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Delivery Optimization for Antiretroviral Therapy (The DO ART Study)

NCT02929992 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1539

Last updated 2020-10-29

No results posted yet for this study

Summary

The investigators propose the Delivery Optimization for Antiretroviral Therapy Study - The DO ART Study - a prospective randomized study of strategies to optimize community-based ART initiation, monitoring and resupply among HIV-positive persons in South Africa and Uganda. The investigators will work closely with community members, stakeholders, local providers, and the local Department of Health (DoH) to integrate the community-based ART delivery with HIV clinics, pharmacies and labs. Following community sensitization, participants will be recruited through community-based HTC and HIV clinics. HIV-positive persons not engaged in care will receive point-of-care CD4 testing to determine ART eligibility. HIV-positive persons who are eligible for ART by national guidelines will be randomized to one of three ART delivery arms: (i) Home ART initiation and mobile van ART monitoring and resupply, (ii) Hybrid model with clinic ART initiation and mobile van ART monitoring and resupply, and (iii) Clinic ART initiation, monitoring and resupply - the current standard of care (SOC)

Conditions

Interventions

OTHER

ART initiation in the home

Participants initiate ART use in the home without visiting a clinic

OTHER

Mobile Van Refill and Monitoring

Participants will pick up their medication refills from the mobile van and have all clinical monitoring conducted in the mobile van.

OTHER

Clinic ART Initiation

Participants are referred to the clinic to initiate ART use

OTHER

Clinic ART Refill and Monitoring

Participants will return to the clinic for ART refill and clinical monitoring.

Sponsors & Collaborators

Principal Investigators

  • Ruanne Barnabas, MBChB, DPhil · Assistant Professor

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2019-11-30
Completion
2020-01-21

Countries

  • South Africa
  • Uganda

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT02929992 on ClinicalTrials.gov