<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04446611</url>
  </required_header>
  <id_info>
    <org_study_id>R01AI149339</org_study_id>
    <secondary_id>R01AI149339</secondary_id>
    <nct_id>NCT04446611</nct_id>
  </id_info>
  <brief_title>Clinical Study of STI Screening to Prevent Adverse Birth and New-born Outcomes</brief_title>
  <official_title>Clinical Study of STI Screening to Prevent Adverse Birth and New-born Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Foundation for Professional Development (Pty) Ltd</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Cape Town</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Louisiana State University Health Sciences Center in New Orleans</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Foundation for Professional Development (Pty) Ltd</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to evaluate different screening strategies to decrease the burden of&#xD;
      Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT) and Trichomonas vaginalis (TV) among&#xD;
      pregnant women, and reduce adverse birth outcomes. In turn it aims to evaluate the cost per&#xD;
      pregnant woman screened and treated, cost of adverse birth outcomes, and cost-effectiveness&#xD;
      per sexually transmitted infection (STI) and disability-adjusted life-year (DALY) averted.&#xD;
      Furthermore, this study will incorporate a vaginal microbiome sub-study aimed to investigate&#xD;
      the relationship between the vaginal microbiome and persistent Chlamydial infections in&#xD;
      pregnant women.&#xD;
&#xD;
      Aim 1 and 2: The intervention includes diagnostic testing at a woman's first antenatal care&#xD;
      visit using the Xpert® platform with same-day treatment for Neisseria gonorrhoeae, Chlamydia&#xD;
      trachomatis and Trichomonas vaginalis infection with either a test-of-cure three weeks&#xD;
      post-treatment (arm 1) or a repeat test at 30-34 weeks gestation (arm 2) compared to the&#xD;
      standard of care, i.e. syndromic management (arm 3).&#xD;
&#xD;
      Aim 3: Case-control study to investigate role vaginal microbiome in STI treatment outcomes&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prevalence of STIs is high among pregnant women in South Africa and most infections remain&#xD;
      untreated. Untreated infections impact on pregnancy and birth outcomes. Good diagnostic and&#xD;
      point-of-care (POC) tests are available, such as the GeneXpert platform. The health impact,&#xD;
      cost-effectiveness and approaches to optimization of STI diagnostic screening during&#xD;
      pregnancy are unknown.&#xD;
&#xD;
      In order to 1) identify optimal, cost-effective screening strategies that decrease the burden&#xD;
      of STIs during pregnancy and reduce adverse birth outcomes, 2) informs evidence to WHO's&#xD;
      guidelines to introduce aetiologic STI screening globally and 3) elucidate the role of the&#xD;
      vaginal microbiome in STI treatment outcomes, the investigators propose three Specific Aims:&#xD;
&#xD;
        1. Evaluate different screening strategies to decrease the burden of Neisseria gonorrhoeae,&#xD;
           Chlamydia trachomatis and Trichomonas vaginalis among pregnant women and reduce adverse&#xD;
           birth outcomes&#xD;
&#xD;
        2. Evaluate cost per pregnant woman screened and treated, cost of adverse birth outcomes,&#xD;
           and cost-effectiveness per STI and disability-adjusted life-year (DALY) averted&#xD;
&#xD;
        3. Investigate the relationship between the vaginal microbiome and persistent Chlamydial&#xD;
           infections in pregnant women&#xD;
&#xD;
      STI screening and treatment for Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas&#xD;
      vaginalis will be offered to HIV-infected and non-infected women (age &gt;18 years) whom present&#xD;
      for first antenatal care services. An effectiveness-implementation hybrid type 1 three-arm&#xD;
      (1:1:1) randomized controlled trial (RCT), will be employed to evaluate different screening&#xD;
      strategies to decrease the burden of Chlamydia trachomatis, Neisseria gonorrhoeae and&#xD;
      Trichomonas vaginalis among pregnant women, and reduce adverse birth outcomes.&#xD;
&#xD;
      The costs of the different STI screening strategies relative to control will be estimated&#xD;
      based on literature review and performance/implementation characteristics and compared, in&#xD;
      addition to the costs of managing adverse birth outcomes. Decision analytic modelling will&#xD;
      estimate the cost-effectiveness per STI, and DALY averted (Aim 2).&#xD;
&#xD;
      Depending on the randomization arm, participants will be scheduled to be seen various times&#xD;
      throughout pregnancy by the study team; antenatal care visits will be conducted in line with&#xD;
      national policy. All post-partum mothers and infants will be asked to be seen at the first&#xD;
      post-delivery clinic visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 29, 2021</start_date>
  <completion_date type="Anticipated">April 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_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.</intervention_model_description>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>The allocation of study arm is concealed to study staff during randomization</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of adverse birth outcomes among study arms</measure>
    <time_frame>Recorded within 2 weeks of delivery</time_frame>
    <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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in STI prevalence (a) between baseline visit and delivery within the experimental arms and (b) between the experimental and control arms by delivery.</measure>
