NCT05786703

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
333

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 27, 2023

Completed
Last Updated

May 8, 2023

Status Verified

May 1, 2023

Enrollment Period

6 months

First QC Date

March 12, 2023

Last Update Submit

May 5, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • CHANGE IN BLOOD PRESSURE LEVEL

    Change in the mean blood pressure at the beginning and the end of the study

    SIX MONTHS

Interventions

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.

Eligibility Criteria

Age18 Years - 54 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • All PLHIV who attended CTC 18 years and above

You may not qualify if:

  • Pregnant women living with HIV/AIDS
  • Patients with mental diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Temeke Regional Referral Hospital

Dar es Salaam, Tanzania

Location

MeSH Terms

Conditions

Diabetes MellitusHypertensionHIV Infections

Interventions

Blood Pressure

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Vital SignsPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisHemodynamicsCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Atuganile Musyani, Masters

    Muhimbili University of Health and Allied Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 12, 2023

First Posted

March 27, 2023

Study Start

January 1, 2020

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

May 8, 2023

Record last verified: 2023-05

Locations