Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202505691710271 Date of Approval: 22/05/2025
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Genesis
Official scientific title Evaluation of a point-of-care diagnostic device to improve Sexually Transmitted Infections management and outcomes in Kenya
Brief summary describing the background and objectives of the trial The World Health Organization (WHO) recently released new guidance promoting a diagnostic-led approach for Sexually Transmitted Infections (STIs), encouraging integration of laboratory or Point of Care (POC) testing to enhance syndromic management, increasing the accuracy of STI diagnosis and quality of management. The guidance recognizes the need for new models of STI services to keep up with scientific advances in STI treatment and testing, and for antibiotic use and stewardship. The Bill & Melinda Gates Foundation is investing in the development of lower-cost, true POC diagnostics that will identify Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV) infections, and has funded Jhpiego and sub-partner International Centre for Reproductive Health Kenya to conduct a field evaluation of the Aptitude MetrixTM research-use-only diagnostic test for CT, NG and TV in health facilities in Kenya to inform strategies for further scale-up of diagnostic-led STI management approaches for low and middle income countries (LMICs). The aim of this study is to generate evidence on the feasibility, acceptability, and operational considerations for implementing point-of-care (POC) diagnostic-led STI management in the public health sector in Kenya. For this study, we are defining POC as “testing conducted in clinical settings that can produce a test result rapidly enough to allow same day result communication”
Type of trial Observational
Acronym (If the trial has an acronym then please provide) Genesis
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Chlamydia, Gonorrhea and Trichomoniasis
Purpose of the trial Early detection /Screening
Anticipated trial start date 01/07/2025
Actual trial start date
Anticipated date of last follow up 29/05/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 4100
Actual target sample size (number of participants)
Recruitment status Active, not recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Single Group Non-randomised Allocation Sequence/Code was not concealed Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Aptitude Metrix device point of care for STI Not applicable This will be a cross-sectional study, participants are expected to provide samples at enrollment only; however, a fraction of participants will be invited to participate in in-depth interviews regarding their experience. Vaginal (female) or penile meatal swab and urine (male) samples will be collected from potential clients suspected of having STIs based on either syndromic or behavioural risk assessment. Three vaginal swab samples will either be self-collected or clinician-collected (based on clients’ preference) from each female client agreeing to participate in the study. Clients will be sensitized by the healthcare providers at their respective facilities on how to self-collect samples. One penile meatal swab sample will either be self-collected or clinician-collected from each male client agreeing to participate in the study (also based on clients’ preference). Additionally, one urine sample will also be collected from each male client. Collection procedures will adhere to the manufacturer’s instructions for use. The volume of each specimen collected will also be documented according to predetermined manufacturer’s guidelines. Sample collection will only occur once during the potential clients’ clinic visits. Biospecimens will be used for this study’s laboratory analyses, including diagnostic testing for NG, CT and TV with the Aptitude MetrixTM device, Hologic and GeneXpert (as reference) platforms. Specimens will be used to validate the performance of the POC device against the reference platforms. Biospecimens will be handled in accordance with manufacturers’ guidelines for specimen handling and storage to maintain sample integrity and stability. Each collected biospecimen will be labelled with unique identifiers to ensure proper identification and traceability throughout the study period. Labels will include essential information such as specimen type, collection date, and participants’ unique ID to facilitate accurate tracking and retrieval. The samples will be tested for CT, NG & TV using both Aptitude MetrixTM and reference platforms. The Aptitude MetrixTM assay will be performed either onsite in the clinic or in the laboratory depending on the clinic setting. GeneX 4100
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participants Participants aged 18 years and above /or mature minors* Individuals suspected of/at high risk of having STIs, based on either syndromic or behavioural risk assessments. Willing to provide 3 vaginal swabs (women) or 1 penile meatal swab and 1 first catch urine (men) sample for STI testing Willing and able to provide voluntary written informed consent Health facilities A level 5, 4 or 3 public health facility within Kilifi or Nairobi which has all the following: MCH/FP, ANC, OPD/STI Clinics, and a CCC GeneXpert onsite or having an established sample transport to a nearby testing lab with GeneXpert Health facilities with higher STI caseloads Or a drop-in centre (DIC) & private pharmacy providing clinical services including STI screening and treatment Or a private pharmacy providing clinical services including STI screening and treatment Participants Individuals undergoing antimicrobial therapy for STI at the time of sample collection Clients who have used a vaginal cream or ointment product; douched; or used spermicides, vaginal lubricants; or used traditional products (e.g., herbs or drying agents) for cleaning inside the vagina within 48 hours (about 2 days) of testing Participants unwilling or who decline to provide voluntary written informed consent to participate in the study. Health facilities Facilities not willing to participate in the study Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 15 Year(s) 64 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/03/2025 KEMRI SERU
Ethics Committee Address
Street address City Postal code Country
P.O. Box 54840-00200 Nairobi 00200 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome CT: Sensitivity, specificity, PPV, NPV NG: Sensitivity, specificity, PPV, NPV TV: Sensitivity, specificity, PPV, NPV At enrollment.
Primary Outcome · Feasibility: Ease and implementation of sample collection, same day sample processing, same day result communication, same day treatment initiation, partner notification, partner return; Aptitude MetrixTM result interpretation; error/invalid rates · Acceptability to facility staff: Client/provider feedback on sample collection, incorporating STI testing (both POC and non-POC) in clinic workflow, ease of use of Aptitude MetrixTM by provider · Acceptability to clients: willingness to provide sample, wait for same day test result, disclose test result to partner, pay for service · Impact of POC testing: STI client load, testing volume, testing coverage, treatment initiation and completion rates, partner notification rates, partner return rates · Operationalization: changes to clinic workflow, provider experience, client experience enrollment
Secondary Outcome Prevalence of chlamydia, gonorrhea and trichomonas enrollment.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Internation centre for reprouctive health Kenya P.O. BOX 91109 Mombasa 80103 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Gates Foundation 500 Fifth Avenue North Seattle 98109 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Jhpiego 1615 Thames Street Baltimore 21231 United States of America University
COLLABORATORS
Name Street address City Postal code Country
jhpiego 1615 Thames Street Baltimore 21231 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dismas Ouma dismas@icrhk.org +254714553285 Starwood Apartment
City Postal code Country Position/Affiliation
Nairobi Kenya Technical Lead ICRHK
Role Name Email Phone Street address
Principal Investigator Patricia Ongwen Patricia.Ongwen@jhpiego.org 254722210196 14 Riverside
City Postal code Country Position/Affiliation
Nairobi Kenya Deputy Project Director
Role Name Email Phone Street address
Principal Investigator Rose Wafula rosewafular@gmail.com 254729213755 Afya Annex
City Postal code Country Position/Affiliation
Nairobi Kenya Ministry of Health
Role Name Email Phone Street address
Scientific Enquiries Daniel Were Daniel.Were@jhpiego.org 254708000322 14 Riverside
City Postal code Country Position/Affiliation
Nairobi Kenya Project Director
Role Name Email Phone Street address
Public Enquiries Dismas Ouma dismas@icrhk.org 254714553285 Starwood Apartment
City Postal code Country Position/Affiliation
Nairobi Kenya Technical Lead
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained through this study may be provided to qualified researchers with academic interest in point of care STI diagnostics. Data or samples shared will be coded, and de-identified. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Statistical Analysis Plan,Study Protocol Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA)
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 22/05/2025 PACTR Admin EVALUATION OF A POINT-OF-CARE DIAGNOSTIC DEVICE TO IMPROVE SEXUALLY TRANSMITTED INFECTIONS MANAGEMENT AND OUTCOMES IN KENYA Evaluation of a point-of-care diagnostic device to improve Sexually Transmitted Infections management and outcomes in Kenya