Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07711366

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

HIV Behavior Cardiovascular Disease Prevention Cardiovascular Diseases Health Behavior Hypertension Medication Adherence Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kitale County Referral Hospital, Kitale, Trans Nzoia County, Kenya

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

INTEGRATE-RX

Behavioral

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.

Primary outcomes

  1. Mean change in systolic blood pressure

    Time frame: Baseline, Month 6, Month 12

    Mean change in systolic blood pressure from Baseline to Month 6 and Month 12

  2. Adherence to medications

    Time frame: Baseline, Month 6, Month 12

    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).

  3. Implementation fidelity

    Time frame: Baseline, Month 6, and Month 12

    Level of adherence and consistency to each of the implementation strategy component

Secondary outcomes

  1. Viral load

    Time frame: Baseline and Month 12

    HIV viral load at baseline and Month 12

  2. Mean change in Low Density Lipoprotein (LDL)

    Time frame: Baseline and Month 12

    Mean change in Low Density Lipoprotein (LDL) from Baseline to Month 12

  3. Change in patient-reported Quality of Life (QOL)

    Time frame: Baseline and Month 12

    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.

Other outcomes

  1. Reach (RE-AIM)

    Time frame: Baseline

    Number of enrolled participants as a proportion of eligible individuals; Representativeness of participants

  2. Implementation (RE-AIM)

    Time frame: Up to 12 months

    Adaptations made to the implementation strategy, patient satisfaction, cost-effectiveness analysis, budget impact analysis

  3. Adoption (RE-AIM)

    Time frame: Baseline and Month 12

    Proportion of clinics who agree to implement; Proportion of health facilities that implement INTEGRATE RX

  4. Maintenance (RE-AIM)

    Time frame: 6 months after the intervention completion period

    Continuity of intervention during the follow-up period

Study contacts

Contact information is provided by the study sponsor or research team.

Dan Tran, PharmD

CONTACT

[email protected]

215-707-6014

Erica Maier, BA

CONTACT

[email protected]

215-707-9809

Sponsors and collaborators

Lead sponsor

Temple University

Other

Collaborators

  • Brown University
  • Duke University
  • Moi Teaching and Referral Hospital
  • NYU Langone Health
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Purdue University

Registry information

Acronym: INTEGRATE-RX

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Jul 17, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.