- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07597824
DYnamic decisioN Support for IntegrAting PrEP in Clinics for Young People in Alabama and Botswana (DYNAMIC PrEP)
This study evaluates strategies to improve access to HIV prevention through the integration of pre-exposure prophylaxis (PrEP) into existing healthcare settings, rather than limiting delivery to specialty clinics. The study addresses barriers to PrEP uptake, including limited awareness, stigma, and restricted access, and recognizes that availability alone may not ensure initiation or sustained use.
The study includes two components. First, a longitudinal cohort of current PrEP users will be followed to assess changes in access, preferences, and PrEP use over time in real-world settings. Second, a dynamic decision-support toolkit will be developed and evaluated to support patients and providers in PrEP-related decision-making. The toolkit will include patient- and provider-facing components to support clinical decision-making, improve risk understanding, and facilitate integration of PrEP into routine healthcare. The toolkit will be refined and beta-tested in selected healthcare facilities in Botswana and Alabama.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Pre-exposure prophylaxis (PrEP) is an evidence-based and effective approach to HIV prevention, yet it has not reached its full potential due to factors such as limited awareness, constrained service resources, and stigma. Currently, most PrEP prescriptions are issued in specialty care settings, offering limited access. Therefore, achieving global implementation goals will require expanding PrEP delivery within other existing health facilities.
Making PrEP available in existing outpatient or inpatient settings alone does not guarantee its initiation or sustained use, even among individuals at risk for HIV acquisition. Appropriate decision-making regarding PrEP use requires collaboration between patients and providers, supported by an enabling clinic infrastructure. Moreover, the PrEP journey can be dynamic, with more PrEP modalities becoming available in recent years, and choices can change over time, underscoring the need for decision-support toolkits that help patients and providers navigate this evolving decision-making process. A decision support toolkit that has components that are either patient- or provider-facing, or both, could enhance patients' risk perception and increase their knowledge of PrEP, enabling them to make informed decisions about its use, as well as decrease the decision-making burden on the provider side.
As such, the investigators aim to (1) propose an implementation strategy that integrates PrEP into existing health facilities and (2) develop a dynamic choice decision support toolkit that supports PrEP integration into these existing health facilities.
Thus, our specific aims are:
- Aim 1: To conduct a prospective cohort study of existing PrEP users to better understand how their PrEP access and choices change over time in real-world settings.
Aim 2: To conduct formative work to better understand the landscape of focal points of integration of PrEP into existing healthcare facilities (Aim 2a) and develop and beta-test a dynamic PrEP toolkit prototype needed to support this integration (Aim 2b), in parallel in Botswana and Alabama.
- 2a: To better understand the landscape of potential focal points for PrEP integration across various healthcare facility types, with attention to the appropriate population, setting, and facility context, and prioritization of 1-2 of such clinic types for subsequent integration.
- 2b: To develop and refine a dynamic PrEP toolkit prototype with components needed to support PrEP integration. Potential dynamic PrEP toolkit components may include, for instance, a patient-facing and provider-facing clinical decision support tool (e.g., decision-making applications), another tool to enable commodities tracking for clinics, etc.
- 2c: To beta-test the refined dynamic PrEP toolkit prototype in the selected 1-2 facility types.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Rena Patel, MD, MPH
- Numéro de téléphone: +12059348145
- E-mail: renapatel@uabmc.edu
Lieux d'étude
-
-
Gaborone
-
Bontleng, Gaborone, Bostwana
- Princess Marina Hospital
-
Contact:
- Bame Bame
- Numéro de téléphone: +267 72727347
- E-mail: bbame@bhp.org.bw
-
Contact:
- Chelsea Morroni, MBChB, DFSRH, DTMH, MPhil, MP
- Numéro de téléphone: +267 765 24112
- E-mail: cmorroni@ed.ac.uk
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
Group 1
Inclusion for Alabama site:
- 18 years of age or older
- Currently using or eligible for PrEP
Inclusion for Botswana site:
- 18 years of age or older
- Participated in the parent Tshireletso study in Botswana
Exclusion for both sites:
- Under the age of 18
- HIV positive
Group 2
Inclusion for both sites:
- 18 years of age or older
- Currently working as PrEP providers or clinic administrators at outpatient clinics
Exclusion for both sites:
- Under the age of 18
Group 3
Inclusion for both sites:
- 18 years of age or older
- Currently working as policy makers or program leaders at outpatient clinics
Exclusion for both sites:
- Under the age of 18
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Group 1: Adults Using or Eligible for PrEP
PrEP users - Individuals aged 18 years or older who are currently using or eligible for PrEP
|
No intervention
|
|
Group 2: PrEP Providers and Clinic Administrators
PrEP providers and clinic administrators - Individuals aged 18 years or older who work as PrEP providers or clinic administrators at outpatient clinics or inpatient settings
|
No intervention
|
|
Group 3: Policy Makers and Program Leaders
Policy makers and program leaders - Individuals aged 18 years or older who work as policy makers or program leaders at outpatient clinics or inpatient settings
|
No intervention
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
PrEP Continuation (Aim 2)
Délai: Up to 2 years
|
Among participants who initiate PrEP, to determine the proportion who continue PrEP use over 2 years.
|
Up to 2 years
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
PrEP Initiation (Aim 1)
Délai: Within 2 years after the initial PrEP clinic visit
|
To determine the number and proportion of participants in the PrEP clinic who initiate PrEP.
|
Within 2 years after the initial PrEP clinic visit
|
|
PrEP Switching (Aim 3)
Délai: Up to 2 years
|
Among participants who initiate PrEP, to determine the number and proportion who switch between PrEP modalities.
|
Up to 2 years
|
|
PrEP Discontinuation (Aim 4)
Délai: Up to 2 years
|
Among participants who initiate PrEP, to determine the number and proportion who discontinue PrEP.
|
Up to 2 years
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Rena Patel, MD, MPH, MPhil, University of Alabama at Birmingham
- Chercheur principal: Rebecca Zash, Division of Infectious Disease Beth Israel Deaconess Medical Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Infections transmissibles par le sang
- Maladies urogénitales
- Maladies génitales
- Maladies du système immunitaire
- Infections
- Infections par virus à ARN
- Maladies virales
- Maladies transmissibles
- Maladies sexuellement transmissibles, virales
- Maladies sexuellement transmissibles
- Infections à lentivirus
- Infections à rétroviridae
- Syndromes d'immunodéficience
- Infections à VIH
Autres numéros d'identification d'étude
- IRB-300016575
- R01AI155052 (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) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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 .