eisseria Gonorrhoeae and Chlamydia Trachomatis Infection Prevalence in Lusaka, Zambia

Not Applicable

• Conditions: Sexually Transmitted Infections

• Registration Number: PACTR202403598655447
• Lead Sponsor: Global Antibiotics Research and Development Partnership

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-03-05
• Last Update Posted: 8 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 1973

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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