Integrating Hypertension and Cardiovascular Diseases Care Into Existing HIV Services Package in Botswana (InterCARE)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- HIV Infections
- Sponsor
- University of Botswana
- Enrollment
- 4655
- Locations
- 3
- Primary Endpoint
- Implementation
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
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.
Investigators
Mosepele Mosepele
Associate Professor
University of Botswana
Eligibility Criteria
Inclusion Criteria
- Not provided
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.
Outcomes
Primary Outcomes
Implementation
Time Frame: 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
Time Frame: Every 6 months for 2 years
Proportion of PLWHIV with diagnosed hypertension receiving anti-hypertensive medication with controlled blood pressure
Secondary Outcomes
- Adoption(Every 6 months for 2 years)
- Fidelity(Every 6 months for 2 years)
- Maintenance(At the end of the trial (24 months))
- Reach(Every 6 months for 2 years)
- Effectiveness(Every 6 months for 2 years)
- Acceptability(At the end of the trial)