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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05541081
Acronym
IPSAZ
Enrollment
1005
Registered
2022-09-15
Start date
2023-01-12
Completion date
2024-04-29
Last updated
2025-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Antenatal care, Sexual and reproductive healthcare, Zimbabwe

Brief summary

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

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.

Interventions

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)

Sponsors

Biomedical Research and Training Institute
CollaboratorOTHER
London School of Hygiene and Tropical Medicine
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Composite STI prevalenceThrough study completion, up to 1 yearComposite % of participants with chlamydia, gonorrhoea, trichomoniasis, syphilis, and/or hepatitis B
Individual STI prevalencesThrough study completion, up to 1 yearIndividual % of participants with chlamydia, gonorrhoea, trichomoniasis, syphilis, and hepatitis B

Secondary

MeasureTime frameDescription
Uptake of treatmentThrough study completion, up to 1 year% of participants with a curable STI who accept treatment
Uptake of partner notificationThrough study completion, up to 1 year% of participants with a curable STI who undertake partner notification
Uptake of STI testingThrough study completion, up to 1 year% of individuals approached who accept and undergo testing
Prevalence of adverse birth outcomesThrough study completion, up to 2 years% of pregnancies with premature birth, miscarriage, or low birth weight
Prevalence of antimicrobial resistance in gonococcal isolatesThrough study completion, up to 1 year% of gonococcal isolates with resistance to ceftriaxone, cefixime, azithromycin, and ciprofloxacin
Yield of STI testingThrough study completion, up to 1 year% of individuals approached who test positive for an STI

Countries

Zimbabwe

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 9, 2026