Controlling chronic diseases in Africa: Development and evaluation of integrated community-based management for HIV, diabetes and hypertension in Tanzania and Uganda
| ISRCTN | ISRCTN15319595 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15319595 |
- Submission date
- 24/05/2022
- Registration date
- 07/06/2022
- Last edited
- 30/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
In Africa, diseases such as high blood pressure (hypertension) and high blood sugar (diabetes) are now common and require treatment for life. HIV is also common and also requires treatment for life. Some health facilities in Tanzania and Uganda have combined the care for these three chronic conditions into the same clinic, this is known as integrated care. Within this study, our aim is to understand whether running integrated care clinics at the health facility is the best way to manage patients with chronic conditions that are well-controlled or whether they could be better managed by receiving integrated care in their local communities.
Who can participate?
Male and female patients aged 18 years or older with a diagnosis of hypertension, diabetes or HIV, but whose condition has been stable for the last 6 months.
What does the study involve?
Study participants will receive integrated care either at their health facility or a community location. If they are assigned to receive facility-based care, then they will be asked to attend as normal and be seen by their usual doctors and nurses. If they are assigned to receive care in the community, they will be asked to come to a place in the community (such as health outpost or maybe a school or church) at their usual frequency (e.g. every month). Here, they will receive their care at the community point and be seen by a nurse and a trained lay-worker. The participants medicines will be brought to the community point by the nurse for collection. The health care workers will check blood pressure and blood sugar in the usual way as they do now, either at the facility or in the community, depending on which type of care is assigned. If the participant has HIV, they should also attend the facility to have their viral load test done when this is due. These routine tests will be used by the health care staff to guide treatment, but the research team will also use these data in their evaluations. Thus, they will access clinical notes. Participants will receive the same quality of care no matter which study arm they are allocated to.
What are the possible benefits and risks of participating?
The research team will be supporting the health service in monitoring patients. Patients will fund their medication in the usual way. We will not pay for your medicines but will help the health services to have a small stock of emergency supplies of medicines so as to reduce the number of stock-outs of medicines. So there might be small improvements in the health care received. The information from this study will help policy-makers in each country to decide on how to provide service for long-term conditions. Regarding potential risks, the participant may spend more time at the clinic or the community meeting point on the days we will be asking questions. We will try to keep this time to a minimum and ensure that they do not lose their place in the queue to see the health service provider.
Where is the study run from?
The study will take place in Uganda and Tanzania but is being run through a partnership between the Medical Research Council/Uganda Virus Research Institute/London School of Hygiene & Tropical Medicine, the National Institute for Medical Research Tanzania and University College London in the UK.
When is the study starting and how long is it expected to run for?
October 2020 to October 2024
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).
Who is the main contact?
Professor Shabbar Jaffar
s.jaffar@ucl.ac.uk
Contact information
Principal Investigator
Institute for Global Health
University College London
30 Guilford Street
Liverpool
WC1N 1EH
United Kingdom
 ORCID ID |
0000-0002-9615-1588 |
|---|---|
| Phone | +44 151 705 2591 |
| s.jaffar@ucl.ac.uk |
Study information
| Study design | Cluster randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Community, Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Development and evaluation of integrated community-based management for HIV, diabetes and hypertension in Tanzania and Uganda |
| Study acronym | INTE-COMM |
| Study objectives | Community-based integrated management of HIV, diabetes and hypertension is more, or equally as, effective at improving patient outcomes when compared to health facility-based integrated management of these conditions. |
| Ethics approval(s) | 1. Approved 25/10/2022, University College London Research Ethics Committee (Graduate School, North Cloisters, Wilkins Building UCL, Gower Street, London, WC1E 6BT, United Kingdom; +44 020 3108 4312; ethics@ucl.ac.uk), ref: 23821/001 2. Approval pending, LSTM Research Ethics Committee (Pembroke Place, L3 5QA, UK; +44(0)151 705 3100; lstmrec@lstmed.ac.uk), ref: 21-091 3. Approval pending, Uganda Virus Research Institute Research Ethics Committee, Plot 51-59 Nakiwogo Road, P.O.Box 49, Entebbe, Uganda; no telephone number provided; directoruvri@uvri.go.ug), ref: GC/127/872 4. Approval pending, National Institute for Medical Research (3 Barack Obama Drive, PO Box 965, 11101 Dar es Salaam, Tanzania; +255 (0)22 2121400; nimrethics@gmail.com), ref: NIMR/HQ/R8aVOL III /157 |
| Health condition(s) or problem(s) studied | Development of integrated community care for patients with diabetes, hypertension and HIV |
