NCT06919614 STI Testing to Enhance PrEP Use in Pregnancy
| NCT ID | NCT06919614 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Botswana Harvard AIDS Institute Partnership |
| Condition | PrEP Adherence |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2025-06-18 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 600 participants in total. It began in 2025-06-18 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Male gender * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06919614 clinical trial?
This trial is open to female participants only, studying PrEP Adherence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06919614 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 600 participants.
Is NCT06919614 currently recruiting?
Yes, NCT06919614 is actively recruiting participants. Contact the research team at chelseaamorroni@gmail.com for enrollment information.
Where is the NCT06919614 trial being conducted?
This trial is being conducted at Gaborone, Botswana.
Who is sponsoring the NCT06919614 clinical trial?
NCT06919614 is sponsored by Botswana Harvard AIDS Institute Partnership. The trial plans to enroll 600 participants.