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NCT Number: NCT06919614

STI Testing to Enhance PrEP Use in Pregnancy

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.

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Key information

Conditions

PrEP Adherence Bacterial Infections Bacterial Infections and Mycoses Chlamydia Infections Chlamydiaceae Infections Communicable Diseases Disease Attributes Genital Diseases Gonorrhea Gram-Negative Bacterial Infections Infections Neisseriaceae Infections Parasitic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Protozoan Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Bacterial Sexually Transmitted Infections (STIs) Trichomonas Infections Urogenital Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

DHMT Clinics

Gaborone, Botswana

Location status: Recruiting

Location contact

District Health Management Team, Greater Gaborone

CONTACT

[email protected]

+2673905792

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis testing

Diagnostic Test

Xpert® CT/NG and TV testing

Primary outcomes

  1. PrEP initiation among pregnant women seeking antenatal care

    Time frame: Enrolment to 1 month post enrolment

    PrEP initiation among pregnant women seeking antenatal care defined as accepting either daily oral PrEP pills or the DPV-VR when offered at enrolment and evidence of self-reported use at 1-month.

  2. PrEP persistence

    Time frame: Enrolment to 9 months postpartum

    Evidence of PrEP persistence at 9 months postpartum among women who initiated PrEP.

  3. PrEP adherence

    Time frame: Enrolment to 9 months postpartum

    PrEP adherence defined as either TFV or DPV hair levels (depending on PrEP method) at 9 months postpartum.

Secondary outcomes

  1. PrEP Choice

    Time frame: Enrolment to 9 months postpartum

    Secondary outcomes are PrEP choice (pills vs. DPV-VR)

  2. STI rates

    Time frame: Enrolment to 9 months postpartum

    Prevalence of chlamydia, gonorrhoea and trichomonas at enrolment, third trimester and 9 months postpartum

Study contacts

Contact information is provided by the study sponsor or research team.

Chelsea Morroni, MBChB, DFSRH, MPH, PhD

CONTACT

[email protected]

‭+267 316 6657‬

Sponsors and collaborators

Lead sponsor

Botswana Harvard AIDS Institute Partnership

Other

Collaborators

  • University of Botswana
  • University of Washington

Registry information

Official study title

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

Acronym: STEP-UP

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Apr 9, 2025
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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