Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06203951 |
| Other study ID # |
STUDY00019163 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2024 |
| Est. completion date |
August 31, 2028 |
Study information
| Verified date |
January 2024 |
| Source |
University of Washington |
| Contact |
Lauren Gomez |
| Phone |
206-685-5044 |
| Email |
gomezL4[@]uw.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
In Aim 1, 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 SOC (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, and tests of cure per national guidelines. 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.
Antenatal clinic selection for RCT (Aim 1): The investigators conducted a landscape analysis
of antenatal clinics in Kisumu and Siaya, Kenya as part of our team's ongoing PrEP studies.
The investigators gathered data on the clients who attend antenatal care (e.g., HIV
prevalence), the types of STI/HIV services offered (e.g., dual HIV and syphilis testing), and
availability of the GeneXpert® platform. The investigators selected 9 high-volume clinics
(>350 antenatal clients annually); all clinics must provide syndromic STI management per
national guidelines, have a laboratory that runs Xpert® assays, and provide a full range of
antenatal services (e.g., syphilis and HIV testing). The investigators consulted with county
health officials, facility in-charges, and laboratory staff, who have assured us that
providing Xpert® STI testing on existing GeneXpert® machines in facilities is possible (see
letters of support from County Health Directors).
Study population and eligibility criteria (Aim 1): 3132 pregnant women seeking antenatal care
will be recruited from 9 routine ANC facilities in Kisumu and Siaya, Kenya, to participate in
the randomized trial. Eligibility criteria include identifying as a cisgender woman, seeking
antenatal care that day, planning to receive antenatal and postnatal care at that clinic, and
being willing and able to provide informed consent. The investigators will not exclude
clients who report intimate partner violence from enrolling in the study as they may
especially benefit from STI services.76. The investigators will also not exclude women based
on age, HIV status, or gestational age at enrollment to produce findings based on a study
sample most representative of the underlying population of antenatal clients in the region as
these data will be most useful for policy decisions.
Recruitment, screening and enrollment of antenatal clients (Aim 1): At each clinic,
enrollment will occur over a 14-month period (~25 antenatal clients enrolled per month, with
seasonal variability) with an approximately 12-month follow-up period. Following registration
at the clinic, study nurses will recruit clients and determine eligibility. Based on our
recent studies in antenatal clinics in/near Kisumu, median gestational for clients seeking
antenatal care is 24 weeks which is later than inclusion criteria of ongoing studies using
Xpert® testing in other settings. Following screening consent, a brief form will capture age,
HIV status, eligibility characteristics, and willingness to consent to join the study.
Following written informed consent for participation, clients will be enrolled and assessed
for demographic and behavioral characteristics, sexual history, education, marital status,
income, relationship characteristics, HIV status, and clinical characteristics (e.g.
pregnancy history, etc). Recruitment strategies will include collaborating with clinic staff
and enrolled participants who will refer other clients who meet eligibility criteria.
Recruitment materials will educate antenatal clients about STI risk based on available data,
risks of having a partner of unknown STI status, and will emphasize the benefits of STI
screening.
Randomization procedures (Aim 1): Randomization will occur following all routine antenatal
procedures and enrollment into the study. Block randomization (1:1:1) in random sized blocks
of no more than 9, stratified by recruitment site and HIV status at enrollment to ensure
balance of arms within sites, will be overseen by the study biostatistician. Study nurses
will be given randomly generated treatment allocations (SOC or universal testing or only
asymptomatic testing) within sealed opaque envelopes. Once a participant has consented to
enter the trial, an envelope will be opened, and the participant will be assigned the
treatment allocation. The randomization code will be maintained by the Study Coordinator at
the study site. Once assigned, the randomization allocation will be unblinded. To minimize
the influence of the unblinded nature of the study on outcomes, ongoing data monitoring will
not include information about endpoints disaggregated by site or arm. Only the study
statistician will review data on study endpoints by arm or site.
