An interventional study of InterCARE package in HIV Infections and Hypertension, sponsored by University of Botswana. Completed at 3 sites in Botswana. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-12.
Sponsored by University of Botswana · Not applicable, Interventional, and Other
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.
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.
Phase 2 is anticipated to take place from January 2023 to July 2025.
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's enrollment of 4,655 is above the median of 80 across 3,489 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →University of Botswana is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
● Positive for -related dementia
Inclusion criteria for participants' treatment partners:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: InterCARE 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.
Effectiveness
Proportion of PLWHIV with diagnosed hypertension receiving anti-hypertensive medication with controlled blood pressure
Time frame: Every 6 months for 2 years
Implementation
Proportion of clinic encounters in electronic health records where anti-hypertensive medications are prescribed if indicated, as attained from electronic health records
Time frame: Every 6 months for 2 years
Reach
Proportion of PLWHIV who are aware of their hypertension status
Time frame: Every 6 months for 2 years
Effectiveness
Decrease in mean systolic blood pressure and mean diastolic blood pressure at 12 and 24 months
Time frame: Every 12 months for 2 years
Adoption
Proportion of PLWHIV with hypertension with 10-year cardiovascular risk calculated in the electronic health records
Time frame: Every 6 months for 2 years
Reach
Proportion of PLWHIV with diagnosed hypertension receiving anti-hypertensive medication or with BP control not on medications
Time frame: Every 6 months for 2 years
Maintenance
Proportion of PLWHIV with HTN enrolled in InterCARE with BP control who maintain blood pressure control in next study visit
Time frame: Every 6 months for 2 years
Adoption
Proportion of PLWHIV with HTN enrolled in InterCARE receiving HTN and HIV care in the same clinic visit
Time frame: Every 6 months for 2 years
Fidelity
Proportion of PLWH and HTN on medications with correct regimen per national guidelines
Time frame: Every 6 months for 2 years
Maintenance
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
Time frame: Every 12 months for 2 years
Maintenance
Proportion of intervention clinics that implemented the three components of InterCARE
Time frame: At the end of the trial (24 months)
Acceptability
Acceptability to patients,mopati and providers (survey and interviews) of the implementation strategy
Time frame: At the end of the trial
Effectiveness
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%
Time frame: Every 6 months for 2 years
Plan to share: No — Data recorded as part of the study will be anonymised and will be deposited in a secured archiving facility at the University of Botswana Health Records Unit. Researchers may request access to data as part of transparency and data sharing however this is strictly upon request and will be governed through the required legal office, with at the least, a Data Sharing Agreement in place. Further details on this can be found in our Data Management plan.
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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