INTEGRATE-RX: Integrating Clinical Pharmacists in HIV Care to Mitigate Last-Mile Challenges and Reduce Cardiovascular Disease Burden
INTEGRATE-RX
3 other identifiers
interventional
450
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hiv
Started Oct 2026
Typical duration for not_applicable hiv
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 29, 2026
CompletedFirst Posted
Study publicly available on registry
July 17, 2026
CompletedStudy Start
First participant enrolled
October 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2029
Study Completion
Last participant's last visit for all outcomes
July 31, 2030
July 17, 2026
June 1, 2026
3 years
June 29, 2026
July 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Mean change in systolic blood pressure
Mean change in systolic blood pressure from Baseline to Month 6 and Month 12
Baseline, Month 6, Month 12
Adherence to medications
Adherence to non-HIV medications using the Voils DOSE-Nonadherence questionnaire (responses are scored on a 5-point Likert scale with 1 = perfectly adherent and 5 = non-adherent) and to HIV medications using the AIDS Clinical Trials Group (ACTG) Adherence questionnaire (responses are expressed as mean 4-day adherence ratio of 0 through 1 with 1 = perfect adherent and 0 = non-adherent).
Baseline, Month 6, Month 12
Implementation fidelity
Level of adherence and consistency to each of the implementation strategy component
Baseline, Month 6, and Month 12
Secondary Outcomes (3)
Viral load
Baseline and Month 12
Mean change in Low Density Lipoprotein (LDL)
Baseline and Month 12
Change in patient-reported Quality of Life (QOL)
Baseline and Month 12
Other Outcomes (4)
Reach (RE-AIM)
Baseline
Implementation (RE-AIM)
Up to 12 months
Adoption (RE-AIM)
Baseline and Month 12
- +1 more other outcomes
Study Arms (2)
Usual care
NO INTERVENTIONDuring usual care, patient living with HIV with comorbid hypertension, diabetes, or hyperlipidemia do not interact with clinical pharmacists. The usual care phase of the intervention will be delivered by physicians, clinical officers, and nurses, with medications dispensed by pharmaceutical technologists.
INTEGRATE-RX
EXPERIMENTALINTEGRATE-RX intervention 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.
Interventions
PLWH will be managed by the clinical pharmacist based on the established clinical care protocols that include comprehensive risk reduction strategies that incorporate counselling on diet and lifestyle, screening for, and management of other cardiovascular disease (CVD) risk factors, including but not limited to dyslipidemia and dysglycemia. The core components of the INTEGRATE-RX strategy will be: 1) integration of clinical pharmacists for CVD medication initiation and maintenance, (2) pharmacist-coordinated access to CVD essential medicines, and (3) pharmacist-coordinated peer support for medication delivery and psychosocial counselling.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Temple Universitylead
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- Purdue Universitycollaborator
- Brown Universitycollaborator
- Duke Universitycollaborator
- NYU Langone Healthcollaborator
- Moi Teaching and Referral Hospitalcollaborator
Study Sites (2)
Kitale County Referral Hospital
Kitale, Trans Nzoia County, Kenya
Moi Teaching and Referral Hospital
Eldoret, Uasin Gishu County, Kenya
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Benson Njuguna, MPharm, MPH, MPP
Moi Teaching and Referral Hospital
- PRINCIPAL INVESTIGATOR
Dan Tran, PharmD
Temple University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2026
First Posted
July 17, 2026
Study Start (Estimated)
October 1, 2026
Primary Completion (Estimated)
September 30, 2029
Study Completion (Estimated)
July 31, 2030
Last Updated
July 17, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- The investigator who proposed to access and use the data will be granted access upon reasonable request and a methodologically sound proposal. Requests should be directed to Tran.nk.tina@temple.edu. To gain access, data requestors will need to sign a data access agreement.
Quantitative and qualitative data will be shared in the form of de-identified data sets. The de-identified participant data from the final research datasets used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication, or as required by a condition of awards and agreements supporting the research. All shared data must abide by a data use agreement that is fully executed between the requesting research investigator with Temple University. Requests of data use proposals may be directed to: Tran.nk.tina@temple.edu. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.