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Healthy Expectancy Through Routine Antenatal STI Screening

Study acronym: HERA
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Recruitment openedv2 Show 5 more changesShow less
    • Primary completion date: Jan 2030 to Jan 1, 2030
    • Study completion date: Jul 2030 to Jul 1, 2030
    • Start date changed from estimate of Feb 2026 to May 25, 2026
    • Study description expanded, about 7 words
    • Site details revised
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
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
(from sponsor)
Antenatal Health, Antenatal Care, STI, Chlamydia Trachomatis Infection in Pregnancy, Chlamydia, Chlamydia Trachomatis, Chlamydia Trachomatis Infection, Preterm Birth
Related terms Chlamydia Infections, Premature Birth, Sexually Transmitted Diseases
Enrollment 2,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov