Rationale and design of leveraging the HIV platform for hypertension control in Africa: protocol of a cluster-randomised controlled trial in Uganda.


Journal

BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874

Informations de publication

Date de publication:
08 12 2022
Historique:
entrez: 4 1 2023
pubmed: 5 1 2023
medline: 7 1 2023
Statut: epublish

Résumé

There is a high burden of hypertension (HTN) among HIV-infected people in Uganda. However, capacity to prevent, diagnose and treat HTN is suboptimal. This study seeks to leverage the existing HIV-related infrastructure in primary care health facilities (HFs) using the integrated HIV/HTN care model to improve health outcomes of patients with HIV and HTN. Integrated HIV/HTN study a type-1 effectiveness/implementation cluster randomised trial, will evaluate the effectiveness of a multicomponent model intervention in 13 districts randomised to the intervention arm compared with 13 districts randomised to control. Two randomly selected HFs per district and their patients will be eligible to participate. The intervention will comprise training of primary healthcare (PHC) providers followed by regular supervision, integration of HTN care into HIV clinics, improvement of the health management information system, IT-based messaging to improve communication among frontline PHCs and district-level managers. HTN care guidelines, sphygmomanometers, patient registers and a buffer stock of essential drugs will be provided to HFs in both study arms. We will perform cross-sectional surveys at baseline, 12 and 24 months, on a random sample of patients attending HFs to measure effectiveness of the integrated care model between 2021 and 2024. We will perform in-depth interviews of providers, patients and healthcare managers to assess barriers and facilitators of integrated care. We will measure the cost of the intervention through microcosting and time-and-motion studies. The outcomes will be analysed taking the clustered structure of the data set into account. Ethics approval has been obtained from the Research Ethics Committees at London School of Hygiene and Tropical Medicine, and Makerere University School of Medicine. All participants will provide informed consent prior to study inclusion. Strict confidentiality will be applied throughout. Findings will be disseminated to public through meetings, and publications. NCT04624061.

Identifiants

pubmed: 36600388
pii: bmjopen-2022-063227
doi: 10.1136/bmjopen-2022-063227
pmc: PMC9743290
doi:

Banques de données

ClinicalTrials.gov
['NCT04624061']

Types de publication

Clinical Trial Protocol Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

e063227

Subventions

Organisme : NIMH NIH HHS
ID : P30 MH062246
Pays : United States

Informations de copyright

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: None declared.

Références

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Auteurs

Mucunguzi Atukunda (M)

Infectious Diseases Research Collaboration, Kampala, Uganda mucungua@gmail.com.

Jane Kabami (J)

Infectious Diseases Research Collaboration, Kampala, Uganda.

Gerald Mutungi (G)

Non-Communicable Diseases prevention and control Department, Uganda Ministry of Health, Kampala, Uganda.

Brian Twinamatsiko (B)

Infectious Diseases Research Collaboration, Kampala, Uganda.

Joan Nangendo (J)

Makerere University, Kampala, Uganda.

Starley B Shade (SB)

University of California, San Francisco, San Francisco, California, USA.

Edwin Charlebois (E)

University of California, San Francisco, San Francisco, California, USA.

Heiner Grosskurth (H)

Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.

Moses Kamya (M)

Makerere University, Kampala, Uganda.

Emmy Okello (E)

Uganda Heart Institute, Kampala, Uganda.

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Classifications MeSH