Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2025-12-25 @ 5:01 PM
Study NCT ID:
NCT05786703
Status:
COMPLETED
Last Update Posted:
2023-05-08
First Post:
2023-03-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Integrated Hypertension and Diabetes Mellitus Type II Treatment and Care Among People Living With HIV/AIDS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001794', 'term': 'Blood Pressure'}], 'ancestors': [{'id': 'D055986', 'term': 'Vital Signs'}, {'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006439', 'term': 'Hemodynamics'}, {'id': 'D002320', 'term': 'Cardiovascular Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 333}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-05', 'studyFirstSubmitDate': '2023-03-12', 'studyFirstSubmitQcDate': '2023-03-25', 'lastUpdatePostDateStruct': {'date': '2023-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CHANGE IN BLOOD PRESSURE LEVEL', 'timeFrame': 'SIX MONTHS', 'description': 'Change in the mean blood pressure at the beginning and the end of the study'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus', 'Hypertension', 'HIV Infections']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '54 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll PLHIV who attended CTC 18 years and above\n\nExclusion Criteria:\n\n* Pregnant women living with HIV/AIDS\n* Patients with mental diseases.'}, 'identificationModule': {'nctId': 'NCT05786703', 'briefTitle': 'Integrated Hypertension and Diabetes Mellitus Type II Treatment and Care Among People Living With HIV/AIDS', 'organization': {'class': 'OTHER', 'fullName': 'Muhimbili University of Health and Allied Sciences'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'MUHAS-REC-1-2020-074'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Biochemical, weight measurements, Blood pressure and blood sugar level', 'type': 'DIAGNOSTIC_TEST', 'description': "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."}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dar es Salaam', 'country': 'Tanzania', 'facility': 'Temeke Regional Referral Hospital', 'geoPoint': {'lat': -6.82349, 'lon': 39.26951}}], 'overallOfficials': [{'name': 'Atuganile Musyani, Masters', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Muhimbili University of Health and Allied Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Muhimbili University of Health and Allied Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Atuganile Musyani', 'investigatorAffiliation': 'Muhimbili University of Health and Allied Sciences'}}}}