CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 8,000 enrolled
Drug / intervention
Quality Improvement Model of Careother
Likely dose
Not stated in record
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Search/NCT02654613
NCT02654613N/ACompleted

Addressing Challenges in Scaling up TB and HIV Treatment Integration in Public Health Settings in South Africa

Centre for the AIDS Programme of Research in South Africa·interventional·Posted Jan 13, 2016·Updated Feb 1, 2021

In Brief

A clinical study evaluating Quality Improvement Model of Care for HIV and Tuberculosis. Completed, enrolled 8,000 participants across 1 site.

Detailed 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. 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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV, Tuberculosis
CountriesSouth Africa

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 13, 2016
Enrollment StartJun 1, 2015
Primary CompletionDec 30, 2020
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 10.5 years ago

Interventions

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.