| Intervention | Patients will be cluster randomised to either a model of community-based integrated care (intervention) or health facility-based integrated care (control) using a computer generated random number. Community-based integrated care arm (intervention): After an initial baseline visit at the health facility, participants will attend 10 monthly meetings in the community with a nurse and trained lay-worker. Medication adherence, diet and lifestyle advice will be provided each time. A nurse will monitor participants with similar frequency as monitoring conducted in the control arm (e.g. monthly blood pressure, 3-monthly glycaemia). Medicines will be dispensed at the facility, taken and handed to participants at the community point. Participants will end the study at a 12-month health facility visit Health-facility integrated care arm (control): As per standard care, participants will visit health facilities monthly for medicines and basic adherence, diet and lifestyle over the course of 12-months. They will have BP checked monthly and glycaemia 3-monthly and medicines dispensed monthly. |
| Intervention type | Mixed |
| Primary outcome measure | 1. Blood pressure measured using electronic blood pressure monitor every month for 12-months 2. Blood glucose measured using fasting blood glucose test every three months for 12-months 3. HIV disease activity measured using viral load test at baseline (if not already available in medical records) and 12-month follow-up |
| Secondary outcome measures | 1. General health information (i.e., Family history, comorbidities, smoking & alcohol status) measured via patient completed survey at study baseline clinic 2. Height and weight measured by health facility scales and tape measure at study baseline clinic 3. Retention in care measured as the proportion of people alive and in care at 12 months of follow-up 4. Medication use will be measured via patient completed survey each month for the 12-months of the study 5. Health-related quality of life measured using SF-12 at baseline and 12-month follow up clinics 6. Health economics measured using the EuroQoL-5D at baseline and 12-month follow-up clinics |
| Overall study start date | 01/10/2020 |
| Completion date | 30/10/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 1736 |
| Total final enrolment | 1864 |
| Key inclusion criteria | 1. Either diagnosed with HIV or diagnosed with diabetes type 2 or hypertension (or with combinations of these conditions. 2. In regular care at the health facility for 6 months or more (i.e. attending routine appointments) 3. considered by the clinical team not to have any complications/co-infections or that these are well managed. Also has remained on the same treatment regimen for at least 3-6 months (both the type of medication and dose) and does not require a change in management. 4. considered adherent to treatment by clinical team over the last 6 months. 5. Adult, age 18 years or older. 6. Living within the catchment population of the health facility. 7. Planning to remain in the area for at least 6 months. 8. Willing to attend for health services in the community. |
| Key exclusion criteria | 1. Blood pressure >160/100 mmHg at the current visit (average of 2 readings). 2. Blood pressure recorded on more than one occasion as over 180/110 mmHg any time in the last 6 months. 3. Fasting glycaemia recorded on more than one occasion as over >13 mmol/L any time in the last 6 months. 4. Complications of diabetes or hypertension that are unmanaged/uncontrolled. 5. Any clinical condition that requires health facility management. 6. Pregnant women as these require specialist care. However, we will refer patients who become pregnant in the course of the study to the health facility for antenatal care and further management. These patients will be welcome to attend community meetings after delivery. |
| Date of first enrolment | 02/12/2022 |
| Date of final enrolment | 06/10/2023 |
Locations
Countries of recruitment
- Tanzania
- Uganda
Study participating centres
Entebbe
PO Box 49
Uganda
P.O.Box 9653
Dar-es-Salaam
11101
Tanzania
Liverpool
L3 5QA
United Kingdom
London
WC1N 1EH
United Kingdom
Sponsor information
University/education
Institute for Global Health, 30 Guilford Street
London
WC1N 1EH
England
United Kingdom
| Phone | +44 (0)20 7242 9789 |
|---|---|
| uclh.randd@nhs.net | |
| Website | https://www.ucl.ac.uk/about/ |
"ROR" |
https://ror.org/02jx3x895 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1.1 | 02/03/2022 | 07/06/2022 | No | No |
| Protocol article | 20/03/2024 | 30/06/2025 | Yes | No |
Additional files
Editorial Notes
30/06/2025: Publication reference added.
03/04/2024: The Sponsor was changed from Liverpool School of Tropical Medicine to University College London.
04/03/2024: The following changes were made to the trial record:
1. The ethics approval (1) was added.
2. The overall start date was changed from 01/01/2021 to 01/10/2020.
3. The overall end date was changed from 31/12/2023 to 30/10/2024.
4. The total final enrolment was added.
5. The recruitment start date was changed from 01/07/2022 to 02/12/2022.
6. The recruitment end date was changed from 31/12/2022 to 06/10/2023.
7. The study participating centres Liverpool School of Tropical Medicine and Institute for Global Health University College London were added.
8. The intention to publish date was changed from 01/03/2024 to 30/06/2025.
9. The PI contact details were changed.
10. The plain English summary was updated to reflect these changes.
07/06/2022: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
