Cardiovascular Disease Prevention, HIV, Hypertension
Conditions
Keywords
clinical pharmacist, integrated HIV and cardiovascular disease care, implementation science, HIV, cost effectiveness analysis, budget impact analysis, stepped-wedge cluster randomized trial, hybrid type 2 effectiveness-implementation trial, human centered design, clinical pharmacy, cardiovascular disease prevention, medication adherence, cardiovascular disease risk factors, peer navigators
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.
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.
Interventions
BEHAVIORALINTEGRATE-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.
Sponsors
Temple University
National Heart, Lung, and Blood Institute (NHLBI)
Purdue University
Brown University
Duke University
NYU Langone Health
Moi Teaching and Referral Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
This is a stepped-wedge cluster randomized trial (SW-CRT). SW-CRT design offers a rigorous method of evaluation of the effectiveness of an intervention in pragmatic settings. Briefly, at pre-defined regular intervals, one cluster will be randomized to cross from receiving usual care (control group) to the intervention. This process then continues until all clusters are exposed to the intervention. Data collection occurs throughout the entire study, and each cluster contributes observations under both control and intervention periods. In this study, randomization will occur at the cluster level, each of which is represented by a distinct HIV clinic (also known as HIV module) within the AMPATH catchment area. There will be a total of 5 clusters. Each participating cluster will start with a Usual Care phase and are block-randomized to receive INTEGRATE-RX intervention in 5 steps, with one clinic per step.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in systolic blood pressure | Baseline, Month 6, Month 12 | Mean change in systolic blood pressure from Baseline to Month 6 and Month 12 |
| Adherence to medications | 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). |
| Implementation fidelity | Baseline, Month 6, and Month 12 | Level of adherence and consistency to each of the implementation strategy component |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Viral load | Baseline and Month 12 | HIV viral load at baseline and Month 12 |
| Mean change in Low Density Lipoprotein (LDL) | Baseline and Month 12 | Mean change in Low Density Lipoprotein (LDL) from Baseline to Month 12 |
| Change in patient-reported Quality of Life (QOL) | 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. |
Countries
Kenya
Contacts
CONTACTDan Tran, PharmD
CONTACTErica Maier, BA
PRINCIPAL_INVESTIGATORBenson Njuguna, MPharm, MPH, MPP
Moi Teaching and Referral Hospital
PRINCIPAL_INVESTIGATORDan Tran, PharmD
Temple University
Outcome results
None listed