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NCT07711366Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 17 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
450 (estimated)
First submitted
29 Jun 2026
Start date
1 Oct 2026
Primary completion date
30 Sept 2029
Lead sponsor
Temple University
NCT number
NCT07711366

What you commit to

  • Study type: Interventional
  • Planned participants: 450
  • From 1 Oct 2026 to the primary completion date, 30 Sept 2029
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Terminal illness

Other

  • Hypertensive emergency requiring immediate medical attention
  • Pregnancy
  • Inability to provide informed consent

Who the study is looking for

  • 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

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Moi Teaching and Referral Hospital
Coordinator of this site? Confirm its status
EldoretKenyaUnknown status
Kitale County Referral Hospital
Coordinator of this site? Confirm its status
KitaleKenyaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.