Diabetes MellitusNCT05786703
Integrated Hypertension and Diabetes Mellitus Type II Treatment and Care Among People Living With HIV/AIDS
An observational study of Diabetes Mellitus and Hypertension, run by Muhimbili University of Health and Allied Sciences at 1 site in Tanzania.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 54 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Hypertension, HIV Infections
- What is being tested?
- Biochemical, weight measurements, Blood pressure and blood sugar level
- How many people
- 333 participants
- Where
- 1 siteTanzania
- Study dates
- 1 Jan 2020to 30 Jun 2020
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 54 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- All PLHIV who attended CTC 18 years and above
Who cannot join
- Pregnant women living with HIV/AIDS
- Patients with mental diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes Mellitus, Hypertension, HIV Infections
- Being tested
- Biochemical, weight measurements, Blood pressure and blood sugar level
- Medical subject headings
- Diabetes Mellitus, Hypertension, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biochemical, weight measurements, Blood pressure and blood sugar levelDiagnostic test
At first visit short interview using the STEPwise approach of the STEPS surveillance tool for NCDs from the WHO will be conducted. On subsequent visits, hypertension and blood sugar level and cholesterol levels will be measured and adherence to medication will be assessed. The patient's registry will be developed following recommendation from the HEARTS technical package of World Health Organization (WHO) with some modification if needed.
What is being measured
The primary outcome is the main question the study is designed to answer.
CHANGE IN BLOOD PRESSURE LEVEL
Change in the mean blood pressure at the beginning and the end of the study
Measured: SIX MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start1 Jan 2020
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 333 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Muhimbili University of Health and Allied Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atuganile Musyani, Muhimbili University of Health and Allied Sciences
- Investigators
- Atuganile Musyani, Masters, Principal investigator, Muhimbili University of Health and Allied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05786703
- Sponsor's protocol ID
- MUHAS-REC-1-2020-074
- Status last verified
- May 2023
- First submitted
- 12 Mar 2023
- Last updated
- 8 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05786703
- Acronym / sponsor ID
- MUHAS-REC-1-2020-074
- Conditions
- Diabetes Mellitus, Hypertension, HIV Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 333 participants (actual)
- Lead sponsor
- Muhimbili University of Health and Allied SciencesUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 to 54 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- All PLHIV who attended CTC 18 years and above
Key exclusion criteria (2 listed)
- Pregnant women living with HIV/AIDS
- Patients with mental diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biochemical, weight measurements, Blood pressure and blood sugar levelAt first visit short interview using the STEPwise approach of the STEPS surveillance tool for NCDs from the WHO will be conducted. On subsequent visits, hypertension and blood sugar level and cholesterol levels will be measured and adherence to medication will be assessed. The patient's registry will be developed following recommendation from the HEARTS technical package of World Health Organization (WHO) with some modification if needed. | Diagnostic test | – |
Primary outcome
CHANGE IN BLOOD PRESSURE LEVEL
Time frame: SIX MONTHS
Change in the mean blood pressure at the beginning and the end of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Atuganile Musyani, Masters principal investigator
Muhimbili University of Health and Allied Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Hypertension, run by Muhimbili University of Health and Allied Sciences at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CHANGE IN BLOOD PRESSURE LEVEL (time frame: SIX MONTHS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2023.