Integrated care for HIV and non-communicable diseases in Africa: a pilot study to inform a large-scale trial (MOCCA and MOCCA Extension Study)
| ISRCTN | ISRCTN71437522 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71437522 |
| Secondary identifying numbers | Protocol version 4.2 |
- Submission date
- 31/08/2021
- Registration date
- 28/09/2021
- Last edited
- 12/12/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Between 2018 and 2019 the Management of Chronic Conditions in Africa (MOCCA) study delivered care in an integrated approach whereby patients with either HIV infection, diabetes or hypertension (high blood pressure) were managed in a single clinic (i.e. with shared waiting and consultation rooms, shared pharmacy, and similar adherence counselling support, medical records, and tracing of patients lost from care). The study was done in 10 health facilities (five in Tanzania and five in Uganda) with varying clinical infrastructure, ranging from health centres to district hospitals offering primary care. In the MOCCA extension study, the researchers are re-establishing the integrated care clinics and inviting the participants of the original MOCCA study to attend the clinics again. The aim is to determine if the integrated care clinic remains acceptable to patients and to determine the clinical impact of participating in integrated care.
Who can participate?
Participants of the original MOCCA trial who were alive and in care at the end of the MOCCA follow-up
What does the study involve?
The integrated care clinic will be re-established (as was previously ran during the original MOCCA study) where patients who have either HIV, diabetes, hypertension or any combination of these conditions can receive care. Patients who have more than one condition will receive care in a single consultation. Patients will attend the clinic as directed by the health facility staff, following standard of care visit schedules. All aspects of clinical care, including blood testing, clinical monitoring and drug prescriptions will be according to the national guidelines and as prescribed by the health facility staff. In addition, cross-testing for diabetes, hypertension and HIV will be offered to recruited participants, for example, patients who have diabetes will be offered testing for hypertension and HIV. A blood lipid test for all patients will be done at enrolment. Biomedical measurements including blood glucose, blood pressure and plasma viral loads will be recorded according to the conditions that patients are being treated for at enrolment, the end of study follow up and if they are taken during any follow-up appointments.
What are the possible benefits and risks of participating?
Participants may have to change from the facility or clinic they were attending in order to re-attend at the integrated care clinic. As there will be cross-testing of conditions, participants will have the opportunity to be screened for diabetes, hypertension or HIV (as appropriate). Early diagnosis of any of these conditions is very important in order to prevent the development of poor health and complications. There will also be a test of blood cholesterol. If participants are found to have high cholesterol, they can make changes to their diet and lifestyle to prevent the development of heart disease.
Where is the study run from?
This study is run by a partnership of institutions including the Liverpool School of Tropical Medicine (UK), the National Institute of Medical Research (Tanzania), and the MRC/LSHTM/UVRI Uganda research institute.
When is the study starting and how long is it expected to run for?
