STI Testing to Enhance PrEP Use in Pregnancy

Last updated: July 27, 2025
Sponsor: Botswana Harvard AIDS Institute Partnership
Overall Status: Active - Recruiting

Phase

3

Condition

Sexually Transmitted Diseases (Stds)

Pregnancy

Treatment

Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis testing

Clinical Study ID

NCT06919614
BHP180
  • Female
  • Accepts Healthy Volunteers

Study 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

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

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

Study Design

Total Participants: 600
Treatment Group(s): 1
Primary Treatment: Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis testing
Phase: 3
Study Start date:
June 18, 2025
Estimated Completion Date:
August 31, 2029

Study Description

The investigators are conducting a 2-arm 1:1 randomized trial to compare PrEP delivery with co-offer of STI testing for Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis (using Xpert CT/NG and TV assays) vs. standard-of-care (SOC, syndromic management) among pregnant women without HIV (n=600) in Botswana. Antenatal care clients will be offered PrEP (self-select oral pills or DPV-VR).

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.

Connect with a study center

  • DHMT Clinics

    Gaborone,
    Botswana

    Active - Recruiting

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