Integrating Hypertension and Cardiovascular Diseases Care Into Existing HIV Services Package in Botswana (InterCARE)

Hypertension Clinical Trial

— InterCARE  

Official title:

Integrating Hypertension and Cardiovascular Diseases Care Into Existing HIV Services Package in Botswana (InterCARE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05414526
• Other study ID #: InterCARE project
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: August 2025

Study information

• Verified date: June 2023
• Source: University of Botswana
• Contact: Mosepele Mosepele, MD
• Phone: +26771897691
• Email: mosepele.mosepele[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The InterCARE research project proposes to leverage a successful national ART program to develop an effective package to improve the uptake of established effective hypertension and CVD risk factors management interventions among PLWHIV in Botswana and other low- and middle-income countries.

Being the first project of its kind in Botswana, if successful, the InterCARE package could be readily rolled out to health facilities nationwide to diagnose, treat, track, and support the estimated 25-30% Batswana with hypertension.

Description:

The InterCARE research project is in 2 phases:

1. Phase 1 is a pilot study to refine the 3 interventions mentioned above will take place until November 2022. Clinics staff will receive training on the management of CVD (and hypertension in particular) in-person or online. Attendees feedback will be sought to improve the curriculum prior to being rolled-out in the next phase of this research project.

In parallel, the InterCARE Study Team will work with the 2 clinics Information Technology teams to adapt the existing electronic health records with CVD-specific flags, medication lists and laboratory panels.

Finally, up to 288 participants (PLWHIV) and their treatment partners will be enrolled from those 2 clinics patients lists to pilot the overall InterCARE package.

The results and experiences from the pilot stage will be assessed and collated to make improvements to each of the 3 intervention in the package. This final set of improved interventions will be the basis of the second phase of the InterCARE research project.

Phase 1 is anticipated to last until November 2022.

2. The InterCARE package will be tested as a cluster randomised trial in 14 clinics around Botswana: 7 clinics will receive the InterCARE package while the remaining 7 clinics will not received any intervention, continuing with the local standard of care, with a target combined recruitment target of 4652 participants overall, to be followed up for 24 months.

Phase 2 is anticipated to take place from January 2023 to July 2025.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 288
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Inclusion criteria for participants:

• Adults aged 20-75 years old

• Documented HIV-infection on ART

• Confirmed diagnosis of hypertension or elevated blood pressure >140/90mmHg versus >130/80mmHg if they have underlying Diabetes Mellitus or Chronic Kidney Disease

• Receiving regular care at the selected clinics

Exclusion Criteria:

? Positive for HIV-related dementia

Inclusion criteria for participants' treatment partners:

• Adults aged 18 years of age or older

• Selected to be a treatment partner by participant.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• HIV Infections
• Hypertension

Intervention

Other:
• InterCARE package
The InterCARE package includes: Healthcare Provider HTN/CVD Curriculum A new HTN curriculum will be developed in collaboration with local stakeholders using KITSO Master trainer program documents (Healthcare provider HIV curriculum), Primary Care Guidelines, HTN/CVD curriculum/protocols trialled in Kweneng District and the CDC Prevention Hypertension Management Curriculum. Adaptation of HIV care EHR for HTN/CVD care EHR modifications will be done to enhance data collection around HTN/CVD care, with input from MoH. Patient and treatment partner sessions Clinic staff will provide in-clinic education and counselling on HTN/CVD to all PLWHIV with a diagnosis of hypertension during their routine HIV clinic visit. All patients will be provided a take-home easy-to-read pamphlet on HTN/CVD risk factor management. All PLWHIV will be asked to bring a treatment partner from their social network at the 2nd study visit so that they can practice role-plays with each other.

Locations

Country	Name	City	State
Botswana	Phitsane-Molopo IDCC Clinic	Pitsane
Botswana	Tonota IDCC Clinic	Tonota

Sponsors (1)

Lead Sponsor	Collaborator
University of Botswana

Country where clinical trial is conducted

Botswana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary quantitative implementation outcome 1a	Change from baseline in % of patients with HIV who are aware of their hypertension	At 6 months
Primary	Primary quantitative implementation outcome 1b	Change from baseline in % of patients with HIV who are aware of their hypertension	At 12 months
Primary	Primary quantitative implementation outcome 2a	Effectiveness - The proportion with controlled blood pressure as measured by blood pressure readings taken at the 6 months study visit	At 6 months
Primary	Primary quantitative implementation outcome 2b	Effectiveness - The proportion with controlled blood pressure as measured by blood pressure readings taken at the 6 months study visit	At 12 months
Primary	Primary quantitative implementation outcome 3a	Adoption - The proportion of clinic encounters in EHR where anti-hypertensive medications are prescribed if indicated, as attainted from EHR proportion of clinic encounters in EHR where 10-year CVD risk is calculated	At 6 months
Primary	Primary quantitative implementation outcome 3b	Adoption - The proportion of clinic encounters in EHR where anti-hypertensive medications are prescribed if indicated, as attainted from EHR proportion of clinic encounters in EHR where 10-year CVD risk is calculated	At 12 months
Primary	Primary quantitative implementation outcome 3c	Adoption - The proportion of clinic encounters in which 10-year CVD risk is calculated, data obtained from the EHR	At 6 months
Primary	Primary quantitative implementation outcome 3d	Adoption - The proportion of clinic encounters in which 10-year CVD risk is calculated, data obtained from the EHR	At 12 months
Primary	Co-primary qualitative implementation outcome 1	Fidelity - Audit of intervention implementation as designed as measured by weekly research assistant auditing checklist	Weekly and summative at 12 months
Primary	Co-primary qualitative implementation outcome 2a	Maintenance - Provider perceptions of ability to maintain plus change in blood pressure control at 12 months as measured by providers qualitative interviews	At 12 months
Primary	Co-primary qualitative implementation outcome 2b	Maintenance - Patients perceptions of ability to maintain plus change in blood pressure control at 12 months as measured by patients qualitative interviews	At 12 months
Secondary	Secondary implementation outcome 1a	Feasibility - The ability to implement integrated HIV/HTN care, HIV/HTN/CVD care, clinic viral suppression as measured by clinics-administered interviews at baseline	At baseline visit
Secondary	Secondary implementation outcome 1b	Feasibility - The ability to implement integrated HIV/HTN care, HIV/HTN/CVD care, clinic viral suppression as measured by clinics-administered interviews at 12 months	At 12 months
Secondary	Secondary implementation outcome 2a	Acceptability - The patient perception of acceptability of the interCARE intervention package measured by survey and interviews at baseline	At baseline
Secondary	Secondary implementation outcome 2b	Acceptability - The provider perception of acceptability of the interCARE intervention package measured by survey and interviews at baseline	At baseline
Secondary	Secondary implementation outcome 2c	Acceptability - The provider perception of acceptability of the interCARE intervention package measured by survey and interviews at 12 months	At 12 months
Secondary	Secondary implementation outcome 2d	Acceptability - The patient perception of acceptability of the interCARE intervention package measured by survey and interviews at 12 months	At 12 months
Secondary	Exploratory secondary outcomes 3a	Change from baseline in % PLWHIV and HTN screened for any CVD risk factors, data collected from the EHR at 6 months	At 6 months
Secondary	Exploratory secondary outcomes 3b	Change from baseline in % PLWHIV and HTN screened for any CVD risk factors, data collected from the EHR at 12 months	At 12 months