Clinical trial NCT06919614: STI Testing to Enhance PrEP Use in Pregnancy
Official title: Improving PrEP Outcomes Among Pregnant Women in Botswana With an Integrated STI Testing and PrEP Delivery Model
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: PrEP Adherence
Sexually Transmitted Infections (STIs)
Pregnancy
Keywords: Pregancy
PrEP
HIV
STIs
Chlamydia
Gonorrhoea
Gonorrhea
Trichomonas
Dapivirine
Truvada
Oral PrEP
Lead sponsor: Botswana Harvard AIDS Institute Partnership
Sponsor class: OTHER
Collaborators: name: University of Washington
name: University of Botswana
First posted: 2025-04-09
Enrollment: 600
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

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

Primary outcomes:
measure: PrEP initiation among pregnant women seeking antenatal care
timeFrame: Enrolment to 1 month post enrolment
measure: PrEP persistence
timeFrame: Enrolment to 9 months postpartum
measure: PrEP adherence
timeFrame: Enrolment to 9 months postpartum
Secondary outcomes:
measure: PrEP Choice
timeFrame: Enrolment to 9 months postpartum
measure: STI rates
timeFrame: Enrolment to 9 months postpartum
Other outcomes:
Locations:
city: Gaborone
country: Botswana
facility: DHMT Clinics
Study officials:
References: