A clinical performance evaluation of two point of care diagnostic tests for sexually transmitted infections in South Africa

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR202607681588946

Enrollment

600

Registered

2026-07-16

Start date

2026-09-01

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

Sexually Transmitted Infections: gonorrhoea, chlamydia, and trichomoniasis

Interventions

STI point of care testing devices

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Aged 18-35 years at time of study enrolment. • Reports being sexually active in the last three months. • Willing and able to give written informed consent to study procedures and abstraction of relevant medical history from medical records • Willing to provide locator information and to be contacted if required. • For symptomatic clients: presenting with vaginal discharge (women) or urethral discharge (men). • For asymptomatic clients: attending PHC for antenatal care, HIV testing or PrEP services.

Exclusion criteria

Exclusion criteria: • Prior enrolment in the study. • Current antibiotic use or history of use of antibiotics effective against CT, NG or TV in past 14 days. • Unwilling or unable to provide written informed consent. • Unable to provide contact information. • For women: heavy menstrual bleeding at time of visit.

Design outcomes

Primary

Measure	Time frame
Sensitivity, specificity, positive and negative predictive values of the Metrix CT/NG/TV test and the Pluslife CT/NG/TV test for detecting CT, NG and TV, compared against the laboratory-based reference standard (BD MAX CTGCTV2 [BD, Sparks, MD, USA] or Alinity m STI assay [Abbott Molecular Inc, Des Plaines, IL, USA]).	—

Secondary

Measure	Time frame
Prevalence of CT, NG and TV among participants attending the four PHC clinics. ;Factors associated with CT, NG, and TV infection, including demographic, behavioural, and clinical characteristics.;Proportion of participants testing positive for CT, NG, or TV who successfully initiate appropriate STI treatment.;Mean and median scores for acceptability, appropriateness, and feasibility of the POC tests among clients, measured using validated quantitative instruments ;Proportion of clients rating the POC tests as acceptable, appropriate, or feasible according to pre-specified thresholds.	—

Measure

Time frame

Prevalence of CT, NG and TV among participants attending the four PHC clinics. ;Factors associated with CT, NG, and TV infection, including demographic, behavioural, and clinical characteristics.;Proportion of participants testing positive for CT, NG, or TV who successfully initiate appropriate STI treatment.;Mean and median scores for acceptability, appropriateness, and feasibility of the POC tests among clients, measured using validated quantitative instruments ;Proportion of clients rating the POC tests as acceptable, appropriate, or feasible according to pre-specified thresholds.

—

Countries

South Africa

Contacts

Public ContactSinead Delany Moretlwe

University of Witwatersrand

sdelany@wrhi.ac.za+27113585300

Outcome results

None listed

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