HIVDO ARTNCT02929992
Delivery Optimization for Antiretroviral Therapy (The DO ART Study)
A study testing ART initiation in the home, Mobile Van Refill and Monitoring and Clinic ART Initiation in people with HIV and ART, run by University of Washington at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- ART initiation in the home, Mobile Van Refill and Monitoring and Clinic ART Initiation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,539 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2016to 21 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- No separate exclusion criteria
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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
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)
Read the detailed 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.
- Being tested
- ART initiation in the home, Mobile Van Refill and Monitoring, Clinic ART Initiation, Clinic ART Refill and Monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ART initiation in the homeOther
Participants initiate ART use in the home without visiting a clinic
Mobile Van Refill and MonitoringOther
Participants will pick up their medication refills from the mobile van and have all clinical monitoring conducted in the mobile van.
Clinic ART InitiationOther
Participants are referred to the clinic to initiate ART use
Clinic ART Refill and MonitoringOther
Participants will return to the clinic for ART refill and clinical monitoring.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Clinic ART Initiation; Other: Clinic ART Refill and Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 Months
Secondary outcomes (5)
Measurement of safety across study arms
Compare the rates of clinical adverse events across study arms.
Measured: 1 month, 3 months, 6 months, 9 months, 12 months
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.
Measured: 12 months
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.
Measured: 1 month, 3 months, 6 months, 9 months, 12 months
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
Measured: 12 months
Measurement of social harms
Compare the rates of reported social harms across study arms.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2016 (estimated)
- Study startMay 2016
- Primary completion30 Nov 2019
- Study completion21 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,539 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Principal investigator, Ruanne Barnabas, University of Washington
- Investigators
- Ruanne Barnabas, MBChB, DPhil, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02929992
- Sponsor's protocol ID
- 50607
- Acronym
- DO ART
- Status last verified
- Oct 2020
- First submitted
- 12 Jul 2016
- Last updated
- 29 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 32971053
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02929992
- Acronym / sponsor ID
- DO ART / 50607
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,539 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- May 2016 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 21 Jan 2020 (actual)
- First posted
- 11 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Home ART initiation | Experimental | Other: ART initiation in the home, Other: Mobile Van Refill and MonitoringParticipants who are eligible to initiate ART will start in the home and will pick up their medication refills from a mobile van. |
| Hybrid model | Experimental | Other: Mobile Van Refill and Monitoring, Other: Clinic ART InitiationParticipants will be referred to the clinic to initiate ART, once started they will pick up their medication refills from a mobile van. |
| Clinic ART initiation, monitoring and resupply | Active comparator | Other: Clinic ART Initiation, Other: Clinic ART Refill and MonitoringThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- No separate exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ART initiation in the homeParticipants initiate ART use in the home without visiting a clinic | Other | Home ART initiation |
| Mobile Van Refill and MonitoringParticipants will pick up their medication refills from the mobile van and have all clinical monitoring conducted in the mobile van. | Other | Home ART initiation, Hybrid model |
| Clinic ART InitiationParticipants are referred to the clinic to initiate ART use | Other | Clinic ART initiation, monitoring and resupply, Hybrid model |
| Clinic ART Refill and MonitoringParticipants will return to the clinic for ART refill and clinical monitoring. | Other | Clinic ART initiation, monitoring and resupply |
Primary outcome
HIV viral suppression at 12 months
Time frame: 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
5 secondary outcomes
Measurement of safety across study arms
Time frame: 1 month, 3 months, 6 months, 9 months, 12 months
Estimate cost-effectiveness of each arm
Time frame: 12 months
Qualitative review
Time frame: 1 month, 3 months, 6 months, 9 months, 12 months
Minimize the cost of achieving viral suppression
Time frame: 12 months
Measurement of social harms
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2020.
- Derived from this study: PubMed 32971053Barnabas 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.
- Individual participant dataSharing planned: No
Related trials for HIV
Not yet recruitingPhase 1
huCART19-IL18-CD428z Cells for the Treatment of Patients With HIV With CD19+ Cancers
Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia
Enrolling by invitation
Evaluating the Efficacy of Annual CHTC Retesting Among Male Couples at High Risk of HIV Infection
HIV Infections
RecruitingPhase 1/2
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
Tuberculosis
Enrolling by invitation
Intervention to Reduce HIV Related Stigma Among Pregnant and Postpartum Women
HIV, HIV - Human Immunodeficiency Virus
Not yet recruitingPhase 4
Study of BIC/LEN FDC Versus Stable Baseline Regimens in Virologically Suppressed People With HIV
HIV-1 Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruanne Barnabas, MBChB, DPhil principal investigator
Assistant Professor
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ART initiation in the home, Mobile Van Refill and Monitoring and Clinic ART Initiation in people with HIV and ART, run by University of Washington at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Africa, Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV viral suppression at 12 months (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02929992, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2020.