Trial Outcomes & Findings for GonoScreen: Efficacy of Screening STIs in MSM (NCT NCT04269434)
NCT ID: NCT04269434
Last Updated: 2024-10-16
Results Overview
number of diagnoses of Ng plus Ct in 12 months in screening/non-screening arms divided by number of scheduled study visits with available results for the diagnosis of Ng/Ct. The denominator does not include unscheduled visits.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1014 participants
Primary outcome timeframe
12 months
Results posted on
2024-10-16
Participant Flow
Recruitment started on 21st September 2020 and was completed on 4th June 2021. Participants were recruited at 5 sites (Institute of Tropical Medicine Antwerp, University Hospital Ghent, University Hospital Erasme Brussels, University Hospital Saint-Pierre Brussels and University Hospital Liège.
Participant milestones
| Measure |
Screening
In the screening arm, Ng/Ct results will be sent by the STI Laboratory to the study physicians and these participants will be treated and partner contact tracing will be done.
|
No Screening
In the no screening arm, the STI Laboratory will only process the samples/report the results from the non-screening arm at the end of the study.
No Screening: the STI Laboratory will only process the samples/report the results from the non-screening arm at the end of the study.
|
|---|---|---|
|
Overall Study
STARTED
|
506
|
508
|
|
Overall Study
COMPLETED
|
439
|
440
|
|
Overall Study
NOT COMPLETED
|
67
|
68
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Screening
n=506 Participants
In the screening arm, Ng/Ct results will be sent by the STI Laboratory to the study physicians and these participants will be treated and partner contact tracing will be done.
|
No Screening
n=508 Participants
In the no screening arm, the STI Laboratory will only process the samples/report the results from the non-screening arm at the end of the study.
No Screening: the STI Laboratory will only process the samples/report the results from the non-screening arm at the end of the study.
|
Total
n=1014 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39 years
n=506 Participants
|
39 years
n=508 Participants
|
39 years
n=1014 Participants
|
|
Sex/Gender, Customized
Sex · Male
|
506 Participants
n=506 Participants
|
505 Participants
n=508 Participants
|
1011 Participants
n=1014 Participants
|
|
Sex/Gender, Customized
Sex · Transwoman
|
0 Participants
n=506 Participants
|
3 Participants
n=508 Participants
|
3 Participants
n=1014 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Number of sex partners (last 3 months)
|
4 Number of sex partners
n=506 Participants
|
4 Number of sex partners
n=508 Participants
|
4 Number of sex partners
n=1014 Participants
|
|
Number of sex partners (mean)
|
6.28 Number of sex partners
n=506 Participants
|
7.26 Number of sex partners
n=508 Participants
|
6.77 Number of sex partners
n=1014 Participants
|
|
Number of unprotected sex partners in the last 3 months
|
2 Number of unprotected sex partners
n=506 Participants
|
2 Number of unprotected sex partners
n=508 Participants
|
2 Number of unprotected sex partners
n=1014 Participants
|
|
Number of unprotected sex partners (mean)
|
3.80 Number of unprotected sex partners
n=506 Participants
|
4.28 Number of unprotected sex partners
n=508 Participants
|
4.04 Number of unprotected sex partners
n=1014 Participants
|
|
STI symptoms
Missing
|
0 Participants
n=506 Participants
|
1 Participants
n=508 Participants
|
1 Participants
n=1014 Participants
|
|
STI symptoms
No
|
504 Participants
n=506 Participants
|
503 Participants
n=508 Participants
|
1007 Participants
n=1014 Participants
|
|
STI symptoms
Yes
|
2 Participants
n=506 Participants
|
4 Participants
n=508 Participants
|
6 Participants
n=1014 Participants
|
|
Antibiotics in the last 6 months
Any
|
192 Participants
n=506 Participants
|
173 Participants
n=508 Participants
|
365 Participants
n=1014 Participants
|
|
Antibiotics in the last 6 months
Cephalosporins
|
67 Participants
n=506 Participants
|
77 Participants
n=508 Participants
|
144 Participants
n=1014 Participants
|
|
Antibiotics in the last 6 months
Macroloides
|
81 Participants
n=506 Participants
|
94 Participants
n=508 Participants
|
175 Participants
n=1014 Participants
|
|
Antibiotics in the last 6 months
Penicillins
|
63 Participants
n=506 Participants
|
47 Participants
n=508 Participants
|
110 Participants
n=1014 Participants
|
|
Antibiotics in the last 6 months
Quinolones
|
11 Participants
n=506 Participants
|
5 Participants
n=508 Participants
|
16 Participants
n=1014 Participants
|
|
Antibiotics in the last 6 months
Tetracyclines
|
57 Participants
n=506 Participants
|
54 Participants
n=508 Participants
|
111 Participants
n=1014 Participants
|
|
Antibiotics in the last 6 months
Other
|
3 Participants
n=506 Participants
|
3 Participants
n=508 Participants
|
6 Participants
n=1014 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Per protocol analysis
number of diagnoses of Ng plus Ct in 12 months in screening/non-screening arms divided by number of scheduled study visits with available results for the diagnosis of Ng/Ct. The denominator does not include unscheduled visits.
