who started study intervention

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.

Outcome measures

Outcome measures
Measure	Standard of Care (SOC) n=45 Participants Standard of care for adherence support at site	TERA Intervention (TERA) n=43 Participants Triggered, escalating, real-time adherence (TERA) intervention for 12 weeks
Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Week 12	35.6 Percentage of participants	34.9 Percentage of participants

SECONDARY outcome

Timeframe: 24, 36 and 48 weeks post enrollment

Population: Includes participants who started study intervention and with the opportunity to reach the targeted study visit prior to the Coronavirus Disease 2019 (COVID-19) study pause on March 20, 2020

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.

Outcome measures

Outcome measures
Measure	Standard of Care (SOC) n=45 Participants Standard of care for adherence support at site	TERA Intervention (TERA) n=43 Participants Triggered, escalating, real-time adherence (TERA) intervention for 12 weeks
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 24, 36 and 48 Week 24	36.4 Percentage of participants	23.3 Percentage of participants
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 24, 36 and 48 Week 36	15.6 Percentage of participants	19.4 Percentage of participants
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 24, 36 and 48 Week 48	24.0 Percentage of participants	27.6 Percentage of participants

SECONDARY outcome

Timeframe: 24, 36 and 48 weeks post enrollment

Population: Includes participants who started study intervention and with the opportunity to reach the targeted study visit prior to the COVID-19 study pause on March 20, 2020

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.

Outcome measures

Outcome measures
Measure	Standard of Care (SOC) n=45 Participants Standard of care for adherence support at site	TERA Intervention (TERA) n=43 Participants Triggered, escalating, real-time adherence (TERA) intervention for 12 weeks
Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Weeks 24, 36 and 48 Week 24	40.9 Percentage of participants	27.9 Percentage of participants
Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Weeks 24, 36 and 48 Week 36	21.9 Percentage of participants	33.3 Percentage of participants
Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Weeks 24, 36 and 48 Week 48	32.0 Percentage of participants	27.6 Percentage of participants

SECONDARY outcome

Timeframe: 48 weeks post enrollment

Population: Includes participants who started study intervention and with the opportunity to reach the Week 48 visit prior to the COVID-19 study pause on March 20, 2020

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.

Outcome measures

Outcome measures
Measure	Standard of Care (SOC) n=25 Participants Standard of care for adherence support at site	TERA Intervention (TERA) n=29 Participants Triggered, escalating, real-time adherence (TERA) intervention for 12 weeks
Percentage of Participants With HIV-1 RNA < 200 Copies/mL at 12 Weeks and Maintained Through 48 Weeks	8.0 Percentage of participants	13.8 Percentage of participants

SECONDARY outcome

Timeframe: Enrollment through 48 weeks

Population: Includes participants who started study intervention and with data reported in the adherence EDM up to the COVID-19 pause on March 20, 2020

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).

Outcome measures

Outcome measures
Measure	Standard of Care (SOC) n=45 Participants Standard of care for adherence support at site	TERA Intervention (TERA) n=42 Participants Triggered, escalating, real-time adherence (TERA) intervention for 12 weeks
Percentage of Days With Dose Taken From Weeks 0-12, >12-24, >24-36 and >36-48 Weeks 0 - 12	41.0 Percentage of days with dose taken Interval 20.5 to 59.0	72.1 Percentage of days with dose taken Interval 46.5 to 89.2
Percentage of Days With Dose Taken From Weeks 0-12, >12-24, >24-36 and >36-48 Weeks >12 - 24	14.3 Percentage of days with dose taken Interval 1.2 to 32.1	40.5 Percentage of days with dose taken Interval 10.7 to 70.2
Percentage of Days With Dose Taken From Weeks 0-12, >12-24, >24-36 and >36-48 Weeks >24 - 36	2.4 Percentage of days with dose taken Interval 0.0 to 14.3	17.2 Percentage of days with dose taken Interval 2.3 to 40.5
Percentage of Days With Dose Taken From Weeks 0-12, >12-24, >24-36 and >36-48 Weeks >36 - 48	1.2 Percentage of days with dose taken Interval 0.0 to 7.4	1.2 Percentage of days with dose taken Interval 0.0 to 30.0

SECONDARY outcome

Timeframe: Enrollment through 48 weeks

Population: Includes participants who started study intervention and with data reported in the adherence EDM up to the COVID-19 pause on March 20, 2020

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.

