Improving Perinatal Outcomes Among Kenyan Pregnant Women With an Integrated STI Testing Model
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorUniversity of Washington
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Self-identifying as a cisgender woman
Seeking antenatal services from the clinic
Planning to receive antenatal and postnatal care at the clinic
Willingness to receive syndromic STI screening and HIV/syphilis testing per national guidelines
Disqualifiers
Male gender
Not seeking antenatal services from the clinic
Not planning to receive antenatal and postnatal care at the clinic
Not willing to receive syndromic STI screening and HIV/syphilis testing per national guidelines
Trial design
Design model
Parallel
Treatments tested in this trial
Xpert® CT/NG and TV testing
Diagnostic testParticipants 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.
Treatment groups
3,132 Participants
are divided into 3 treatment groupsGroup A: Standard of CareNo intervention 0 interventions
Group B: Universal TestingExperimental treatment 1 intervention
Group C: Asymptomatic Only TestingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Perinatal outcomes
Binary endpoint (Yes/No) of a composite of fetal loss, PTB\<37 weeks gestation, SGA \<10th percentile, and neonatal death compared between randomization arms
Time frame
6 weeks postpartumSecondary outcomes
1
EPT outcomes and factors
Binary endpoint (Yes/No) of whether participant offered EPT to partner and if partner took EPT medications in intervention arm only
Time frame
At each follow up visit2
Quality of Care
Binary endpoints (Yes/No) based on MEASURE Evaluation's indicators for QOC in reproductive health (eg Did provider ask if you were having a problem with your FP method?) compared between randomization arms
Time frame
At each follow-up visit3
CT/NG/TV prevalence and cofactors
Frequency of CT/NG/TV detection (Yes/No) at 6-weeks postpartum compared between randomization arms
Time frame
6 weeks postpartum4
Maternal HIV incidence
Frequency of HIV diagnosis at follow-up visits compared between randomization arms
Time frame
9 months postpartumSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Washington
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov