Article Text

Protocol
Decentralising chronic disease management in sub-Saharan Africa: a protocol for the qualitative process evaluation of community-based integrated management of HIV, diabetes and hypertension in Tanzania and Uganda
  1. Marie-Claire Van Hout1,
  2. Mathias Akugizibwe2,
  3. Elizabeth Henry Shayo3,
  4. Moreen Namulundu2,
  5. Francis Xavier Kasujja2,
  6. Ivan Namakoola2,
  7. Josephine Birungi2,
  8. Joseph Okebe4,
  9. Jamie Murdoch5,
  10. Sayoki Godfrey Mfinanga6,
  11. Shabbar Jaffar4
  1. 1Public Health Institute, Liverpool John Moores University, Liverpool, UK
  2. 2MRC/UVRI and LSHTM Uganda Research Unit, Entebbe, Wakiso, Uganda
  3. 3Health Systems, Policy and Translational Reseach Section, National Institute for Medical Research, Dar es Salaam, Tanzania, United Republic
  4. 4Institute for Global Health, University College London, London, UK
  5. 5School of Life Course and Population Sciences, King's College London, London, London, UK
  6. 6Muhimbili Medical Research Centre, National Institute for Medical Research Tanzania, Dar es Salaam, Tanzania, United Republic of
  1. Correspondence to Professor Marie-Claire Van Hout; M.C.VanHout{at}ljmu.ac.uk

Abstract

Introduction Sub-Saharan Africa continues to experience a syndemic of HIV and non-communicable diseases (NCDs). Vertical (stand-alone) HIV programming has provided high-quality care in the region, with almost 80% of people living with HIV in regular care and 90% virally suppressed. While integrated health education and concurrent management of HIV, hypertension and diabetes are being scaled up in clinics, innovative, more efficient and cost-effective interventions that include decentralisation into the community are required to respond to the increased burden of comorbid HIV/NCD disease.

Methods and analysis This protocol describes procedures for a process evaluation running concurrently with a pragmatic cluster-randomised trial (INTE-COMM) in Tanzania and Uganda that will compare community-based integrated care (HIV, diabetes and hypertension) with standard facility-based integrated care. The INTE-COMM intervention will manage multiple conditions (HIV, hypertension and diabetes) in the community via health monitoring and adherence/lifestyle advice (medicine, diet and exercise) provided by community nurses and trained lay workers, as well as the devolvement of NCD drug dispensing to the community level. Based on Bronfenbrenner’s ecological systems theory, the process evaluation will use qualitative methods to investigate sociostructural factors shaping care delivery and outcomes in up to 10 standard care facilities and/or intervention community sites with linked healthcare facilities. Multistakeholder interviews (patients, community health workers and volunteers, healthcare providers, policymakers, clinical researchers and international and non-governmental organisations), focus group discussions (community leaders and members) and non-participant observations (community meetings and drug dispensing) will explore implementation from diverse perspectives at three timepoints in the trial implementation. Iterative sampling and analysis, moving between data collection points and data analysis to test emerging theories, will continue until saturation is reached. This process of analytic reflexivity and triangulation across methods and sources will provide findings to explain the main trial findings and offer clear directions for future efforts to sustain and scale up community-integrated care for HIV, diabetes and hypertension.

Ethics and dissemination The protocol has been approved by the University College of London (UK), the London School of Hygiene and Tropical Medicine Ethics Committee (UK), the Uganda National Council for Science and Technology and the Uganda Virus Research Institute Research and Ethics Committee (Uganda) and the Medical Research Coordinating Committee of the National Institute for Medical Research (Tanzania). The University College of London is the trial sponsor. Dissemination of findings will be done through journal publications and stakeholder meetings (with study participants, healthcare providers, policymakers and other stakeholders), local and international conferences, policy briefs, peer-reviewed journal articles and publications.

Trial registration number ISRCTN15319595.

  • DIABETES & ENDOCRINOLOGY
  • Hypertension
  • HIV & AIDS

Data availability statement

No data are available. Not applicable.

https://creativecommons.org/licenses/by/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

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Data availability statement

No data are available. Not applicable.

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Footnotes

  • Twitter @mcvanhout

  • Contributors All authors contributed to the conceptualisation of the research and contributed to writing the manuscript. MCVH, MA, EHS, MN, IN, JM, AK, SGM and SJ designed the process evaluation protocol. SJ, JO, FXK and JB led the development of the INTE-COMM trial. MCVH drafted the manuscript and all co-authors edited and commented on subsequent drafts. All authors approved the final draft for submission. All authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

  • Funding This work was supported by NIHR; GHPSR Project: NIHR 131273.

  • Competing interests None declared.

  • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.