Menu
Recruiting NCT06919614

STI Testing to Enhance PrEP Use in Pregnancy

Phase III Interventional PrEP Adherence Sexually Transmitted Infections (STIs) Pregnancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis testing.
Who it may be relevant to
Registry conditions: PrEP Adherence, Sexually Transmitted Infections (STIs), Pregnancy. Basic parameters: No limits · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Botswana
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed 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.

Interventions

  • Diagnostic test Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis testing
    Xpert® CT/NG and TV testing

Primary outcome measures

  • PrEP initiation among pregnant women seeking antenatal care [Time frame: Enrolment to 1 month post enrolment]
  • PrEP persistence [Time frame: Enrolment to 9 months postpartum]
  • PrEP adherence [Time frame: Enrolment to 9 months postpartum]
Secondary outcome measures (2)
  • PrEP Choice [Time frame: Enrolment to 9 months postpartum]
  • STI rates [Time frame: Enrolment to 9 months postpartum]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Botswana · 1 center
  • DHMT Clinics — Gaborone

Identifiers

NCT: NCT06919614 · BHP180

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