Sexually Transmitted InfectionIPSAZNCT05541081
Investigating Point-of-care Diagnostics for Sexually Transmitted Infections and Antimicrobial Resistance in Primary Care in Zimbabwe
A study testing Point-of-care STI testing in people with Sexually Transmitted Infection and Chlamydia, run by London School of Hygiene and Tropical Medicine at 1 site in Zimbabwe.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Sexually Transmitted Infection, Chlamydia, Gonorrhea
- What is being tested?
- Point-of-care STI testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,005 participants
- Where
- 1 siteZimbabwe
- Study dates
- 12 Jan 2023to 29 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pregnant woman
- Attending a study site for antenatal care
Who cannot join
- Enrolment in this study on a previous antenatal visit
- Unable to provide consent in English or Shona
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- 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.
- Conditions
- Sexually Transmitted Infection, Chlamydia, Gonorrhea, Trichomoniasis, Syphilis, Hepatitis B
- Being tested
- Point-of-care STI testing
- Keywords
- Antenatal care, Sexual and reproductive healthcare, Zimbabwe
- Medical subject headings
- Sexually Transmitted Diseases, Chlamydia Infections, Gonorrhea, Trichomonas Infections, Syphilis, Hepatitis B, HIV Infections, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of-care STI testingDiagnostic test
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)
| Study group | Role | What they receive |
|---|---|---|
| Point-of-care STI testing | Other | Provision of point-of-care testing for chlamydia, gonorrhoea, trichomoniasis, syphilis, HIV, and hepatitis B, with comprehensive case management including partner notification Receives: Diagnostic Test: Point-of-care STI testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite STI prevalence
Composite % of participants with chlamydia, gonorrhoea, trichomoniasis, syphilis, and/or hepatitis B
Measured: Through study completion, up to 1 year
Individual STI prevalences
Individual % of participants with chlamydia, gonorrhoea, trichomoniasis, syphilis, and hepatitis B
Measured: Through study completion, up to 1 year
Secondary outcomes (6)
Uptake of STI testing
% of individuals approached who accept and undergo testing
Measured: Through study completion, up to 1 year
Yield of STI testing
% of individuals approached who test positive for an STI
Measured: Through study completion, up to 1 year
Uptake of treatment
% of participants with a curable STI who accept treatment
Measured: Through study completion, up to 1 year
Uptake of partner notification
% of participants with a curable STI who undertake partner notification
Measured: 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
Measured: Through study completion, up to 1 year
Prevalence of adverse birth outcomes
% of pregnancies with premature birth, miscarriage, or low birth weight
Measured: Through study completion, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start12 Jan 2023
- Primary completion23 Oct 2023
- Study completion29 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sexually Transmitted InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,005 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Biomedical Research and Training Institute
- Responsible party
- Sponsor
- Investigators
- Kevin Martin, MBBS, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05541081
- Sponsor's protocol ID
- 26787
- Acronym
- IPSAZ
- Status last verified
- Sep 2025
- First submitted
- 23 Aug 2022
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Martin K, Bath D, Nyamwanza R, Dauya E, Bandason T, Dziva Chikwari C, Simms V, Tucker JD, Machiha A, Marks M, Kranzer K, Ferrand RA. Point-of-care screening for curable sexually transmitted infections in antenatal care in Zimbabwe: a costing study. Sex Transm Infect. 2026 Jul 7:sextrans-2025-056899. doi: 10.1136/sextrans-2025-056899. Online ahead of print.
PubMed 42414214Martin K, Mackworth-Young CRS, Dauya E, Nyamwanza R, Dziva Chikwari C, Tshuma M, Tucker JD, Simms V, Bandason T, Ndowa F, Katsidzira L, Mugurungi O, Machiha A, Peters RPH, Marks M, Kranzer K, Ferrand RA. Integrating point-of-care screening for curable sexually transmitted infections with HIV, syphilis and hepatitis B screening in antenatal care services in Zimbabwe: a mixed-methods process evaluation. BMJ Glob Health. 2025 Dec 5;10(12):e019820. doi: 10.1136/bmjgh-2025-019820.
PubMed 41360480Martin K, Mackworth-Young CRS, Nyamwanza R, Chikwari CD, Dauya E, Tucker JD, Simms V, Bandason T, Ndowa F, Machiha A, Bernays S, Marks M, Kranzer K, Ferrand RA. Financial incentives to improve uptake of partner treatment for sexually transmitted infections in antenatal care: a cluster randomised trial in Zimbabwe. Lancet Glob Health. 2025 Dec;13(12):e2097-e2110. doi: 10.1016/S2214-109X(25)00306-7.
PubMed 41240948Martin K, Dziva Chikwari C, Dauya E, Mackworth-Young CRS, Bath D, Tucker J, Simms V, Bandason T, Ndowa F, Katsidzira L, Mugurungi O, Machiha A, Marks M, Kranzer K, Ferrand R. Investigating point-of-care diagnostics for sexually transmitted infections and antimicrobial resistance in antenatal care in Zimbabwe (IPSAZ): protocol for a mixed-methods study. BMJ Open. 2023 Apr 20;13(4):e070889. doi: 10.1136/bmjopen-2022-070889.