Outcome measures

Outcome measures
Measure	Standard of Care (SOC) n=45 Participants Standard of care for adherence support at site	TERA Intervention (TERA) n=42 Participants Triggered, escalating, real-time adherence (TERA) intervention for 12 weeks
Percentage of Days With Dose Taken Within Defined Acceptable Window (+/- 4 Hours) From Weeks 0-12, >12-24, >24-36 and >36-48 Weeks 0 - 12	21.4 Percentage of days dose taken on time Interval 8.4 to 38.6	62.7 Percentage of days dose taken on time Interval 30.1 to 84.3
Percentage of Days With Dose Taken Within Defined Acceptable Window (+/- 4 Hours) From Weeks 0-12, >12-24, >24-36 and >36-48 Weeks >12 - 24	7.1 Percentage of days dose taken on time Interval 0.0 to 16.7	27.4 Percentage of days dose taken on time Interval 7.1 to 57.1
Percentage of Days With Dose Taken Within Defined Acceptable Window (+/- 4 Hours) From Weeks 0-12, >12-24, >24-36 and >36-48 Weeks >24 - 36	2.4 Percentage of days dose taken on time Interval 0.0 to 9.5	10.7 Percentage of days dose taken on time Interval 0.0 to 35.7
Percentage of Days With Dose Taken Within Defined Acceptable Window (+/- 4 Hours) From Weeks 0-12, >12-24, >24-36 and >36-48 Weeks >36 - 48	0.0 Percentage of days dose taken on time Interval 0.0 to 4.8	1.2 Percentage of days dose taken on time Interval 0.0 to 22.5

SECONDARY outcome

Timeframe: Enrollment through 48 weeks

Population: Includes participants who started study intervention and with data reported in the adherence EDM up to the COVID-19 pause on March 20, 2020.

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.

Outcome measures

Outcome measures
Measure	Standard of Care (SOC) n=45 Participants Standard of care for adherence support at site	TERA Intervention (TERA) n=42 Participants Triggered, escalating, real-time adherence (TERA) intervention for 12 weeks
Incidence Rate of 7-day Gaps Between Dosing for Weeks 0-12, >12-24, >24-36 and >36-48 Weeks >12 - 24	6.91 Ratio Interval 6.16 to 7.75	4.43 Ratio Interval 3.81 to 5.15
Incidence Rate of 7-day Gaps Between Dosing for Weeks 0-12, >12-24, >24-36 and >36-48 Weeks 0 - 12	4.17 Ratio Interval 3.61 to 4.82	1.66 Ratio Interval 1.31 to 2.11
Incidence Rate of 7-day Gaps Between Dosing for Weeks 0-12, >12-24, >24-36 and >36-48 Weeks >24 - 36	8.19 Ratio Interval 7.28 to 9.21	6.65 Ratio Interval 5.84 to 7.57
Incidence Rate of 7-day Gaps Between Dosing for Weeks 0-12, >12-24, >24-36 and >36-48 Weeks >36 - 48	9.54 Ratio Interval 8.37 to 10.89	8.81 Ratio Interval 7.76 to 10.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 48 weeks post enrollment

Population: Includes participants who started study intervention. Excludes participants who died from non-HIV-related causes before Week 48.

Participants with HIV-1 RNA \< 200 copies/mL at Week 48 are classified as successes. Participants with HIV-1 RNA \>= 200 copies/mL or with no HIV-1 RNA measurement after 44 weeks follow-up are classified as failures.

