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.
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
Hypertensive emergency requiring immediate medical attention
Terminal illness
Pregnancy
Inability to provide informed consent
Crossover
INTEGRATE-RX
BehavioralPLWH 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.
Mean change in systolic blood pressure
Mean change in systolic blood pressure from Baseline to Month 6 and 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).
Implementation fidelity
Level of adherence and consistency to each of the implementation strategy component
Viral load
HIV viral load at baseline and Month 12
Mean change in Low Density Lipoprotein (LDL)
Mean change in Low Density Lipoprotein (LDL) from Baseline to 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.
Reach (RE-AIM)
Number of enrolled participants as a proportion of eligible individuals; Representativeness of participants
Implementation (RE-AIM)
Adaptations made to the implementation strategy, patient satisfaction, cost-effectiveness analysis, budget impact analysis
Adoption (RE-AIM)
Proportion of clinics who agree to implement; Proportion of health facilities that implement INTEGRATE RX
Maintenance (RE-AIM)
Continuity of intervention during the follow-up period
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Temple University
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Purdue University
Collaborator
Brown University
Collaborator
Duke University
Collaborator
NYU Langone Health
Collaborator
Moi Teaching and Referral Hospital
Collaborator
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