Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
600 participants
INTERVENTIONAL
2025-06-18
2029-08-31
Brief Summary
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Detailed Description
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Participants will be followed up to 9 months postpartum. Women will be able to switch PrEP methods and start, stop, or restart PrEP at any time.
Primary outcomes are the proportion of clients who initiate PrEP, persist with use at 9 months postpartum, and adhere (quantified by hair drug levels). Secondary outcomes are PrEP choice (pills vs. DPV-VR), STI rates, and birth outcomes by randomization arm. Exploratory outcomes are HIV incidence, quality of care, adherence cofactors, and antimicrobial resistance.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Intervention arm
Participants randomized to the intervention arm will be offered Xpert® CT/NG and TV testing and treatment (in addition to syndromic STI assessment) at three time points (enrolment, at the 32 weeks' gestation visit and 9-month post-delivery visit) or two time points for participants enrolled in their third trimester. If a client accepts Xpert® testing, they will be instructed by the study clinician/research assistant on how to self-collect a vaginal swab.
Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis testing
Xpert® CT/NG and TV testing
Standard-of-care arm
Participants in the standard-of-care arm will receive syndromic STI assessment per Botswana national guidelines. They will be offered Xpert® CT/NG and TV testing at the 9-month post-delivery visit only.
No interventions assigned to this group
Interventions
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Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis testing
Xpert® CT/NG and TV testing
Eligibility Criteria
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Inclusion Criteria
* Self-identifying as a cis-gender woman
* Living without HIV
* Not currently using PrEP
* Planning to remain in the city/town of enrolment until 9 months post-delivery.
* Planning to receive antenatal and postnatal care in the city/town of enrolment.
* Willing and able to provide informed consent
Exclusion Criteria
* Not pregnant
* Living with HIV
* Currently using PrEP
* Not planning to remain in the city/town of enrolment until 9 months post-delivery
* Not planning to receive antenatal and postnatal care in the city/town to enrolment
* Not able or willing to provide informed consent for participation
FEMALE
Yes
Sponsors
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University of Washington
OTHER
University of Botswana
OTHER
Botswana Harvard AIDS Institute Partnership
OTHER
Responsible Party
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Locations
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DHMT Clinics
Gaborone, , Botswana
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BHP180
Identifier Type: -
Identifier Source: org_study_id
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