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Genesis

Evaluation of a point-of-care diagnostic device to improve Sexually Transmitted Infections management and outcomes in Kenya

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202505691710271
Enrollment
4100
Registered
2025-05-22
Start date
2025-07-01
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chlamydia, Gonorrhea and Trichomoniasis

Interventions

Aptitude Metrix device point of care for STI

Sponsors

Jhpiego
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
CT: Sensitivity, specificity, PPV, NPV NG: Sensitivity, specificity, PPV, NPV TV: Sensitivity, specificity, PPV, NPV ;·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

Secondary

MeasureTime frame
Prevalence of chlamydia, gonorrhea and trichomonas

Countries

Kenya

Contacts

Public ContactDismas Ouma

Technical Lead

dismas@icrhk.org254714553285

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026