February 2018 to December 2021
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Dr Anupam Garrib
anupam.garrib@lstmed.ac.uk
Contact information
Public
Liverpool School of Tropical Medicine
Pembroke Place
Liverpool
L5 3QA
United Kingdom
| Phone | +44 (0)151 705 3229 |
|---|---|
| anupam.garrib@lstmed.ac.uk |
Scientific
Director UCL Institute of Global Health
30 Guildford Street
London
WC1N 1EH
United Kingdom
| Phone | +44(0)20 7679 2352 |
|---|---|
| s.jaffar@ucl.ac.uk |
Study information
| Study design | Single-arm intervention study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Management of chronic conditions in Africa extension study |
| Study acronym | MOCCA Extension |
| Study objectives | Does the provision of integrated care (as delivered during the original MOCCA study) remain acceptable to patients and what is the impact on clinical outcomes? |
| Ethics approval(s) | 1. Approved 07/08/2018, amendment approved 04/12/2019, LSTM Research Ethics Committee (Pembroke Place, L3 5QA, UK; +44(0)151 705 3100; lstmrec@lstmed.ac.uk), ref: 18-044 2. Approved 21/05/2018, amendment approved 07/12/2020, The AIDS Support Organisation (TASO, TASO Headquarters, Mulago Hospital Complex, PO Box 10443, Kampala, Uganda; +256 (0)414 532 580/1; mail@tasouganda.org), ref: TASOREC/015/18-UG-REC-009 3. Approved 23/05/2018, amendment approved 07/12/2020, 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/R.8a/Vol. IX/2793 |
| Health condition(s) or problem(s) studied | Integration of care for patients with diabetes, hypertension or HIV |
| Intervention | Implementation of an integrated care clinic (as previously ran during the original MOCCA Study) where patients who have either HIV, diabetes, hypertension or any combination of these conditions can receive care. Patients who have more than one condition will receive care in a single consultation. Patients will attend the clinic as directed by the health facility staff. The MOCCA visit schedule will follow the standard of care visit schedules. All aspects of clinical care, including blood testing, clinical monitoring and drug prescriptions will be according to the national guidelines and as prescribed by the health facility staff. In addition, cross-testing for diabetes, hypertension and HIV will be offered to recruited participants, for example, patients who have diabetes will be offered testing for hypertension and HIV. A blood lipid test for all patients will be done at enrolment. Biomedical measurements including blood glucose, blood pressure and plasma viral loads will be recorded according to the conditions that patients are being treated for, at enrolment, end of study follow up and if they are taken during any follow-up appointments. |
| Intervention type | Other |
| Primary outcome measure | Retention in care (defined as being alive and in care in a MOCCA clinic) at 12 and 24 months from enrolment into MOCCA. |
| Secondary outcome measures | Biomedical measurements at 12 and 24 months including: 1. Fasting blood glucose in diabetic patients measured using a point of care blood glucose monitor 2. Blood pressure in patients with hypertension measured using a digital blood pressure monitor 3. Plasma viral load measured in the HIV treatment programme in each country and recorded in patient clinical notes |
| Overall study start date | 09/02/2018 |
| Completion date | 31/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 1911 |
| Key inclusion criteria | 1. All participants who were alive and in care in the integrated care clinics in the original MOCCA study 2. Adult >18 years old 3. Living within the catchment population of the health facility 4. Planning to remain in the area for at least 6 months |
| Key exclusion criteria | 1. Pregnant women 2. Very sick, requiring immediate hospital |
| Date of first enrolment | 05/01/2021 |
| Date of final enrolment | 31/08/2021 |
Locations
Countries of recruitment
- Tanzania
- Uganda
Study participating centres
Dar es Salaam
-
Tanzania
Dar es Salaam
-
Tanzania
Dar es Salaam
-
Tanzania
Dar es Salaam
-
Tanzania
Dar es Salaam
-
Tanzania
PO Box 10443
Kampala
-
Uganda
Namirembe Rd
Wakiso
Kampala
-
Uganda
-
Uganda
Kampala
-
Uganda
Kampala
-
Uganda
Sponsor information
University/education
Pembroke Place
Liverpool
L5 3QA
England
United Kingdom
| Phone | +44 (0)151 705 3100 |
|---|---|
| info@lstmed.ac.uk | |
| Website | https://www.lstmed.ac.uk/ |
"ROR" |
https://ror.org/03svjbs84 |
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 | 31/03/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. The protocol will be made available at a later date. |
| IPD sharing plan | The 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? |
|---|---|---|---|---|---|
| Results article | health economics | 10/09/2021 | 12/12/2022 | Yes | No |
| Results article | retention in care and clinical indicators | 02/11/2021 | 12/12/2022 | Yes | No |
Editorial Notes
12/12/2022: The following changes have been made:
1. Two publication references have been added.
2. The scientific contact has been changed.
28/09/2021: Trial's existence confirmed by the Liverpool School of Tropical Medicine ethics committee.
