Strengthening primary care for diabetes and hypertension in Eswatini: study protocol for a nationwide cluster-randomized controlled trial

Michaela Theilmann; Ntombifuthi Ginindza; John Myeni; Sijabulile Dlamini; Bongekile Thobekile Cindzi; Dumezweni Dlamini; Thobile L Dlamini; Maike Greve; Harsh Vivek Harkare; Mbuso Hleta; Philile Khumalo; Lutz M Kolbe; Simon Lewin; Lisa-Rufaro Marowa; Sakhile Masuku; Dumsile Mavuso; Marjan Molemans; Nyasatu Ntshalintshali; Nomathemba Nxumalo; Brianna Osetinsky; Christopher Pell; Ria Reis; Fortunate Shabalala; Bongumusa R Simelane; Lisa Stehr; Fabrizio Tediosi; Frank van Leth; Jan-Walter De Neve; Till Bärnighausen; Pascal Geldsetzer

doi:10.1186/s13063-023-07096-4

Strengthening primary care for diabetes and hypertension in Eswatini: study protocol for a nationwide cluster-randomized controlled trial

Michaela Theilmann
, Ntombifuthi Ginindza
, John Myeni
, Sijabulile Dlamini
, Bongekile Thobekile Cindzi
, Dumezweni Dlamini
, Thobile L Dlamini
, Maike Greve
, Harsh Vivek Harkare
, Mbuso Hleta
, Philile Khumalo
, Lutz M Kolbe
, Simon Lewin
, Lisa-Rufaro Marowa
, Sakhile Masuku
, Dumsile Mavuso
, Marjan Molemans
, Nyasatu Ntshalintshali
, Nomathemba Nxumalo
, Brianna Osetinsky

Christopher Pell, Ria Reis, Fortunate Shabalala, Bongumusa R Simelane, Lisa Stehr, Fabrizio Tediosi, Frank van Leth, Jan-Walter De Neve, Till Bärnighausen, Pascal Geldsetzer

Research output: Contribution to Journal › Article › Academic › peer-review

Abstract

BACKGROUND: Diabetes and hypertension are increasingly important population health challenges in Eswatini. Prior to this project, healthcare for these conditions was primarily provided through physician-led teams at tertiary care facilities and accessed by only a small fraction of people living with diabetes or hypertension. This trial tests and evaluates two community-based healthcare service models implemented at the national level, which involve health care personnel at primary care facilities and utilize the country's public sector community health worker cadre (the rural health motivators [RHMs]) to help generate demand for care.

METHODS: This study is a cluster-randomized controlled trial with two treatment arms and one control arm. The unit of randomization is a primary healthcare facility along with all RHMs (and their corresponding service areas) assigned to the facility. A total of 84 primary healthcare facilities were randomized in a 1:1:1 ratio to the three study arms. The first treatment arm implements differentiated service delivery (DSD) models at the clinic and community levels with the objective of improving treatment uptake and adherence among clients with diabetes or hypertension. In the second treatment arm, community distribution points (CDPs), which previously targeted clients living with human immunodeficiency virus, extend their services to clients with diabetes or hypertension by allowing them to pick up medications and obtain routine nurse-led follow-up visits in their community rather than at the healthcare facility. In both treatment arms, RHMs visit households regularly, screen clients at risk, provide personalized counseling, and refer clients to either primary care clinics or the nearest CDP. In the control arm, primary care clinics provide diabetes and hypertension care services but without the involvement of RHMs and the implementation of DSD models or CDPs. The primary endpoints are mean glycated hemoglobin (HbA1c) and systolic blood pressure among adults aged 40 years and older living with diabetes or hypertension, respectively. These endpoints will be assessed through a household survey in the RHM service areas. In addition to the health impact evaluation, we will conduct studies on cost-effectiveness, syndemics, and the intervention's implementation processes.

DISCUSSION: This study has the ambition to assist the Eswatini government in selecting the most effective delivery model for diabetes and hypertension care. The evidence generated with this national-level cluster-randomized controlled trial may also prove useful to policy makers in the wider Sub-Saharan African region.

TRIAL REGISTRATION: NCT04183413. Trial registration date: December 3, 2019.

