STI Testing to Enhance PrEP Use in Pregnancy

NCT06919614 | Recruiting Phase 3 DMC

• 1 other identifier: BHP180
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

PrEP Adherence; Sexually Transmitted Infections (STIs); Pregnancy

Keywords

Pregancy; PrEP; HIV; STIs; Chlamydia; Gonorrhoea; Gonorrhea; Trichomonas; Dapivirine; Truvada; Oral PrEP

Outcome Measures

Primary Outcomes (3)

• PrEP initiation among pregnant women seeking antenatal care

  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

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

  Enrolment to 9 months postpartum

• PrEP adherence

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

  Enrolment to 9 months postpartum

Secondary Outcomes (2)

• PrEP Choice

  Enrolment to 9 months postpartum

• STI rates

  Enrolment to 9 months postpartum

Study Arms (2)

Intervention arm

EXPERIMENTAL

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

Standard-of-care arm

NO INTERVENTION

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.

Interventions

Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis testing DIAGNOSTIC_TEST

Xpert® CT/NG and TV testing

Intervention arm

Eligibility Criteria

• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Botswana Harvard AIDS Institute Partnership: lead
• University of Washington: collaborator
• University of Botswana: collaborator

Study Sites (1)

DHMT Clinics

Gaborone, Botswana

RECRUITING

MeSH Terms

Conditions

Sexually Transmitted Diseases; Chlamydia Infections; Gonorrhea; Trichomonas Infections

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Chlamydiaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sexually Transmitted Diseases, Bacterial; Neisseriaceae Infections; Protozoan Infections; Parasitic Diseases

Central Study Contacts

Chelsea Morroni, MBChB, DFSRH, MPH, PhD

CONTACT

‭+267 316 6657‬; chelseaamorroni@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 9, 2025
• Study Start: June 18, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2029
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

BO (1)