CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 93 enrolled
Drug / intervention
Early spaced-out appointmentsother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04567693
NCT04567693N/ACompleted

Reducing Time to Spaced-out Appointments for Newly-diagnosed People Living With HIV: a Pilot Study

Montefiore Medical Center·interventional·Posted Sep 28, 2020·Updated Oct 25, 2023

In Brief

A clinical study evaluating Early spaced-out appointments for Hiv and Aids. Completed, enrolled 93 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHiv, Aids
CountriesRwanda

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedSep 28, 2020
Enrollment StartOct 22, 2020
Primary CompletionApr 26, 2022
Study CompletionJul 18, 2022
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 5.8 years ago

Interventions

Early spaced-out appointmentsother

Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In the intervention arms, participants will attend health centers quarterly for ART pick-up and semi-annually for clinical visits.