Outcome measures
| Measure |
Screening
n=357 Participants
In the screening arm, Ng/Ct results will be sent by the STI Laboratory to the study physicians and these participants will be treated and partner contact tracing will be done.
|
No Screening
n=344 Participants
In the no screening arm, the STI Laboratory will only process the samples/report the results from the non-screening arm at the end of the study.
No Screening: the STI Laboratory will only process the samples/report the results from the non-screening arm at the end of the study.
|
|---|---|---|
|
Incidence Rate of Ng Plus Ct Detected at Any Site Whilst Individuals Are Screened vs. Not Screened
|
0.155 Ng or CT cases per study visit
Interval 0.128 to 0.186
|
0.205 Ng or CT cases per study visit
Interval 0.171 to 0.246
|
SECONDARY outcome
Timeframe: 12 monthsNumber of standard doses per 1000 person-years for azithromycin, ceftriaxone and doxycycline
Outcome measures
| Measure |
Screening
n=357 Participants
In the screening arm, Ng/Ct results will be sent by the STI Laboratory to the study physicians and these participants will be treated and partner contact tracing will be done.
|
No Screening
n=344 Participants
In the no screening arm, the STI Laboratory will only process the samples/report the results from the non-screening arm at the end of the study.
No Screening: the STI Laboratory will only process the samples/report the results from the non-screening arm at the end of the study.
|
|---|---|---|
|
Cumulative Antimicrobial Exposure (Ceftriaxone/Azithromycin/Doxycycline)
Azithromycin
|
0.0059 doses per 1000 person-years
Interval 0.0055 to 0.0063
|
0.0046 doses per 1000 person-years
Interval 0.0043 to 0.005
|
|
Cumulative Antimicrobial Exposure (Ceftriaxone/Azithromycin/Doxycycline)
Ceftriaxone
|
0.0008 doses per 1000 person-years
Interval 0.0007 to 0.0009
|
0.0004 doses per 1000 person-years
Interval 0.0004 to 0.0006
|
|
Cumulative Antimicrobial Exposure (Ceftriaxone/Azithromycin/Doxycycline)
Doxycycline
|
0.0081 doses per 1000 person-years
Interval 0.0075 to 0.0086
|
0.0044 doses per 1000 person-years
Interval 0.0041 to 0.0048
|
SECONDARY outcome
Timeframe: 12 monthsNumber of diagnoses of symptomatic Ng and Ct infections over 12 months divided by number of visits
Outcome measures
| Measure |
Screening
n=357 Participants
In the screening arm, Ng/Ct results will be sent by the STI Laboratory to the study physicians and these participants will be treated and partner contact tracing will be done.
|
No Screening
n=344 Participants
In the no screening arm, the STI Laboratory will only process the samples/report the results from the non-screening arm at the end of the study.
No Screening: the STI Laboratory will only process the samples/report the results from the non-screening arm at the end of the study.
|
|---|---|---|
|
Incidence Rate of Symptomatic Ng Plus Ct
|
0.034 Symptomatic infections per study visit
Interval 0.023 to 0.049
|
0.046 Symptomatic infections per study visit
Interval 0.032 to 0.067
|
SECONDARY outcome
Timeframe: 12 monthsNumber of diagnoses of syphilis over 12 months divided by number of visits
Outcome measures
| Measure |
Screening
n=357 Participants
In the screening arm, Ng/Ct results will be sent by the STI Laboratory to the study physicians and these participants will be treated and partner contact tracing will be done.
|
No Screening
n=344 Participants
In the no screening arm, the STI Laboratory will only process the samples/report the results from the non-screening arm at the end of the study.
No Screening: the STI Laboratory will only process the samples/report the results from the non-screening arm at the end of the study.
|
|---|---|---|
|
Incidence Rate of Syphilis
|
0.018 Syphilis cases per study visit
Interval 0.011 to 0.029
|
0.026 Syphilis cases per study visit
Interval 0.016 to 0.042
|
Adverse Events
Screening
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Screening
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Chris Kenyon
Instituut van Tropische Geneeskunde Antwerpen
Phone: +3232470786
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER