N/A
N=83
Adherence Interventions for HIV Youth Via Text & Cell Phone - Sequential Multiple Assignment Randomized Trial (SMART)
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT03535337 ↗Enrolled (actual)
83
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Undetectable Viral Load — 58.8; 62.9; 89.5; 87.5 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CPS (Behavioral); SMS (Behavioral)
- Age
- Pediatric, Adult · 15+ yrs
- Sex
- All
- Sponsor
- Florida State University
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Undetectable Viral Load |
58.8; 62.9; 89.5; 87.5; 100; 100 | — |
| PRIMARY Medication Adherence Rate - 7 Day |
63.68; 74.52; 90.69; 76.18; 70.00; 100 | 0.03 sig |
| PRIMARY Medication Adherence - 30 Days |
68.55; 74.33; 87.56; 84.87; 75.00; 53.00 | 0.82 |
Summary
The purpose of this study is to test an adaptive adherence intervention, which utilizes two mobile health (mHealth) intervention designs, in an effort to promote adherence to antiretroviral therapy (ART) and achieve and maintain viral load (VL) suppression in youth living with HIV (YLH) while increasing understanding of the context for wide-scale implementation of cell phone support (CPS) and text messaging support (SMS), with and without incentives.
Eligibility Criteria
Inclusion Criteria
- HIV diagnosis
- Viral load ≥ 200 copies/mL within 3 months prior to enrollment or self-reported adherence ≤ 80%
- ART medication regimen prescribed minimum of 3 months prior to eligibility VL or self-reported adherence
- Sole owner of device capable of sending/receiving calls and text messages
- Willingness to permit research team to communicate with their HIV care provider team
Exclusion Criteria
- Mental, physical, or emotional capacity prevents completion of protocol as written
- Inability to understand written/spoken English
- Concurrent participant in any adherence behavioral research intervention
Data sourced from ClinicalTrials.gov (NCT03535337). 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.