An interventional study of Point-of-care STI testing in Sexually Transmitted Infection, Chlamydia and Gonorrhea, sponsored by London School of Hygiene and Tropical Medicine. Completed at 1 site in Zimbabwe. Open to female participants. Per ClinicalTrials.gov, last updated 2025-09-25.
Sponsored by London School of Hygiene and Tropical Medicine · Not applicable, Interventional, and Health services research
A prospective interventional study to evaluate a strategy of point-of-care testing for sexually transmitted infections including chlamydia, gonorrhoea, trichomoniasis, syphilis, and Hepatitis B with comprehensive case management including partner notification in antenatal settings in Harare province, Zimbabwe.
Sexually transmitted infections (STIs) can cause serious morbidity including pelvic inflammatory disease, infertility, poor mental health, adverse pregnancy outcomes and an increased risk of HIV transmission. In low and middle-income countries (LMICs), STIs are treated using syndromic management, which has poor sensitivity and specificity, leading to considerable levels of both underdiagnosis and overtreatment. In recent years, simpler diagnostic platforms for STIs have been developed. Development and evaluation of strategies for provision of diagnostic testing in LMICs are needed and the World Health Organization (WHO) has called for evidence to inform replacement of syndromic management by diagnostic testing.
The aim of this project is to evaluate a strategy of point-of-care (POC) testing for STIs including chlamydia, gonorrhoea, trichomoniasis, syphilis, and Hepatitis B with comprehensive case management including partner notification in antenatal settings in Harare province, Zimbabwe.
The objectives are to:
A prospective interventional study will be conducted in three primary healthcare clinics (PHCs) in Harare province, Zimbabwe. 1000 pregnant women will be recruited over a nine month period when registering for routine antenatal care. Testing will be staggered across sites so that testing will be available at each site for three months within the nine-month study period. All Identified STIs will be managed comprehensively including treatment and/or referral if required according to national guidelines, and partner notification and risk reduction counselling.
Given the relatively low number of gonococcal isolates likely to be obtained from pregnant women alone, men attending the PHCs with urethral discharge will be recruited to gain sufficient numbers to establish a surveillance programme. Urethral samples will be collected from 140 men with urethral discharge, to support the assessment of antimicrobial resistance amongst patients with gonorrhoea.
523 studies on the registry are indexed under Sexually Transmitted Diseases; 77 are open to participants now.
This study's enrollment of 1,005 is above the median of 449 across 425 interventional studies indexed under Sexually Transmitted Diseases.
Browse Sexually Transmitted Diseases studies →London School of Hygiene and Tropical Medicine is the lead sponsor of 298 studies on the registry; 15 are open to participants now.
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Exclusion criteria:
Provision of point-of-care testing for chlamydia, gonorrhoea, trichomoniasis, syphilis, HIV, and hepatitis B, with comprehensive case management including partner notification
Diagnostic Test: Point-of-care STI testing
Testing for: * Chlamydia and gonorrhoea using the GeneXpert platform (Cepheid) * Trichomoniasis using the OSOM Trichomonas Rapid Test (Sekisui Diagnostics) * HIV and syphilis using the SD BIOLINE HIV/Syphilis Duo (Abbott Diagnostics Medical Co. Ltd) * Hepatitis B using the HBsAg2 rapid test (Abbott Diagnostics Medical Co. Ltd)
Composite STI prevalence
Composite % of participants with chlamydia, gonorrhoea, trichomoniasis, syphilis, and/or hepatitis B
Time frame: Through study completion, up to 1 year
Individual STI prevalences
Individual % of participants with chlamydia, gonorrhoea, trichomoniasis, syphilis, and hepatitis B
Time frame: Through study completion, up to 1 year
Uptake of STI testing
% of individuals approached who accept and undergo testing
Time frame: Through study completion, up to 1 year
Yield of STI testing
% of individuals approached who test positive for an STI
Time frame: Through study completion, up to 1 year
Uptake of treatment
% of participants with a curable STI who accept treatment
Time frame: Through study completion, up to 1 year
Uptake of partner notification
% of participants with a curable STI who undertake partner notification
Time frame: Through study completion, up to 1 year
Prevalence of antimicrobial resistance in gonococcal isolates
% of gonococcal isolates with resistance to ceftriaxone, cefixime, azithromycin, and ciprofloxacin
Time frame: Through study completion, up to 1 year
Prevalence of adverse birth outcomes
% of pregnancies with premature birth, miscarriage, or low birth weight
Time frame: Through study completion, up to 2 years
Plan to share: Yes — At the time of publication of research, the subset of data required for the purposes of verifying research findings will be made available for sharing and will be placed in Data Compass (the LSHTM institutional research data repository). This repository will enable direct download of records with codebooks to enable replication of the data analyses. A more complete sharing of data with any research group requesting access to individual data records will be done 12 months after publication. At this point, all data and study tools will be made available through Data Compass. Data for sharing will be de-identified prior to release. In addition, annotated questionnaires and STATA do-files used for data cleaning and analysis will be available. All databases will be accessible to authorised personnel only. Details of how to access data will be published with each study publication.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Complete data will be shared 12 months after publication
Access criteria: If access to the data is requested for the purposes of re-analysis and publication, such access will only be granted if a Zimbabwean colleague is included in any resulting manuscripts as a collaborator and author. Data users will be required to acknowledge the source of data and to ensure that the regulatory requirements of the Medical Research Council of Zimbabwe (MRCZ) are met.
Ran from Jan 2023 to primary completion in Oct 2023, 9 months.
Of 172 non-industry interventional studies with no phase under Sexually Transmitted Diseases, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 47. This study's 9 months is below that.
Counting every sponsor, half of 182 studies reached it within 31 months; a quarter within 16 and three quarters within 46.
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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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