Clinical trial NCT05414526: Integrating Hypertension and Cardiovascular Diseases Care Into Existing HIV Services Package in Botswana (InterCARE)
Official title: Integrating Hypertension and Cardiovascular Diseases Care Into Existing HIV Services Package in Botswana (InterCARE)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: HIV Infections
Hypertension
Lead sponsor: University of Botswana
Sponsor class: OTHER
First posted: 2022-06-10
Enrollment: 4655
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Effectiveness
timeFrame: Every 6 months for 2 years
measure: Implementation
timeFrame: Every 6 months for 2 years
Secondary outcomes:
measure: Reach
timeFrame: Every 6 months for 2 years
measure: Effectiveness
timeFrame: Every 12 months for 2 years
measure: Adoption
timeFrame: Every 6 months for 2 years
measure: Reach
timeFrame: Every 6 months for 2 years
measure: Maintenance
timeFrame: Every 6 months for 2 years
measure: Adoption
timeFrame: Every 6 months for 2 years
measure: Fidelity
timeFrame: Every 6 months for 2 years
measure: Maintenance
timeFrame: Every 12 months for 2 years
measure: Maintenance
timeFrame: At the end of the trial (24 months)
measure: Acceptability
timeFrame: At the end of the trial
measure: Effectiveness
timeFrame: Every 6 months for 2 years
Other outcomes:
Locations:
city: Gaborone
country: Botswana
facility: 14 Infectious Diseases Care centres (IDCCs) nationwide
city: Pitsane
country: Botswana
facility: Phitsane-Molopo IDCC Clinic
city: Tonota
country: Botswana
facility: Tonota IDCC Clinic
Study officials:
affiliation: University of Botswana
name: Mosepele Mosepele, MD
role: PRINCIPAL_INVESTIGATOR
References: