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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| InterCARE package | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| InterCARE package | Other | The InterCARE package includes:
|
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness | Proportion of PLWHIV with diagnosed hypertension receiving anti-hypertensive medication with controlled blood pressure | 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 | Every 6 months for 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Reach | Proportion of PLWHIV who are aware of their hypertension status | Every 6 months for 2 years |
| Effectiveness | Decrease in mean systolic blood pressure and mean diastolic blood pressure at 12 and 24 months |
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Inclusion criteria for participants:
Exclusion Criteria:
● Positive for HIV-related dementia
Inclusion criteria for participants' treatment partners:
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| Name | Affiliation | Role |
|---|---|---|
| Mosepele Mosepele, MD | University of Botswana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 14 Infectious Diseases Care centres (IDCCs) nationwide | Gaborone | 0000 | Botswana | |||
| Phitsane-Molopo IDCC Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39075506 | Derived | Youssouf N, Mogaetsho GE, Moshomo T, Gaolathe T, Ponatshego P, Ramotsababa M, Molefe-Baikai OJ, Dintwa E, Kiki T, Van Pelt AE, Steger-May K, Bogart LM, Jaffar S, Gala P, Wang D, Seipone K, Bennett K, Hurwitz KW, Kebotsamang K, Hirschhorn LR, Mosepele M. Designing an implementation science clinical trial to integrate hypertension and cardiovascular diseases care into existing HIV services package in Botswana (InterCARE). Trials. 2024 Jul 29;25(1):510. doi: 10.1186/s13063-024-08333-0. | |
| 39039609 |
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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.
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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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:
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|
| Every 12 months for 2 years |
| Adoption | Proportion of PLWHIV with hypertension with 10-year cardiovascular risk calculated in the electronic health records | Every 6 months for 2 years |
| Reach | Proportion of PLWHIV with diagnosed hypertension receiving anti-hypertensive medication or with BP control not on medications | 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 | 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 | Every 6 months for 2 years |
| Fidelity | Proportion of PLWH and HTN on medications with correct regimen per national guidelines | 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 | Every 12 months for 2 years |
| Maintenance | Proportion of intervention clinics that implemented the three components of InterCARE | At the end of the trial (24 months) |
| Acceptability | Acceptability to patients,mopati and providers (survey and interviews) of the implementation strategy | 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% | Every 6 months for 2 years |
| Pitsane |
| Botswana |
| Tonota IDCC Clinic | Tonota | Botswana |
| Derived |
| Moshomo T, Gaolathe T, Ramotsababa M, Molefe-Baikai OJ, Mogaetsho E, Dintwa E, Gala P, Ponatshego P, Bogart LM, Youssouf N, Seipone K, Van Pelt AE, Bennett K, Jaffar S, Ilias M, Tonwe V, Hurwitz KW, Kebotsamang K, Steger-May K, Hirschhorn LR, Mosepele M. Quantitative outcomes of a type 2 single arm hybrid effectiveness implementation pilot study for hypertension-HIV integration in Botswana. Implement Sci Commun. 2024 Jul 22;5(1):80. doi: 10.1186/s43058-024-00620-w. |
| 38902846 | Derived | Gala P, Ponatshego P, Bogart LM, Youssouf N, Ramotsababa M, Van Pelt AE, Moshomo T, Dintwa E, Seipone K, Ilias M, Tonwe V, Gaolathe T, Hirschhorn LR, Mosepele M. A mixed methods approach identifying facilitators and barriers to guide adaptations to InterCARE strategies: an integrated HIV and hypertension care model in Botswana. Implement Sci Commun. 2024 Jun 20;5(1):67. doi: 10.1186/s43058-024-00603-x. |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |