Adults 13 to 24, any sex, with HIV Infections. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With Plasma Human Immunodeficiency Virus - Type I Ribonucleic Acid (HIV-1 RNA) Levels Less Than (<) 50 Copies/mL at Week 12Primary· 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.
Group
Value
95% CI
Standard of Care (SOC)
24.4
TERA Intervention (TERA)
20.9
Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Week 12Primary· 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.
Group
Value
95% CI
Standard of Care (SOC)
35.6
TERA Intervention (TERA)
34.9
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 24, 36 and 48Secondary· 24, 36 and 48 weeks post enrollment
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.
Week 24
Group
Value
95% CI
Standard of Care (SOC)
36.4
TERA Intervention (TERA)
23.3
Week 36
Group
Value
95% CI
Standard of Care (SOC)
15.6
TERA Intervention (TERA)
19.4
Week 48
Group
Value
95% CI
Standard of Care (SOC)
24.0
TERA Intervention (TERA)
27.6
Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Weeks 24, 36 and 48Secondary· 24, 36 and 48 weeks post enrollment
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.
Week 24
Group
Value
95% CI
Standard of Care (SOC)
40.9
TERA Intervention (TERA)
27.9
Week 36
Group
Value
95% CI
Standard of Care (SOC)
21.9
TERA Intervention (TERA)
33.3
Week 48
Group
Value
95% CI
Standard of Care (SOC)
32.0
TERA Intervention (TERA)
27.6
Percentage of Participants With HIV-1 RNA < 200 Copies/mL at 12 Weeks and Maintained Through 48 WeeksSecondary· 48 weeks post enrollment
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.
Group
Value
95% CI
Standard of Care (SOC)
8.0
TERA Intervention (TERA)
13.8
Percentage of Days With Dose Taken From Weeks 0-12, >12-24, >24-36 and >36-48Secondary· Enrollment through 48 weeks
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).
Weeks 0 - 12
Group
Value
95% CI
Standard of Care (SOC)
41.0
20.5 – 59.0
TERA Intervention (TERA)
72.1
46.5 – 89.2
Weeks >12 - 24
Group
Value
95% CI
Standard of Care (SOC)
14.3
1.2 – 32.1
TERA Intervention (TERA)
40.5
10.7 – 70.2
Weeks >24 - 36
Group
Value
95% CI
Standard of Care (SOC)
2.4
0.0 – 14.3
TERA Intervention (TERA)
17.2
2.3 – 40.5
Weeks >36 - 48
Group
Value
95% CI
Standard of Care (SOC)
1.2
0.0 – 7.4
TERA Intervention (TERA)
1.2
0.0 – 30.0
Percentage of Days With Dose Taken Within Defined Acceptable Window (+/- 4 Hours) From Weeks 0-12, >12-24, >24-36 and >36-48Secondary· Enrollment through 48 weeks
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.
Weeks 0 - 12
Group
Value
95% CI
Standard of Care (SOC)
21.4
8.4 – 38.6
TERA Intervention (TERA)
62.7
30.1 – 84.3
Weeks >12 - 24
Group
Value
95% CI
Standard of Care (SOC)
7.1
0.0 – 16.7
TERA Intervention (TERA)
27.4
7.1 – 57.1
Weeks >24 - 36
Group
Value
95% CI
Standard of Care (SOC)
2.4
0.0 – 9.5
TERA Intervention (TERA)
10.7
0.0 – 35.7
Weeks >36 - 48
Group
Value
95% CI
Standard of Care (SOC)
0.0
0.0 – 4.8
TERA Intervention (TERA)
1.2
0.0 – 22.5
Incidence Rate of 7-day Gaps Between Dosing for Weeks 0-12, >12-24, >24-36 and >36-48Secondary· Enrollment through 48 weeks
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.
Weeks 0 - 12
Group
Value
95% CI
Standard of Care (SOC)
4.17
3.61 – 4.82
TERA Intervention (TERA)
1.66
1.31 – 2.11
Weeks >12 - 24
Group
Value
95% CI
Standard of Care (SOC)
6.91
6.16 – 7.75
TERA Intervention (TERA)
4.43
3.81 – 5.15
Weeks >24 - 36
Group
Value
95% CI
Standard of Care (SOC)
8.19
7.28 – 9.21
TERA Intervention (TERA)
6.65
5.84 – 7.57
Weeks >36 - 48
Group
Value
95% CI
Standard of Care (SOC)
9.54
8.37 – 10.89
TERA Intervention (TERA)
8.81
7.76 – 10.00
Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Week 48Secondary· 48 weeks post enrollment
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.
Group
Value
95% CI
Standard of Care (SOC)
23.3
TERA Intervention (TERA)
25.6
Percentage of Participants With HIV-1 RNA < 200 Copies/mL at 12 Weeks and Maintained Through 48 WeeksSecondary· 12, 24, 36, and 48 weeks post enrollment
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.
Group
Value
95% CI
Standard of Care (SOC)
7.0
TERA Intervention (TERA)
11.6
Adverse events — posted to ClinicalTrials.gov
Time frame: From study entry to study completion (approximately 48 weeks).
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Standard of Care (SOC)
Serious: 3/45 (7%)
Deaths: 2/45
TERA Intervention (TERA)
Serious: 4/43 (9%)
Deaths: 1/43
Serious adverse events (10 terms)
Reaction
System
Standard of Care (SOC)
TERA Intervention (TERA)
Cardiac event
Cardiac disorders
—
—
Esophageal candidiasis and pelvic inflammatory disease
Infections and infestations
—
—
Gunshot wound to head
Injury, poisoning and procedural complications
—
—
Axillary abscess
Infections and infestations
—
—
Pneumothorax acute recurrent with shortness of breath, hypoxia and hypokalemia
Respiratory, thoracic and mediastinal disorders
—
—
Pneumothorax
Respiratory, thoracic and mediastinal disorders
—
—
HSV proctitis
Infections and infestations
—
—
Pneumonia
Respiratory, thoracic and mediastinal disorders
—
—
Facial cellulitis and MRSA positive wound of the tragus
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.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07225530 — Implementation of Screen, Treat, and Triage for Women Living With HIV in La Romana (iSTAR)
· NA
· recruiting
NCT07202546 — A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study)
· Phase 2
· recruiting
NCT06694753 — Safety and Immunogenicity Study of Three mRNAs Encoding HIV Immunogens in Adult Participants Without HIV and in Overall
· Phase 1
· recruiting
NCT07235852 — Pilot Testing Into the Feasibility of the Developed Cognitive Behavioral Therapy Intervention
· NA
· recruiting
NCT06665646 — Clinical Trial to Evaluate the Safety and Immunogenicity of Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env (VRIPRO) in Ad
· Phase 1
· recruiting
Other University of North Carolina, Chapel Hill trials
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of North Carolina, Chapel Hill
Last refreshed: 11 March 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03292432.