Delivery Optimization for Antiretroviral Therapy (The DO ART Study)

NCT02929992 | Completed DMC

• 1 other identifier: 50607
• Study Type: interventional
• Target: 1,539
• Locations: 2 countries
• Sites: 2

Brief 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

HIV; ART

Outcome Measures

Primary Outcomes (1)

• HIV viral suppression at 12 months

  Maximize, through community-based ART initiation and maintenance, the proportion of HIV-positive ART eligible persons who achieve viral suppression at 12 months

  12 Months

Secondary Outcomes (5)

• Measurement of safety across study arms

  1 month, 3 months, 6 months, 9 months, 12 months

• Estimate cost-effectiveness of each arm

  12 months

• Qualitative review

  1 month, 3 months, 6 months, 9 months, 12 months

• Minimize the cost of achieving viral suppression

  12 months

• Measurement of social harms

  12 months

Study Arms (3)

Home ART initiation

EXPERIMENTAL

Participants who are eligible to initiate ART will start in the home and will pick up their medication refills from a mobile van.

Other: ART initiation in the home; Other: Mobile Van Refill and Monitoring

Hybrid model

EXPERIMENTAL

Participants will be referred to the clinic to initiate ART, once started they will pick up their medication refills from a mobile van.

Other: Mobile Van Refill and Monitoring; Other: Clinic ART Initiation

Clinic ART initiation, monitoring and resupply

ACTIVE COMPARATOR

This is the standard of care arm. Participants will be given a referral to the clinic to initiate ART and will pick up their medication refills from the clinic.

Other: Clinic ART Initiation; Other: Clinic ART Refill and Monitoring

Interventions

ART initiation in the home OTHER

Participants initiate ART use in the home without visiting a clinic

Home ART initiation

Mobile Van Refill and Monitoring OTHER

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

Home ART initiation; Hybrid model

Clinic ART Initiation OTHER

Participants are referred to the clinic to initiate ART use

Clinic ART initiation, monitoring and resupply; Hybrid model

Clinic ART Refill and Monitoring OTHER

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

Clinic ART initiation, monitoring and resupply

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Reside in the study community for the duration of follow-up
• Able and willing to provide informed consent
• HIV positive and eligible to start ART according to national guidelines
• Not pregnant
• Normal renal function
• Not receiving treatment for active tuberculosis or other opportunistic infections

Sponsors & Collaborators

• University of Washington: lead
• Bill and Melinda Gates Foundation: collaborator

Study Sites (2)

HSRC Sweetwaters

Sweetwaters, KwaZulu-Natal, South Africa

Location

ICOBI

Kabwohe, Bushenyi, Uganda

Location

Related Publications (1)

• Barnabas RV, Szpiro AA, van Rooyen H, Asiimwe S, Pillay D, Ware NC, Schaafsma TT, Krows ML, van Heerden A, Joseph P, Shahmanesh M, Wyatt MA, Sausi K, Turyamureeba B, Sithole N, Morrison S, Shapiro AE, Roberts DA, Thomas KK, Koole O, Bershteyn A, Ehrenkranz P, Baeten JM, Celum C; Delivery Optimization of Antiretroviral Therapy (DO ART) Study Team. Community-based antiretroviral therapy versus standard clinic-based services for HIV in South Africa and Uganda (DO ART): a randomised trial. Lancet Glob Health. 2020 Oct;8(10):e1305-e1315. doi: 10.1016/S2214-109X(20)30313-2.

  PMID: 32971053 DERIVED

Study Officials

• Ruanne Barnabas, MBChB, DPhil

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Global Health

Study Record Dates

• First Submitted: July 12, 2016
• First Posted: October 11, 2016
• Study Start: May 1, 2016
• Primary Completion: November 30, 2019
• Study Completion: January 21, 2020
• Last Updated: October 29, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1); ZA (1)