Gonococcal Infection Clinical Trial
Official title:
Self-Obtained Vaginal Swabs for Chlamydia and Gonorrhea Testing: Concurrence in Non-Clinical Settings vs. Clinical Settings
To evaluate the agreement between NAAT results for Chlamydia trachomatis and Neisseria gonorrhoeae infection obtained with self-obtained vaginal swabs (SOVS), collected in a non-clinical setting vs. NAAT results using SOVS collected in a clinical setting. This is a new use of this specimen type as SOVS are FDA cleared only for use in clinics. The NAAT (Gen-Probe APTIMA Combo 2® Assay (AC2)) result with the home-collected SOVS specimen will be compared to the result obtained with an SOVS collected in the clinic on multiple platforms (Direct Tube Sampling (DTS) / Panther / Tigris). The term "home-collected" is used to refer to any specimen that is not collected in a clinic, since there is no certainty that a specimen is collected "at home" or in a restroom in an office setting, etc. To compare the SOVS results to an FDA cleared predicate test with the collection of two clinician collected vaginal swabs.
All potential participants enrolled in this study will undergo the following procedures:
- Informed consent (written) to participate in this study along with review of the
Participant Information Sheet and Experimental Subject's Bill of Rights (per site
requirements)
- Assessment of eligibility by nurse/clinician
- Collection of two SOVS in clinic
- Collection of two clinician collected vaginal swabs in the clinic
- Assessment of clinical signs or symptoms
- Group 1 - participants will collect two SOVS before clinic visit and deliver specimens
to study staff at the clinic visit.
- Group 2 - participants will repeat collection of two SOVS at home after clinic visit
and mail the specimens directly to the laboratory.
Clinical examinations will be conducted as appropriate to the reason for the visit/exam but
the clinic procedures are not included as part of the protocol.
The enrollment strategy is designed to recruit a total of 3500 women with an average of
42-60 women per month over a 12-month recruitment period (500-700 women per site over the
recruitment period). Participants will be seen and recruited in clinics at the participating
STI-CTG, and other site clinics. At each participating clinical center, recruitment
personnel will follow a site specific process that is designed to help identify potential
participants. Only one visit is required to complete the study procedures. The total time
required for a participant to complete this study may vary but is expected to be 45 minutes
total time over 1 or 2 days. Intervals of several days between collection of the two
specimens are likely for some women.
Clinic staff will approach women in the clinic or via phone and explain the object of the
study and requirements of participation. The consenting process adopted by each site will be
dependent on their IRB approval. Written consent will be obtained for all participants.
Participants will be given a Participant Information Sheet to read and keep. [In addition,
sites and clinics in California must utilize the "Experimental Subject's Bill of Rights"
that explains their rights as a research subject per California law.] For Group 1, the
discussions will be by phone and the Information Sheet and Experimental Subject's Bill of
Rights will be included in the collection kit that is mailed to participants. Clinic staff
will utilize a standard script including a form of Q&A to ensure that participants have a
basic understanding of the SOVS procedures. Participants will be encouraged to call the
clinic staff with any questions when they receive the home collection kit.
After the participant provides informed consent, the nurse/clinician will assign a unique
participant number (PN) and note the consenting procedure and appropriate eligibility
information on a Case Report Form (CRF). The nurse/clinician will discuss basic demographic,
medical history and concomitant medication information with each participant and record the
information either on a study specific notes page, or a CRF. These will be maintained in the
participant's research study record. This information will be used to assess eligibility.
Participants in both study groups will be provided with swab collection kits along with a
diagram showing how to collect the SOVS specimens. The participant will collect the swabs in
a designated place in the clinic (often a rest room) at the beginning of the visit before
any other specimens are collected. Next, the nurse/clinician will conduct the examination to
manage the participant's healthcare. If the standard of care at the clinic is an SOVS
processed using AC2, the participant will undergo an additional specimen collection as per
the local clinic's standard of care for diagnosis and management of Ct/GC. Standard
protocols for clinical management may differ by study site and will not be modified as a
result of this study. Beyond the laboratory's AC2 Ct/GC NAAT clinical results, site standard
protocols are not relevant to this study. Participants will not be notified regarding test
results from the SOVS collected solely for this study. This will end the Study participation
for Group 1.
At the end of the clinic visit for Group 2 participants, the nurse/clinician will provide
them with the HOLOGIC|Gen-Probe, Inc. provided home swab collection kits (the same as those
mailed to participants in Group 1). The kits are identical to the kits used in the clinic
with the addition of a mailing container and relevant mailing labels. Participants will be
instructed to return home (or to another non-clinical private location) and collect two
additional specimens:
- within 24 hours of the clinic visit
- prior to resuming sexual activity
- prior to taking any antibiotics that have been prescribed
Group 2 participants will then mail the specimens to the laboratory in the mailer provided
within 24 hours of collecting the sample. Participants will be given the same instructions
for collecting the swabs regardless of whether it is in the clinic restroom or at home.
Group 2 participants will receive a follow-up communication 48 hours after their clinic
appointment.
Participants in both groups will complete all other study procedures at the clinic during
the initial visit. One questionnaire will be administered to the participants (the
Home-collected SOVS CRF) and only the following clinical data will be collected as part of
this study - participant's age, gender, race/ethnicity, clinical signs & symptoms, date of
exam, date/time specimen collected/mailed/received, UADEs (if any), and AC2 results.
All laboratory evaluations will use the APTIMA Combo 2® assay for detection of Ct/GC
infection on the SOVS specimens collected "at home" and "in clinic" across 3 different
platforms (DTS, Panther, and Tigris). One set of specimen collection tubes ("at home" and
"in clinic") will be tested on DTS at each of 5 to 7 laboratories associated with the
clinical sites. A matched set of specimen collection tubes will be shipped to 1 of 3
designated laboratory sites to be tested on Panther. Once the Panther testing is completed,
the same set of tubes will be shipped to 1 of 3 different laboratory sites to be tested on
Tigris. Results will be compared to assess agreement of the paired specimens tested within
each platform (DTS / Panther / Tigris).
The APTIMA Combo 2® Assay (HOLOGIC | Gen-Probe Inc., San Diego, CA) is a nucleic acid
amplification test (NAAT) that utilizes target capture for the detection and differentiation
of ribosomal RNA (rRNA) from Chlamydia trachomatis and/or Neisseria gonorrhoeae in
clinician-collected endocervical, vaginal (VS-C), and male urethral swab specimens, SOVS
specimens (when obtained in the clinic), and female and male urine specimens. The assay is
FDA cleared for use with specimens from symptomatic and asymptomatic individuals.
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Observational Model: Cohort, Time Perspective: Prospective
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