MedTrace Logo

Reducing Time to Spaced-out Appointments for Newly-diagnosed People Living With HIV

NCT04567693 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2023-10-25

Study results available
· View outcomes & findings →

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).

Conditions

Interventions

OTHER

Early spaced-out appointments

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.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Albert Einstein College of Medicine

    collaborator OTHER

  • Rwanda Military Hospital

    collaborator OTHER

  • Montefiore Medical Center

    lead OTHER

Principal Investigators

  • Jonathan Ross · Montefiore Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-22
Primary Completion
2022-04-26
Completion
2022-07-18

Countries

  • Rwanda

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04567693 on ClinicalTrials.gov