Leveraging the HIV Platform for Hypertension Control in Uganda (INTEGRATED HIV/HTN) STUDY

Hypertension Clinical Trial

Official title:

Leveraging the HIV Platform for Hypertension Control in Uganda

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04624061
• Other study ID #: 2020-156
• Secondary ID: 22196
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 16, 2020
• Est. completion date: February 28, 2024

Study information

• Verified date: July 2022
• Source: Infectious Diseases Research Collaboration, Uganda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The investigators propose to evaluate a multi-component integrated HIV/HTN care intervention through a cluster randomised controlled trial. A cluster has been defined at the level of the district which is the randomisation unit. A total of 26 districts will be randomised. Selected health facilities within the 13 intervention districts will receive the multi-component intervention of combined HIV and (hypertension) HTN care which includes; 1) Training and capacity building on the INTEGRATED HIV/HTN model and NCD care; 2) the Integrated HIV/HTN care delivery model by promoting HTN screening and care in HIV clinics; 3) Health management information system (HMIS) enhancements through mentorship and coaching on the use of NCD registers and NCD patient cards and HTN data capture in the EMR system; and 4) Short messaging system (SMS) and/or WhatsApp for data coordination and communication among providers, DHOs and the study team (who acts as mentors). The 13 control districts will continue implementing the current standard of care as per MoH guidelines.

The investigators will test the hypothesis that 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.

Specific Objectives are as follows;

1. To determine the effectiveness of an integrated HIV/HTN care model on HTN and dual HIV/HTN control among adult patients in HIV clinics.

2. To assess the barriers and facilitators of the integrated HIV/HTN care model for HIV patients at different levels.

3. To determine the cost, cost-effectiveness and incremental gain costs of the integrated HIV/Hypertension care model approach.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2600
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients who are very sick

• Patients not willing to continue seeking care from the study health facility

Related Conditions & MeSH terms

• HIV
• Hypertension

Intervention

Behavioral:
• Integrated HIV/HTN care model
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

Locations

Country	Name	City	State
Uganda	Infectious Diseases Research Collaboration	Kampala	Central Region

Sponsors (5)

Lead Sponsor	Collaborator
Infectious Diseases Research Collaboration, Uganda	London School of Hygiene and Tropical Medicine, Makerere University, Ministry of Health, Uganda, Uganda Heart Institute

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Proportion of HTN patients diagnosed and started on treatment	Proportion of HTN patients diagnosed and started on treatment	Month 24
Primary	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
Primary	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	Lowered blood pressure	Proportion of HTN patients with successfully lowered BP (by at least 10 mmHg systolic and/or diastolic) compared to the time at the first HTN diagnosis	24 months
Secondary	Routine Hypertension care	Proportion of health facilities providing hypertension care as routine practice;	12 and 24 months
Secondary	Adoption of the integrated model	Proportion of HC IIIs and IVs adopting the integrated HIV/HTN care model;	12 and 24 months
Secondary	Knowledge of HTN management and HTN complications among health workers	Knowledge of HTN management and complications among health workers (measured through conducting surveys among health workers working in the HIV clinics using a standardised knowledge test)	12 and 24 months
Secondary	Patient satisfaction	Patient satisfaction outcomes in a sub-sample of facilities (survey)	12 and 24 months
Secondary	Adoption of HMIS tools	Adoption of the integrated HIV/HTN HMIS tools particularly NCD registers and NCD patient card approved by the MoH	24 months
Secondary	Service readiness for delivering hypertension care	Proportion of health facilities (HFs) that demonstrate service readiness for delivering adequate hypertension care for patients with and without HIV-infection	24 months
Secondary	Adherence to national guidelines	Proportion of hypertensive patients (HIV-positive and -negative) registered at HFs that are being managed according to national guidelines.	24 months
Secondary	Cost effectiveness of the integrated HIV/HTN care model	Incremental costs of the intervention (will be measured using micro-costing through interviews with coordinators, site visits and time-and-motion studies with clinic	24 months