HIV InfectionsDYNAMIC PrEPNCT07597824
DYnamic decisioN Support for IntegrAting PrEP in Clinics for Young People in Alabama and Botswana
An observational study of HIV Infections and Contraception, run by University of Alabama at Birmingham at 1 site in Botswana.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Contraception, PrEP
- What is being tested?
- Observational cohort (PrEP use in real-world settings)
- How many people
- 1,000 participants
- Where
- 1 siteBotswana
- Study dates
- Dec 2026to Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Current PrEP users, providers or clinic administrators, and policy makers or program leaders related to PrEP usage in AL and Botswana
Who may be able to join
- 18 years of age or older
- Currently using or eligible for PrEP
- 18 years of age or older
- Participated in the parent Tshireletso study in Botswana
- 18 years of age or older
- Currently working as PrEP providers or clinic administrators at outpatient clinics
- 18 years of age or older
- Currently working as policy makers or program leaders at outpatient clinics
Who cannot join
- Under the age of 18
- HIV positive
- Group 2
- Under the age of 18
- Group 3
- Under the age of 18
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Botswana1 site
Princess Marina Hospital
Bontleng, Gaborone
Chelsea Morroni, MBChB, DFSRH, DTMH, MPhil, MP, +267 765 24112, cmorroni@ed.ac.uk
Bame Bame, +267 72727347, bbame@bhp.org.bw
About this study
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.
Read the 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.
- Conditions
- HIV Infections, Contraception, PrEP
- Being tested
- Observational cohort (PrEP use in real-world settings)
- Keywords
- HIV adherence, PrEP, young adults, Botswana, Alabama
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational cohort (PrEP use in real-world settings)Other
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Adults Using or Eligible for PrEP | PrEP users - Individuals aged 18 years or older who are currently using or eligible for PrEP Receives: 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 Receives: 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 Receives: Other: Observational cohort (PrEP use in real-world settings) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP Continuation (Aim 2)
Among participants who initiate PrEP, to determine the proportion who continue PrEP use over 2 years.
Measured: Up to 2 years
Secondary outcomes (3)
PrEP Initiation (Aim 1)
To determine the number and proportion of participants in the PrEP clinic who initiate PrEP.
Measured: 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.
Measured: Up to 2 years
PrEP Discontinuation (Aim 4)
Among participants who initiate PrEP, to determine the number and proportion who discontinue PrEP.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2031 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Beth Israel Deaconess Medical Center, Harvard School of Public Health (HSPH)
- Responsible party
- Principal investigator, Rena Patel, University of Alabama at Birmingham
- Investigators
- Rena Patel, MD, MPH, MPhil, Principal investigator, University of Alabama at BirminghamRebecca Zash, Principal investigator, Division of Infectious Disease Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07597824
- Sponsor's protocol ID
- IRB-300016575
- Other IDs
- R01AI155052
- Acronym
- DYNAMIC PrEP
- Status last verified
- Oct 2026
- First submitted
- 6 May 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DYnamic decisioN Support for IntegrAting PrEP in Clinics for Young People in Alabama and Botswana
- ClinicalTrials.gov ID
- NCT07597824
- Acronym / sponsor ID
- DYNAMIC PrEP / IRB-300016575
- Conditions
- HIV Infections, Contraception, PrEP
- Keywords
- HIV adherence, PrEP, young adults, Botswana, Alabama
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Beth Israel Deaconess Medical Center, Harvard School of Public Health (HSPH)
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2031 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Adults Using or Eligible for PrEP | – | Other: Observational cohort (PrEP use in real-world settings)PrEP users - Individuals aged 18 years or older who are currently using or eligible for PrEP |
| Group 2: PrEP Providers and Clinic Administrators | – | Other: Observational cohort (PrEP use in real-world settings)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 |
| Group 3: Policy Makers and Program Leaders | – | Other: Observational cohort (PrEP use in real-world settings)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Current PrEP users, providers or clinic administrators, and policy makers or program leaders related to PrEP usage in AL and Botswana
Key inclusion criteria (8 listed)
Key exclusion criteria (6 listed)
- Group 2
- Group 3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational cohort (PrEP use in real-world settings)No intervention | Other | Group 1: Adults Using or Eligible for PrEP, Group 2: PrEP Providers and Clinic Administrators, Group 3: Policy Makers and Program Leaders |
Primary outcome
PrEP Continuation (Aim 2)
Time frame: Up to 2 years
Among participants who initiate PrEP, to determine the proportion who continue PrEP use over 2 years.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rena Patel, MD, MPH, MPhil principal investigator
University of Alabama at Birmingham
Rebecca Zash principal investigator
Division of Infectious Disease Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Contraception, run by University of Alabama at Birmingham at 1 site in Botswana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Botswana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rena Patel, MD, MPH (+12059348145, renapatel@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PrEP Continuation (Aim 2) (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.