Integrating Hypertension and Cardiovascular Diseases Care Into Existing HIV Services Package in Botswana (InterCARE)
- Conditions
- HIV InfectionsHypertension
- Interventions
- Other: InterCARE package
- Registration Number
- NCT05414526
- Lead Sponsor
- University of Botswana
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 4655
Not provided
● 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description InterCARE package InterCARE package The type 2 hybrid effectiveness-implementation study will be cluster randomized trial with 1:1 paired randomization (Intervention arm vs Control arm )Using the coin flip randomization method, one clinic will be randomized to the intervention condition, and one to the control condition.
- Primary Outcome Measures
Name Time Method 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
Effectiveness Every 6 months for 2 years Proportion of PLWHIV with diagnosed hypertension receiving anti-hypertensive medication with controlled blood pressure
- Secondary Outcome Measures
Name Time Method Adoption Every 6 months for 2 years Proportion of PLWHIV with HTN enrolled in InterCARE receiving HTN and HIV care in the same clinic visit
Fidelity Every 6 months for 2 years Proportion of PLWH and HTN on medications with correct regimen per national guidelines
Maintenance At the end of the trial (24 months) Proportion of intervention clinics that implemented the three components of InterCARE
Reach Every 6 months for 2 years Proportion of PLWHIV with diagnosed hypertension receiving anti-hypertensive medication or with BP control not on medications
Effectiveness Every 6 months for 2 years 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%
Acceptability At the end of the trial Acceptability to patients,mopati and providers (survey and interviews) of the implementation strategy
Trial Locations
- Locations (3)
Phitsane-Molopo IDCC Clinic
🇧🇼Pitsane, Botswana
Tonota IDCC Clinic
🇧🇼Tonota, Botswana
14 Infectious Diseases Care centres (IDCCs) nationwide
🇧🇼Gaborone, Botswana