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

Kogieleum Naidoo, Santhanalakshmi Gengiah, Nonhlanhla Yende-Zuma, Nesri Padayatchi, Pierre Barker, Andrew Nunn, Priashni Subrayen, Salim S Abdool Karim, Kogieleum Naidoo, Santhanalakshmi Gengiah, Nonhlanhla Yende-Zuma, Nesri Padayatchi, Pierre Barker, Andrew Nunn, Priashni Subrayen, Salim S Abdool Karim

Abstract

Background: A large and compelling clinical evidence base has shown that integrated TB and HIV services leads to reduction in human immunodeficiency virus (HIV)- and tuberculosis (TB)-associated mortality and morbidity. Despite official policies and guidelines recommending TB and HIV care integration, its poor implementation has resulted in TB and HIV remaining the commonest causes of death in several countries in sub-Saharan Africa, including South Africa. This study aims to reduce mortality due to TB-HIV co-infection through a quality improvement strategy for scaling up of TB and HIV treatment integration in rural primary healthcare clinics in South Africa.

Methods: The study is designed as an open-label cluster randomized controlled trial. Sixteen clinic supervisors who oversee 40 primary health care (PHC) clinics in two rural districts of KwaZulu-Natal, South Africa will be randomized to either the control group (provision of standard government guidance for TB-HIV integration) or the intervention group (provision of standard government guidance with active enhancement of TB-HIV care integration through a quality improvement approach). The primary outcome is all-cause mortality among TB-HIV patients. Secondary outcomes include time to antiretroviral therapy (ART) initiation among TB-HIV co-infected patients, as well as TB and HIV treatment outcomes at 12 months. In addition, factors that may affect the intervention, such as conditions in the clinic and staff availability, will be closely monitored and documented.

Discussion: This study has the potential to address the gap between the establishment of TB-HIV care integration policies and guidelines and their implementation in the provision of integrated care in PHC clinics. If successful, an evidence-based intervention comprising change ideas, tools, and approaches for quality improvement could inform the future rapid scale up, implementation, and sustainability of improved TB-HIV integration across sub-Sahara Africa and other resource-constrained settings.

Trial registration: Clinicaltrials.gov, NCT02654613 . Registered 01 June 2015.

Keywords: Implementation science; Quality improvement; TB-HIV co-infection; TB-HIV integration.

Conflict of interest statement

Ethics approval and consent to participate

Trial was registered (NCT02654613) and subsequently approved by the biomedical research ethics committee (BREC), University of Kwa-Zulu Natal (BF108/14). Gateway permission from the Department of Health to conduct the study at the clinics and also access patient records has been obtained. Signed written informed consent will be obtained from the participants to be interviewed. These participants include the health staff working at the clinics. This study will not require any direct patient contact with research staff; rather, the research staff will work with the clinic staff to implement the interventions. Data collected for analysis purposes will be de-identified and not contain personal information. This is in order to protect the privacy of the study participant by maintaining anonymity and ensuring confidentiality is achieved so that no harm comes to the study participants. Beneficence will be attained through provision of study findings for improved TB-HIV integration and reduced burden of the aforementioned diseases. The database and program files will be made available for review by authorized persons, e.g., study statisticians, institutional review board, study investigators, etc. Also, during the study period and few years after, cabinets containing study administered forms will remain locked. Access will be enabled if needed to allow responsible staff perform required data management and any other relevant function.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
SUTHI study theoretical framework. IPT isoniazid preventive therapy, CPT cotrimoxazole preventive therapy, PLWHA people living with HIV/AIDS, ICF intensified case finding, HCT HIV counseling and testing
Fig. 2
Fig. 2
SUTHI study enrolment, randomization, follow-up, and outcome following TB-HIV integration intervention

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