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:

1. Determine the uptake, prevalence and yield of chlamydia, gonorrhoea, trichomoniasis, syphilis and hepatitis B testing, and risk factors for infection among women attending for antenatal care
2. Assess the acceptability and feasibility of this intervention
3. Estimate the cost and cost-effectiveness of POC STI testing
4. Investigate the prevalence of antimicrobial resistance for Neisseria gonorrhoeae to inform the development of a gonococcal antimicrobial resistance surveillance programme
5. Assess an incentives-based approach to optimize uptake of client-referral partner notification.

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.

Inclusion criteria:

• Pregnant woman
• Attending a study site for antenatal care

Exclusion criteria:

• Enrolment in this study on a previous antenatal visit
• Unable to provide consent in English or Shona

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.

Complete data will be shared 12 months after publication

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.