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

NCT07597824 | Not Yet Recruiting

• 2 other identifiers: IRB-300016575R01AI155052
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Infections; Contraception; PrEP

Keywords

HIV adherence; PrEP; young adults; Botswana; Alabama

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• PrEP Initiation (Aim 1)

  Within 2 years after the initial PrEP clinic visit

• PrEP Switching (Aim 3)

  Up to 2 years

• PrEP Discontinuation (Aim 4)

  Up to 2 years

Study Arms (3)

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)

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)

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)

Interventions

Observational cohort (PrEP use in real-world settings) OTHER

No intervention

Group 1: Adults Using or Eligible for PrEP; Group 2: PrEP Providers and Clinic Administrators; Group 3: Policy Makers and Program Leaders

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Beth Israel Deaconess Medical Center: collaborator
• Harvard School of Public Health (HSPH): collaborator

Study Sites (1)

Princess Marina Hospital

Bontleng, Gaborone, Botswana

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Rena Patel, MD, MPH, MPhil

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Rebecca Zash

  Division of Infectious Disease Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rena Patel, MD, MPH

CONTACT

+12059348145; renapatel@uabmc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 19, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): December 1, 2031
• Last Updated: May 19, 2026

Record last verified: 2026-05

Locations

BO (1)