Clinical trial NCT05541081: Investigating Point-of-care Diagnostics for Sexually Transmitted Infections and Antimicrobial Resistance in Primary Care in Zimbabwe
Official title: Investigating Point-of-care Diagnostics for Sexually Transmitted Infections and Antimicrobial Resistance in Primary Care in Zimbabwe
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Sexually Transmitted Infection
Chlamydia
Gonorrhea
Trichomoniasis
Syphilis
Hepatitis B
HIV Infections
Pregnancy
Sexually Transmitted Diseases
Keywords: Antenatal care
Sexual and reproductive healthcare
Zimbabwe
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Biomedical Research and Training Institute
First posted: 2022-09-15
Enrollment: 1005
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite STI prevalence
timeFrame: Through study completion, up to 1 year
measure: Individual STI prevalences
timeFrame: Through study completion, up to 1 year
Secondary outcomes:
measure: Uptake of STI testing
timeFrame: Through study completion, up to 1 year
measure: Yield of STI testing
timeFrame: Through study completion, up to 1 year
measure: Uptake of treatment
timeFrame: Through study completion, up to 1 year
measure: Uptake of partner notification
timeFrame: Through study completion, up to 1 year
measure: Prevalence of antimicrobial resistance in gonococcal isolates
timeFrame: Through study completion, up to 1 year
measure: Prevalence of adverse birth outcomes
timeFrame: Through study completion, up to 2 years
Other outcomes:
Locations:
city: Harare
country: Zimbabwe
facility: Mbare polyclinic
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Kevin Martin, MBBS
role: PRINCIPAL_INVESTIGATOR
References: