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Clinical Study of STI Screening to Prevent Adverse Birth and New-born Outcomes

Primary Purpose

Sexually Transmitted Infection, HIV/AIDS, Cost-effectiveness

Status
Recruiting
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
First antenatal care + test-of-cure
First antenatal care + week 30-34 gestation (no test-of-cure)
Sponsored by
Foundation for Professional Development (Pty) Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Sexually Transmitted Infection focused on measuring Sexually transmitted infection, Neisseria gonorrhoeae, Chlamydia trachomatis, Trichomonas vaginalis, Antenatal care, HIV/AIDS, Birth outcomes, South Africa, Vaginal microbiome, Pregnancy, Diagnostic testing

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria for pregnant women:

  1. Age≥18 years
  2. Currently pregnant based on positive urine pregnancy test
  3. Attending first ANC visit for current pregnancy
  4. Gestational age <20 weeks
  5. Agreeing to nurse-collected specimens
  6. Resident in Buffalo City Municipality (BCM)
  7. Intent to deliver in one of the four midwife obstetric units (MOUs) in BCM

Gestational age will be confirmed via ultrasound

Exclusion Criteria:

  1. Planning to relocate during pregnancy or deliver in an MOU outside of BCM
  2. Unknown HIV status (e.g. refusal, invalid test result)
  3. Currently participating in another ANC/HIV study
  4. When the ultrasound confirms ≥20 weeks gestation at first ANC

Inclusion criteria for Neonates:

1) born to mothers that provided informed consent to participate in study, 2) provision of updated verbal consent by mother to collect and test specimens for STIs

Sites / Locations

  • Buffalo City MetroRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Test at 1st ANC + Test-of-Cure (Treatment 1)

Test at 1st ANC + 30-34 gestation (Treatment 2)

Syndromic Management (Control)

Arm Description

Single point-in-time diagnostic screening plus test-of-cure three weeks post-treatment

Repeated diagnostic screening at first antenatal care and 30-34 weeks gestation

Syndromic management (standard of care) at every antenatal care visit per South African National Guidelines.

Outcomes

Primary Outcome Measures

Frequency of adverse birth outcomes among study arms
Adverse birth outcomes as defined by a composite measure of preterm birth (born alive before 370/7 weeks gestation) or low birth weight (less than 2500g) as recorded in the maternity case records

Secondary Outcome Measures

Change in STI prevalence (a) between baseline visit and delivery within the experimental arms and (b) between the experimental and control arms by delivery.
To calculate the relative and absolute change in Chlamydia, Gonorrhea, and Trichomoniasis prevalence. Additionally, generalized estimating equations to test for variation in STI prevalence among study arms will be done, adjusting for potential effect modifiers and confounding variables
Correlation between Bacterial vaginosis-associated vaginal community state types and clearance of Chlamydia infection
To determine the correlation between Bacterial vaginosis-associated vaginal community state types and chlamydial infection clearance as measured by a positive or negative chlamydial test result no less than three weeks after treatment and thence weekly until a negative Chlamydia test result is recorded.
Incidence of Preterm birth among study arms
The frequency of live births before 37 weeks' gestation, as validated by ultrasound dating at first antenatal visit
Incidence of Low birthweight infants among study arms
The frequency of live births with birth weight < 2500g, as recorded in the maternity case records
Incidence of STI in infants exposed to infection in their mothers
Frequency of Chlamydia, Gonorrhoeae, and/or Trichomonas infection among infants born to a mother in whom infection is detected post-delivery
Frequency of fetal loss (miscarriage or stillbirth) among study arms
Composite frequency of miscarriage (<28 weeks' gestation) or stillbirth (> 28 weeks' gestation) and the individual components, as indicated in the maternal case records

Full Information

First Posted
April 15, 2020
Last Updated
January 4, 2023
Sponsor
Foundation for Professional Development (Pty) Ltd
Collaborators
University of Southern California, National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), University of Cape Town, University of Alabama at Birmingham, Louisiana State University Health Sciences Center in New Orleans
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1. Study Identification

Unique Protocol Identification Number
NCT04446611
Brief Title
Clinical Study of STI Screening to Prevent Adverse Birth and New-born Outcomes
Official Title
Clinical Study of STI Screening to Prevent Adverse Birth and New-born Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 29, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Foundation for Professional Development (Pty) Ltd
Collaborators
University of Southern California, National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), University of Cape Town, University of Alabama at Birmingham, Louisiana State University Health Sciences Center in New Orleans

