Healthy Expectancy Through Routine Antenatal STI Screening

NCT07458802 | Recruiting DMC

• 2 other identifiers: R01HD1169891R01HD116989-01
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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. 1.Standard of care group: Women receive routine antenatal care only.
2. 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.

Conditions

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

Keywords

antenatal health; antenatal screening; chlamydia; chlamydia trachomatis; chlamydia screening; chlamydia treatment; pregnancy screening; STI; STI screening; STI in pregnancy; preterm delivery; Botswana; CT infection; chlamydia in pregnancy; birth outcomes

Outcome Measures

Primary Outcomes (1)

• Preterm birth

  \<37 weeks gestation

  Weeks gestation at birth, calculated from delivery date and date of last menstrual period and first trimester ultrasound dating

Secondary Outcomes (2)

• Infant Outcomes: low birth weight, and a composite measure of preterm or low birth weight; very preterm birth; and preterm birth sub-types.

  Number of weeks gestation at birth, calculated from delivery date and date of last menstrual period and first trimester ultrasound dating.

• Pregnancy/maternal outcomes: gestational hypertension, preeclampsia, incident HIV infection.

  First trimester ANC through post-delivery obstetrical follow-up

Study Arms (2)

Standard of Care

NO INTERVENTION

Participants in the standard-of-care arm will receive syndromic STI assessment per Botswana national guidelines.

Intervention

EXPERIMENTAL

Participants randomized to the Intervention arm will receive the standard of care with additional Chlamydia trachomatis (CT) and Neisseria gonorrhea (NG) screening and treatment, at two time points: 1) first antenatal care visit and 2) third trimester between 28-32 weeks gestation (n=1,000). If participants are positive for CT and/or NG they will receive counseling and treatment according to US CDC guidelines, counseling and information about partner notification and treatment with several options available for partner treatment, and a test of cure after four weeks.

Diagnostic Test: Chlamydia trachomatis and Neisseria gonorrhoeae screening

Interventions

Chlamydia trachomatis and Neisseria gonorrhoeae screening DIAGNOSTIC_TEST

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

Intervention

Eligibility Criteria

• Age: 15 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Attending first ANC visit
• Residence in Gaborone, Bostwana or surrounding villages through the time of delivery
• Mentally competent to understand study procedures or give informed consent

Sponsors & Collaborators

• Adriane Wynn: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Botswana Harvard AIDS Institute Partnership: collaborator

Study Sites (1)

Botswana Harvard Health Partnership

Gaborone, Botswana

RECRUITING

MeSH Terms

Conditions

Sexually Transmitted Diseases; Chlamydia Infections; Premature Birth

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Chlamydiaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sexually Transmitted Diseases, Bacterial; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications

Central Study Contacts

Adriane Wynn, PhD MPP

CONTACT

+1 (916) 662-1497; awynn@health.ucsd.edu

Chelsea Morroni, MBChB, DFSRH, MPH, PhD

CONTACT

cmorroni@ed.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 9, 2026
• Study Start: May 25, 2026
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: July 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BO (1)