Investigating Point-of-care Diagnostics for Sexually Transmitted Infections and Antimicrobial Resistance in Primary Care in Zimbabwe

Study Overview
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Brief Summary
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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.

Detailed Description
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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: 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 Assess the acceptability and feasibility of this intervention Estimate the cost and cost-effectiveness of POC STI testing Investigate the prevalence of antimicrobial resistance for Neisseria gonorrhoeae to inform the development of a gonococcal antimicrobial resistance surveillance programme 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.

Official Title
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Investigating Point-of-care Diagnostics for Sexually Transmitted Infections and Antimicrobial Resistance in Primary Care in Zimbabwe

Conditions
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Sexually Transmitted Infection, Chlamydia, Gonorrhea, Trichomoniasis, Syphilis, Hepatitis B, HIV Infections, Pregnancy, Sexually Transmitted Diseases

Intervention / Treatment
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* Diagnostic Test: Point-of-care STI testing


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Point-of-care STI testing<br>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<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite STI prevalence | Composite % of participants with chlamydia, gonorrhoea, trichomoniasis, syphilis, and/or hepatitis B | Through study completion, up to 1 year | 
| Individual STI prevalences | Individual % of participants with chlamydia, gonorrhoea, trichomoniasis, syphilis, and hepatitis B | Through study completion, up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uptake of STI testing | % of individuals approached who accept and undergo testing | Through study completion, up to 1 year | 
| Yield of STI testing | % of individuals approached who test positive for an STI | Through study completion, up to 1 year | 
| Uptake of treatment | % of participants with a curable STI who accept treatment | Through study completion, up to 1 year | 
| Uptake of partner notification | % of participants with a curable STI who undertake partner notification | 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 | Through study completion, up to 1 year | 
| Prevalence of adverse birth outcomes | % of pregnancies with premature birth, miscarriage, or low birth weight | Through study completion, up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antenatal care, Sexual and reproductive healthcare, Zimbabwe