Controlling chronic diseases in Africa: Development and evaluation of integrated community-based management for HIV, diabetes and hypertension in Tanzania and Uganda

Not Applicable

• Conditions: Development of integrated community care for patients with diabetes, hypertension and HIV; Not Applicable

• Registration Number: ISRCTN15319595
• Lead Sponsor: niversity College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-07
• Last Update Posted: 15 April 2024
• Study Completion: 2024-10-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 1864

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.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Blood pressure measured using electronic blood pressure monitor every month for 12-months <br>2. Blood glucose measured using fasting blood glucose test every three months for 12-months<br>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

Name	Time	Method
1. General health information (i.e., Family history, comorbidities, smoking & alcohol status) measured via patient completed survey at study baseline clinic <br>2. Height and weight measured by health facility scales and tape measure at study baseline clinic <br>3. Retention in care measured as the proportion of people alive and in care at 12 months of follow-up <br>4. Medication use will be measured via patient completed survey each month for the 12-months of the study<br>5. Health-related quality of life measured using SF-12 at baseline and 12-month follow up clinics <br>6. Health economics measured using the EuroQoL-5D at baseline and 12-month follow-up clinics