Not Yet RecruitingNot Applicable

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

Kenya450 participantsStarted 2026-10-01

Plain-language summary

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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial focuses on pharmacists helping people with HIV manage their blood pressure — given my specific situation with HIV and any cardiovascular risk factors I have, does my doctor think having a clinical pharmacist more involved in my care could actually make a difference for me?
2Since this trial hasn't started recruiting yet, how long might it be before I could even join, and in the meantime, what steps should I be taking right now to manage my blood pressure and reduce my heart disease risk?
3One of the main things this study is measuring is how well people stick to their medications — does my doctor think medication adherence is a challenge in my current regimen, and are there things we should already be addressing together regardless of this trial?
4This is listed as Phase NA, which I understand means it's more of a care delivery or implementation study rather than a drug trial — can my doctor explain what that means for my safety, and whether my standard HIV and cardiovascular care would continue normally if I were to participate?
5Are there already proven standard-of-care options for managing blood pressure alongside my HIV treatment that my doctor would recommend I pursue now, rather than waiting for this trial to open?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean change in systolic blood pressure

Timeframe: Baseline, Month 6, Month 12

Adherence to medications

Timeframe: Baseline, Month 6, Month 12

Implementation fidelity

Timeframe: Baseline, Month 6, and Month 12

Trial details

NCT IDNCT07711366

SponsorTemple University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-09-30

Contact for this trial

Dan Tran, PharmD

215-707-6014 tran.nk.tina@temple.edu

View on ClinicalTrials.gov More HIV trials