Evaluating the integration of health services for chronic diseases in Africa

ISRCTN ISRCTN43896688
DOI https://doi.org/10.1186/ISRCTN43896688
Secondary identifying numbers 19-100
Submission date
04/04/2020
Registration date
21/04/2020
Last edited
04/04/2024
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
In Africa, chronic diseases such as high blood pressure (hypertension) and high blood sugar (diabetes) are now common and require treatment for life. HIV-infection is also common and also requires life-long treatment.
At the moment, in most African countries, health services for hypertension, diabetes and HIV-infection are provided in separate clinics or on separate days. Given the growing need for these services, the researchers don’t know if this is the best way or whether services for these conditions should be provided together (i.e. all provided in one clinic). The researchers call bringing these services under one roof, integrated care. Integrating these services under one roof could be easier for patients and for health services but it might put pressure on the health worker seeing people with different conditions.
The goal is to compare a model of integrated care for people living with HIV-infection, diabetes or hypertension against the current standard model of separate clinics for each of these conditions.
The researchers will compare these models in terms of various health indicators measured among people with these conditions and the costs that both patients and the health services incur.
The researchers are working closely in partnership with health policy makers in Tanzania and Uganda. They will be the principal users of the research. They will use the information from the study to decide how future health care should be organised for chronic conditions.

Who can participate?
Adults over 18 years, with confirmed HIV-infection, diabetes, hypertension or any combination of these

What does the study involve?
The researchers want to generate clear evidence that can feed into consideration of future policy. In this trial, some health facilities will be asked to provide integrated care, and some will continue with the current stand-alone care. Health facilities will be randomly assigned (i.e. by chance) to deliver one of the two options of care. This is called a cluster-randomised trial.
Within each health facility, patients will be selected systematically for the study. They will be invited to join if they meet the criteria (for example that they live within reasonable distance). They will receive care from the regular health workers who will receive refresher training on how to manage HIV-infection, hypertension and diabetes. Participants will be followed up over 12 months to work out how well their disease has been managed, the financial costs that they incurred to come to the health facility, costs incurred by the health services to provide the care, and other indicators.
The researchers plan to enrol 32 health facilities in the two countries and a total of about 220 participants at each facility with one of the target diseases (HIV-infection, high blood pressure or high blood sugar). These participants will be included in the main overall evaluation of the two models of care.

What are the possible benefits and risks of participating?
There are no direct or immediate benefits to participants but the information from this study will help the Ministry of Health to decide on how to provide service for people who need chronic care.

Where is the study run from?
1. Medical Research Council/Uganda Viral Research Institute/London School of Hygiene & Tropical Medicine Uganda Research Unit (Uganda)
2. The AIDS Support Organisation (Uganda)
3. National Institute for Medical Research (Tanzania)

When is the study starting and how long is it expected to run for?
March 2020 to May 2022

Who is funding the study?
European Union

Who is the main contact?
Prof. Shabbar Jaffar
s.jaffar@ucl.ac.uk

Study website

Contact information

Prof Shabbar Jaffar
Scientific

Institute for Global Health, University College London, 30 Guildford Street
London
WC1N 1EH
United Kingdom

ORCiD logoORCID ID 0000-0002-9615-1588
Phone None provided
Email s.jaffar@ucl.ac.uk
Dr Joseph Okebe
Scientific

Department of International Public Health
Liverpool School of Tropical Medicine
Pembroke Place
Liverpool
L3 5QA
United Kingdom

ORCiD logoORCID ID 0000-0001-5466-1611
Phone +44 151 702 9361
Email Joseph.Okebe@lstmed.ac.uk
Dr Anupam Garrib
Scientific

Institute for Global Health, University College London, 30 Guildford Street
London
WC1N 1EH
United Kingdom

ORCiD logoORCID ID 0000-0003-2305-3749
Phone None provided
Email a.garrib@ucl.ac.uk
Dr Kaushik Ramaiya
Scientific

Shree Hindu Mandal Hospital
Dar es Salaam
-
Tanzania

ORCiD logoORCID ID 0000-0003-3309-5395
Phone +255 753333332
Email ceo@hc.shm.or.tz
Prof Sayoki Mfinanga
Scientific

National Institute for Medical Research (NIMR)
Muhimbili Centre
Dar es Salaam
-
Tanzania

ORCiD logoORCID ID 0000-0001-9067-2684
Phone +255 784755632
Email gsmfinanga@yahoo.com

Study information

Study designMulti-centre open-label parallel 2-arm cluster-randomized controlled trial
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)Hospital
Study typeOther
Participant information sheet Not available in web format, please use contact details to request a participation information sheet.
Scientific titleIntegrating HIV, diabetes and hypertension services in Africa: a cluster-randomised trial in Tanzania and Uganda
Study acronymINTE-AFRICA Trial
Study objectivesIntegration of chronic care services will lead to improved outcomes for people living with diabetes or hypertension and will not compromise outcomes among people living HIV-infection.
Ethics approval(s)1. Approved 16/01/2020, Liverpool School of Tropical Medicine (LSTM) Governance and Ethics Committee (Pembroke Place, L3 5QA, Liverpool, UK; +44 (0)151 705 3762; lstmrec@lstmed.ac.uk), ref: 19-100
2. Approved 23/03/2020, National Health Research Ethics Sub-Committee (3 Barack Obama Drive, P.O.Box 9653, 11101, Dar es Salaam, Tanzania; +255 222 121 400; nimrethics@gmail.com), ref: NIMR/HQ/8.a/Vol. IX/3394
3. Approved 03/02/2020, The AIDS Support Organisation ethics committee (Mulago Hospital Complex, P.O.Box 10443, Kampala, Uganda; +256 414320385/6, mijumbia@tasouganda.org), ref: TASOREC/090/19-UG-REC-009
Health condition(s) or problem(s) studiedHIV-infection, diabetes, or hypertension or combinations of these conditions
InterventionExperimental arm: Integrated health service provision at health facilities providing primary care for HIV infection, diabetes and hypertension.
Control arm: standard care – separate stand-alone services for HIV infection, diabetes or hypertension.

Integration will involve
- A single one-stop clinic where patients with either HIV infection, diabetes or hypertension will be managed. Patients can have one or more of these conditions.
- They will be seen and managed by the same clinicians, nurses, counsellors and other staff
- There will be one pharmacy where dispensing is integrated
- Patient records will be the same – a similar card will be used for all patients
- Laboratory tests will be done by the same laboratory service

Participants will be followed up from enrolment into the study for a period of 12 months.

Randomisation of the health facilities will be stratified in each country by location, type of health facility (as defined by the clinical infrastructure available at the health facility) and by patient load at the health facility (i.e. the numbers of patients attending the facility on a monthly basis). Within each stratum, the researchers will randomise in a 1:1 ratio to either the experimental integration arm or the standard care arm using a computer-generated randomisation list.
Intervention typeMixed
Primary outcome measure1. Retention in care for patients on diabetes and hypertension management measured using patient records at 12 months
2. Plasma viral load suppression among persons HIV-infected measured using lab test (suppression will be defined as plasma viral load < 1000 copies per ml.) at 12 months
Secondary outcome measures1. Cost-effectiveness measured using a decision analytical model at 12 months
2. Biomedical indicators measured at baseline and 12 months
2.1. Fasting blood glucose
2.2. HbA1c
2.3. Blood pressure (mmHg)
3. Clinic usage (aggregated data on day-to-day patient numbers, time spent at clinic by patients, and basic indicators of quality of service such as consultation times) measured over 12 months
Overall study start date15/02/2020
Completion date16/05/2022

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants7,040
Total final enrolment7030
Key inclusion criteria1. Adults, 18 years and above
2. Confirmed HIV infection, diabetes, hypertension or any combination of these
3. Living within the catchment population of the health facility
4. Likely to remain in the catchment population for 6 months
5. Willing to provide written informed consent
Key exclusion criteriaSick patients requiring immediate hospital care at time of assessment
Date of first enrolment02/07/2020
Date of final enrolment01/04/2021