Outcome measures

Outcome measures
Measure	Standard of Care (SOC) n=43 Participants Standard of care for adherence support at site	TERA Intervention (TERA) n=43 Participants Triggered, escalating, real-time adherence (TERA) intervention for 12 weeks
Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Week 48	23.3 Percentage of participants	25.6 Percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12, 24, 36, and 48 weeks post enrollment

Population: Includes participants who started study intervention. Excludes participants who died from non-HIV-related causes before Week 48.

Outcome measures

Outcome measures
Measure	Standard of Care (SOC) n=43 Participants Standard of care for adherence support at site	TERA Intervention (TERA) n=43 Participants Triggered, escalating, real-time adherence (TERA) intervention for 12 weeks
Percentage of Participants With HIV-1 RNA < 200 Copies/mL at 12 Weeks and Maintained Through 48 Weeks	7.0 Percentage of participants	11.6 Percentage of participants

Adverse Events

Standard of Care (SOC)

Serious events: 3 serious events

Other events: 0 other events

Deaths: 2 deaths

TERA Intervention (TERA)

Serious events: 4 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Standard of Care (SOC) n=45 participants at risk Standard of care for adherence support at site	TERA Intervention (TERA) n=43 participants at risk Triggered, escalating, real-time adherence (TERA) intervention for 12 weeks
Cardiac disorders Cardiac event	2.2% 1/45 • Number of events 1 • From study entry to study completion (approximately 48 weeks) In addition to collection of serious adverse events, the study collected 'Untoward events' of Grade 3 or higher and related to the study. Untoward events were defined as unexpected occurrences involving study participants, study staff, or the community where the study was taking place, that may reasonably be judged as related to study procedures and that led to harm, distress, or increased risk of harm or distress, but that did not otherwise meet the definition of an adverse event.	0.00% 0/43 • From study entry to study completion (approximately 48 weeks) In addition to collection of serious adverse events, the study collected 'Untoward events' of Grade 3 or higher and related to the study. Untoward events were defined as unexpected occurrences involving study participants, study staff, or the community where the study was taking place, that may reasonably be judged as related to study procedures and that led to harm, distress, or increased risk of harm or distress, but that did not otherwise meet the definition of an adverse event.
Infections and infestations Esophageal candidiasis and pelvic inflammatory disease	2.2% 1/45 • Number of events 1 • From study entry to study completion (approximately 48 weeks) In addition to collection of serious adverse events, the study collected 'Untoward events' of Grade 3 or higher and related to the study. Untoward events were defined as unexpected occurrences involving study participants, study staff, or the community where the study was taking place, that may reasonably be judged as related to study procedures and that led to harm, distress, or increased risk of harm or distress, but that did not otherwise meet the definition of an adverse event.	0.00% 0/43 • From study entry to study completion (approximately 48 weeks) In addition to collection of serious adverse events, the study collected 'Untoward events' of Grade 3 or higher and related to the study. Untoward events were defined as unexpected occurrences involving study participants, study staff, or the community where the study was taking place, that may reasonably be judged as related to study procedures and that led to harm, distress, or increased risk of harm or distress, but that did not otherwise meet the definition of an adverse event.
Injury, poisoning and procedural complications Gunshot wound to head	2.2% 1/45 • Number of events 1 • From study entry to study completion (approximately 48 weeks) In addition to collection of serious adverse events, the study collected 'Untoward events' of Grade 3 or higher and related to the study. Untoward events were defined as unexpected occurrences involving study participants, study staff, or the community where the study was taking place, that may reasonably be judged as related to study procedures and that led to harm, distress, or increased risk of harm or distress, but that did not otherwise meet the definition of an adverse event.	0.00% 0/43 • From study entry to study completion (approximately 48 weeks) In addition to collection of serious adverse events, the study collected 'Untoward events' of Grade 3 or higher and related to the study. Untoward events were defined as unexpected occurrences involving study participants, study staff, or the community where the study was taking place, that may reasonably be judged as related to study procedures and that led to harm, distress, or increased risk of harm or distress, but that did not otherwise meet the definition of an adverse event.
Infections and infestations Axillary abscess	0.00% 0/45 • From study entry to study completion (approximately 48 weeks) In addition to collection of serious adverse events, the study collected 'Untoward events' of Grade 3 or higher and related to the study. Untoward events were defined as unexpected occurrences involving study participants, study staff, or the community where the study was taking place, that may reasonably be judged as related to study procedures and that led to harm, distress, or increased risk of harm or distress, but that did not otherwise meet the definition of an adverse event.	2.3% 1/43 • Number of events 1 • From study entry to study completion (approximately 48 weeks) In addition to collection of serious adverse events, the study collected 'Untoward events' of Grade 3 or higher and related to the study. Untoward events were defined as unexpected occurrences involving study participants, study staff, or the community where the study was taking place, that may reasonably be judged as related to study procedures and that led to harm, distress, or increased risk of harm or distress, but that did not otherwise meet the definition of an adverse event.
