INTEGRATE-RX: Integrating Clinical Pharmacists in HIV Care to Mitigate Last-Mile Challenges and Reduce Cardiovascular Disease Burden (INTEGRATE-RX)
14 juillet 2026 mis à jour par: Temple University
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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
450
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Dan Tran, PharmD
- Numéro de téléphone: 215-707-6014
- E-mail: tran.nk.tina@temple.edu
Sauvegarde des contacts de l'étude
- Nom: Erica Maier, BA
- Numéro de téléphone: 215-707-9809
- E-mail: erica.maier@temple.edu
Lieux d'étude
-
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Trans Nzoia County
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Kitale, Trans Nzoia County, Kenya
- Kitale County Referral Hospital
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Uasin Gishu County
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Eldoret, Uasin Gishu County, Kenya
- Moi Teaching and Referral Hospital
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La 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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Aucune 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.
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Expérimental: 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.
|
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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Mean change in systolic blood pressure
Délai: Baseline, Month 6, Month 12
|
Mean change in systolic blood pressure from Baseline to Month 6 and Month 12
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Baseline, Month 6, Month 12
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Adherence to medications
Délai: 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).
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Baseline, Month 6, Month 12
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Implementation fidelity
Délai: Baseline, Month 6, and Month 12
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Level of adherence and consistency to each of the implementation strategy component
|
Baseline, Month 6, and Month 12
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Viral load
Délai: Baseline and Month 12
|
HIV viral load at baseline and Month 12
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Baseline and Month 12
|
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Mean change in Low Density Lipoprotein (LDL)
Délai: Baseline and Month 12
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Mean change in Low Density Lipoprotein (LDL) from Baseline to Month 12
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Baseline and Month 12
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Change in patient-reported Quality of Life (QOL)
Délai: Baseline and Month 12
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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.
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Baseline and Month 12
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Reach (RE-AIM)
Délai: Baseline
|
Number of enrolled participants as a proportion of eligible individuals; Representativeness of participants
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Baseline
|
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Implementation (RE-AIM)
Délai: Up to 12 months
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Adaptations made to the implementation strategy, patient satisfaction, cost-effectiveness analysis, budget impact analysis
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Up to 12 months
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Adoption (RE-AIM)
Délai: Baseline and Month 12
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Proportion of clinics who agree to implement; Proportion of health facilities that implement INTEGRATE RX
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Baseline and Month 12
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Maintenance (RE-AIM)
Délai: 6 months after the intervention completion period
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Continuity of intervention during the follow-up period
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6 months after the intervention completion period
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Benson Njuguna, MPharm, MPH, MPP, Moi Teaching and Referral Hospital
- Chercheur principal: Dan Tran, PharmD, Temple University
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 octobre 2026
Achèvement primaire (Estimé)
30 septembre 2029
Achèvement de l'étude (Estimé)
31 juillet 2030
Dates d'inscription aux études
Première soumission
29 juin 2026
Première soumission répondant aux critères de contrôle qualité
14 juillet 2026
Première publication (Réel)
17 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
17 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
14 juillet 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Mots clés
- VIH
- adhésion aux médicaments
- science de la mise en œuvre
- prévention des maladies cardiovasculaires
- pharmacien clinicien
- pharmacie clinique
- analyse coût-efficacité
- facteurs de risque des maladies cardiovasculaires
- essai randomisé en grappes étagées
- navigateurs de pairs
- integrated HIV and cardiovascular disease care
- budget impact analysis
- hybrid type 2 effectiveness-implementation trial
- human centered design
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 32418
- 1R01HL179904-01 (Subvention/contrat des NIH des États-Unis)
- 3R01HL179904-01S1 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
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.
Délai de partage IPD
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Critères d'accès au partage IPD
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.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .