- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05786703
Integrated Hypertension and Diabetes Mellitus Type II Treatment and Care Among People Living With HIV/AIDS
May 5, 2023 updated by: Atuganile Musyani, Muhimbili University of Health and Allied Sciences
Integrated Hypertension and Diabetes Mellitus Type II Treatment and Care Among People Living With HIV/AIDS Attending Care and Treatment Center in Dar es Salaam, Tanzania
This project was a facility-based program intervention for People Living with HIV (PLHIV) aged 18 years and above who attended a Care and Treatment Center (CTC) in Dar es Salaam, Tanzania.
Clients received preventive, diagnostic, and treatment services for Hypertension (HTN) and Type Two Diabetes Mellitus (T2DM).
The primary health outcomes were all-cause mortality, disease-specific morbidity, HTN, and T2DM control rates.
Secondary outcomes included access to care, retention in care adherence, and quality of care.
Results obtained can be used to strengthen Non-Communicable Diseases (NCDs) care delivery in HIV/AIDS care in CTC in Tanzania.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A cohort of patients who were diagnosed with hypertension and diabetes was created and followed up for 6 months.
Patients were required to attend clinics on a monthly basis.
At the first visit short interview using the STEPwise approach of the STEPS surveillance tool for NCDs from the World Health Organization (WHO) was conducted.
On subsequent visits, hypertension and blood sugar levels and cholesterol levels will be measured and adherence to medication were assessed.
The patient registry was developed following recommendations from the HEARTS (Healthy lifestyle, Evidence-based protocols, Access to essential medicines and technology, Risk-based Cardiovascular Disease (CVD) management, Team-based care Guidance Systems for monitoring)technical package of WHO with some modifications if needed.
A simple surveillance system was developed for all patients diagnosed with hypertension and diabetes so that there is continuous evaluation and monitoring of all patients attending NCDs care at the HIV clinic.
Study Type
Observational
Enrollment (Actual)
333
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Dar Es Salaam, Tanzania
- Temeke Regional Referral Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 54 years (Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
The target population was PLHIV aged 18 years or above attending Temeke RRH in Temeke District in Dar es Salaam, Tanzania.
We used convinient sampling to select PLHIV who attended CTC within the 5 days of data collection.
Clients were randomly selected based on availability at the time of interview.
The project excluded pregnant women living with HIV/AIDS and patients with mental diseases.
Description
Inclusion Criteria:
All PLHIV who attended CTC 18 years and above
Exclusion Criteria:
- Pregnant women living with HIV/AIDS
- Patients with mental diseases.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CHANGE IN BLOOD PRESSURE LEVEL
Time Frame: SIX MONTHS
|
Change in the mean blood pressure at the beginning and the end of the study
|
SIX MONTHS
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Atuganile Musyani, Masters, Muhimbili University of Health and Allied Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2020
Primary Completion (Actual)
June 30, 2020
Study Completion (Actual)
June 30, 2020
Study Registration Dates
First Submitted
March 12, 2023
First Submitted That Met QC Criteria
March 25, 2023
First Posted (Actual)
March 27, 2023
Study Record Updates
Last Update Posted (Actual)
May 8, 2023
Last Update Submitted That Met QC Criteria
May 5, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MUHAS-REC-1-2020-074
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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