Sexually Transmitted Infections
Conditions
Interventions
STI screening test
Sponsors
Global Antibiotics Research and Development Partnership
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Pregnant women: 1. Pregnant women aged =15 years attending the ANC clinic in the 1st or 2nd trimester of pregnancy 2. Willingness and ability to provide laboratory specimens for NAAT NG/CT testing 3. Willingness and ability to give written informed assent or consent Adolescent girls and boys: 1. Sexually active girls and boys aged =15 to <19 years 2. Non-pregnant adolescent girls and boys attending the Youth Friendly Corner 3. Willingness and ability to provide laboratory specimens for NAAT NG/CT testing NG/CT testing 4. Willingness and ability to give written informed assent or consent KPs: 1. Male and female key population (HRM and FSW) attending the STI clinic =18 years 2. Willingness and ability to provide laboratory specimens for NAAT NG/CT testing 3. Willingness and ability to give written informed consent
Exclusion criteria
Exclusion criteria: Pregnant women: 1. Previously enrolled study participants (to avoid duplicate sampling) 2. Pregnant women with a high risk of obstetric complications following vaginal swab collection (e.g., history of recurrent pregnancy loss, ongoing spotting/bleeding, threatened abortion, cervical conization, etc.) as per investigator judgment. Adolescent girls and boys: 1. Previously enrolled study participants (to avoid duplicate sampling) 2. Use of any systemic or intravaginal antibiotics for syndromic management of STIs, for vaginal discharge or with activity against NG or CT within 30 days prior to study screening. KPs: 1. Previously enrolled study participants (to avoid duplicate sampling) 2. Use of any systemic or intravaginal antibiotics for syndromic management of STIs, for vaginal discharge or with activity against NG or CT within 30 days prior to study screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total number of cases of disease at a given time period/total population at the same time period, overall prevalence of NG, CT and NG+CT infection in each subgroup | — |
Secondary
| Measure | Time frame |
|---|---|
| - Prevalence and 95% CI of NG, CT and NG+CT infections by baseline sociodemographic characteristics including but not limited to category of age, FSW vs HRM, rural vs urban, trimester of pregnancy, HIV status, number of sexual partners. - Unadjusted and adjusted prevalence ratios and 95% CI for NG, CT and NG+CT infections in each cohort by same sociodemographic characteristics. - Prevalence of HIV (and syphilis in pregnant women) infections in each subgroup from existing health records obtained either at the same Screening visit or within 3 months prior to Screening visit. - Antimicrobial susceptibility profile (MIC for standard of care antibiotics + zoliflodacin) of gonococcal strains isolated on culture. - Uptake of partner referral, testing, and linkage to care | — |
Countries
Zambia
Contacts
Public ContactLebogang Tshehla
Clinical Trial Manager
Outcome results
None listed