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

Leveraging the HIV Platform for Hypertension Control in Uganda

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hypertension; HIV
• Intervention / Treatment: Behavioral: Integrated HIV/HTN care model

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 2600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Uganda
  • Central Region
    • Kampala, Central Region, Uganda
      • Infectious Diseases Research Collaboration

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; The integrated HIV/HTN care model with the following components; Training and capacity building on the INTEGRATED HIV/HTN model and NCD care; Integrated HIV/HTN care delivery model by promoting HTN screening and care in HIV clinics.; 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.; 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; 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
No Intervention: Control; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Routine Hypertension care	Proportion of health facilities providing hypertension care as routine practice;	12 and 24 months
Adoption of the integrated model	Proportion of HC IIIs and IVs adopting the integrated HIV/HTN care model;	12 and 24 months
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
Patient satisfaction	Patient satisfaction outcomes in a sub-sample of facilities (survey)	12 and 24 months
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
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
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
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

Collaborators and Investigators

• Sponsor: Infectious Diseases Research Collaboration, Uganda
• Collaborators: London School of Hygiene and Tropical Medicine; Makerere University; Ministry of Health, Uganda; Uganda Heart Institute
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2020
• Primary Completion (Anticipated): February 28, 2024
• Study Completion (Anticipated): February 28, 2024

Study Registration Dates

• First Submitted: October 27, 2020
• First Submitted That Met QC Criteria: November 5, 2020
• First Posted (Actual): November 10, 2020

Study Record Updates

• Last Update Posted (Actual): November 4, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 2020-156; 22196 (London School of Hygiene and Tropical Medicine)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No