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

Botswana Harvard AIDS Institute Partnership

Status and phase: Enrolling; Phase 3

Conditions: PrEP Adherence; Sexually Transmitted Infections (STIs); Pregnancy

Treatments: Diagnostic Test: Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis testing

Study type: Interventional

Funder types: Other

Identifiers

NCT06919614

BHP180

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

Intervention arm

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis testing

Standard-of-care arm

No Intervention group

Description:

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.