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

Infectious Diseases Research Collaboration, Uganda

Status: Active, not recruiting

Conditions: Hypertension; HIV

Treatments: Behavioral: Integrated HIV/HTN care model

Study type: Interventional

Funder types: Other

Identifiers

NCT04624061

22196

2020-156

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,600 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Integrated HIV/HTN care model

Control

No Intervention group

Description:

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