Investigating Point-of-care Diagnostics for Sexually Transmitted Infections and Antimicrobial Resistance in Primary Care in Zimbabwe
IPSAZ
1 other identifier
interventional
1,005
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 23, 2022
CompletedFirst Posted
Study publicly available on registry
September 15, 2022
CompletedStudy Start
First participant enrolled
January 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 23, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 29, 2024
CompletedSeptember 25, 2025
September 1, 2025
9 months
August 23, 2022
September 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (6)
Uptake of STI testing
Through study completion, up to 1 year
Yield of STI testing
Through study completion, up to 1 year
Uptake of treatment
Through study completion, up to 1 year
Uptake of partner notification
Through study completion, up to 1 year
Prevalence of antimicrobial resistance in gonococcal isolates
Through study completion, up to 1 year
- +1 more secondary outcomes
Study Arms (1)
Point-of-care STI testing
OTHERProvision of point-of-care testing for chlamydia, gonorrhoea, trichomoniasis, syphilis, HIV, and hepatitis B, with comprehensive case management including partner notification
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)
Eligibility Criteria
You may qualify if:
- Pregnant woman
- Attending a study site for antenatal care
You may not qualify if:
- Enrolment in this study on a previous antenatal visit
- Unable to provide consent in English or Shona
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mbare polyclinic
Harare, Zimbabwe
Related Publications (3)
Martin 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.
PMID: 41360480DERIVEDMartin 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.
PMID: 41240948DERIVEDMartin 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.
PMID: 37080628DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kevin Martin, MBBS
London School of Hygiene and Tropical Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2022
First Posted
September 15, 2022
Study Start
January 12, 2023
Primary Completion
October 23, 2023
Study Completion
April 29, 2024
Last Updated
September 25, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, 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.
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.