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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Rena Patel, MD, MPH
- Numero di telefono: +12059348145
- Email: renapatel@uabmc.edu
Luoghi di studio
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Gaborone
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Bontleng, Gaborone, Botswana
- Princess Marina Hospital
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Contatto:
- Bame Bame
- Numero di telefono: +267 72727347
- Email: bbame@bhp.org.bw
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Contatto:
- Chelsea Morroni, MBChB, DFSRH, DTMH, MPhil, MP
- Numero di telefono: +267 765 24112
- Email: cmorroni@ed.ac.uk
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
Group 1: Adults Using or Eligible for PrEP
PrEP users - Individuals aged 18 years or older who are currently using or eligible for PrEP
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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
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No intervention
|
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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
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No intervention
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
PrEP Continuation (Aim 2)
Lasso di tempo: Up to 2 years
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Among participants who initiate PrEP, to determine the proportion who continue PrEP use over 2 years.
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Up to 2 years
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
PrEP Initiation (Aim 1)
Lasso di tempo: Within 2 years after the initial PrEP clinic visit
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To determine the number and proportion of participants in the PrEP clinic who initiate PrEP.
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Within 2 years after the initial PrEP clinic visit
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|
PrEP Switching (Aim 3)
Lasso di tempo: Up to 2 years
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Among participants who initiate PrEP, to determine the number and proportion who switch between PrEP modalities.
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Up to 2 years
|
|
PrEP Discontinuation (Aim 4)
Lasso di tempo: Up to 2 years
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Among participants who initiate PrEP, to determine the number and proportion who discontinue PrEP.
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Up to 2 years
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Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Rena Patel, MD, MPH, MPhil, University of Alabama at Birmingham
- Investigatore principale: Rebecca Zash, Division of Infectious Disease Beth Israel Deaconess Medical Center
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Infezioni a trasmissione ematica
- Malattie urogenitali
- Malattie genitali
- Malattie del sistema immunitario
- Infezioni
- Infezioni da virus a RNA
- Malattie virali
- Malattie trasmissibili
- Malattie sessualmente trasmissibili, virali
- Malattie trasmesse sessualmente
- Infezioni da lentivirus
- Infezioni da retroviridae
- Sindromi da deficit immunologico
- Infezioni da HIV
Altri numeri di identificazione dello studio
- IRB-300016575
- R01AI155052 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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prodotto fabbricato ed esportato dagli Stati Uniti
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