Delivery Optimization for Antiretroviral Therapy (The DO ART Study)

HIV Clinical Trial

— DO ART  

Official title:

Delivery Optimization for Antiretrovial Therapy (The DO ART Study): A Prospective, Interventional, Randomized Study of Community-based ART Initiation, Delivery, and Monitoring in South Africa and Uganda

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02929992
• Other study ID #: 50607
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: January 21, 2020

Study information

• Verified date: October 2020
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Description:

Antiretroviral therapy (ART) has tremendous potential to prevent HIV-associated morbidity, mortality and transmission. With reliable ART supply and monitoring, the life expectancy of HIV-positive persons in southern Africa is comparable to that of HIV-negative persons. However, HIV-associated mortality continues to be high among HIV-positive persons not diagnosed and not engaged in care. Of the 35 million persons worldwide who meet WHO (World Health Organization) guidelines for ART, only 15 million are on ART. For already burdened health care systems faced with more than doubling of persons on ART, effective and efficient ART initiation and monitoring strategies are needed. First line ART regimens are once daily oral regimens and well-tolerated, which increases the simplicity of ART delivery in general, including community-based ART delivery a feasible alternative to clinic-based delivery. A priority for optimization of ART delivery is to directly compare and evaluate the impact and cost of community-based ART initiation and resupply to clinic delivery of ART in high prevalence settings in Africa, in order to expand capacity to provide ART coverage.

The investigators have extensive experience with community-based strategies for HIV testing and linkage to care. In a series of studies, the investigators have demonstrated that community-based HIV testing and counseling (HTC) results in >90% knowledge of serostatus and similarly high linkage rates for HIV-positive persons to HIV care. However, the investigators observed bottlenecks within HIV clinics that resulted in delays in ART initiation, particularly for those with higher CD4 counts; only 59% of HIV-positive ART eligible persons were virally suppressed at 12 months, far below the UNAIDS target of 80%. Those findings suggest that community-based strategies for ART initiation and maintenance could address clinic inefficiencies and patient opportunity costs and barriers to optimize ART delivery.

South Africa and Uganda plan to provide decentralized services, including community health workers, CHWs, (known as community health extension workers, CHEWs, in Uganda) conducting HTC and linkage to care and local pharmacy pick-up locations for medication, to meet the challenge of scaling up ART. The investigators proposed Delivery Optimization for Antiretroviral Therapy (The DO ART Study). A rigorous evaluation of an innovative, decentralized ART optimization strategy to safely and cost-effectively deliver ART and monitor viral suppression among HIV-positive persons in South Africa and Uganda. Using a prospective individually-randomized design, the investigators will compare home ART initiation and local mobile van ART resupply to clinic centered care among HIV-positive persons in South Africa and Uganda. Following community sensitization, participants will be recruited through community-based HTC and HIV clinics. 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) A hybrid model of clinic ART initiation with mobile van ART monitoring and resupply, and (iii) Clinic ART initiation, monitoring and resupply - the standard of care (SOC).

The co-primary outcomes are 1) the proportion of HIV-positive persons who initiate ART and achieve viral suppression and 2) cost per HIV-positive person with suppressed HIV viral load at 12 months. The secondary outcomes are safety, social harms, acceptability, the cost-effectiveness of community-based ART delivery, and understanding qualitatively the drivers of engagement in care.

The investigators hypothesize that community-based ART initiation will be acceptable, efficient and improve outcomes, specifically with prompter ART initiation and a higher proportion of HIV-positive persons achieving viral suppression, compared to the standard clinic ART delivery model. Decentralizing HIV care for asymptomatic individuals will expand the overall capacity of the health system to provide care for HIV-positive persons using the existing clinical infrastructure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1539
• Est. completion date: January 21, 2020
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• No separate exclusion criteria

Related Conditions & MeSH terms

• ART
• HIV

Intervention

Other:
• ART initiation in the home
Participants initiate ART use in the home without visiting a clinic
• 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.
• Clinic ART Initiation
Participants are referred to the clinic to initiate ART use
• Clinic ART Refill and Monitoring
Participants will return to the clinic for ART refill and clinical monitoring.

Locations

Country	Name	City	State
South Africa	HSRC Sweetwaters	Sweetwaters	Kwa-Zulu Natal
Uganda	ICOBI	Kabwohe	Bushenyi

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Bill and Melinda Gates Foundation

Countries where clinical trial is conducted

South Africa,  Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Measurement of safety across study arms	Compare the rates of clinical adverse events across study arms.	1 month, 3 months, 6 months, 9 months, 12 months
Secondary	Estimate cost-effectiveness of each arm	Estimate the cost-effectiveness for community-based ART initiation compared to clinic-based programs, using mathematical models and study results.	12 months
Secondary	Qualitative review	Use qualitative methods to assess "how" and "why" community-based strategies of ART initiation, re-supply and monitoring impact viral suppression and other study outcomes.	1 month, 3 months, 6 months, 9 months, 12 months
Secondary	Minimize the cost of achieving viral suppression	Minimize the cost per HIV-positive person achieving viral suppression and retention in the continuum of HIV care through community-based strategies compared to clinic standard of care	12 months
Secondary	Measurement of social harms	Compare the rates of reported social harms across study arms.	12 months