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

2. september 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Detaljert beskrivelse

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

Observasjonsmessig

Registrering (Antatt)

1000

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

    • Gaborone
      • Bontleng, Gaborone, Botswana
        • Princess Marina Hospital
        • Ta kontakt med:
        • Ta kontakt med:
          • Chelsea Morroni, MBChB, DFSRH, DTMH, MPhil, MP
          • Telefonnummer: +267 765 24112
          • E-post: cmorroni@ed.ac.uk

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
PrEP Continuation (Aim 2)
Tidsramme: Up to 2 years
Among participants who initiate PrEP, to determine the proportion who continue PrEP use over 2 years.
Up to 2 years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
PrEP Initiation (Aim 1)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: Up to 2 years
Among participants who initiate PrEP, to determine the number and proportion who discontinue PrEP.
Up to 2 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. oktober 2026

Primær fullføring (Antatt)

1. desember 2031

Studiet fullført (Antatt)

1. desember 2031

Datoer for studieregistrering

Først innsendt

6. mai 2026

Først innsendt som oppfylte QC-kriteriene

13. mai 2026

Først lagt ut (Faktiske)

19. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. september 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

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Nei

produkt produsert i og eksportert fra USA

Nei

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