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

HIV Infections Clinical Trial

— IPSAZ  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05541081
• Other study ID #: 26787
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 12, 2023
• Est. completion date: April 2024

Study information

• Verified date: March 2024
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1005
• Est. completion date: April 2024
• Est. primary completion date: October 23, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Chlamydia
• Communicable Diseases
• Gonorrhea
• Hepatitis B
• HIV Infections
• Infections
• Pregnancy
• Sexually Transmitted Diseases
• Sexually Transmitted Infection
• Syphilis
• Trichomonas Infections
• Trichomoniasis

Intervention

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)

Locations

Country	Name	City	State
Zimbabwe	Mbare polyclinic	Harare

Sponsors (2)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	Biomedical Research and Training Institute

Country where clinical trial is conducted

Zimbabwe, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite STI prevalence	Composite % of participants with chlamydia, gonorrhoea, trichomoniasis, syphilis, and/or hepatitis B	Through study completion, up to 1 year
Primary	Individual STI prevalences	Individual % of participants with chlamydia, gonorrhoea, trichomoniasis, syphilis, and hepatitis B	Through study completion, up to 1 year
Secondary	Uptake of STI testing	% of individuals approached who accept and undergo testing	Through study completion, up to 1 year
Secondary	Yield of STI testing	% of individuals approached who test positive for an STI	Through study completion, up to 1 year
Secondary	Uptake of treatment	% of participants with a curable STI who accept treatment	Through study completion, up to 1 year
Secondary	Uptake of partner notification	% of participants with a curable STI who undertake partner notification	Through study completion, up to 1 year
Secondary	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
Secondary	Prevalence of adverse birth outcomes	% of pregnancies with premature birth, miscarriage, or low birth weight	Through study completion, up to 2 years

External Links

•   LSHTM Data Compass
•   The Health Research Unit Zimbabwe (THRU ZIM)