HIVSUTHINCT02654613
Scaling up TB and HIV Treatment Integration
A study testing Quality Improvement Model of Care in people with HIV and Tuberculosis, run by Centre for the AIDS Programme of Research in South Africa at 1 site in South Africa.
Trial summary
This study addresses the highest ranking health research priority in South Africa, which is, to develop and test optimal models of HIV-TB service delivery that will enhance retention, adherence and coverage of HIV-TB co-infected patients. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- HIV, Tuberculosis
- What is being tested?
- Quality Improvement Model of Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,000 participants
- Where
- 1 siteSouth Africa
- Study dates
- 1 Jun 2015to 30 Dec 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- South African Department of Health Primary Health Care Clinics
- ART site
- Supported by BroadReach Healthcare
Who cannot join
- Mobile clinics
- Clinics that do not offer ART
- Clinics with only 1 nurse
- Hospitals and Gateway clinics
Trial locations and contacts
1 site in 1 country.
South Africa1 site
CAPRISA eThekwini Clinical Research Site
Durban, KwaZulu-Natal, 4001
About this study
Official title: Addressing Challenges in Scaling up TB and HIV Treatment Integration in Public Health Settings in South Africa
This study addresses the highest ranking health research priority in South Africa, which is, to develop and test optimal models of HIV-TB service delivery that will enhance retention, adherence and coverage of HIV-TB co-infected patients. HIV and TB are highest in sub-Saharan Africa, a region with limited health budgets, infrastructure, human resources, and suboptimal TB infection control practices. There is compelling clinical evidence suggesting that integrating HIV and TB services saves lives and presents an effective and efficient use of resources directed at optimizing health outcomes. Quality improvement (QI) methods are increasingly being used to systematically test and incorporate local ideas into strategies for reliable implementation and scale up. This trial is designed to test a practical, implementable and affordable strategy aimed at improving HIV-TB service integration to reduce TB and HIV associated deaths. This is a cluster randomized controlled trial, which evaluates and tests the effectiveness of implementing a QI model to integrate HIV-TB service delivery in primary health care clinics, on reducing morbidity and mortality in TB-HIV co-infected patients. This study will be conducted in 2 districts, Ugu and uThungulu, in KwaZulu-Natal, South Africa. The model of integrated care delivery for TB and HIV using the QI method offers a systems approach to care delivery to directly enhance treatment outcomes by enabling comprehensive effective care designed around the patients journey from entry to the clinic, through screening treatment initiation, treatment completion, and retention in care that is directed at the goals of cure for TB, effective sustainable HIV viral suppression and reduced HIV associated TB mortality as the main health impact. The scalability of the model, once proven effective, is the critical element that makes it increase population coverage of quality diagnosis and treatment of HIV-TB co-infection. QI methods promote front line staff engagement in identification and rapid testing of local implementation solutions to gaps in performance of processes of care along the steps of the patient journey. Gaps in care are identified through continuous feedback on a core set of indicators collected monthly as routine collection of data.
Read the detailed description
The primary aim of this study is to test the effectiveness of a peer mentor-led, quality-improvement model of service delivery of integrated HIV-TB treatment on mortality in HIV-TB co-infected patients treated in rural primary health care clinics in KwaZulu-Natal, South Africa
Specific Objectives (i) To determine the impact of a QI-mediated HIV-TB service integration on patient mortality. All patients that access services in intervention and control clinics, via either the TB entry point or via the HIV entry point will be tracked during clinic follow-up visits or, through a community care giver, and will have their vital status ascertained 12 months after clinic randomization.
(ii) To determine the effectiveness of peer-led Quality Improvement (QI) to integrate HIV-TB services. The effect, on HIV-TB integrated processes of care, of the deployment of a QI approach (systems view, data driven decision making, culture of continuous improvement, trained peer mentors) to ensure uniform implementation of an essential package of evidence based HIV-TB interventions that support HIV-TB integration. The impact on clinical outcomes of using QI methods to implement integrated HIV and TB management will be assessed using the following indicators: Time to ART initiation among HIV infected TB suspects and cases; HIV testing rates in TB patients; Number of HIV-TB co-infected patients receiving co-treatment for TB and HIV at the same facility; Number of patients infected with HIV or TB that are retained in care at 12 months; Indicators of treatment adherence such as - number of HIV patients that are virologically suppressed at 12 months and TB treatment outcomes; Hospitalisation rates among patients receiving co-treatment for TB and HIV.
(iii) To identify clinic-level factors that impact on integrated HIV-TB services. Understanding the context (environmental, social and political factors) in which we are working is essential to identifying factors that promote or inhibit the implementation of the intervention. We will use the COACH tool (Context Assessment for Community Health) [8] to collect data and assess the organizational context and the influence of factors such as organizational culture, leadership, resources and HCWs remuneration etc. on the intervention
(iv) To determine the cost-effectiveness of implementing HIV-TB services using Quality Improvement methodology (Intervention Clinics) versus the base-case of implementing HIV-TB services independently, through a within-trial approach using both health service (e.g. training, remuneration) and patient costs (e.g. travel, opportunity costs) as inputs. We will also calculate total intervention costs to assess its affordability and explore cost-effectiveness under various scenarios (e.g. different TB-HIV co-infection rates) using decision analytical modeling.
(v) To identify a set of interventions, change ideas, tools and approaches that can be used to scale up adoption, implementation and sustainability of integrated HIV-TB services across South Africa and in other resource constrained settings.
(vi) To strengthen the capacity of CAPRISA to independently perform implementation research in PRDs, including community-randomized trials and health economic analysis, through expert mentoring and supervision of PhD programmes.
- Conditions
- HIV, Tuberculosis
- Being tested
- Quality Improvement Model of Care
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality Improvement Model of CareOther
QI addresses the "how" of program implementation. Technically, QI improves process performance by developing a common simplified view of the components and linkages of integrated care, real-time data feed-back to track system performance, understanding the psychology of system change, and crucially, the iterative testing and incorporation of ideas for performance improvement from the front-line practitioners, managers, and customers in the local context.
| Study group | Role | What they receive |
|---|---|---|
| Quality Improvement Intervention | Active comparator | In intervention clinics, staff will follow QI methodology to undertake a detailed assessment of their HIV-TB care and to prioritize the steps to improve treatment outcomes. A senior nurse will be identified to be the QI champion and will be trained by the study team to fulfil this role. The QI champion in the clinic then provides peer-leadership, mentorship and support for the implementation of the prioritized changes until the checklist is complete and all integrated HIV-TB service components meet the required standard. Receives: Other: Quality Improvement Model of Care |
| Control Standard of Care | No intervention | The control arm will continue with the usual support that is received for HIV-TB service integration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality rate in TB-HIV co-infected patients
Measured: 12 months
Secondary outcomes (7)
HIV testing rates
HIV testing rates in TB patients
Measured: 12 months
Intensified Case Finding for TB
TB Screening in HIV infected patients
Measured: 12 Months
Cotrimoxazole for HIV-TB patients
Initiating Cotrimoxazole in HIV-TB patients
Measured: 12 months
Retention in HIV-TB patients
Enhanced retention in care strategies including the use of community care workers for retention and for community based management of selected patients
Measured: 12 months
ART initiation in HIV-TB co-infected patients
Initiating ART in co-infected patients irrespective of CD4 count
Measured: 12 months
Integrated Data Management System
1 data management system for co-infected patients , including 1 file , 1 appointment and 1 health care worker addressing both HIV and TB care and treatment
Measured: 12 months
HIV and TB Adherence Strategy
- Enhanced ART and TB treatment adherence strategies including the use of community care workers for adherence support and for community based management of selected patients
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 posted13 Jan 2016 (estimated)
- Study start1 Jun 2015
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- 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
- 8,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for the AIDS Programme of Research in South Africa
- Sponsor type
- Research network
- Collaborators
- BroadReach Healthcare, Institute for Healthcare Improvement
- Responsible party
- Principal investigator, Dr Kogieleum Naidoo, Centre for the AIDS Programme of Research in South Africa
- Investigators
- Kogieleum Naidoo, MBChB, Principal investigator, Centre for the AIDS Programme of Research in South Africa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02654613
- Sponsor's protocol ID
- CAP013
- Acronym
- SUTHI
- Status last verified
- Jan 2021
- First submitted
- 11 Jan 2016
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Naidoo K, Zuma NY, Moodley M, Made F, Perumal R, Gengiah S, Ngozo J, Padayatchi N, Nunn A, Karim SA. High mortality among patients with tuberculosis accessing primary care facilities: secondary analysis from an open-label cluster-randomised trial. EClinicalMedicine. 2025 Mar 18;82:103151. doi: 10.1016/j.eclinm.2025.103151. eCollection 2025 Apr.
