INTEGRATE-RX: Integrating Clinical Pharmacists in HIV Care to Mitigate Last-Mile Challenges and Reduce Cardiovascular Disease Burden
Starting soon · Not applicable
Conditions studied: HIV, Hypertension, Cardiovascular Disease Prevention
In brief
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.
Key facts
- Study ID
- NCT07711366
- Run by
- Temple University
- People needed
- 450
- Starts
- 2026-10-01
- Expected to finish
- 2030-07-31
- Last updated by the study team
- 2026-07-17
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Hypertensive emergency requiring immediate medical attention
- Terminal illness
- Pregnancy
- Inability to provide informed consent
Where it is running
- Kitale County Referral Hospital — Kitale, Trans Nzoia County, Kenya
- Moi Teaching and Referral Hospital — Eldoret, Uasin Gishu County, Kenya
Full record on ClinicalTrials.gov
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