RecruitingNot ApplicableNCT06203951

Improving Perinatal Outcomes Among Kenyan Pregnant Women With an Integrated STI Testing Model

Sponsor

University of Washington

Enrollment

3,132 participants

Start Date

Jan 27, 2025

Study Type

INTERVENTIONAL

Conditions

HIV Sexually Transmitted Infections (Not HIV or Hepatitis)

Summary

The investigators will conduct a 3-arm individual-level RCT in Kisumu and Siaya, Kenya to compare perinatal outcomes associated with 3 models of STI testing and management in antenatal care. The investigators will enroll 3132 pregnant women and randomize 1:1:1 to receive standard-of-care (syndromic management only without CT, NG, or TV testing) vs. CT, NG, and TV testing using Xpert® assays universally vs. only among women without STI symptoms. All women with STIs detected and/or symptoms per Ministry of Health algorithms will receive immediate treatment, EPT per national guidelines, and tests of cure. All participants will be enrolled during routine antenatal care and followed through 9-months postpartum. The investigators will quantify and compare a composite outcome of pregnancy loss/stillbirth, PTB, LBW, SGA, and neonatal death, between randomization arms, in addition to several secondary and exploratory outcomes.

Eligibility

Sex: FEMALE

Plain Language Summary

Simplified for easier understanding

This study tests whether combining STI screening with routine prenatal visits can improve health outcomes for pregnant women and their babies in Kenya. **You may be eligible if...** - You are a woman seeking prenatal care services - You plan to continue receiving prenatal and postnatal care at the participating clinic - You are willing to be screened for sexually transmitted infections including HIV and syphilis - You are able to provide informed consent **You may NOT be eligible if...** - You are male - You are not seeking prenatal care services - You are not willing to receive STI testing - You are unable to provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTXpert® CT/NG and TV testing

Participants randomized to universal STI testing will be offered Xpert® CT/NG and TV testing regardless of symptoms, and they will receive a standard syndromic STI assessment. Participants randomized to the asymptomatic only testing will be offered Xpert® CT/NG and TV testing if no signs or symptoms of CT, NG, or TV are identified during STI assessment. Participants assigned to receive Xpert® testing will be counseled on CT/NG/TV testing, including the benefits of testing even in the absence of symptoms to detect asymptomatic infections (as informed by pilot evaluation). If a client accepts Xpert® testing, she will be instructed by the study nurse on how to self-collect a vaginal swab.