PubMed 40166654Naidoo K, Gengiah S, Yende-Zuma N, Mlobeli R, Ngozo J, Memela N, Padayatchi N, Barker P, Nunn A, Karim SSA. Mortality in HIV and tuberculosis patients following implementation of integrated HIV-TB treatment: Results from an open-label cluster-randomized trial. EClinicalMedicine. 2022 Feb 12;44:101298. doi: 10.1016/j.eclinm.2022.101298. eCollection 2022 Feb.
PubMed 35198922Gengiah S, Connolly C, Yende-Zuma N, Barker PM, Nunn AJ, Padayatchi N, Taylor M, Loveday M, Naidoo K. Organizational contextual factors that predict success of a quality improvement collaborative approach to enhance integrated HIV-tuberculosis services: a sub-study of the Scaling up TB/HIV Integration trial. Implement Sci. 2021 Sep 17;16(1):88. doi: 10.1186/s13012-021-01155-7.
PubMed 34535170Gengiah S, Barker PM, Yende-Zuma N, Mbatha M, Naidoo S, Taylor M, Loveday M, Mhlongo M, Jackson C, Nunn AJ, Padayatchi N, Karim SSA, Naidoo K. A cluster-randomized controlled trial to improve the quality of integrated HIV-tuberculosis services in primary healthcareclinics in South Africa. J Int AIDS Soc. 2021 Sep;24(9):e25803. doi: 10.1002/jia2.25803.
PubMed 34498370Naidoo K, Gengiah S, Yende-Zuma N, Padayatchi N, Barker P, Nunn A, Subrayen P, Abdool Karim SS. Addressing challenges in scaling up TB and HIV treatment integration in rural primary healthcare clinics in South Africa (SUTHI): a cluster randomized controlled trial protocol. Implement Sci. 2017 Nov 13;12(1):129. doi: 10.1186/s13012-017-0661-1.
PubMed 29132380
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Challenges in Scaling up TB and HIV Treatment Integration in Public Health Settings in South Africa
- ClinicalTrials.gov ID
- NCT02654613
- Acronym / sponsor ID
- SUTHI / CAP013
- Conditions
- HIV, Tuberculosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,000 participants (actual)
- Lead sponsor
- Centre for the AIDS Programme of Research in South AfricaResearch network
- Collaborators
- BroadReach Healthcare, Institute for Healthcare Improvement
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 13 Jan 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.
This study addresses the highest ranking health research priority in South Africa, which is, to develop and test optimal models of HIV-TB service delivery that will enhance retention, adherence and coverage of HIV-TB co-infected patients. HIV and TB are highest in sub-Saharan Africa, a region with limited health budgets, infrastructure, human resources, and suboptimal TB infection control practices. There is compelling clinical evidence suggesting that integrating HIV and TB services saves lives and presents an effective and efficient use of resources directed at optimizing health outcomes. Quality improvement (QI) methods are increasingly being used to systematically test and incorporate local ideas into strategies for reliable implementation and scale up. This trial is designed to test a practical, implementable and affordable strategy aimed at improving HIV-TB service integration to reduce TB and HIV associated deaths. This is a cluster randomized controlled trial, which evaluates and tests the effectiveness of implementing a QI model to integrate HIV-TB service delivery in primary health care clinics, on reducing morbidity and mortality in TB-HIV co-infected patients. This study will be conducted in 2 districts, Ugu and uThungulu, in KwaZulu-Natal, South Africa. The model of integrated care delivery for TB and HIV using the QI method offers a systems approach to care delivery to directly enhance treatment outcomes by enabling comprehensive effective care designed around the patients journey from entry to the clinic, through screening treatment initiation, treatment completion, and retention in care that is directed at the goals of cure for TB, effective sustainable HIV viral suppression and reduced HIV associated TB mortality as the main health impact. The scalability of the model, once proven effective, is the critical element that makes it increase population coverage of quality diagnosis and treatment of HIV-TB co-infection. QI methods promote front line staff engagement in identification and rapid testing of local implementation solutions to gaps in performance of processes of care along the steps of the patient journey. Gaps in care are identified through continuous feedback on a core set of indicators collected monthly as routine collection of data.
