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.
The InterCARE research project is in 2 phases: 1. Phase 1 is a pilot study to refine the 3 interventions mentioned above. This formative phase will take place between September 2021 and 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 was successfully completed in 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
4,655
The InterCARE package includes: 1. 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. 2. 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. 3. 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.
14 Infectious Diseases Care centres (IDCCs) nationwide
Gaborone, Botswana
Phitsane-Molopo IDCC Clinic
Pitsane, Botswana
Tonota IDCC Clinic
Tonota, Botswana
Effectiveness
Proportion of PLWHIV with diagnosed hypertension receiving anti-hypertensive medication with controlled blood pressure
Time frame: Every 6 months for 2 years
Implementation
Proportion of clinic encounters in electronic health records where anti-hypertensive medications are prescribed if indicated, as attained from electronic health records
Time frame: Every 6 months for 2 years
Reach
Proportion of PLWHIV who are aware of their hypertension status
Time frame: Every 6 months for 2 years
Effectiveness
Decrease in mean systolic blood pressure and mean diastolic blood pressure at 12 and 24 months
Time frame: Every 12 months for 2 years
Adoption
Proportion of PLWHIV with hypertension with 10-year cardiovascular risk calculated in the electronic health records
Time frame: Every 6 months for 2 years
Reach
Proportion of PLWHIV with diagnosed hypertension receiving anti-hypertensive medication or with BP control not on medications
Time frame: Every 6 months for 2 years
Maintenance
Proportion of PLWHIV with HTN enrolled in InterCARE with BP control who maintain blood pressure control in next study visit
Time frame: Every 6 months for 2 years
Adoption
Proportion of PLWHIV with HTN enrolled in InterCARE receiving HTN and HIV care in the same clinic visit
Time frame: Every 6 months for 2 years
Fidelity
Proportion of PLWH and HTN on medications with correct regimen per national guidelines
Time frame: Every 6 months for 2 years
Maintenance
Provider and patient perceptions of ability to maintain a change in blood pressure control:Pre and Post implementation surveys will be used to assess this outcome
Time frame: Every 12 months for 2 years
Maintenance
Proportion of intervention clinics that implemented the three components of InterCARE
Time frame: At the end of the trial (24 months)
Acceptability
Acceptability to patients,mopati and providers (survey and interviews) of the implementation strategy
Time frame: At the end of the trial
Effectiveness
Proportion of PLWHIV with \>70% pass on Heart Disease Fact Questionnaire (HDFQ) (health knowledge) .HDFQ score (out of 100):Minimum 0,maximum score 100 :Better Score \>70%
Time frame: Every 6 months for 2 years
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