Trial Outcomes & Findings for Preventive Sexual Health Screening Among Female-to-Male (FTM) Transgender Adult Patients (NCT NCT02401867)
NCT ID: NCT02401867
Last Updated: 2017-06-28
Results Overview
Quantitatively assessed the non-inferiority of vaginal self-swab for HPV DNA compared to provider-collected cervical swab for HPV via laboratory confirmed testing in sexually active FTM adults. Compared the concordance of the positive self-swab HPV DNA test results to the positive cervical provider swab HPV DNA test results (reference) using the McNemar's test, a two-sample test for binomial proportions for matched-pair data.
COMPLETED
150 participants
1 day
2017-06-28
Participant Flow
Participant milestones
| Measure |
Overall Sample
Overall sample reported as all participants received both the self and the provider swab.
|
|---|---|
|
Enrolled
STARTED
|
150
|
|
Enrolled
COMPLETED
|
150
|
|
Enrolled
NOT COMPLETED
|
0
|
|
Specimen Collection
STARTED
|
150
|
|
Specimen Collection
COMPLETED
|
140
|
|
Specimen Collection
NOT COMPLETED
|
10
|
|
Analysis
STARTED
|
140
|
|
Analysis
COMPLETED
|
131
|
|
Analysis
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Overall Sample
Overall sample reported as all participants received both the self and the provider swab.
|
|---|---|
|
Specimen Collection
Didn't receive 1 or more tests
|
10
|
|
Analysis
Cervical assay could not be conducted
|
9
|
Baseline Characteristics
Preventive Sexual Health Screening Among Female-to-Male (FTM) Transgender Adult Patients
Baseline characteristics by cohort
| Measure |
Full Sample
n=150 Participants
Descriptive characteristics for the full sample (n=150).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
150 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
27.49 years
STANDARD_DEVIATION 5.74 • n=99 Participants
|
|
Sex/Gender, Customized
Trans Masculine/ Male to Female
|
150 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
112 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
23 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Yes, Hispanic/Latino
|
14 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic/Latino
|
133 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
3 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
150 participants
n=99 Participants
|
|
Diagnosed with Chlamydia - Lifetime
Yes
|
8 Participants
n=99 Participants
|
|
Diagnosed with Chlamydia - Lifetime
No
|
142 Participants
n=99 Participants
|
|
Diagnosed with Gonorrhea - Lifetime
Yes
|
5 Participants
n=99 Participants
|
|
Diagnosed with Gonorrhea - Lifetime
No
|
145 Participants
n=99 Participants
|
|
Diagnosed with Syphilis - Lifetime
Yes
|
1 Participants
n=99 Participants
|
|
Diagnosed with Syphilis - Lifetime
No
|
149 Participants
n=99 Participants
|
|
Diagnosed with Trichomoniasis - Lifetime
Yes
|
6 Participants
n=99 Participants
|
|
Diagnosed with Trichomoniasis - Lifetime
No
|
144 Participants
n=99 Participants
|
|
Diagnosed with Hepatitis C - Lifetime
Yes
|
1 Participants
n=99 Participants
|
|
Diagnosed with Hepatitis C - Lifetime
No
|
149 Participants
n=99 Participants
|
|
Diagnosed with Genital Herpes - Lifetime
Yes
|
5 Participants
n=99 Participants
|
|
Diagnosed with Genital Herpes - Lifetime
No
|
145 Participants
n=99 Participants
|
|
Diagnosed with Genital Warts - Lifetime
Yes
|
4 Participants
n=99 Participants
|
|
Diagnosed with Genital Warts - Lifetime
No
|
146 Participants
n=99 Participants
|
|
Diagnosed with HPV - Lifetime
Yes
|
11 Participants
n=99 Participants
|
|
Diagnosed with HPV - Lifetime
No
|
135 Participants
n=99 Participants
|
|
Diagnosed with HPV - Lifetime
Don't Know
|
3 Participants
n=99 Participants
|
|
Diagnosed with HPV - Lifetime
Prefer Not to Answer
|
1 Participants
n=99 Participants
|
|
HIV Status - Lifetime
Positive
|
1 Participants
n=99 Participants
|
|
HIV Status - Lifetime
Negative
|
120 Participants
n=99 Participants
|
|
HIV Status - Lifetime
Don't Know
|
28 Participants
n=99 Participants
|
|
HIV Status - Lifetime
Prefer Not to Answer
|
1 Participants
n=99 Participants
|
|
Provider-Collected Cervical Cytology (Current)
Abnormal
|
9 Participants
n=99 Participants
|
|
Provider-Collected Cervical Cytology (Current)
Normal
|
111 Participants
n=99 Participants
|
|
Provider-Collected Cervical Cytology (Current)
Assay could not be tested
|
27 Participants
n=99 Participants
|
|
Provider-Collected Cervical Cytology (Current)
Assay not collected
|
3 Participants
n=99 Participants
|
|
Provider-Collected Cervical HPV DNA (Current)
Positive
|
21 Participants
n=99 Participants
|
|
Provider-Collected Cervical HPV DNA (Current)
Negative
|
111 Participants
n=99 Participants
|
|
Provider-Collected Cervical HPV DNA (Current)
Assay could not be tested
|
9 Participants
n=99 Participants
|
|
Provider-Collected Cervical HPV DNA (Current)
Assay not collected
|
9 Participants
n=99 Participants
|
|
Self-Collected Vaginal HPV DNA (Current)
Positive
|
21 Participants
n=99 Participants
|
|
Self-Collected Vaginal HPV DNA (Current)
Negative
|
126 Participants
n=99 Participants
|
|
Self-Collected Vaginal HPV DNA (Current)
Assay not collected
|
3 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 1 dayPopulation: Analytic sample =131: 10 participants did not receive both the vaginal self-swab HPV DNA test and the provider cervical test (reference); 7 received the self, but not the provider; 1 received the provider, but not the self; 2 did not receive either test. Additionally, 9 of the provider samples could not be assayed due to low cellular content.
Quantitatively assessed the non-inferiority of vaginal self-swab for HPV DNA compared to provider-collected cervical swab for HPV via laboratory confirmed testing in sexually active FTM adults. Compared the concordance of the positive self-swab HPV DNA test results to the positive cervical provider swab HPV DNA test results (reference) using the McNemar's test, a two-sample test for binomial proportions for matched-pair data.
Outcome measures
| Measure |
Participants With Positive Cervical HPV DNA Test Result
n=21 Participants
Positive result determined by reference test: provider cervical HPV DNA Hybridization assay
|
Participants With a Negative Cervical HPV DNA Test Result
n=110 Participants
Negative result determined by reference test: provider cervical HPV DNA Hybridization assay
|
|---|---|---|
|
Concordance Between Vaginal Self-swab Results and Provider-collected Cervical Swab Results for HPV DNA Among Sexually Active FTM Adults
Positive vaginal self-swab HPV DNA test
|
15 Participants
|
2 Participants
|
|
Concordance Between Vaginal Self-swab Results and Provider-collected Cervical Swab Results for HPV DNA Among Sexually Active FTM Adults
Negative vaginal self-swab HPV DNA test
|
6 Participants
|
108 Participants
|
Adverse Events
Full Sample
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60