Clinical Trials Logo
  1. Home
  2. HIV Infections
  3. NCT05541081
  4. Details
NCT05541081 Clinical Trial

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
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
See also
  Status Clinical Trial Phase
Completed NCT05454514 - Automated Medication Platform With Video Observation and Facial Recognition to Improve Adherence to Antiretroviral Therapy in Patients With HIV/AIDS N/A
Completed NCT03760458 - The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age Phase 1/Phase 2
Completed NCT03067285 - A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study Phase 4
Completed NCT03141918 - Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS N/A
Recruiting NCT04579146 - Coronary Artery Disease (CAD) in Patients HIV-infected
Completed NCT06212531 - Papuan Indigenous Model of Male Circumcision N/A
Active, not recruiting NCT03256422 - Antiretroviral Treatment Taken 4 Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients Phase 3
Completed NCT03256435 - Retention in PrEP Care for African American MSM in Mississippi N/A
Completed NCT00517803 - Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies N/A
Active, not recruiting NCT03572335 - Systems Biology of Diffusion Impairment in Human Immunodeficiency Virus (HIV)
Completed NCT04165200 - Fecal Microbiota Transplantation as a Therapeutic Strategy for Patients Infected With HIV N/A
Recruiting NCT03854630 - Hepatitis B Virus Vaccination in HIV-positive Patients and Individuals at High Risk for HIV Infection Phase 4
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A
Completed NCT02234882 - Study on Pharmacokinetics Phase 1
Completed NCT01618305 - Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission Phase 4
Recruiting NCT05043129 - Safety and Immune Response of COVID-19 Vaccination in Patients With HIV Infection
Not yet recruiting NCT05536466 - The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine N/A
Recruiting NCT04985760 - Evaluation of Trimer 4571 Therapeutic Vaccination in Adults Living With HIV on Suppressive Antiretroviral Therapy Phase 1
Completed NCT05916989 - Stimulant Use and Methylation in HIV
Terminated NCT02116660 - Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284) Phase 2

External Links