- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02654613
Scaling up TB and HIV Treatment Integration (SUTHI)
Addressing Challenges in Scaling up TB and HIV Treatment Integration in Public Health Settings in South Africa
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
KwaZulu Natal
-
Durban, KwaZulu Natal, South Africa, 4001
- CAPRISA eThekwini Clinical Research Site
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- South African Department of Health Primary Health Care Clinics
- ART site
- Supported by BroadReach Healthcare
Exclusion Criteria:
- Mobile clinics
- Clinics that do not offer ART
- Clinics with only 1 nurse
- Hospitals and Gateway clinics
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Quality Improvement Intervention
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.
|
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.
|
No Intervention: Control Standard of Care
The control arm will continue with the usual support that is received for HIV-TB service integration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: 12 months
|
Mortality rate in TB-HIV co-infected patients
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HIV testing rates
Time Frame: 12 months
|
HIV testing rates in TB patients
|
12 months
|
Intensified Case Finding for TB
Time Frame: 12 Months
|
TB Screening in HIV infected patients
|
12 Months
|
Cotrimoxazole for HIV-TB patients
Time Frame: 12 months
|
Initiating Cotrimoxazole in HIV-TB patients
|
12 months
|
Retention in HIV-TB patients
Time Frame: 12 months
|
Enhanced retention in care strategies including the use of community care workers for retention and for community based management of selected patients
|
12 months
|
ART initiation in HIV-TB co-infected patients
Time Frame: 12 months
|
Initiating ART in co-infected patients irrespective of CD4 count
|
12 months
|
Integrated Data Management System
Time Frame: 12 months
|
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
|
12 months
|
HIV and TB Adherence Strategy
Time Frame: 12 months
|
• 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
|
12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Kogieleum Naidoo, MBChB, Centre for the AIDS Programme of Research in South Africa
Publications and helpful links
General Publications
- Naidoo 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.
- Gengiah 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.
- Gengiah 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.
- Naidoo 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. Erratum In: Implement Sci. 2019 Jun 13;14(1):59.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAP013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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