N/A
Completed N=93
Reducing Time to Spaced-out Appointments for Newly-diagnosed People Living With HIV
Source: ClinicalTrials.gov NCT04567693 ↗Enrolled (actual)
93
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcomePrimary: Viral Suppression — 25; 25; 19 Participants
Summary
The objectives of this study are to pilot test the effect of reducing time to spaced-out appointments from 18 to 6 months for newly-diagnosed people living with HIV (PLWH) in Rwanda who have initiated antiretroviral therapy (ART). PLWH are currently required to visit the health center monthly for ART and clinical appointments for the first 18 months on ART, after which they can attend quarterly. Reducing the time to spaced-out appointments from 18 to 6 months has the potential to reduce the burden on patients and the health system, but may lead to suboptimal treatment outcomes. To better understand the effects of early spaced-out appointments as well as the degree of viral load monitoring needed to determine stability on ART, the investigators will conduct a 3-arm pilot intervention study. The investigators will randomize participants to 1) 6-month advancement to spaced-out appointments after 1 viral load measurement; 2) 6-month advancement to spaced-out appointments after 2 viral load measurements; or 3) usual care. The investigators will compare the study arms with respect to viral suppression at 12 months after enrollment in ART care (primary outcome) and appointment/ pharmacy adherence (secondary outcome).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Viral Suppression |
25; 25; 19 | — |
| SECONDARY Appointment Adherence |
— | — |
| SECONDARY Participant Acceptability of Reduced Time to Spaced-out Appointments |
4.2; 4.3; 4.2; 3.9; 4.0; 3.9 | — |
| SECONDARY Provider Acceptability of Reduced Time to Spaced-out Appointments |
7; 6; 0 | — |
Eligibility Criteria
Inclusion Criteria
- ≥15 years;
- newly-diagnosed with HIV (within 6 months);
- enrolled in care at study health facility;
- initiated ART.
Exclusion Criteria
- planning on moving away from health center/Kigali in the next 12 months;
- unable to provide informed consent;
- enrolled in care while pregnant;
- co-infected with tuberculosis;
- concurrent known mental health or substance use disorder.
Data sourced from ClinicalTrials.gov (NCT04567693). 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. Informational only — not medical advice.