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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension; HIV; Cardiovascular Disease Prevention
• Intervention / Treatment: Behavioral: INTEGRATE-RX

Detailed Description

Aim 1 will design a pharmacist-led HIV/CVD integrated care implementation strategy in western Kenya. Using a human-centered design approach, the investigators will refine a pharmacist-led multicomponent cardiovascular risk reduction intervention to enhance HIV/CVD care. The investigators will evaluate the acceptability and appropriateness of the implementation strategy amongst patients, pharmacists, physicians, other providers, peers, and administrators. Aim 2 will evaluate the clinical effectiveness by conducting an implementation hybrid type 2 stepped-wedge clustered randomized controlled trial comparing: INTEGRATE-RX implementation strategy and Usual Care. The primary clinical outcome will be one-year change in systolic blood pressure (SBP). The primary adherence outcome will be medication adherence. The primary implementation outcome will be fidelity. Secondary outcomes will include change in viral load, low-density lipoprotein (LDL), patient-reported quality of life, and RE-AIM metrics. Aim 3 will estimate the cost-effectiveness and budget impact of INTEGRATE-RX in terms of cost per patient with controlled hypertension and per disability-adjusted life year (DALY) saved. To assess the financial impact of adopting this high-value intervention, the investigators will estimate the incremental cost per unit reduction in SBP and per DALY saved, compared to Usual Care. The investigators will model the budget impact of increasing intervention coverage to 50% of the eligible population by 2030 to promote wider county-level adoption. This research is conducted by a transdisciplinary team of research investigators with diverse and complementary expertise. Data generated from this study will provide important policy guidance for countries trying to address the growing burden of CVD and CVD risk factors amongst the adult and aging population living with HIV. In addition, this study contributes rigorous evidence on the roles and effectiveness of clinical pharmacists in integrated communicable and non-communicable chronic disease management in sub-Saharan Africa and other resource-constraint settings in the US and globally.

• Study Type: Interventional
• Enrollment (Estimated): 450
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dan Tran, PharmD; Phone Number: 215-707-6014; Email: tran.nk.tina@temple.edu
• Study Contact Backup: Name: Erica Maier, BA; Phone Number: 215-707-9809; Email: erica.maier@temple.edu

Study Locations

• Kenya
  • Trans Nzoia County
    • Kitale, Trans Nzoia County, Kenya
      • Kitale County Referral Hospital
  • Uasin Gishu County
    • Eldoret, Uasin Gishu County, Kenya
      • Moi Teaching and Referral Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care; During 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.
Experimental: INTEGRATE-RX; INTEGRATE-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.	Behavioral: INTEGRATE-RX; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Viral load	HIV viral load at baseline and Month 12	Baseline and Month 12
Mean change in Low Density Lipoprotein (LDL)	Mean change in Low Density Lipoprotein (LDL) from Baseline to Month 12	Baseline and Month 12
Change in patient-reported Quality of Life (QOL)	Change in patient-reported quality of life using the World Health Organization Quality of Life Brief Questionnaire in HIV population (WHOQOL-HIV BREF). The questionnaire items are grouped into six domains, with each domain rated on a 5-point Likert scale, where 1 indicates low quality of life and 5 indicates a positive high quality of life.	Baseline and Month 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reach (RE-AIM)	Number of enrolled participants as a proportion of eligible individuals; Representativeness of participants	Baseline
Implementation (RE-AIM)	Adaptations made to the implementation strategy, patient satisfaction, cost-effectiveness analysis, budget impact analysis	Up to 12 months
Adoption (RE-AIM)	Proportion of clinics who agree to implement; Proportion of health facilities that implement INTEGRATE RX	Baseline and Month 12
Maintenance (RE-AIM)	Continuity of intervention during the follow-up period	6 months after the intervention completion period

Collaborators and Investigators

• Sponsor: Temple University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Brown University; NYU Langone Health; Duke University; Purdue University; Moi Teaching and Referral Hospital
• Investigators: Principal Investigator: Benson Njuguna, MPharm, MPH, MPP, Moi Teaching and Referral Hospital; Principal Investigator: Dan Tran, PharmD, Temple University

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): July 31, 2030

Study Registration Dates

• First Submitted: June 29, 2026
• First Submitted That Met QC Criteria: July 14, 2026
• First Posted (Actual): July 17, 2026

Study Record Updates

• Last Update Posted (Actual): July 17, 2026
• Last Update Submitted That Met QC Criteria: July 14, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: HIV; medication adherence; implementation science; cardiovascular disease prevention; clinical pharmacist; clinical pharmacy; cost effectiveness analysis; cardiovascular disease risk factors; stepped-wedge cluster randomized trial; peer navigators; integrated HIV and cardiovascular disease care; budget impact analysis; hybrid type 2 effectiveness-implementation trial; human centered design
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Compliance; Patient Acceptance of Health Care; Hypertension; Medication Adherence
• Other Study ID Numbers: 32418; 1R01HL179904-01 (U.S. NIH Grant/Contract); 3R01HL179904-01S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No