    <time_frame>Between baseline (first antenatal visit &lt;27 weeks' gestation) and delivery outcome (collected within 2 weeks post-delivery)</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between Bacterial vaginosis-associated vaginal community state types and clearance of Chlamydia infection</measure>
    <time_frame>Assessed through study completion</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Preterm birth among study arms</measure>
    <time_frame>At delivery</time_frame>
    <description>The frequency of live births before 37 weeks' gestation, as validated by ultrasound dating at first antenatal visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Low birthweight infants among study arms</measure>
    <time_frame>Within 2 weeks post-delivery</time_frame>
    <description>The frequency of live births with birth weight &lt; 2500g, as recorded in the maternity case records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of STI in infants exposed to infection in their mothers</measure>
    <time_frame>STI testing in mother and infants within 2 weeks post-delivery to a maximum of 6 weeks post-delivery</time_frame>
    <description>Frequency of Chlamydia, Gonorrhoeae, and/or Trichomonas infection among infants born to a mother in whom infection is detected post-delivery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of fetal loss (miscarriage or stillbirth) among study arms</measure>
    <time_frame>Assessed through study completion</time_frame>
    <description>Composite frequency of miscarriage (&lt;28 weeks' gestation) or stillbirth (&gt; 28 weeks' gestation) and the individual components, as indicated in the maternal case records</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">2500</enrollment>
  <condition>Sexually Transmitted Infection</condition>
  <condition>HIV/AIDS</condition>
  <condition>Cost-effectiveness</condition>
  <condition>Birth Outcomes</condition>
  <condition>Vaginal Microbiome</condition>
  <condition>Neisseria Gonorrhoeae</condition>
  <condition>Chlamydia Trachomatis</condition>
  <condition>Trichomonas Vaginalis</condition>
  <condition>Antenatal Care</condition>
  <condition>Pregnancy</condition>
  <arm_group>
    <arm_group_label>Test at 1st ANC + Test-of-Cure (Treatment 1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single point-in-time diagnostic screening plus test-of-cure three weeks post-treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Test at 1st ANC + 30-34 gestation (Treatment 2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Repeated diagnostic screening at first antenatal care and 30-34 weeks gestation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Syndromic Management (Control)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Syndromic management (standard of care) at every antenatal care visit per South African National Guidelines.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>First antenatal care + test-of-cure</intervention_name>
    <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.</description>
    <arm_group_label>Test at 1st ANC + Test-of-Cure (Treatment 1)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>First antenatal care + week 30-34 gestation (no test-of-cure)</intervention_name>
    <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.</description>
    <arm_group_label>Test at 1st ANC + 30-34 gestation (Treatment 2)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria for pregnant women:&#xD;
&#xD;
          1. Age≥18 years&#xD;
&#xD;
          2. Currently pregnant based on positive urine pregnancy test&#xD;
&#xD;
          3. Attending first ANC visit for current pregnancy&#xD;
&#xD;
          4. Gestational age &lt;20 weeks&#xD;
&#xD;
          5. Agreeing to nurse-collected specimens&#xD;
&#xD;
          6. Resident in Buffalo City Municipality (BCM)&#xD;
&#xD;
          7. Intent to deliver in one of the four midwife obstetric units (MOUs) in BCM&#xD;
&#xD;
        Gestational age will be confirmed via ultrasound&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Planning to relocate during pregnancy or deliver in an MOU outside of BCM&#xD;
&#xD;
          2. Unknown HIV status (e.g. refusal, invalid test result)&#xD;
&#xD;
          3. Currently participating in another ANC/HIV study&#xD;
&#xD;
          4. When the ultrasound confirms ≥20 weeks gestation at first ANC&#xD;
&#xD;
        Inclusion criteria for Neonates:&#xD;
&#xD;
        1) born to mothers that provided informed consent to participate in study, 2) provision of&#xD;
        updated verbal consent by mother to collect and test specimens for STIs&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew Medina-Marino, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Foundation for Professional Development</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jeffrey Klausner, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>USC Keck School of Medicine - University of Southern California</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Andrew Medina-Marino, PhD, MPH</last_name>
    <phone>+27 43 726 7538</phone>
    <email>AndrewM@foundation.co.za</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jeffrey Klausner, MD, MPH</last_name>
    <phone>+1 323-442-1100</phone>
    <email>jdklausner@med.usc.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Buffalo City Metro</name>
      <address>
        <city>East London</city>
        <state>Eastern Cape</state>
        <zip>5217</zip>
        <country>South Africa</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrew Medina-Marino, PhD, MPH</last_name>
      <phone>+27 43 726 7538</phone>
      <email>AndrewM@foundation.co.za</email>
    </contact>
    <investigator>