Locations

Countries of recruitment

  • Tanzania
  • Uganda

Study participating centres

Medical Research Council/Uganda Viral Research Institute/London School of Hygiene & Tropical Medicine Uganda Research Unit
Plot 51-59 Nakiwogo Road
Entebbe
P.O.Box 49
Uganda
The AIDS Support Organisation
Mulago Hospital Complex
Kampala
P.O BOX 10443
Uganda
National Institute for Medical Research
Muhimbili Medical Research Centre
Dar es Salaam
P.O.Box 9653
Tanzania

Sponsor information

Liverpool School of Tropical Medicine
University/education

Pembroke Place
Liverpool
L3 5QA
England
United Kingdom

Phone +44 (0)151 705 3100
Email lstmgov@lstmed.ac.uk
Website http://www.lstmed.ac.uk/
ROR logo "ROR" https://ror.org/03svjbs84

Funders

Funder type

Government

European Union

No information available

Results and Publications

Intention to publish date30/10/2022
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryStored in repository
Publication and dissemination planINTE-AFRICA is designed to generate the evidence to inform scale up of integrated chronic care services. The research programme will work closely with policy makers and senior programme managers in both countries. We will provide them with the findings and support them in the decision that they take.
If the trial demonstrates the effectiveness of integrated care, we will support the health facilities to scale this up. We will share protocols on integration and monitor the scale up to record the lessons learnt to facilitate other health facilities to follow.
The findings will also be published in at least one peer-reviewed journal and data will be made accessible to other bodies for further dissemination.
IPD sharing planThe datasets generated during and/or analysed during the current study will be stored in a non-publically available repository. The LSTM subscribes to the FAIR Guiding Principles for scientific data management and stewardship. All datasets from research are committed to the Electronic Data Repository with associated study documentation as well as metadata. Currently, this repository is only accessible to staff. Interested parties can request for metadata of projects in certain disease areas or keywords by contacting the Data controller via email.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article Protocol of qualitative process evaluation 07/10/2020 14/10/2020 Yes No
Protocol article Protocol of RCT 13/10/2021 15/10/2021 Yes No
Other publications Process evaluation 02/06/2023 05/06/2023 Yes No
Other unpublished results qualitative study in women living with HIV 02/12/2022 04/04/2024 No No
Other unpublished results qualitative-observational study undertanding stigma 09/01/2023 04/04/2024 No No
Results article 07/10/2023 04/04/2024 Yes No

Editorial Notes

04/04/2024: The following changes have been made:
1. Publication references added.
2. Scientific contact information was updated.
05/06/2023: Publication reference added.
19/05/2022: The following changes have been made:
1. The overall trial end date has been changed from 31/05/2022 to 16/05/2022.
2. The total final enrolment number has been changed from 7047 to 7030.
21/04/2022: The following changes have been made:
1. The overall trial end date has been changed from 30/04/2022 to 31/05/2022 and the plain English summary has been updated to reflect this change.
2. The intention to publish date has been changed from 30/09/2022 to 30/10/2022.
15/10/2021: Publication reference added.
22/09/2021: The IPD sharing statement has been added and participant level data has been changed from "To be made available at a later date" to "Stored in a repository".
06/04/2021: The following changes have been made:
1. The recruitment end date has been changed from 31/01/2021 to 01/04/2021.
2. The overall trial end date has been changed from 31/01/2022 to 30/04/2022.
3. The intention to publish date has been changed from 30/06/2022 to 30/09/2022.
4. The final enrolment number has been added.
04/12/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/11/2020 to 31/01/2021.
2. The recruitment start date was changed from 19/03/2020 to 02/07/2020.
14/10/2020: Publication reference added.
13/07/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 29/06/2020 to 30/11/2020.
2. The overall trial end date was changed from 30/04/2021 to 31/01/2022.
3. The intention to publish date was changed from 30/11/2021 to 30/06/2022.
20/04/2020: Trial’s existence confirmed by Liverpool School of Tropical Medicine