PubMed 37080628
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Point-of-care Diagnostics for Sexually Transmitted Infections and Antimicrobial Resistance in Primary Care in Zimbabwe
- ClinicalTrials.gov ID
- NCT05541081
- Acronym / sponsor ID
- IPSAZ / 26787
- Conditions
- Sexually Transmitted Infection, Chlamydia, Gonorrhea, Trichomoniasis, Syphilis, Hepatitis B
- Keywords
- Antenatal care, Sexual and reproductive healthcare, Zimbabwe
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,005 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Biomedical Research and Training Institute
- Study start
- 12 Jan 2023 (actual)
- Primary completion
- 23 Oct 2023 (actual)
- Study completion
- 29 Apr 2024 (actual)
- First posted
- 15 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Point-of-care STI testing | Other | Diagnostic Test: Point-of-care STI testingProvision of point-of-care testing for chlamydia, gonorrhoea, trichomoniasis, syphilis, HIV, and hepatitis B, with comprehensive case management including partner notification |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Pregnant woman
- Attending a study site for antenatal care
Key exclusion criteria (2 listed)
- Enrolment in this study on a previous antenatal visit
- Unable to provide consent in English or Shona
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point-of-care STI testingTesting 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) | Diagnostic test | Point-of-care STI testing |
Primary outcome
Composite STI prevalence
Time frame: Through study completion, up to 1 year
Composite % of participants with chlamydia, gonorrhoea, trichomoniasis, syphilis, and/or hepatitis B
Individual STI prevalences
Time frame: Through study completion, up to 1 year
Individual % of participants with chlamydia, gonorrhoea, trichomoniasis, syphilis, and hepatitis B
6 secondary outcomes
Uptake of STI testing
Time frame: Through study completion, up to 1 year
Yield of STI testing
Time frame: Through study completion, up to 1 year
Uptake of treatment
Time frame: Through study completion, up to 1 year
Uptake of partner notification
Time frame: Through study completion, up to 1 year
Prevalence of antimicrobial resistance in gonococcal isolates
Time frame: Through study completion, up to 1 year
Prevalence of adverse birth outcomes
Time frame: Through study completion, up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Derived from this study: PubMed 42414214Martin K, Bath D, Nyamwanza R, Dauya E, Bandason T, Dziva Chikwari C, Simms V, Tucker JD, Machiha A, Marks M, Kranzer K, Ferrand RA. Point-of-care screening for curable sexually transmitted infections in antenatal care in Zimbabwe: a costing study. Sex Transm Infect. 2026 Jul 7:sextrans-2025-056899. doi: 10.1136/sextrans-2025-056899. Online ahead of print.
- Derived from this study: PubMed 41360480Martin K, Mackworth-Young CRS, Dauya E, Nyamwanza R, Dziva Chikwari C, Tshuma M, Tucker JD, Simms V, Bandason T, Ndowa F, Katsidzira L, Mugurungi O, Machiha A, Peters RPH, Marks M, Kranzer K, Ferrand RA. Integrating point-of-care screening for curable sexually transmitted infections with HIV, syphilis and hepatitis B screening in antenatal care services in Zimbabwe: a mixed-methods process evaluation. BMJ Glob Health. 2025 Dec 5;10(12):e019820. doi: 10.1136/bmjgh-2025-019820.
- Derived from this study: PubMed 41240948Martin K, Mackworth-Young CRS, Nyamwanza R, Chikwari CD, Dauya E, Tucker JD, Simms V, Bandason T, Ndowa F, Machiha A, Bernays S, Marks M, Kranzer K, Ferrand RA. Financial incentives to improve uptake of partner treatment for sexually transmitted infections in antenatal care: a cluster randomised trial in Zimbabwe. Lancet Glob Health. 2025 Dec;13(12):e2097-e2110. doi: 10.1016/S2214-109X(25)00306-7.
- Derived from this study: PubMed 37080628Martin K, Dziva Chikwari C, Dauya E, Mackworth-Young CRS, Bath D, Tucker J, Simms V, Bandason T, Ndowa F, Katsidzira L, Mugurungi O, Machiha A, Marks M, Kranzer K, Ferrand R. Investigating point-of-care diagnostics for sexually transmitted infections and antimicrobial resistance in antenatal care in Zimbabwe (IPSAZ): protocol for a mixed-methods study. BMJ Open. 2023 Apr 20;13(4):e070889. doi: 10.1136/bmjopen-2022-070889.
- The Health Research Unit Zimbabwe (THRU ZIM)Link provided by the sponsor.
- LSHTM Data CompassLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Martin, MBBS principal investigator
London School of Hygiene and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Point-of-care STI testing in people with Sexually Transmitted Infection and Chlamydia, run by London School of Hygiene and Tropical Medicine at 1 site in Zimbabwe.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zimbabwe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite STI prevalence (time frame: Through study completion, up to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05541081, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.