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

March 12, 2024 updated by: London School of Hygiene and Tropical Medicine
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1005

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Zimbabwe
      • Harare, Zimbabwe
        • Mbare polyclinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Point-of-care STI testing
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

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite STI prevalence
Time Frame: Through study completion, up to 1 year
Composite % of participants with chlamydia, gonorrhoea, trichomoniasis, syphilis, and/or hepatitis B
Through study completion, up to 1 year
Individual STI prevalences
Time Frame: Through study completion, up to 1 year
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
Time Frame: Through study completion, up to 1 year
% of individuals approached who accept and undergo testing
Through study completion, up to 1 year
Yield of STI testing
Time Frame: Through study completion, up to 1 year
% of individuals approached who test positive for an STI
Through study completion, up to 1 year
Uptake of treatment
Time Frame: Through study completion, up to 1 year
% of participants with a curable STI who accept treatment
Through study completion, up to 1 year
Uptake of partner notification
Time Frame: Through study completion, up to 1 year
% of participants with a curable STI who undertake partner notification
Through study completion, up to 1 year
Prevalence of antimicrobial resistance in gonococcal isolates
Time Frame: Through study completion, up to 1 year
% of gonococcal isolates with resistance to ceftriaxone, cefixime, azithromycin, and ciprofloxacin
Through study completion, up to 1 year
Prevalence of adverse birth outcomes
Time Frame: Through study completion, up to 2 years
% of pregnancies with premature birth, miscarriage, or low birth weight
Through study completion, up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

London School of Hygiene and Tropical Medicine

Collaborators

Biomedical Research and Training Institute

Investigators

  • Principal Investigator: Kevin Martin, MBBS, London School of Hygiene and Tropical Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2023

Primary Completion (Actual)

October 23, 2023

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

August 23, 2022

First Submitted That Met QC Criteria

September 12, 2022

First Posted (Actual)

September 15, 2022

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26787

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Complete data will be shared 12 months after publication

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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