An observational study in HIV Infections, Contraception and PrEP, sponsored by University of Alabama at Birmingham. Not yet recruiting at 1 site in Botswana. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by University of Alabama at Birmingham · Observational
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.
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 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.
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 200 across 781 observational studies indexed under HIV Infections.
Browse HIV Infections studies →University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
Inclusion for Botswana site:
Exclusion for both sites:
Group 2
Inclusion for both sites:
Exclusion for both sites:
Group 3
Inclusion for both sites:
Exclusion for both sites:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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)
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
PrEP Continuation (Aim 2)
Among participants who initiate PrEP, to determine the proportion who continue PrEP use over 2 years.
Time frame: Up to 2 years
PrEP Initiation (Aim 1)
To determine the number and proportion of participants in the PrEP clinic who initiate PrEP.
Time frame: 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.
Time frame: Up to 2 years
PrEP Discontinuation (Aim 4)
Among participants who initiate PrEP, to determine the number and proportion who discontinue PrEP.
Time frame: Up to 2 years
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Dec 2031, 60 months later.
Of 187 non-industry observational studies under HIV Infections, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 69. This study's planned 60 months is above that.
Counting every sponsor, half of 201 studies reached it within 38 months; a quarter within 16 and three quarters within 69.
Start moved once since we started tracking on Sep 25, 2026: Oct 2026 → Dec 2026, on Oct 14, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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University of Alabama at Birmingham →