Scaling up TB and HIV Treatment Integration (SUTHI)

January 29, 2021 updated by: Dr Kogieleum Naidoo, Centre for the AIDS Programme of Research in South Africa

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.

Study Overview

Status

Completed

Conditions

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

Interventional

Enrollment (Actual)

8000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • KwaZulu Natal
      • Durban, KwaZulu Natal, South Africa, 4001
        • CAPRISA eThekwini Clinical Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Kogieleum Naidoo, MBChB, Centre for the AIDS Programme of Research in South Africa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

December 30, 2020

Study Completion (Actual)

December 30, 2020

Study Registration Dates

First Submitted

January 11, 2016

First Submitted That Met QC Criteria

January 11, 2016

First Posted (Estimate)

January 13, 2016

Study Record Updates

Last Update Posted (Actual)

February 1, 2021

Last Update Submitted That Met QC Criteria

January 29, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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