Original language	English
Article number	210
Pages (from-to)	1-16
Number of pages	16
Journal	Trials
Volume	24
Issue number	1
Early online date	22 Mar 2023
DOIs	https://doi.org/10.1186/s13063-023-07096-4
Publication status	Published - 2023

Bibliographical note

Funding

Open Access funding enabled and organized by Projekt DEAL. For the publication fee we acknowledge financial support by Deutsche Forschungsgemeinschaft within the funding programme “Open Access Publikationskosten” as well as by Heidelberg University. The study protocol reported in this paper has been evaluated through a competitive peer-review process as part of the European Commission Horizon2020 program (grant reference: 825823). The funders had no role in the study design, data collection, management, manuscript writing, or decision to submit the protocol for publication. The implementation of the health service decentralization is funded by the Eswatini Ministry of Health. We thank all Ministry of Health staff and health personnel on the ground whose hard work and dedication make the implementation of the WHO-PEN@Scale study possible. Furthermore, we thank the Heidelberg Institut für Medizinische Biometrie for conducting the randomization.

Funders
Eswatini Ministry of Health
Heidelberg Institut für Medizinische Biometrie
Deutsche Forschungsgemeinschaft
Universität Heidelberg

Keywords

Adult
Humans
Middle Aged
Eswatini
Diabetes Mellitus/diagnosis
Hypertension/diagnosis
Delivery of Health Care
Primary Health Care
Randomized Controlled Trials as Topic

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Theilmann, M., Ginindza, N., Myeni, J., Dlamini, S., Cindzi, B. T., Dlamini, D., Dlamini, T. L., Greve, M., Harkare, H. V., Hleta, M., Khumalo, P., Kolbe, L. M., Lewin, S., Marowa, L.-R., Masuku, S., Mavuso, D., Molemans, M., Ntshalintshali, N., Nxumalo, N., ... Geldsetzer, P. (2023). Strengthening primary care for diabetes and hypertension in Eswatini: study protocol for a nationwide cluster-randomized controlled trial. Trials, 24(1), 1-16. Article 210. https://doi.org/10.1186/s13063-023-07096-4

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Theilmann, M, Ginindza, N, Myeni, J, Dlamini, S, Cindzi, BT, Dlamini, D, Dlamini, TL, Greve, M, Harkare, HV, Hleta, M, Khumalo, P, Kolbe, LM, Lewin, S, Marowa, L-R, Masuku, S, Mavuso, D, Molemans, M, Ntshalintshali, N, Nxumalo, N, Osetinsky, B, Pell, C, Reis, R, Shabalala, F, Simelane, BR, Stehr, L, Tediosi, F, van Leth, F, De Neve, J-W, Bärnighausen, T & Geldsetzer, P 2023, 'Strengthening primary care for diabetes and hypertension in Eswatini: study protocol for a nationwide cluster-randomized controlled trial', Trials, vol. 24, no. 1, 210, pp. 1-16. https://doi.org/10.1186/s13063-023-07096-4