Detailed description
The primary aim of this study is to test the effectiveness of a peer mentor-led, quality-improvement model of service delivery of integrated HIV-TB treatment on mortality in HIV-TB co-infected patients treated in rural primary health care clinics in KwaZulu-Natal, South Africa
Specific Objectives (i) To determine the impact of a QI-mediated HIV-TB service integration on patient mortality. All patients that access services in intervention and control clinics, via either the TB entry point or via the HIV entry point will be tracked during clinic follow-up visits or, through a community care giver, and will have their vital status ascertained 12 months after clinic randomization.
(ii) To determine the effectiveness of peer-led Quality Improvement (QI) to integrate HIV-TB services. The effect, on HIV-TB integrated processes of care, of the deployment of a QI approach (systems view, data driven decision making, culture of continuous improvement, trained peer mentors) to ensure uniform implementation of an essential package of evidence based HIV-TB interventions that support HIV-TB integration. The impact on clinical outcomes of using QI methods to implement integrated HIV and TB management will be assessed using the following indicators: Time to ART initiation among HIV infected TB suspects and cases; HIV testing rates in TB patients; Number of HIV-TB co-infected patients receiving co-treatment for TB and HIV at the same facility; Number of patients infected with HIV or TB that are retained in care at 12 months; Indicators of treatment adherence such as - number of HIV patients that are virologically suppressed at 12 months and TB treatment outcomes; Hospitalisation rates among patients receiving co-treatment for TB and HIV.
(iii) To identify clinic-level factors that impact on integrated HIV-TB services. Understanding the context (environmental, social and political factors) in which we are working is essential to identifying factors that promote or inhibit the implementation of the intervention. We will use the COACH tool (Context Assessment for Community Health) [8] to collect data and assess the organizational context and the influence of factors such as organizational culture, leadership, resources and HCWs remuneration etc. on the intervention
(iv) To determine the cost-effectiveness of implementing HIV-TB services using Quality Improvement methodology (Intervention Clinics) versus the base-case of implementing HIV-TB services independently, through a within-trial approach using both health service (e.g. training, remuneration) and patient costs (e.g. travel, opportunity costs) as inputs. We will also calculate total intervention costs to assess its affordability and explore cost-effectiveness under various scenarios (e.g. different TB-HIV co-infection rates) using decision analytical modeling.
(v) To identify a set of interventions, change ideas, tools and approaches that can be used to scale up adoption, implementation and sustainability of integrated HIV-TB services across South Africa and in other resource constrained settings.
