Condition category
Infections and Infestations
Date applied
04/04/2020
Date assigned
21/04/2020
Last edited
04/12/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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 January 2022

Who is funding the study?
European Union

Who is the main contact?
Prof. Shabbar Jaffar
shabbar.jaffar@lstmed.ac.uk

Trial website

https://inteafrica.org/

Contact information

Type

Scientific

Primary contact

Prof Shabbar Jaffar

ORCID ID

http://orcid.org/0000-0002-9615-1588

Contact details

Liverpool School of Tropical Medicine
Liverpool
L3 5QA
United Kingdom
+44 151 705 2591
shabbar.jaffar@lstmed.ac.uk

Type

Scientific

Additional contact

Dr Joseph Okebe

ORCID ID

http://orcid.org/0000-0001-5466-1611

Contact details

Department of International Public Health
Liverpool School of Tropical Medicine
Pembroke Place
Liverpool
L3 5QA
United Kingdom
+44 151 702 9361
Joseph.Okebe@lstmed.ac.uk

Type

Scientific

Additional contact

Dr Anupam Garrib

ORCID ID

http://orcid.org/0000-0003-2305-3749

Contact details

Department of Clinical Sciences
Liverpool School of Tropical Medicine
Pembroke Place
Liverpool
L3 5QA
United Kingdom
+44 151 705 3229
Anupam.Garrib@lstmed.ac.uk

Type

Scientific

Additional contact

Dr Kaushik Ramaiya

ORCID ID

http://orcid.org/0000-0003-3309-5395

Contact details

Shree Hindu Mandal Hospital
Dar es Salaam
-
Tanzania
+255 753333332
ceo@hc.shm.or.tz

Type

Scientific

Additional contact

Prof Sayoki Mfinanga

ORCID ID

http://orcid.org/0000-0001-9067-2684

Contact details

National Institute for Medical Research (NIMR)
Muhimbili Centre
Dar es Salaam
-
Tanzania
+255 784755632
gsmfinanga@yahoo.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

19-100

Study information

Scientific title

Integrating HIV, Diabetes and Hypertension services in Africa: a cluster-randomised trial in Tanzania and Uganda

Acronym

INTE-AFRICA Trial

Study hypothesis

Integration 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

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

Study design

Multi-centre open-label parallel 2-arm cluster-randomized controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participation information sheet.

Condition

HIV-infection, diabetes, or hypertension or combinations of these conditions

Intervention

Experimental 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 type

Mixed

Phase

Drug names

Primary outcome measure

1. 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 measures

1. 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 trial start date

15/02/2020

Overall trial end date

31/01/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

7,040

Participant exclusion criteria

Sick patients requiring immediate hospital care at time of assessment

Recruitment start date

02/07/2020

Recruitment end date

31/01/2021

Locations

Countries of recruitment

Tanzania, Uganda

Trial participating centre

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

Trial participating centre

The AIDS Support Organisation
Mulago Hospital Complex
Kampala
P.O BOX 10443
Uganda

Trial participating centre

National Institute for Medical Research
Muhimbili Medical Research Centre
Dar es Salaam
P.O.Box 9653
Tanzania

Sponsor information

Organisation

Liverpool School of Tropical Medicine

Sponsor details

Pembroke Place
Liverpool
L3 5QA
United Kingdom
+44 (0)151 705 3100
lstmgov@lstmed.ac.uk

Sponsor type

University/education

Website

http://www.lstmed.ac.uk/

Funders

Funder type

Government

Funder name

European Union

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

INTE-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 statement:
The current data sharing plans for this study are unknown and will be available at a later date.

Intention to publish date

30/06/2022

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

2020 protocol in https://pubmed.ncbi.nlm.nih.gov/33033029/ (added 14/10/2020)

Publication citations

Additional files

Editorial Notes

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