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Health services research
Protocol
Evaluating the impact of a community health worker programme on non-communicable disease, malnutrition, tuberculosis, family planning and antenatal care in Neno, Malawi: protocol for a stepped-wedge, cluster randomised controlled trial
  1. Elizabeth L Dunbar1,2,
  2. Emily B Wroe1,
  3. Basimenye Nhlema1,
  4. Chiyembekezo Kachimanga1,
  5. Ravi Gupta1,
  6. Celia Taylor3,
  7. Annie Michaelis4,
  8. Katie Cundale1,
  9. Luckson Dullie1,
  10. Arnold Jumbe5,
  11. Lawrence Nazimera5,
  12. Ryan McBain4,
  13. Richard J Lilford3,
  14. Samuel Ian Watson3
  1. 1 Abwenzi Pa Za Umoyo/Partners In Health, Neno, Malawi
  2. 2 Partners In Health Liberia, Harper, Liberia
  3. 3 University of Warwick, Coventry, UK
  4. 4 Partners In Health, Boston, Massachusetts, USA
  5. 5 Ministry of Health, Neno, Malawi
  1. Correspondence to Elizabeth L Dunbar; edunbar{at}pih.org

Abstract

Introduction This protocol concerns the implementation and evaluation of an intervention designed to realign the existing cadre of community health workers (CHWs) in Neno district, Malawi to better support the care needs of the clients they serve. The proposed intervention is a ‘Household Model’ where CHWs will be reassigned to households, rather than to specific patients with HIV and/or tuberculosis (TB).

Methods and analysis Using a stepped-wedge, cluster-randomised design, this study investigates whether high HIV retention rates can be replicated for non-communicable diseases (NCDs), and the model’s impact on TB and paediatric malnutrition case finding, as well as the uptake of family planning and antenatal care. Eleven sites (health centres and hospitals) were arranged into six clusters (average cluster population 21 800). Primary outcomes include retention in care for HIV and chronic NCDs, TB case finding, paediatric malnutrition case finding, and utilisation of early and complete antenatal care. Clinical outcomes are based on routinely collected data from the Ministry of Health’s District Health Information System 2 and an OpenMRS electronic medical record supported by Partners In Health. Additionally, semistructured qualitative interviews with various stakeholders will assess community perceptions and context of the Household Model.

Ethics and dissemination Ethics approval has been obtained from the Malawian National Health Science Research Committee (#16/11/1694) in Lilongwe, Malawi; Partners Healthcare Human Research Committee (#2017P000548/PHS) in Somerville, Massachusetts; and the Biomedical and Scientific Research Ethics Sub-Committee (REGO-2017–2060) at the University of Warwick in Coventry, UK. Dissemination will include manuscripts for peer-reviewed publication as well as a full report detailing the findings of the intervention for the Malawian Ministry of Health.

Trial registration number NCT03106727.

Primary sponsor Partners In Health | Abwenzi Pa Za Umoyo P.O. Box 56, Neno, Malawi. Protocol Version 4, March 2018.

  • community health workers
  • integrated care
  • primary care
  • community child health
  • community health

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:©http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2017-019473

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    Footnotes

    • Contributors EBW, ELD, BN, CK, RG, AJ and LN conceptualised the household model and tailored it to the setting, and led the implementation of the model in Neno District. SIW, RJL, CT, ELD, EBW, RM and LD developed the methodology to evaluate the model, with SIW developing the quantitative analysis plan. AM drafted the qualitative methods and analysis. ELD prepared the first draft of the protocol. KC adapted the protocol to the BMJ format. All authors reviewed and revised subsequent protocol drafts.

    • Funding This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests None declared.

    • Patient consent Not required.

    • Ethics approval Malawian National Health Science Research Committee (#16/11/1694) in Lilongwe, Malawi; Partners Healthcare Human Research Committee (#2017P000548/PHS) in Somerville, Massachusetts; and the Biomedical and Scientific Research Ethics Sub-Committee (REGO-2017-2060) at the University of Warwick in Coventry, UK.

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