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| ID | Type | Description | Link |
|---|---|---|---|
| R01AI149339 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Southern California | OTHER |
| National Institutes of Health (NIH) | NIH |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test at 1st ANC + Test-of-Cure (Treatment 1) | Experimental | Single point-in-time diagnostic screening plus test-of-cure three weeks post-treatment |
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| Test at 1st ANC + 30-34 gestation (Treatment 2) | Experimental | Repeated diagnostic screening at first antenatal care and 30-34 weeks gestation |
|
| Syndromic Management (Control) | No Intervention | Syndromic management (standard of care) at every antenatal care visit per South African National Guidelines. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| First antenatal care + test-of-cure | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Recorded within 2 weeks of delivery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria for pregnant women:
Gestational age will be confirmed via ultrasound
Exclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Medina-Marino, PhD, MPH | Foundation for Professional Development | Principal Investigator |
| Jeffrey Klausner, MD, MPH | USC Keck School of Medicine - University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Buffalo City Metro | East London | Eastern Cape | 5217 | South Africa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42078373 | Derived | Medina-Marino A, Babalola CM, Mdingi MM, Wilson ML, Mukomana F, Muzny CA, Taylor CM, Gigi RM, Jung H, Low N, Peters RP, Klausner JD. Antenatal Screening for Sexually Transmitted Infections to Reduce Preterm Birth or Low Birthweight (Philani Ndiphile Study): A Randomized Three-Group Trial. medRxiv [Preprint]. 2026 Apr 21:2026.04.15.26350805. doi: 10.64898/2026.04.15.26350805. | |
| 35610666 | Derived | 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. |
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Based on contractual agreement
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 23, 2026 | |
| Reset | Apr 8, 2026 | |
| Release | Apr 13, 2026 |
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| University of Cape Town |
| OTHER |
| University of Alabama at Birmingham | OTHER |
| Louisiana State University Health Sciences Center in New Orleans | OTHER |
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.
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The allocation of study arm is concealed to study staff during randomization
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| First antenatal care + week 30-34 gestation (no test-of-cure) | Diagnostic Test | 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. |
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| Between baseline (first antenatal visit <27 weeks' gestation) and delivery outcome (collected within 2 weeks post-delivery) |
| 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. | Assessed through study completion |
| 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 | At delivery |
| Incidence of Low birthweight infants among study arms | The frequency of live births with birth weight < 2500g, as recorded in the maternity case records | Within 2 weeks post-delivery |
| 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 | STI testing in mother and infants within 2 weeks post-delivery to a maximum of 6 weeks 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 | Assessed through study completion |
| Reset | May 1, 2026 |
| Release | May 6, 2026 |
| Reset | Jun 1, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 23, 2026 | Apr 8, 2026 | |||
| Apr 13, 2026 | May 1, 2026 | |||
| May 6, 2026 | Jun 1, 2026 |
| ID | Term |
|---|---|
| D012749 | Sexually Transmitted Diseases |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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