Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02654613 |
| Other study ID # |
CAP013 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2015 |
| Est. completion date |
December 30, 2020 |
Study information
| Verified date |
January 2021 |
| Source |
Centre for the AIDS Programme of Research in South Africa |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
