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INTEGRATE-RX: Integrating Clinical Pharmacists in HIV Care to Mitigate Last-Mile Challenges and Reduce Cardiovascular Disease Burden

NCT07711366

Not Yet RecruitingNA

Sponsor: Temple University

Conditions: HIV, Hypertension, Cardiovascular Disease Prevention

Interventions: INTEGRATE-RX

Countries: Kenya

The risk of heart attacks and stroke is two times higher among people living with HIV (PLWH), as compared to the general population. Prevention and treatment of cardiovascular disease (CVD) risk factors, such as high blood pressure, high cholesterol, and diabetes, are important in the overall management and CVD risk reduction among PLWH. Clinical pharmacists and their involvement in HIV care through comprehensive medication management have lead to improved medication adherence, undetectable HIV viral load, and continuity in care among PLWH. In addition, when pharmacists work with other health providers, they can also improve access to medications and management of major CVD risk factors like high blood pressure, high cholesterol, and diabetes. However, evaluation of the effectiveness, economic impact, and scalability of pharmacist-led interventions in combined HIV and CVD care in sub-Saharan Africa, where the burden of both HIV and CVD risk factors is high, are still understudied. Therefore, the objective of this study is to evaluate the effectiveness and cost-effectiveness of a pharmacist-led implementation strategy to prevent and manage cardiovascular disease in PLWH. The investigators hypothesize that a pharmacist-led intervention (INTEGRATE-RX) which includes - (1) integration of clinical pharmacists for CVD medication initiation and continuation, (2) pharmacist-coordinated access to CVD essential medicines, and (3) pharmacist-coordinated peer support for medication delivery and psychosocial counseling - will be clinically effective and cost-effective in improving CVD outcomes amongst PLWH.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Adult patients 18 years or above
* Actively enrolled in the AMPATH HIV care program
* Screen positive for and confirmed to have hypertension through repeated blood pressure measurement (SBP ≥ 140 or diastolic BP (DBP) ≥ 90), or those who are already in care for hypertension

Exclusion Criteria:

* Hypertensive emergency requiring immediate medical attention
* Terminal illness
* Pregnancy
* Inability to provide informed consent

Locations (2)

Kitale, Trans Nzoia County, Kenya
Eldoret, Uasin Gishu County, Kenya