- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05414526
Integrating Hypertension and Cardiovascular Diseases Care Into Existing HIV Services Package in Botswana (InterCARE) (InterCARE)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The InterCARE research project is in 2 phases:
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.
- 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mosepele Mosepele, MD
- Phone Number: +26771897691
- Email: mosepele.mosepele@gmail.com
Study Contact Backup
- Name: Nabila FJ Youssouf
- Email: nabila.youssouf@LSHTM.ac.uk
Study Locations
-
-
-
Pitsane, Botswana
- Recruiting
- Phitsane-Molopo IDCC Clinic
-
Contact:
- Matron in charge
- Email: none@onfile.bw
-
Tonota, Botswana
- Completed
- Tonota IDCC Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: InterCARE package
|
The InterCARE package includes:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary quantitative implementation outcome 1a
Time Frame: At 6 months
|
Change from baseline in % of patients with HIV who are aware of their hypertension
|
At 6 months
|
Primary quantitative implementation outcome 1b
Time Frame: At 12 months
|
Change from baseline in % of patients with HIV who are aware of their hypertension
|
At 12 months
|
Primary quantitative implementation outcome 2a
Time Frame: At 6 months
|
Effectiveness - The proportion with controlled blood pressure as measured by blood pressure readings taken at the 6 months study visit
|
At 6 months
|
Primary quantitative implementation outcome 2b
Time Frame: At 12 months
|
Effectiveness - The proportion with controlled blood pressure as measured by blood pressure readings taken at the 6 months study visit
|
At 12 months
|
Primary quantitative implementation outcome 3a
Time Frame: At 6 months
|
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 quantitative implementation outcome 3b
Time Frame: At 12 months
|
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 quantitative implementation outcome 3c
Time Frame: At 6 months
|
Adoption - The proportion of clinic encounters in which 10-year CVD risk is calculated, data obtained from the EHR
|
At 6 months
|
Primary quantitative implementation outcome 3d
Time Frame: At 12 months
|
Adoption - The proportion of clinic encounters in which 10-year CVD risk is calculated, data obtained from the EHR
|
At 12 months
|
Co-primary qualitative implementation outcome 1
Time Frame: Weekly and summative at 12 months
|
Fidelity - Audit of intervention implementation as designed as measured by weekly research assistant auditing checklist
|
Weekly and summative at 12 months
|
Co-primary qualitative implementation outcome 2a
Time Frame: At 12 months
|
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
|
Co-primary qualitative implementation outcome 2b
Time Frame: At 12 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Secondary implementation outcome 1a
Time Frame: At baseline visit
|
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 implementation outcome 1b
Time Frame: At 12 months
|
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 implementation outcome 2a
Time Frame: At baseline
|
Acceptability - The patient perception of acceptability of the interCARE intervention package measured by survey and interviews at baseline
|
At baseline
|
Secondary implementation outcome 2b
Time Frame: At baseline
|
Acceptability - The provider perception of acceptability of the interCARE intervention package measured by survey and interviews at baseline
|
At baseline
|
Secondary implementation outcome 2c
Time Frame: At 12 months
|
Acceptability - The provider perception of acceptability of the interCARE intervention package measured by survey and interviews at 12 months
|
At 12 months
|
Secondary implementation outcome 2d
Time Frame: At 12 months
|
Acceptability - The patient perception of acceptability of the interCARE intervention package measured by survey and interviews at 12 months
|
At 12 months
|
Exploratory secondary outcomes 3a
Time Frame: At 6 months
|
Change from baseline in % PLWHIV and HTN screened for any CVD risk factors, data collected from the EHR at 6 months
|
At 6 months
|
Exploratory secondary outcomes 3b
Time Frame: At 12 months
|
Change from baseline in % PLWHIV and HTN screened for any CVD risk factors, data collected from the EHR at 12 months
|
At 12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mosepele Mosepele, MD, University of Botswana
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- InterCARE project
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Data recorded as part of the study will be anonymised and will be deposited in a secured archiving facility at the University of Botswana Health Records Unit. Researchers may request access to data as part of transparency and data sharing however this is strictly upon request and will be governed through the required legal office, with at the least, a Data Sharing Agreement in place.
Further details on this can be found in our Data Management plan.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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