DYnamic decisioN Support for IntegrAting PrEP in Clinics for Young People in Alabama and Botswana
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Observational cohort (PrEP use in real-world settings).
- Who it may be relevant to
- Registry conditions: HIV Infections, Contraception, PrEP. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Botswana
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Interventions
- Other Observational cohort (PrEP use in real-world settings)
No intervention
Primary outcome measures
- PrEP Continuation (Aim 2) [Time frame: Up to 2 years]
Secondary outcome measures (3)
- PrEP Initiation (Aim 1) [Time frame: Within 2 years after the initial PrEP clinic visit]
- PrEP Switching (Aim 3) [Time frame: Up to 2 years]
- PrEP Discontinuation (Aim 4) [Time frame: Up to 2 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Botswana · 1 center
- Princess Marina Hospital — Bontleng
Identifiers
NCT: NCT07597824 · IRB-300016575 · R01AI155052