TY - JOUR

T1 - Strengthening primary care for diabetes and hypertension in Eswatini

T2 - study protocol for a nationwide cluster-randomized controlled trial

AU - Theilmann, Michaela

AU - Ginindza, Ntombifuthi

AU - Myeni, John

AU - Dlamini, Sijabulile

AU - Cindzi, Bongekile Thobekile

AU - Dlamini, Dumezweni

AU - Dlamini, Thobile L

AU - Greve, Maike

AU - Harkare, Harsh Vivek

AU - Hleta, Mbuso

AU - Khumalo, Philile

AU - Kolbe, Lutz M

AU - Lewin, Simon

AU - Marowa, Lisa-Rufaro

AU - Masuku, Sakhile

AU - Mavuso, Dumsile

AU - Molemans, Marjan

AU - Ntshalintshali, Nyasatu

AU - Nxumalo, Nomathemba

AU - Osetinsky, Brianna

AU - Pell, Christopher

AU - Reis, Ria

AU - Shabalala, Fortunate

AU - Simelane, Bongumusa R

AU - Stehr, Lisa

AU - Tediosi, Fabrizio

AU - van Leth, Frank

AU - De Neve, Jan-Walter

AU - Bärnighausen, Till

AU - Geldsetzer, Pascal

PY - 2023

Y1 - 2023

N2 - BACKGROUND: Diabetes and hypertension are increasingly important population health challenges in Eswatini. Prior to this project, healthcare for these conditions was primarily provided through physician-led teams at tertiary care facilities and accessed by only a small fraction of people living with diabetes or hypertension. This trial tests and evaluates two community-based healthcare service models implemented at the national level, which involve health care personnel at primary care facilities and utilize the country's public sector community health worker cadre (the rural health motivators [RHMs]) to help generate demand for care.METHODS: This study is a cluster-randomized controlled trial with two treatment arms and one control arm. The unit of randomization is a primary healthcare facility along with all RHMs (and their corresponding service areas) assigned to the facility. A total of 84 primary healthcare facilities were randomized in a 1:1:1 ratio to the three study arms. The first treatment arm implements differentiated service delivery (DSD) models at the clinic and community levels with the objective of improving treatment uptake and adherence among clients with diabetes or hypertension. In the second treatment arm, community distribution points (CDPs), which previously targeted clients living with human immunodeficiency virus, extend their services to clients with diabetes or hypertension by allowing them to pick up medications and obtain routine nurse-led follow-up visits in their community rather than at the healthcare facility. In both treatment arms, RHMs visit households regularly, screen clients at risk, provide personalized counseling, and refer clients to either primary care clinics or the nearest CDP. In the control arm, primary care clinics provide diabetes and hypertension care services but without the involvement of RHMs and the implementation of DSD models or CDPs. The primary endpoints are mean glycated hemoglobin (HbA1c) and systolic blood pressure among adults aged 40 years and older living with diabetes or hypertension, respectively. These endpoints will be assessed through a household survey in the RHM service areas. In addition to the health impact evaluation, we will conduct studies on cost-effectiveness, syndemics, and the intervention's implementation processes.DISCUSSION: This study has the ambition to assist the Eswatini government in selecting the most effective delivery model for diabetes and hypertension care. The evidence generated with this national-level cluster-randomized controlled trial may also prove useful to policy makers in the wider Sub-Saharan African region.TRIAL REGISTRATION: NCT04183413. Trial registration date: December 3, 2019.

AB - BACKGROUND: Diabetes and hypertension are increasingly important population health challenges in Eswatini. Prior to this project, healthcare for these conditions was primarily provided through physician-led teams at tertiary care facilities and accessed by only a small fraction of people living with diabetes or hypertension. This trial tests and evaluates two community-based healthcare service models implemented at the national level, which involve health care personnel at primary care facilities and utilize the country's public sector community health worker cadre (the rural health motivators [RHMs]) to help generate demand for care.METHODS: This study is a cluster-randomized controlled trial with two treatment arms and one control arm. The unit of randomization is a primary healthcare facility along with all RHMs (and their corresponding service areas) assigned to the facility. A total of 84 primary healthcare facilities were randomized in a 1:1:1 ratio to the three study arms. The first treatment arm implements differentiated service delivery (DSD) models at the clinic and community levels with the objective of improving treatment uptake and adherence among clients with diabetes or hypertension. In the second treatment arm, community distribution points (CDPs), which previously targeted clients living with human immunodeficiency virus, extend their services to clients with diabetes or hypertension by allowing them to pick up medications and obtain routine nurse-led follow-up visits in their community rather than at the healthcare facility. In both treatment arms, RHMs visit households regularly, screen clients at risk, provide personalized counseling, and refer clients to either primary care clinics or the nearest CDP. In the control arm, primary care clinics provide diabetes and hypertension care services but without the involvement of RHMs and the implementation of DSD models or CDPs. The primary endpoints are mean glycated hemoglobin (HbA1c) and systolic blood pressure among adults aged 40 years and older living with diabetes or hypertension, respectively. These endpoints will be assessed through a household survey in the RHM service areas. In addition to the health impact evaluation, we will conduct studies on cost-effectiveness, syndemics, and the intervention's implementation processes.DISCUSSION: This study has the ambition to assist the Eswatini government in selecting the most effective delivery model for diabetes and hypertension care. The evidence generated with this national-level cluster-randomized controlled trial may also prove useful to policy makers in the wider Sub-Saharan African region.TRIAL REGISTRATION: NCT04183413. Trial registration date: December 3, 2019.

KW - Adult

KW - Humans

KW - Middle Aged

KW - Eswatini

KW - Diabetes Mellitus/diagnosis

KW - Hypertension/diagnosis

KW - Delivery of Health Care

KW - Primary Health Care

KW - Randomized Controlled Trials as Topic

U2 - 10.1186/s13063-023-07096-4

DO - 10.1186/s13063-023-07096-4

M3 - Article

C2 - 36949485

SN - 1745-6215

VL - 24

SP - 1

EP - 16

JO - Trials

JF - Trials

IS - 1

M1 - 210

ER -

Strengthening primary care for diabetes and hypertension in Eswatini: study protocol for a nationwide cluster-randomized controlled trial

Abstract

Bibliographical note

Funding

Keywords

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