TY - JOUR
T1 - Decentralising chronic disease management in sub-Saharan Africa
T2 - a protocol for the qualitative process evaluation of community-based integrated management of HIV, diabetes and hypertension in Tanzania and Uganda
AU - Van Hout, Marie-Claire
AU - Akugizibwe, Mathias
AU - Shayo, Elizabeth Henry
AU - Namulundu, Moreen
AU - Kasujja, Francis Xavier
AU - Namakoola, Ivan
AU - Birungi, Josephine
AU - Okebe, Joseph
AU - Murdoch, Jamie
AU - Mfinanga, Sayoki Godfrey
AU - Jaffar, Shabbar
N1 - Funding Information:
This work was supported by NIHR; GHPSR Project: NIHR 131273.
Funding Information:
RESPOND-AFRICA has operated in Tanzania and Uganda for many years. We have piloted integrated HIV/NCD care in a feasibility single-arm intervention study in Uganda and Tanzania in the Management of Chronic Conditions in Africa (MOCCA) project (2018–2020). MOCCA was followed by scaled-up integrated care for HIV, diabetes and hypertension in the integrating and decentralising HIV, diabetes and hypertension services in Africa (INTE-AFRICA trial) (2019–2023). INTE-COMM is a 4-year research project funded by the National Institute for Health and Care Research (NIHR) (01/10/2020-30/09/2024). We will closely adhere to the Medical Research Council’s (MRC) framework for developing and evaluating complex interventions and frameworks for intervention adaptation and multimorbidity interventions. In a formative phase of 18 months, we have been guided by community-based models of HIV care that include the provision of medicines, peer support and self-management and a series of collaborative stakeholder consultations with policymakers and patient (service user) groups to design a new community-based integrated model of care for the management of patients with HIV, diabetes and hypertension. This has informed the design of INTE-COMM, which will differ from existing community care approaches by managing multiple conditions (HIV, hypertension and diabetes) in the community via health monitoring and adherence/lifestyle advice (medicines, diets and exercise) provided by community nurses and trained lay workers and devolving NCD drug dispensing to the community level. While INTE-COMM is situated in Tanzania and Uganda, we intend to generate evidence potentially transferable to other community settings in the SSA and wider continent.
Publisher Copyright:
© Author(s) (or their employer(s)) 2024.
PY - 2024/3/20
Y1 - 2024/3/20
N2 - 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.
AB - 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.
KW - Humans
KW - HIV Infections/complications
KW - Uganda
KW - Tanzania/epidemiology
KW - Noncommunicable Diseases/therapy
KW - Diabetes Mellitus/therapy
KW - Hypertension/therapy
KW - Chronic Disease
KW - Disease Management
UR - http://www.scopus.com/inward/record.url?scp=85188442040&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2023-078044
DO - 10.1136/bmjopen-2023-078044
M3 - Article
C2 - 38508649
SN - 2044-6055
VL - 14
JO - BMJ Open
JF - BMJ Open
IS - 3
M1 - e078044
ER -
