STI Testing to Enhance PrEP Use in Pregnancy (STEP-UP)

July 27, 2025 updated by: Botswana Harvard AIDS Institute Partnership

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Diagnostic test: Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis testing
Xpert® CT/NG and TV testing
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Enrolment to 1 month post enrolment
PrEP persistence
Time Frame: Enrolment to 9 months postpartum
Evidence of PrEP persistence at 9 months postpartum among women who initiated PrEP.
Enrolment to 9 months postpartum
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.
Enrolment to 9 months postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PrEP Choice
Time Frame: Enrolment to 9 months postpartum
Secondary outcomes are PrEP choice (pills vs. DPV-VR)
Enrolment to 9 months postpartum
STI rates
Time Frame: Enrolment to 9 months postpartum
Prevalence of chlamydia, gonorrhoea and trichomonas at enrolment, third trimester and 9 months postpartum
Enrolment to 9 months postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Botswana Harvard AIDS Institute Partnership

Collaborators

University of Washington
University of Botswana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 18, 2025

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2029

Study Registration Dates

First Submitted

April 2, 2025

First Submitted That Met QC Criteria

April 2, 2025

First Posted (Actual)

April 9, 2025

Study Record Updates

Last Update Posted (Actual)

July 29, 2025

Last Update Submitted That Met QC Criteria

July 27, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BHP180

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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