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

NARecruitingINTERVENTIONAL
Enrollment

3,132

Participants

Timeline

Start Date

January 27, 2025

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2028

Conditions
HivSexually Transmitted Infections (Not HIV or Hepatitis)
Interventions
DIAGNOSTIC_TEST

Xpert® 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.

Trial Locations (8)

Unknown

RECRUITING

Homa Bay Teaching and Referral Hospital, Homa Bay

RECRUITING

Rachuonyo South Sub County Hospital, Homa Bay

RECRUITING

Rangwe Sub County Hospital, Homa Bay

RECRUITING

Chulaimbo County hospital, Kisumu

RECRUITING

Kisumu County Hospital, Kisumu

RECRUITING

Lumumba Sub County hospital, Kisumu

RECRUITING

Migosi Sub County Hospital, Kisumu

RECRUITING

Yala sub County Hospital, Yala

All Listed Sponsors
collaborator

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

NIH

lead

University of Washington

OTHER