Healthy Expectancy Through Routine Antenatal STI Screening

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age15+
SponsorAdriane Wynn

About this trial

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.

Eligibility criteria

Qualifiers

Asymptomatic for cervicovaginitis at first ANC (i.e., not syndromically treated for an STI by clinic midwives at first ANC)

Age ≥ 15 years

Currently pregnant

≤20 weeks gestation (based on gestational age in obstetric record or last menstrual period if gestational age missing from record)

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Chlamydia trachomatis and Neisseria gonorrhoeae screening

Treatment groups

2,000 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Adriane Wynn

Lead sponsor

University of California, San Diego

Sponsor institution

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Botswana Harvard AIDS Institute Partnership

Collaborator