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study aims to evaluate different screening strategies to decrease the burden of Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT) and Trichomonas vaginalis (TV) among pregnant women, and reduce adverse birth outcomes. In turn it aims to evaluate the cost per pregnant woman screened and treated, cost of adverse birth outcomes, and cost-effectiveness per sexually transmitted infection (STI) and disability-adjusted life-year (DALY) averted. Furthermore, this study will incorporate a vaginal microbiome sub-study aimed to investigate the relationship between the vaginal microbiome and persistent Chlamydial infections in pregnant women. Aim 1 and 2: The intervention includes diagnostic testing at a woman's first antenatal care visit using the Xpert® platform with same-day treatment for Neisseria gonorrhoeae, Chlamydia trachomatis and Trichomonas vaginalis infection with either a test-of-cure three weeks post-treatment (arm 1) or a repeat test at 30-34 weeks gestation (arm 2) compared to the standard of care, i.e. syndromic management (arm 3). Aim 3: Case-control study to investigate role vaginal microbiome in STI treatment outcomes
Detailed Description
Prevalence of STIs is high among pregnant women in South Africa and most infections remain untreated. Untreated infections impact on pregnancy and birth outcomes. Good diagnostic and point-of-care (POC) tests are available, such as the GeneXpert platform. The health impact, cost-effectiveness and approaches to optimization of STI diagnostic screening during pregnancy are unknown. In order to 1) identify optimal, cost-effective screening strategies that decrease the burden of STIs during pregnancy and reduce adverse birth outcomes, 2) informs evidence to WHO's guidelines to introduce aetiologic STI screening globally and 3) elucidate the role of the vaginal microbiome in STI treatment outcomes, the investigators propose three Specific Aims: Evaluate different screening strategies to decrease the burden of Neisseria gonorrhoeae, Chlamydia trachomatis and Trichomonas vaginalis among pregnant women and reduce adverse birth outcomes Evaluate cost per pregnant woman screened and treated, cost of adverse birth outcomes, and cost-effectiveness per STI and disability-adjusted life-year (DALY) averted Investigate the relationship between the vaginal microbiome and persistent Chlamydial infections in pregnant women STI screening and treatment for Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis will be offered to HIV-infected and non-infected women (age >18 years) whom present for first antenatal care services. An effectiveness-implementation hybrid type 1 three-arm (1:1:1) randomized controlled trial (RCT), will be employed to evaluate different screening strategies to decrease the burden of Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis among pregnant women, and reduce adverse birth outcomes. The costs of the different STI screening strategies relative to control will be estimated based on literature review and performance/implementation characteristics and compared, in addition to the costs of managing adverse birth outcomes. Decision analytic modelling will estimate the cost-effectiveness per STI, and DALY averted (Aim 2). Depending on the randomization arm, participants will be scheduled to be seen various times throughout pregnancy by the study team; antenatal care visits will be conducted in line with national policy. All post-partum mothers and infants will be asked to be seen at the first post-delivery clinic visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexually Transmitted Infection, HIV/AIDS, Cost-effectiveness, Birth Outcomes, Vaginal Microbiome, Neisseria Gonorrhoeae, Chlamydia Trachomatis, Trichomonas Vaginalis, Antenatal Care, Pregnancy
Keywords
Sexually transmitted infection, Neisseria gonorrhoeae, Chlamydia trachomatis, Trichomonas vaginalis, Antenatal care, HIV/AIDS, Birth outcomes, South Africa, Vaginal microbiome, Pregnancy, Diagnostic testing

