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

Not Applicable

Active, not recruiting

• Conditions: Trichomoniasis; HIV Infections; Pregnancy; Sexually Transmitted Diseases; Sexually Transmitted Infection; Syphilis; Gonorrhea; Hepatitis B; Chlamydia
• Interventions: Diagnostic Test: Point-of-care STI testing

• Registration Number: NCT05541081
• Lead Sponsor: London School of Hygiene and Tropical Medicine

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.

Study Timeline

• Study First Submitted: 2022-08-23
• Study First Submitted QC: 2022-09-12
• Study First Posted: 2022-09-15
• Study Start: 2023-01-12
• Primary Completion: 2023-10-23
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-13
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 1005

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Point-of-care STI testing	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

Primary Outcome Measures

Name	Time	Method
Composite STI prevalence	Through study completion, up to 1 year	Composite % of participants with chlamydia, gonorrhoea, trichomoniasis, syphilis, and/or hepatitis B
Individual STI prevalences	Through study completion, up to 1 year	Individual % of participants with chlamydia, gonorrhoea, trichomoniasis, syphilis, and hepatitis B

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mbare polyclinic; 🇿🇼 Harare, Zimbabwe