(vi) To strengthen the capacity of CAPRISA to independently perform implementation research in PRDs, including community-randomized trials and health economic analysis, through expert mentoring and supervision of PhD programmes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quality Improvement Intervention | Active comparator | Other: Quality Improvement Model of CareIn intervention clinics, staff will follow QI methodology to undertake a detailed assessment of their HIV-TB care and to prioritize the steps to improve treatment outcomes. A senior nurse will be identified to be the QI champion and will be trained by the study team to fulfil this role. The QI champion in the clinic then provides peer-leadership, mentorship and support for the implementation of the prioritized changes until the checklist is complete and all integrated HIV-TB service components meet the required standard. |
| Control Standard of Care | No intervention | –The control arm will continue with the usual support that is received for HIV-TB service integration |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- South African Department of Health Primary Health Care Clinics
- ART site
- Supported by BroadReach Healthcare
Key exclusion criteria (4 listed)
- Mobile clinics
- Clinics that do not offer ART
- Clinics with only 1 nurse
- Hospitals and Gateway clinics
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 |
|---|---|---|
| Quality Improvement Model of CareQI addresses the "how" of program implementation. Technically, QI improves process performance by developing a common simplified view of the components and linkages of integrated care, real-time data feed-back to track system performance, understanding the psychology of system change, and crucially, the iterative testing and incorporation of ideas for performance improvement from the front-line practitioners, managers, and customers in the local context. | Other | Quality Improvement Intervention |
Primary outcome
Mortality
Time frame: 12 months
Mortality rate in TB-HIV co-infected patients
7 secondary outcomes
HIV testing rates
Time frame: 12 months
Intensified Case Finding for TB
Time frame: 12 Months
Cotrimoxazole for HIV-TB patients
Time frame: 12 months
Retention in HIV-TB patients
Time frame: 12 months
ART initiation in HIV-TB co-infected patients
Time frame: 12 months
Integrated Data Management System
Time frame: 12 months
HIV and TB Adherence Strategy
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 1 Feb 2021.
- Derived from this study: PubMed 40166654Naidoo K, Zuma NY, Moodley M, Made F, Perumal R, Gengiah S, Ngozo J, Padayatchi N, Nunn A, Karim SA. High mortality among patients with tuberculosis accessing primary care facilities: secondary analysis from an open-label cluster-randomised trial. EClinicalMedicine. 2025 Mar 18;82:103151. doi: 10.1016/j.eclinm.2025.103151. eCollection 2025 Apr.
- Derived from this study: PubMed 35198922Naidoo K, Gengiah S, Yende-Zuma N, Mlobeli R, Ngozo J, Memela N, Padayatchi N, Barker P, Nunn A, Karim SSA. Mortality in HIV and tuberculosis patients following implementation of integrated HIV-TB treatment: Results from an open-label cluster-randomized trial. EClinicalMedicine. 2022 Feb 12;44:101298. doi: 10.1016/j.eclinm.2022.101298. eCollection 2022 Feb.
- Derived from this study: PubMed 34535170Gengiah S, Connolly C, Yende-Zuma N, Barker PM, Nunn AJ, Padayatchi N, Taylor M, Loveday M, Naidoo K. Organizational contextual factors that predict success of a quality improvement collaborative approach to enhance integrated HIV-tuberculosis services: a sub-study of the Scaling up TB/HIV Integration trial. Implement Sci. 2021 Sep 17;16(1):88. doi: 10.1186/s13012-021-01155-7.
- Derived from this study: PubMed 34498370Gengiah S, Barker PM, Yende-Zuma N, Mbatha M, Naidoo S, Taylor M, Loveday M, Mhlongo M, Jackson C, Nunn AJ, Padayatchi N, Karim SSA, Naidoo K. A cluster-randomized controlled trial to improve the quality of integrated HIV-tuberculosis services in primary healthcareclinics in South Africa. J Int AIDS Soc. 2021 Sep;24(9):e25803. doi: 10.1002/jia2.25803.
- Derived from this study: PubMed 29132380Naidoo K, Gengiah S, Yende-Zuma N, Padayatchi N, Barker P, Nunn A, Subrayen P, Abdool Karim SS. Addressing challenges in scaling up TB and HIV treatment integration in rural primary healthcare clinics in South Africa (SUTHI): a cluster randomized controlled trial protocol. Implement Sci. 2017 Nov 13;12(1):129. doi: 10.1186/s13012-017-0661-1.
- Individual participant dataSharing planned: No
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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.
Kogieleum Naidoo, MBChB principal investigator
Centre for the AIDS Programme of Research in South Africa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality Improvement Model of Care in people with HIV and Tuberculosis, run by Centre for the AIDS Programme of Research in South Africa at 1 site in South Africa.
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 3 inclusion and 4 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 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. 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?
Mortality (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 NCT02654613, which also lists 5 linked publications.
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 1 Feb 2021.