      <last_name>Andrew Medina-Marino, PhD, MPH</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jeffrey Klausner, MD, MPH</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>South Africa</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>April 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>January 4, 2023</last_update_submitted>
  <last_update_submitted_qc>January 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sexually transmitted infection</keyword>
  <keyword>Neisseria gonorrhoeae</keyword>
  <keyword>Chlamydia trachomatis</keyword>
  <keyword>Trichomonas vaginalis</keyword>
  <keyword>Antenatal care</keyword>
  <keyword>HIV/AIDS</keyword>
  <keyword>Birth outcomes</keyword>
  <keyword>South Africa</keyword>
  <keyword>Vaginal microbiome</keyword>
  <keyword>Pregnancy</keyword>
  <keyword>Diagnostic testing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
    <mesh_term>HIV Infections</mesh_term>
    <mesh_term>Chlamydia Infections</mesh_term>
    <mesh_term>Gonorrhea</mesh_term>
    <mesh_term>Sexually Transmitted Diseases</mesh_term>
    <mesh_term>Trichomonas Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_access_criteria>Based on contractual agreement</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04446611
org study id: R01AI149339
secondary id: R01AI149339
nct id: NCT04446611
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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
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:

        1. Evaluate different screening strategies to decrease the burden of Neisseria gonorrhoeae,
           Chlamydia trachomatis and Trichomonas vaginalis among pregnant women and reduce adverse
           birth outcomes

        2. 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

        3. 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.
allocation: Randomized
intervention model: Parallel Assignment
intervention 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.
primary purpose: Screening
masking: None (Open Label)
masking description: The allocation of study arm is concealed to study staff during randomization
measure: Frequency of adverse birth outcomes among study arms
time frame: Recorded within 2 weeks of delivery
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
measure: Change in STI prevalence (a) between baseline visit and delivery within the experimental arms and (b) between the experimental and control arms by delivery.
time frame: Between baseline (first antenatal visit <27 weeks' gestation) and delivery outcome (collected within 2 weeks post-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
measure: Correlation between Bacterial vaginosis-associated vaginal community state types and clearance of Chlamydia infection
time frame: Assessed through study completion
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.
measure: Incidence of Preterm birth among study arms
time frame: At delivery
description: The frequency of live births before 37 weeks' gestation, as validated by ultrasound dating at first antenatal visit
measure: Incidence of Low birthweight infants among study arms
time frame: Within 2 weeks post-delivery
description: The frequency of live births with birth weight < 2500g, as recorded in the maternity case records
measure: Incidence of STI in infants exposed to infection in their mothers
time frame: STI testing in mother and infants within 2 weeks post-delivery to a maximum of 6 weeks post-delivery
description: Frequency of Chlamydia, Gonorrhoeae, and/or Trichomonas infection among infants born to a mother in whom infection is detected post-delivery
measure: Frequency of fetal loss (miscarriage or stillbirth) among study arms
time frame: Assessed through study completion
description: Composite frequency of miscarriage (<28 weeks' gestation) or stillbirth (> 28 weeks' gestation) and the individual components, as indicated in the maternal case records
arm group label: Test at 1st ANC + Test-of-Cure (Treatment 1)
arm group type: Experimental
description: Single point-in-time diagnostic screening plus test-of-cure three weeks post-treatment
arm group label: Test at 1st ANC + 30-34 gestation (Treatment 2)
arm group type: Experimental
description: Repeated diagnostic screening at first antenatal care and 30-34 weeks gestation
arm group label: Syndromic Management (Control)
arm group type: No Intervention
description: Syndromic management (standard of care) at every antenatal care visit per South African National Guidelines.
intervention type: Diagnostic Test
intervention name: First antenatal care + test-of-cure
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.
arm group label: Test at 1st ANC + Test-of-Cure (Treatment 1)
intervention type: Diagnostic Test
intervention name: First antenatal care + week 30-34 gestation (no test-of-cure)
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.
arm group label: Test at 1st ANC + 30-34 gestation (Treatment 2)
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Andrew Medina-Marino, PhD, MPH
role: Principal Investigator
affiliation: Foundation for Professional Development
last name: Jeffrey Klausner, MD, MPH
role: Principal Investigator
affiliation: USC Keck School of Medicine - University of Southern California
last name: Andrew Medina-Marino, PhD, MPH
phone: +27 43 726 7538
email: AndrewM@foundation.co.za
last name: Jeffrey Klausner, MD, MPH
phone: +1 323-442-1100
email: jdklausner@med.usc.edu
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: South Africa
responsible party type: Sponsor
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
mesh term: Chlamydia Infections
mesh term: Gonorrhea
mesh term: Sexually Transmitted Diseases
mesh term: Trichomonas Infections
sharing ipd: Yes
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Analytic Code
ipd access criteria: Based on contractual agreement