Respiratory, thoracic and mediastinal disorders Pneumothorax acute recurrent with shortness of breath, hypoxia and hypokalemia	0.00% 0/45 • From study entry to study completion (approximately 48 weeks) In addition to collection of serious adverse events, the study collected 'Untoward events' of Grade 3 or higher and related to the study. Untoward events were defined as unexpected occurrences involving study participants, study staff, or the community where the study was taking place, that may reasonably be judged as related to study procedures and that led to harm, distress, or increased risk of harm or distress, but that did not otherwise meet the definition of an adverse event.	2.3% 1/43 • Number of events 1 • From study entry to study completion (approximately 48 weeks) In addition to collection of serious adverse events, the study collected 'Untoward events' of Grade 3 or higher and related to the study. Untoward events were defined as unexpected occurrences involving study participants, study staff, or the community where the study was taking place, that may reasonably be judged as related to study procedures and that led to harm, distress, or increased risk of harm or distress, but that did not otherwise meet the definition of an adverse event.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/45 • From study entry to study completion (approximately 48 weeks) In addition to collection of serious adverse events, the study collected 'Untoward events' of Grade 3 or higher and related to the study. Untoward events were defined as unexpected occurrences involving study participants, study staff, or the community where the study was taking place, that may reasonably be judged as related to study procedures and that led to harm, distress, or increased risk of harm or distress, but that did not otherwise meet the definition of an adverse event.	2.3% 1/43 • Number of events 1 • From study entry to study completion (approximately 48 weeks) In addition to collection of serious adverse events, the study collected 'Untoward events' of Grade 3 or higher and related to the study. Untoward events were defined as unexpected occurrences involving study participants, study staff, or the community where the study was taking place, that may reasonably be judged as related to study procedures and that led to harm, distress, or increased risk of harm or distress, but that did not otherwise meet the definition of an adverse event.
Infections and infestations HSV proctitis	0.00% 0/45 • From study entry to study completion (approximately 48 weeks) In addition to collection of serious adverse events, the study collected 'Untoward events' of Grade 3 or higher and related to the study. Untoward events were defined as unexpected occurrences involving study participants, study staff, or the community where the study was taking place, that may reasonably be judged as related to study procedures and that led to harm, distress, or increased risk of harm or distress, but that did not otherwise meet the definition of an adverse event.	2.3% 1/43 • Number of events 1 • From study entry to study completion (approximately 48 weeks) In addition to collection of serious adverse events, the study collected 'Untoward events' of Grade 3 or higher and related to the study. Untoward events were defined as unexpected occurrences involving study participants, study staff, or the community where the study was taking place, that may reasonably be judged as related to study procedures and that led to harm, distress, or increased risk of harm or distress, but that did not otherwise meet the definition of an adverse event.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/45 • From study entry to study completion (approximately 48 weeks) In addition to collection of serious adverse events, the study collected 'Untoward events' of Grade 3 or higher and related to the study. Untoward events were defined as unexpected occurrences involving study participants, study staff, or the community where the study was taking place, that may reasonably be judged as related to study procedures and that led to harm, distress, or increased risk of harm or distress, but that did not otherwise meet the definition of an adverse event.	2.3% 1/43 • Number of events 1 • From study entry to study completion (approximately 48 weeks) In addition to collection of serious adverse events, the study collected 'Untoward events' of Grade 3 or higher and related to the study. Untoward events were defined as unexpected occurrences involving study participants, study staff, or the community where the study was taking place, that may reasonably be judged as related to study procedures and that led to harm, distress, or increased risk of harm or distress, but that did not otherwise meet the definition of an adverse event.
Infections and infestations Facial cellulitis and MRSA positive wound of the tragus	0.00% 0/45 • From study entry to study completion (approximately 48 weeks) In addition to collection of serious adverse events, the study collected 'Untoward events' of Grade 3 or higher and related to the study. Untoward events were defined as unexpected occurrences involving study participants, study staff, or the community where the study was taking place, that may reasonably be judged as related to study procedures and that led to harm, distress, or increased risk of harm or distress, but that did not otherwise meet the definition of an adverse event.	2.3% 1/43 • Number of events 1 • From study entry to study completion (approximately 48 weeks) In addition to collection of serious adverse events, the study collected 'Untoward events' of Grade 3 or higher and related to the study. Untoward events were defined as unexpected occurrences involving study participants, study staff, or the community where the study was taking place, that may reasonably be judged as related to study procedures and that led to harm, distress, or increased risk of harm or distress, but that did not otherwise meet the definition of an adverse event.
Infections and infestations AIDS	0.00% 0/45 • From study entry to study completion (approximately 48 weeks) In addition to collection of serious adverse events, the study collected 'Untoward events' of Grade 3 or higher and related to the study. Untoward events were defined as unexpected occurrences involving study participants, study staff, or the community where the study was taking place, that may reasonably be judged as related to study procedures and that led to harm, distress, or increased risk of harm or distress, but that did not otherwise meet the definition of an adverse event.	2.3% 1/43 • Number of events 1 • From study entry to study completion (approximately 48 weeks) In addition to collection of serious adverse events, the study collected 'Untoward events' of Grade 3 or higher and related to the study. Untoward events were defined as unexpected occurrences involving study participants, study staff, or the community where the study was taking place, that may reasonably be judged as related to study procedures and that led to harm, distress, or increased risk of harm or distress, but that did not otherwise meet the definition of an adverse event.

