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DYnamic decisioN Support for IntegrAting PrEP in Clinics for Young People in Alabama and Botswana (DYNAMIC PrEP)

2 september 2026 bijgewerkt door: Rena Patel, University of Alabama at Birmingham

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

1000

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Botswana
    • Gaborone
      • Bontleng, Gaborone, Botswana
        • Princess Marina Hospital
        • Contact:
        • Contact:
          • Chelsea Morroni, MBChB, DFSRH, DTMH, MPhil, MP
          • Telefoonnummer: +267 765 24112
          • E-mail: cmorroni@ed.ac.uk

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Current PrEP users, providers or clinic administrators, and policy makers or program leaders related to PrEP usage in AL and Botswana

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
Group 1: Adults Using or Eligible for PrEP
PrEP users - Individuals aged 18 years or older who are currently using or eligible for PrEP
Ander: Observational cohort (PrEP use in real-world settings)
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
Ander: Observational cohort (PrEP use in real-world 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
Ander: Observational cohort (PrEP use in real-world settings)
No intervention

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
PrEP Continuation (Aim 2)
Tijdsspanne: Up to 2 years
Among participants who initiate PrEP, to determine the proportion who continue PrEP use over 2 years.
Up to 2 years

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
PrEP Initiation (Aim 1)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: Up to 2 years
Among participants who initiate PrEP, to determine the number and proportion who discontinue PrEP.
Up to 2 years

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Alabama at Birmingham

Medewerkers

National Institute of Allergy and Infectious Diseases (NIAID)
Beth Israel Deaconess Medical Center
Harvard School of Public Health (HSPH)

Onderzoekers

  • Hoofdonderzoeker: Rena Patel, MD, MPH, MPhil, University of Alabama at Birmingham
  • Hoofdonderzoeker: Rebecca Zash, Division of Infectious Disease Beth Israel Deaconess Medical Center

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 oktober 2026

Primaire voltooiing (Geschat)

1 december 2031

Studie voltooiing (Geschat)

1 december 2031

Studieregistratiedata

Eerst ingediend

6 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

13 mei 2026

Eerst geplaatst (Werkelijk)

19 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 september 2026

Laatste update ingediend die voldeed aan QC-criteria

2 september 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • IRB-300016575
  • R01AI155052 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

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