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

Sponsor
University of Alabama at Birmingham
Study ID
NCT07597824
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Observational cohort (PrEP use in real-world settings) — OTHER
    No intervention

Study Details

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.

Key Dates

First listed
May 19, 2026
Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Dec 31, 2031
Completion
Dec 31, 2031

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: Group 1: Adults Using or Eligible for PrEP
    PrEP users - Individuals aged 18 years or older who are currently using or eligible for PrEP
  • Arm: 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
  • Arm: 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

Primary Outcome Measure

PrEP Continuation (Aim 2) [ Time Frame: Up to 2 years ]

Central Contacts

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