Chlamydia Trachomatis Infection, Gonorrhea, Neonatal Infection, Preterm Birth
Conditions
Keywords
chlamydia trachomatis, neisseria gonorrhoeae
Brief summary
To assess the effectiveness of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) testing and treatment during pregnancy to reduce adverse pregnancy and birth outcomes compared to the standard of care (treatment based on symptoms and signs).
Detailed description
In this study investigators are conducting a two-arm, cluster randomized trial to assess the effectiveness of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) testing and treatment during pregnancy to reduce adverse pregnancy and birth outcomes compared to the standard of care (treatment based on symptoms and signs). Investigators will enroll 500 asymptomatic pregnant women in the testing and treatment clinics, and they will receive CT and NG testing and appropriate treatment at their first antenatal care visit and at a visit during their third trimester. An additional 250 asymptomatic pregnant women will be enrolled in the standard of care clinics, and they will receive syndromic management with additional support for partner notification. All participants will be tested for CT and NG at the first postnatal visit and those who test positive will be offered infant testing. Investigators will determine if antenatal testing and treatment reduces maternal infections at delivery, preterm birth, low birth weight, and neonatal CT/NG infection. This study will provide evidence to help evaluate the effects of testing on vertical transmission and clinically important pregnancy neonatal health outcomes, and to evaluate and understand biological correlates of transmission.
Interventions
OTHERChlamydia trachomatis and Neisseria gonorrhoeae screening using the GeneXpert
Chlamydia trachomatis and Neisseria gonorrhoeae testing using the GeneXpert
Sponsors
Botswana Harvard AIDS Institute Partnership
University of California, San Diego
University of Southern California
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Intervention model description
Clinic randomized trial evaluating the effectiveness of antenatal CT and NG screening and treatment compared to the standard of care (treatment based on signs and symptoms) on pregnancy and neonatal outcomes.
Eligibility
Sex/Gender
FEMALE
Age
15 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age ≥ 15 years, * Currently pregnant, * Attending first ANC visit, * 27 weeks gestation or less * Not currently experiencing CT/NG-related symptoms (determined by validated screening tool), * Not treated for CT/NG in the past 30 days, * Willingness to provide self-collected specimens for CT/NG testing (for the STI-testing group, this will take place at their first ANC visit, at another visit in their third trimester, and at postnatal care. For the standard of care group, samples will only be collected at postnatal care), * Willingness to return for a test of cure if CT/NG test is positive during antenatal care, * Will reside in Gaborone through the time of delivery and 1st postnatal visit, * Willingness to have neonates tested for CT/NG at their first postnatal visit, * Mentally competent to understand the informed consent.
Exclusion criteria
* Not mentally competent to understand study procedures or give informed consent, * Individuals \< 15 years, * Men, * Women who are not pregnant, * Pregnant women not attending their first antenatal visit, * Pregnant women at \>27 weeks gestation * Pregnant women with current STI-related symptoms (will receive standard of care), * Treated for an STI in the past 30 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Women Diagnosed With C. Trachomatis and N. Gonorrhoeae Infection at Post-delivery | This outcome was assessed at the first postnatal care visit up to 12 weeks after delivery. | Results from GeneXpert PCR screening for Chlamydia trachomatis (CT) or Neisseria gonorrhoeae (NG) infection among postpartum women up 12 weeks after birth outcome. We compare the proportion with CT and/or NG in both study arms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Neonates Diagnosed With Chlamydia Trachomatis or Neisseria Gonorrhoeae Infection at Post-delivery. | This outcome will be assessed at the first postnatal care visit up to 12 weeks after delivery. | Infants of mothers who tested positive for Chlamydia trachomatis or Neisseria gonorrhoeae infection at the first postnatal care visit will be tested using the GeneXpert PCR. We will compare the number of infected neonates between two arms. |
Countries
Botswana, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Testing and Treatment Participants will receive CT and NG testing and treatment (if necessary) at their first antenatal care visit and a visit during their third trimester. Women will also receive support for partner notification. All women will receive postnatal testing and treatment. Those who test positive at the postnatal visit will be offered infant testing.
Chlamydia trachomatis and Neisseria gonorrhoeae screening using the GeneXpert: Chlamydia trachomatis and Neisseria gonorrhoeae testing using the GeneXpert | 251 |
| Standard of Care Participants will receive the standard of care for STI management, which is treatment based on signs and symptoms. Women will also receive support for partner notification. All women will receive postnatal testing and treatment. Those who test positive at the postnatal visit will be offered infant testing. | 249 |
| Total | 500 |
Baseline characteristics
| Characteristic | Standard of Care | Total | Testing and Treatment |
|---|---|---|---|
| Age, Categorical <=18 years | 13 Participants | 25 Participants | 12 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 236 Participants | 475 Participants | 239 Participants |
| Age, Continuous | 28 years | 28 years | 28 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 249 Participants | 500 Participants | 251 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Botswana | 249 participants | 500 participants | 251 participants |
| Sex: Female, Male Female | 249 Participants | 500 Participants | 251 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 251 | 1 / 249 |
| other Total, other adverse events | 0 / 251 | 0 / 249 |
| serious Total, serious adverse events | 16 / 251 | 15 / 249 |
Outcome results
Primary
Number of Women Diagnosed With C. Trachomatis and N. Gonorrhoeae Infection at Post-delivery
Results from GeneXpert PCR screening for Chlamydia trachomatis (CT) or Neisseria gonorrhoeae (NG) infection among postpartum women up 12 weeks after birth outcome. We compare the proportion with CT and/or NG in both study arms
Time frame: This outcome was assessed at the first postnatal care visit up to 12 weeks after delivery.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Testing and Treatment | Number of Women Diagnosed With C. Trachomatis and N. Gonorrhoeae Infection at Post-delivery | 2 Participants |
| Standard of Care | Number of Women Diagnosed With C. Trachomatis and N. Gonorrhoeae Infection at Post-delivery | 23 Participants |
Secondary
Number of Neonates Diagnosed With Chlamydia Trachomatis or Neisseria Gonorrhoeae Infection at Post-delivery.
Infants of mothers who tested positive for Chlamydia trachomatis or Neisseria gonorrhoeae infection at the first postnatal care visit will be tested using the GeneXpert PCR. We will compare the number of infected neonates between two arms.
Time frame: This outcome will be assessed at the first postnatal care visit up to 12 weeks after delivery.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Testing and Treatment | Number of Neonates Diagnosed With Chlamydia Trachomatis or Neisseria Gonorrhoeae Infection at Post-delivery. | 7 Participants |
| Standard of Care | Number of Neonates Diagnosed With Chlamydia Trachomatis or Neisseria Gonorrhoeae Infection at Post-delivery. | 3 Participants |