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The intervention will incorporate diagnostic testing using the Xpert® platform with same-day treatment for Neisseria gonorrhoeae, Chlamydia trachomatis and Trichomonas vaginalis infection at first ANC (aim 1 and 2) with either a test-of-cure (arm 1) or 30 weeks repeat testing as follow-up (arm 2) compared to the standard of care (arm 3), i.e. syndromic management as per the South African guidelines. It is thus a 3-arm (1:1:1) control trial with additional components of vaginal microbiome analysis, economic evaluation and qualitative insights.
Masking
None (Open Label)
Masking Description
The allocation of study arm is concealed to study staff during randomization
Allocation
Randomized
Enrollment
2500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Test at 1st ANC + Test-of-Cure (Treatment 1)
Arm Type
Experimental
Arm Description
Single point-in-time diagnostic screening plus test-of-cure three weeks post-treatment
Arm Title
Test at 1st ANC + 30-34 gestation (Treatment 2)
Arm Type
Experimental
Arm Description
Repeated diagnostic screening at first antenatal care and 30-34 weeks gestation
Arm Title
Syndromic Management (Control)
Arm Type
No Intervention
Arm Description
Syndromic management (standard of care) at every antenatal care visit per South African National Guidelines.
Intervention Type
Diagnostic Test
Intervention Name(s)
First antenatal care + test-of-cure
Intervention Description
Single point-in-time molecular point-of-care diagnostic screening and treatment for Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis at first antenatal care visit and infection-specific test-of-cure 3 weeks post-treatment. Women with a positive test-of-cure will be re-treated. As CT/NG is a combined Xpert test, women who present with an incident infection (newly diagnosed infection) will be treated and managed accordingly.
Intervention Type
Diagnostic Test
Intervention Name(s)
First antenatal care + week 30-34 gestation (no test-of-cure)
Intervention Description
Repeated molecular point-of-care diagnostic screening and treatment for Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis at first antenatal care visit and at week 30-34 gestation. No test-of-cure will be conducted for women with positive test results; however, additional treatment will be provided to women with persistent/recurrent vaginal discharge.
Primary Outcome Measure Information:
Title
Frequency of adverse birth outcomes among study arms
Description
Adverse birth outcomes as defined by a composite measure of preterm birth (born alive before 370/7 weeks gestation) or low birth weight (less than 2500g) as recorded in the maternity case records
Time Frame
Recorded within 2 weeks of delivery
Secondary Outcome Measure Information:
Title
Change in STI prevalence (a) between baseline visit and delivery within the experimental arms and (b) between the experimental and control arms by delivery.
Description
To calculate the relative and absolute change in Chlamydia, Gonorrhea, and Trichomoniasis prevalence. Additionally, generalized estimating equations to test for variation in STI prevalence among study arms will be done, adjusting for potential effect modifiers and confounding variables
Time Frame
Between baseline (first antenatal visit <27 weeks' gestation) and delivery outcome (collected within 2 weeks post-delivery)
Title
Correlation between Bacterial vaginosis-associated vaginal community state types and clearance of Chlamydia infection
Description
To determine the correlation between Bacterial vaginosis-associated vaginal community state types and chlamydial infection clearance as measured by a positive or negative chlamydial test result no less than three weeks after treatment and thence weekly until a negative Chlamydia test result is recorded.
Time Frame
Assessed through study completion
Title
Incidence of Preterm birth among study arms
Description
The frequency of live births before 37 weeks' gestation, as validated by ultrasound dating at first antenatal visit
Time Frame
At delivery
Title
Incidence of Low birthweight infants among study arms
Description
The frequency of live births with birth weight < 2500g, as recorded in the maternity case records
Time Frame
Within 2 weeks post-delivery
Title
Incidence of STI in infants exposed to infection in their mothers
Description
Frequency of Chlamydia, Gonorrhoeae, and/or Trichomonas infection among infants born to a mother in whom infection is detected post-delivery
Time Frame
STI testing in mother and infants within 2 weeks post-delivery to a maximum of 6 weeks post-delivery
Title
Frequency of fetal loss (miscarriage or stillbirth) among study arms
Description
Composite frequency of miscarriage (<28 weeks' gestation) or stillbirth (> 28 weeks' gestation) and the individual components, as indicated in the maternal case records
Time Frame
Assessed through study completion

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for pregnant women: Age≥18 years Currently pregnant based on positive urine pregnancy test Attending first ANC visit for current pregnancy Gestational age <20 weeks Agreeing to nurse-collected specimens Resident in Buffalo City Municipality (BCM) Intent to deliver in one of the four midwife obstetric units (MOUs) in BCM Gestational age will be confirmed via ultrasound Exclusion Criteria: Planning to relocate during pregnancy or deliver in an MOU outside of BCM Unknown HIV status (e.g. refusal, invalid test result) Currently participating in another ANC/HIV study When the ultrasound confirms ≥20 weeks gestation at first ANC Inclusion criteria for Neonates: 1) born to mothers that provided informed consent to participate in study, 2) provision of updated verbal consent by mother to collect and test specimens for STIs
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew Medina-Marino, PhD, MPH
Phone
+27 43 726 7538
Email
AndrewM@foundation.co.za
First Name & Middle Initial & Last Name or Official Title & Degree
Jeffrey Klausner, MD, MPH
Phone
+1 323-442-1100
Email
jdklausner@med.usc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Medina-Marino, PhD, MPH
Organizational Affiliation
Foundation for Professional Development
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeffrey Klausner, MD, MPH
Organizational Affiliation
USC Keck School of Medicine - University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Buffalo City Metro
City
East London
State/Province
Eastern Cape
ZIP/Postal Code
5217
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Medina-Marino, PhD, MPH
Phone
+27 43 726 7538
Email
AndrewM@foundation.co.za
First Name & Middle Initial & Last Name & Degree
Andrew Medina-Marino, PhD, MPH
First Name & Middle Initial & Last Name & Degree
Jeffrey Klausner, MD, MPH

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Access Criteria
Based on contractual agreement
Citations:
PubMed Identifier
35610666
Citation
Medina-Marino A, Cleary S, Muzny CA, Taylor C, Tamhane A, Ngwepe P, Bezuidenhout C, Facente SN, Mlisana K, Peters RPH, Klausner JD. Sexually transmitted infection screening to prevent adverse birth and newborn outcomes: study protocol for a randomized-controlled hybrid-effectiveness trial. Trials. 2022 May 24;23(1):441. doi: 10.1186/s13063-022-06400-y.
Results Reference
derived

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Clinical Study of STI Screening to Prevent Adverse Birth and New-born Outcomes

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