Other adverse events

Other adverse events
Measure	Standard of Care (SOC) n=45 participants at risk Standard of care for adherence support at site	TERA Intervention (TERA) n=43 participants at risk Triggered, escalating, real-time adherence (TERA) intervention for 12 weeks
Psychiatric disorders Suicidal ideation	0.00% 0/45 • From study entry to study completion (approximately 48 weeks) In addition to collection of serious adverse events, the study collected 'Untoward events' of Grade 3 or higher and related to the study. Untoward events were defined as unexpected occurrences involving study participants, study staff, or the community where the study was taking place, that may reasonably be judged as related to study procedures and that led to harm, distress, or increased risk of harm or distress, but that did not otherwise meet the definition of an adverse event.	4.7% 2/43 • Number of events 2 • From study entry to study completion (approximately 48 weeks) In addition to collection of serious adverse events, the study collected 'Untoward events' of Grade 3 or higher and related to the study. Untoward events were defined as unexpected occurrences involving study participants, study staff, or the community where the study was taking place, that may reasonably be judged as related to study procedures and that led to harm, distress, or increased risk of harm or distress, but that did not otherwise meet the definition of an adverse event.

Additional Information

Rachel Goolsby - Research Manager

University of North Carolina at Chapel Hill

Phone: 9198430685

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place