Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202403598655447 Date of Approval: 18/03/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Neisseria Gonorrhoeae and Chlamydia Trachomatis Infection Prevalence in Lusaka, Zambia
Official scientific title Assessment of Neisseria Gonorrhoeae and Chlamydia Trachomatis Sexually Transmitted Infection Prevalence Among Pregnant Women, Adolescents and Key Populations in Lusaka, Zambia
Brief summary describing the background and objectives of the trial Sexually Transmitted Infections (STIs) are a growing public health issue in Zambia, with an estimated 200,000 cases treated annually. The number of new STIs has been increasing, from 237,531 cases in 2017 to 503,325 cases in 2021. National strategic plans have been implemented to address this issue, with a focus on HIV-positive pregnant women for syphilis testing and treatment. However, the burden of undiagnosed asymptomatic infections and data on STI prevalence and trends are lacking in low and middle-income countries. Target populations at high risk include adolescents, men who have sex with men, and female sex workers. A cross-sectional survey is recommended to estimate the prevalence of Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) infections, which can provide valuable information for advocacy, planning, and monitoring of STI interventions. CIDRZ, a research network with expertise in infectious diseases and maternal health, is well-positioned to conduct such a survey, with support from GARDP, a non-profit organization focused on developing new treatments for bacterial infections. Primary objective: To epidemiologically describe the prevalence of NG and/or CT in Lusaka, Zambia in the following subgroups - Pregnant women - Adolescents (males and non-pregnant females) - Key populations (MSM and FSW)
Type of trial Observational
Acronym (If the trial has an acronym then please provide) Prevalence
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Sexually Transmitted Infections
Purpose of the trial Prevalence Study
Anticipated trial start date 25/03/2024
Actual trial start date
Anticipated date of last follow up 14/04/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 1973
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STIZoli006 NHREB004/11/12/2023
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Single Group Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group STI screening test N/A Once only Vaginal swab or urine sample (males) for CT/NG NAAT 1973
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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 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. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 15 Month(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/11/2023 University of Zambia Biomedical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
P O Box 50110 Lusaka 10101 Zambia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 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 Up to six months
Secondary Outcome - 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 Up to six months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Centre for Infectious Disease Research in Zambia 34620 Corner of Lukasu and Danny Pule Road Lusaka 10101 Zambia
FUNDING SOURCES
Name of source Street address City Postal code Country
Global Antibiotics Research and Development Foundation 15 Chemin Camille-Vidart Geneva 1202 Switzerland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Global Antibiotics Research and Development Partnership 34620 Corner of Lukasu and Danny Pule Road Lusaka 10101 Zambia Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Albert Manasyan albert.manasyan@cidrz.org +260976448994 34620 Corner of Lukasu and Danny Pule Road
City Postal code Country Position/Affiliation
Lusaka 10101 Zambia Associate Professor
Role Name Email Phone Street address
Public Enquiries Lebogang Tshehla ltshehla@gardp.org +27721977932 35 Brickfield Road, Unit 12 First floor Brickfield CANVAS
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Clinical Trial Manager
Role Name Email Phone Street address
Scientific Enquiries Alison Luckey aluckey@gardp.org +41225590539 15 chemin Camille-Vidart
City Postal code Country Position/Affiliation
Geneva 1202 Switzerland Senior Medical Lead
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data will be shared according to GARDP Policy on Sharing of Clinical Trial Data and based on the following principles: * Before data collection, clinical trials sponsored by GARDP are registered on public databases such as the US NIH’s clinicaltrials.gov or the Pan-African Clinical Trials Registry (PACTR). * Before data collection, GARDP will also publish on its global website (GARDP.org) the synopsis of clinical trial protocols. * GARDP will ensure medical confidentiality is fully protected, and the privacy of individuals and the dignity of communities is fully respected when data is collected and, thereafter, shared. Patients will have the rights to refuse data sharing. *Prior to publication and after study completion, data sharing will be available on a request basis for research projects, based on a final and cleaned database. Requests for access will be examined by GARDP’s Scientific Advisory Committee. Criterion to be used by the Scientific Advisory Committee to determine the validity of requests for access to GARDP data include the scientific justification of the request, compliance by the requesting party with ethical considerations, and a commitment from the requesting party to share with GARDP and publish the results of the follow-on research. In addition, the applicant will commit to acknowledge the source of data. * GARDP will post key results of the research 12 months after completion of the trial. * Upon publication of study results: • GARDP will publish its studies, whether results are positive or negative, in open-access peer reviewed journals. • Data will be shared upon publication of study results, in line with the procedures of major medical journals including Nature, PLOS, BMJ, etc. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Data sharing will be made available on a request basis , based on a final and cleaned database (i.e., post database lock) Researchers wishing to access study data should contact GARDP representatives in the first instance.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information