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Healthy Expectancy Through Routine Antenatal STI Screening

NCT07458802 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2000

Last updated 2026-03-09

No results posted yet for this study

Summary

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.

Conditions

  • Antenatal Health
  • Antenatal Care
  • STI
  • Chlamydia Trachomatis Infection in Pregnancy
  • Chlamydia
  • Chlamydia Trachomatis
  • Chlamydia Trachomatis Infection
  • Preterm Birth

Interventions

DIAGNOSTIC_TEST

Chlamydia trachomatis and Neisseria gonorrhoeae screening

Screening with Xpert® CT/NG assay at first antenatal care and third trimester

Sponsors & Collaborators

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

    collaborator NIH

  • Botswana Harvard AIDS Institute Partnership

    collaborator OTHER

  • Adriane Wynn

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2030-01-31
Completion
2030-07-31

Countries

  • Botswana

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07458802 on ClinicalTrials.gov