Integrated Hypertension and Diabetes Mellitus Type II Treatment and Care Among People Living With HIV/AIDS

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05786703
• Other study ID #: MUHAS-REC-1-2020-074
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: June 30, 2020

Study information

• Verified date: May 2023
• Source: Muhimbili University of Health and Allied Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 333
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 54 Years

Eligibility

Inclusion Criteria:

All PLHIV who attended CTC 18 years and above

Exclusion Criteria:

• Pregnant women living with HIV/AIDS

• Patients with mental diseases.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• HIV Infections
• Hypertension

Intervention

Diagnostic Test:
• Biochemical, weight measurements, Blood pressure and blood sugar level
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.

Locations

Country	Name	City	State
Tanzania	Temeke Regional Referral Hospital	Dar Es Salaam

Sponsors (1)

Lead Sponsor	Collaborator
Muhimbili University of Health and Allied Sciences

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CHANGE IN BLOOD PRESSURE LEVEL	Change in the mean blood pressure at the beginning and the end of the study	SIX MONTHS