NCT04624061

Brief Summary

The INTEGRATED HIV/HTN is a hybrid type-1 effectiveness/implementation cluster randomised trial evaluating the introduction of a multi-component integrated HIV/HTN care model intervention, randomised to 13 districts in the intervention arm compared to 13 districts in the control. Selected health facilities within the 13 intervention districts will receive the intervention while those in the 13 control districts will continue implementing the standard of care as per the Ministry of Health (MoH) guidelines. All the participating facilities will receive blood pressure (BP) machines, and Non- communicable diseases (NCDs) registers as a standard of care.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,600

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

November 16, 2020

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
Last Updated

November 4, 2022

Status Verified

July 1, 2022

Enrollment Period

3.3 years

First QC Date

October 27, 2020

Last Update Submit

November 1, 2022

Conditions

HIVHypertension

Outcome Measures

Primary Outcomes (4)

  • Proportion of HIV patients screened for Hypertension(HTN) at Month 24

    Proportion of HIV patients Screened for HTN at 24 months months of follow up

    Month 24

  • Proportion of HTN patients diagnosed and started on treatment

    Proportion of HTN patients diagnosed and started on treatment

    Month 24

  • Proportion of HIV/HTN patients with HTN Control (systolic blood pressure below 140 mm Hg and diastolic blood pressure below 90 mm Hg) at 12 months and 24 months.

    Proportion of HIV infected patients with with documented history of elevated blood pressure or prior HTN diagnosis on medication who are controlled (systolic blood pressure below 140 mm Hg and diastolic blood pressure below 90 mm Hg) at 12 months and 24 months.

    24 months

  • Proportion of HIV/HTN patients with HIV/HTN Dual Control: (who are both "HTN controlled" and have undetectable HIV viral load (at 12 months and 24 months).

    Proportion of HIV/HTN patients with HIV/HTN Dual Control: (who are both "HTN controlled" and have undetectable HIV viral load (at 12 months and 24 months).

    24 months

Secondary Outcomes (9)

  • Lowered blood pressure

    24 months

  • Routine Hypertension care

    12 and 24 months

  • Adoption of the integrated model

    12 and 24 months

  • Knowledge of HTN management and HTN complications among health workers

    12 and 24 months

  • Patient satisfaction

    12 and 24 months

  • +4 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

The integrated HIV/HTN care model with the following components; 1. Training and capacity building on the INTEGRATED HIV/HTN model and NCD care 2. Integrated HIV/HTN care delivery model by promoting HTN screening and care in HIV clinics. 3. HMIS enhancements through mentorship and coaching on the use of NCD registers and NCD patient cards and HTN data capture in the (Electronic Medical Record) EMR system. 4. SMS and/or WhatsApp for data coordination and communication among providers, District Health officers (DHOs) and study team (Mentors) to strengthen feedback.

Behavioral: Integrated HIV/HTN care model

Control

NO INTERVENTION

Standard of care maintained. These are procedures conducted during the routine HIV and Hypertension care visits at the health facilities include;a) Provision of BP machines b)Provision of NCD register and NCD patient card and ; c) Following MOH treatment guidelines

Interventions

Integrated HIV/HTN care modelBEHAVIORAL

The intervention is a multi-component intervention of combined HIV and HTN care, based on the PRECEDE framework, to continuously identify barriers and facilitators leads to better health outcomes including dual control of HIV/HTN among adults in HIV care in the intervention compared to control facilities

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults 18 years and above with HIV for one category
  • Adults 18 years and above with HIV and hypertension for the second category
  • Willing to consent

You may not qualify if:

  • Patients who are very sick
  • Patients not willing to continue seeking care from the study health facility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Infectious Diseases Research Collaboration

Kampala, Central Region, Uganda

Location

Related Publications (1)

  • Atukunda M, Kabami J, Mutungi G, Twinamatsiko B, Nangendo J, Shade SB, Charlebois E, Grosskurth H, Kamya M, Okello E. Rationale and design of leveraging the HIV platform for hypertension control in Africa: protocol of a cluster-randomised controlled trial in Uganda. BMJ Open. 2022 Dec 8;12(12):e063227. doi: 10.1136/bmjopen-2022-063227.

    PMID: 36600388DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Jane Kabami, MPH

    Infectious Diseases Research Collaboration, Uganda

    PRINCIPAL INVESTIGATOR

  • Moses R Kamya, PhD

    Infectious Diseases Research Collaboration, Uganda

    PRINCIPAL INVESTIGATOR

  • Heiner Grosskurth, PhD

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Comparative effectiveness cluster-randomized trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2020

First Posted

November 10, 2020

Study Start

November 16, 2020

Primary Completion

February 28, 2024

Study Completion

February 28, 2024

Last Updated

November 4, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will share

IDRC will use its proprietary Data Management system to manage and store the data throughout the life of the project. Data is transferred to the system from remote sites via an encrypted link using secure File Transfer Protocol. The system includes a data repository specific to this study which is accessible only to designated study personnel. Study staff will access the repository via a password protected website and the data will be transferred over an encrypted connection via secure Hypertext Transfer Protocol. After the study, clean study datasets will be made shareable in a public certified repository that supports open access. Prior to release, all datasets will be reviewed to ensure they are properly de identified. Any workflows will be exactly described and documented such that it will allow any external groups to precisely reproduce results from the raw data. IDRC will also keep the raw data on the IDRC servers for at least 5 years after the end of the study.

Time Frame
During the study and at least 5 years after the end of the study
Access Criteria
All final, clean study datasets will be made shareable in a public certified repository that supports open access.

Locations

UG(1)