Healthy Expectancy Through Routine Antenatal STI Screening

This study will evaluate whether routine screening and treatment for two common sexually transmitted infections, chlamydia and gonorrhoea, during pregnancy can reduce preterm birth and other poor birth outcomes in Botswana, and whether this approach is affordable and cost-effective for the health system. About 2,000 pregnant women attending their first antenatal care visit at up to 10 government clinics in Botswana will be invited to join the study. All women will first receive the usual antenatal care services provided in Botswana, including routine health checks and HIV and syphilis testing. Women who enroll in the study will be randomly assigned to one of two groups: 1. Standard of care group: Women receive routine antenatal care only. 2. Intervention group: In addition to routine antenatal care, women are screened for chlamydia and gonorrhoea using self-collected vaginal swabs at their first antenatal care visit and again in the third trimester. The main outcome of the study is whether screening and treating chlamydia and gonorrhoeae reduces preterm birth (before 37 weeks). Other outcomes include low birth weight, very preterm birth, and maternal health conditions.

NCT Number	NCT07458802
Lead Sponsor	Adriane Wynn Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Botswana Harvard AIDS Institute Partnership
Conditions	Antenatal Health, Antenatal Care, STI, Chlamydia Trachomatis Infection in Pregnancy, Chlamydia, Chlamydia Trachomatis, Chlamydia Trachomatis Infection, Preterm Birth
Enrollment	2,000 participants
Start Date	2026-05-25
Primary Completion	2030-01-01 (estimated)
Study Completion	2030-07-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-02