N/A
N=89
Triggered Escalating Real-time Adherence (TERA) Intervention
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT03292432 ↗Enrolled (actual)
89
Serious AEs
8.0%
Results posted
Jan 2021
Primary outcome: Primary: 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; 20.9 Percentage of participants — p=0.80
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TERA Intervention (TERA) (Behavioral); Standard of Care (SOC) (Behavioral)
- Age
- Pediatric, Adult · 13+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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; 20.9 | 0.80 |
| PRIMARY Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Week 12 |
35.6; 34.9 | >0.99 |
| SECONDARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 24, 36 and 48 |
36.4; 23.3; 15.6; 19.4; 24.0; 27.6 | 0.24 |
| SECONDARY Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Weeks 24, 36 and 48 |
40.9; 27.9; 21.9; 33.3; 32.0; 27.6 | 0.26 |
| SECONDARY Percentage of Participants With HIV-1 RNA < 200 Copies/mL at 12 Weeks and Maintained Through 48 Weeks |
7.0; 11.6 | 0.71 |
| SECONDARY Percentage of Days With Dose Taken From Weeks 0-12, >12-24, >24-36 and >36-48 |
41.0; 72.1; 14.3; 40.5; 2.4; 17.2 | <0.001 sig |
| SECONDARY Percentage of Days With Dose Taken Within Defined Acceptable Window (+/- 4 Hours) From Weeks 0-12, >12-24, >24-36 and >36-48 |
21.4; 62.7; 7.1; 27.4; 2.4; 10.7 | <0.001 sig |
| SECONDARY Incidence Rate of 7-day Gaps Between Dosing for Weeks 0-12, >12-24, >24-36 and >36-48 |
4.17; 1.66; 6.91; 4.43; 8.19; 6.65 | <0.001 sig |
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 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.
Eligibility Criteria
Inclusion Criteria
- 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
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03292432). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.