Improving PrEP Outcomes Among Pregnant Women in Botswana With an Integrated STI Testing and PrEP Delivery Model

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The investigators are conducting a study in Botswana to see if offering STI testing along with expanded HIV prevention options (PrEP) helps more pregnant women start and continue using PrEP during and after pregnancy. Pregnant women (n=600) seeking antenatal care in Botswana will be enrolled and randomly assigned to receive the standard of care (standard STI assessment with no STI testing) versus STI testing for Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis during pregnancy and postpartum. The investigators' hypothesis is that providing STI testing alongside PrEP offer will encourage more women to start and continue using PrEP.

Eligibility
Participation Requirements
Sex: Female
Healthy Volunteers: t
View:

• Pregnant and seeking antenatal care

• 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

Locations
Other Locations
Botswana
DHMT Clinics
RECRUITING
Gaborone
Contact Information
Primary
Chelsea Morroni, MBChB, DFSRH, MPH, PhD
chelseaamorroni@gmail.com
‭+267 316 6657‬
Time Frame
Start Date: 2025-06-18
Estimated Completion Date: 2029-08-31
Participants
Target number of participants: 600
Treatments
Experimental: 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.
No_intervention: 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.
Related Therapeutic Areas
HIV/AIDS
Chlamydia
Sponsors
Collaborators: University of Washington, University of Botswana
Leads: Botswana Harvard AIDS Institute Partnership

This content was sourced from clinicaltrials.gov

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