HIV Infections, Hypertension
Conditions
Brief 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.
Detailed description
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.
Interventions
OTHERInterCARE package
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.
Sponsors
University of Botswana
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
InterCARE is the name of the package of implementation strategies proposed by the investigators that are intended to integrate cardiovascular care services into existing HIV care systems in Botswana. The InterCARE package includes 3 main interventions: 1. a tailored inter-professional training curriculum on management of CVD risk and HIV 2. adaptation of the existing electronic health records (PIMS) 3. adoption of a treatment partner support system.
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness | Every 6 months for 2 years | Proportion of PLWHIV with diagnosed hypertension receiving anti-hypertensive medication with controlled blood pressure |
| Implementation | Every 6 months for 2 years | Proportion of clinic encounters in electronic health records where anti-hypertensive medications are prescribed if indicated, as attained from electronic health records |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reach | Every 6 months for 2 years | Proportion of PLWHIV who are aware of their hypertension status |
| Effectiveness | Every 12 months for 2 years | Decrease in mean systolic blood pressure and mean diastolic blood pressure at 12 and 24 months |
| Adoption | Every 6 months for 2 years | Proportion of PLWHIV with hypertension with 10-year cardiovascular risk calculated in the electronic health records |
| Maintenance | Every 6 months for 2 years | Proportion of PLWHIV with HTN enrolled in InterCARE with BP control who maintain blood pressure control in next study visit |
| Fidelity | Every 6 months for 2 years | Proportion of PLWH and HTN on medications with correct regimen per national guidelines |
| Acceptability | At the end of the trial | Acceptability to patients,mopati and providers (survey and interviews) of the implementation strategy |
Countries
Botswana
Contacts
PRINCIPAL_INVESTIGATORMosepele Mosepele, MD
University of Botswana
Outcome results
None listed