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.

Study Overview

• Status: Not yet recruiting
• Conditions: HIV Infections; PrEP; Contraception
• Intervention / Treatment: Other: Observational cohort (PrEP use in real-world settings)

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Rena Patel, MD, MPH; Phone Number: +12059348145; Email: renapatel@uabmc.edu

Study Locations

• Botswana
  • Gaborone
    • Bontleng, Gaborone, Botswana
      • Princess Marina Hospital
      • Contact: Bame Bame; Phone Number: +267 72727347; Email: bbame@bhp.org.bw
      • Contact: Chelsea Morroni, MBChB, DFSRH, DTMH, MPhil, MP; Phone Number: +267 765 24112; Email: cmorroni@ed.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PrEP Continuation (Aim 2)	Among participants who initiate PrEP, to determine the proportion who continue PrEP use over 2 years.	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PrEP Initiation (Aim 1)	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)	Among participants who initiate PrEP, to determine the number and proportion who switch between PrEP modalities.	Up to 2 years
PrEP Discontinuation (Aim 4)	Among participants who initiate PrEP, to determine the number and proportion who discontinue PrEP.	Up to 2 years

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); Beth Israel Deaconess Medical Center; Harvard School of Public Health (HSPH)
• Investigators: Principal Investigator: Rena Patel, MD, MPH, MPhil, University of Alabama at Birmingham; Principal Investigator: Rebecca Zash, Division of Infectious Disease Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): December 1, 2031

Study Registration Dates

• First Submitted: May 6, 2026
• First Submitted That Met QC Criteria: May 13, 2026
• First Posted (Actual): May 19, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: PrEP; young adults; Botswana; HIV adherence; Alabama
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; HIV Infections
• Other Study ID Numbers: IRB-300016575; R01AI155052 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No