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Completed

NCT Number: NCT05414526

Integrating Hypertension and Cardiovascular Diseases Care Into Existing HIV Services Package in Botswana (InterCARE)

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Cardiovascular Diseases Communicable Diseases Genital Diseases Hypertension Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Vascular Diseases Virus Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

14 Infectious Diseases Care centres (IDCCs) nationwide, Gaborone, Botswana

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About this study

The InterCARE research project is in 2 phases:

  • 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.

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

InterCARE package

Other

The InterCARE package includes:

  • 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.
  • 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.
  • 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.

Primary outcomes

  1. Effectiveness

    Time frame: Every 6 months for 2 years

    Proportion of PLWHIV with diagnosed hypertension receiving anti-hypertensive medication with controlled blood pressure

  2. 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

Secondary outcomes

  1. Reach

    Time frame: Every 6 months for 2 years

    Proportion of PLWHIV who are aware of their hypertension status

  2. Effectiveness

    Time frame: Every 12 months for 2 years

    Decrease in mean systolic blood pressure and mean diastolic blood pressure at 12 and 24 months

  3. Adoption

    Time frame: Every 6 months for 2 years

    Proportion of PLWHIV with hypertension with 10-year cardiovascular risk calculated in the electronic health records

  4. Reach

    Time frame: Every 6 months for 2 years

    Proportion of PLWHIV with diagnosed hypertension receiving anti-hypertensive medication or with BP control not on medications

  5. Maintenance

    Time frame: 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

  6. Adoption

    Time frame: Every 6 months for 2 years

    Proportion of PLWHIV with HTN enrolled in InterCARE receiving HTN and HIV care in the same clinic visit

  7. Fidelity

    Time frame: Every 6 months for 2 years

    Proportion of PLWH and HTN on medications with correct regimen per national guidelines

  8. Maintenance

    Time frame: Every 12 months for 2 years

    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

  9. Maintenance

    Time frame: At the end of the trial (24 months)

    Proportion of intervention clinics that implemented the three components of InterCARE

  10. Acceptability

    Time frame: At the end of the trial

    Acceptability to patients,mopati and providers (survey and interviews) of the implementation strategy

  11. Effectiveness

    Time frame: 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%

Sponsors and collaborators

Lead sponsor

University of Botswana

Other

Registry information

Acronym: InterCARE

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 10, 2022
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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