Clinical trial NCT04624061: Leveraging the HIV Platform for Hypertension Control in Uganda (INTEGRATED HIV/HTN) STUDY
Official title: Leveraging the HIV Platform for Hypertension Control in Uganda
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV
Hypertension
Lead sponsor: Infectious Diseases Research Collaboration, Uganda
Sponsor class: OTHER
Collaborators: name: Makerere University
name: Uganda Heart Institute
name: Ministry of Health, Uganda
name: London School of Hygiene and Tropical Medicine
First posted: 2020-11-10
Enrollment: 2600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparative effectiveness cluster-randomized trial
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of HIV patients screened for Hypertension(HTN) at Month 24
timeFrame: Month 24
measure: Proportion of HTN patients diagnosed and started on treatment
timeFrame: Month 24
measure: 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.
timeFrame: 24 months
measure: 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).
timeFrame: 24 months
Secondary outcomes:
measure: Lowered blood pressure
timeFrame: 24 months
measure: Routine Hypertension care
timeFrame: 12 and 24 months
measure: Adoption of the integrated model
timeFrame: 12 and 24 months
measure: Knowledge of HTN management and HTN complications among health workers
timeFrame: 12 and 24 months
measure: Patient satisfaction
timeFrame: 12 and 24 months
measure: Adoption of HMIS tools
timeFrame: 24 months
measure: Service readiness for delivering hypertension care
timeFrame: 24 months
measure: Adherence to national guidelines
timeFrame: 24 months
measure: Cost effectiveness of the integrated HIV/HTN care model
timeFrame: 24 months
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Infectious Diseases Research Collaboration
state: Central Region
Study officials:
affiliation: Infectious Diseases Research Collaboration, Uganda
name: Jane Kabami, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Infectious Diseases Research Collaboration, Uganda
name: Moses R Kamya, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: London School of Hygiene and Tropical Medicine
name: Heiner Grosskurth, PhD
role: PRINCIPAL_INVESTIGATOR
References: