Cervicitis, Sexually Transmitted Infections, Urethritis
Conditions
Brief summary
This study is a pilot randomized controlled trial evaluating the use of either a) rapid 30-minute desktop assay or b) point-of-care gram stain (current standard of care) to guide the clinical management of patients with symptomatic urethritis or cervicitis evaluated in the Massachusetts General Hospital Sexual Health Clinic. Patients presenting with symptoms of urethritis or cervicitis and meeting inclusion criteria will be randomized to have diagnostic specimens tested during the clinical encounter using either the 30-minute desktop assay or point-of-care gram stain. Patients randomized to the intervention arm of the study will also have a gram stain created, which will be held for interpretation by the clinician following the clinical encounter. Patients will not be followed longitudinally. Recruitment will conclude when 100 participants enroll in the study.
Interventions
DIAGNOSTIC_TESTRapid 30-minute Desktop Assay
Participants will undergo routine evaluation and specimen collection per current clinic protocols. Specimens will be processed by the rapid 30-minute desktop assay. Concurrently, specimens will be used to create a point-of-care gram stain, to be read by the clinician following the clinical encounter. Treatment for urethritis and cervicitis will be provided based on results from the 30-minute assay. Specimens will also be plated for Gonorrhea culture and sent to the Massachusetts Department of Public Health for additional Gonorrhea and Chlamydia polymerase chain reaction testing, as per clinic protocols.
Sponsors
American Sexually Transmitted Diseases Association
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age and older * Presenting with symptoms of acute urethritis or cervicitis * Willing to provide urine or additional vaginal swab specimen
Exclusion criteria
* Younger than 18 years old * Presenting with symptoms not consistent with urethritis or cervicitis * Unwilling or unable to provide urine or vaginal swab specimen * Pregnant * Contact of index patients with Gonorrhea or Chlamydia * Known exposure to Gonorrhea or Chlamydia * Reporting concurrent symptoms at a non-genital site * Suspected or confirmed to have Monkeypox
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Antibiotic Days of Therapy (DOT) Administered Per Patient With Symptomatic Urethritis or Cervicitis | Day 1 | The investigators will compare the mean antibiotic days of therapy (DOT) administered per patient at the time of initial ciinical visit when evaluated with either point-of-care gram stain or rapid 30-minute desktop test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant Visit Duration | Day 1 | The investigators will compare visit duration between participants randomized to the point-of-care test and those to the 30-minute desktop test. Participant visit duration will be calculated as the difference between when the participant enters the exam room and when they check out of the clinic, in minutes. |
| Sample Processing Time | Day 1 | The investigators will compare the time taken to process clinical specimen using either the point-of-care gram stain or rapid 30-minute desktop test. The provider processing the samples will record the start and end times on a time sheet, and the sample processing time will be calculated as the difference between those entries, in minutes. |
| Time to Result | Day 1 | The investigators will compare time from specimen collection to availability of test result between the point-of-care gram stain or rapid 30-minute desktop test. Providers will record time of specimen collection and time of result (for point of care gram stain), time of result for the rapid desktop platform will be extracted from the platform; time to result will be calculated as the difference between those times, in minutes. |
| Diagnosis-concordant Antibiotic Use for Gonorrhea | Day 1 | Proportion of participants in each arm who were prescribed an antibiotic with activity against gonorrhea on the day of clinic visit, either for a positive test result or for a clinical syndrome for which the antibiotics are indicated (e.g., a clinical diagnosis of pelvic inflammatory disease, a diagnosis of non-gonococcal urethritis) as determined by study PI; or who were not prescribed an antibiotic with activity against gonorrhea on the day of clinic visit in the absence of a positive test result for gonorrhea or clinical syndrome for which the antibiotics are indicated. |
| Proportion of Participants With Invalid or Unavailable Point of Care Gram Stain or Rapid STI Test Results | Day 1 | The proportion of point of care gram stain results (control arm) or rapid test results (intervention arm) that were unavailable or invalid (unable to be read or provided an error message) at the time of the clinic visit. |
| Test-concordant Antibiotic Use for Gonorrhea | Day 1 | Proportion of participants in each arm who recevied gonorrhea-active antibiotics if PCR-based testing (rapid test or MDPH) was positive for gonorrhea, or who did not receive gonorrhea-active antibiotics if PCR-based testing (rapid test or MDPH) was negative for gonorrhea |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinic Provider Perspectives on Rapid STI Testing | at study completion: 12 months | Clinic provider perspectives will be elicited during a focus group discussion at the conclusion of the clinical study. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care Point-of-care gram stain | 49 |
| Rapid STI Test Rapid 30-minute Desktop Assay: Participants will undergo routine evaluation and specimen collection per current clinic protocols. Specimens will be processed by the rapid 30-minute desktop assay. Concurrently, specimens will be used to create a point-of-care gram stain, to be read by the clinician following the clinical encounter.
Treatment for urethritis and cervicitis will be provided based on results from the 30-minute assay.
Specimens will also be plated for Gonorrhea culture and sent to the Massachusetts Department of Public Health for additional Gonorrhea and Chlamydia polymerase chain reaction testing, as per clinic protocols. | 49 |
| Total | 98 |
Baseline characteristics
| Characteristic | Standard of Care | Rapid STI Test | Total |
|---|---|---|---|
| Age, Continuous | 28 years | 31 years | 29.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 7 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants | 35 Participants | 65 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 9 Participants | 7 Participants | 16 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 5 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 12 Participants | 20 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 12 Participants | 11 Participants | 23 Participants |
| Race (NIH/OMB) White | 26 Participants | 18 Participants | 44 Participants |
| Sex/Gender, Customized Cisgender female | 13 Participants | 19 Participants | 32 Participants |
| Sex/Gender, Customized Cisgender male | 34 Participants | 28 Participants | 62 Participants |
| Sex/Gender, Customized Other | 1 Participants | 0 Participants | 1 Participants |
| Sex/Gender, Customized Transgender/nonbinary | 1 Participants | 2 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 49 |
| other Total, other adverse events | 0 / 49 | 0 / 49 |
| serious Total, serious adverse events | 0 / 49 | 0 / 49 |
Outcome results
Primary
Mean Antibiotic Days of Therapy (DOT) Administered Per Patient With Symptomatic Urethritis or Cervicitis
The investigators will compare the mean antibiotic days of therapy (DOT) administered per patient at the time of initial ciinical visit when evaluated with either point-of-care gram stain or rapid 30-minute desktop test.
Time frame: Day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care | Mean Antibiotic Days of Therapy (DOT) Administered Per Patient With Symptomatic Urethritis or Cervicitis | 7 Antibiotic days of therapy (DOT) |
| Rapid STI Test | Mean Antibiotic Days of Therapy (DOT) Administered Per Patient With Symptomatic Urethritis or Cervicitis | 1 Antibiotic days of therapy (DOT) |
Comparison: Wilcoxon rank sum testp-value: 0.053Wilcoxon (Mann-Whitney)
Secondary
Diagnosis-concordant Antibiotic Use for Gonorrhea
Proportion of participants in each arm who were prescribed an antibiotic with activity against gonorrhea on the day of clinic visit, either for a positive test result or for a clinical syndrome for which the antibiotics are indicated (e.g., a clinical diagnosis of pelvic inflammatory disease, a diagnosis of non-gonococcal urethritis) as determined by study PI; or who were not prescribed an antibiotic with activity against gonorrhea on the day of clinic visit in the absence of a positive test result for gonorrhea or clinical syndrome for which the antibiotics are indicated.
Time frame: Day 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care | Diagnosis-concordant Antibiotic Use for Gonorrhea | 43 Participants |
| Rapid STI Test | Diagnosis-concordant Antibiotic Use for Gonorrhea | 48 Participants |
Secondary
Participant Visit Duration
The investigators will compare visit duration between participants randomized to the point-of-care test and those to the 30-minute desktop test. Participant visit duration will be calculated as the difference between when the participant enters the exam room and when they check out of the clinic, in minutes.
Time frame: Day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care | Participant Visit Duration | 57 Minutes |
| Rapid STI Test | Participant Visit Duration | 87 Minutes |
Secondary
Proportion of Participants With Invalid or Unavailable Point of Care Gram Stain or Rapid STI Test Results
The proportion of point of care gram stain results (control arm) or rapid test results (intervention arm) that were unavailable or invalid (unable to be read or provided an error message) at the time of the clinic visit.
Time frame: Day 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care | Proportion of Participants With Invalid or Unavailable Point of Care Gram Stain or Rapid STI Test Results | 4 Participants |
| Rapid STI Test | Proportion of Participants With Invalid or Unavailable Point of Care Gram Stain or Rapid STI Test Results | 0 Participants |
Secondary
Sample Processing Time
The investigators will compare the time taken to process clinical specimen using either the point-of-care gram stain or rapid 30-minute desktop test. The provider processing the samples will record the start and end times on a time sheet, and the sample processing time will be calculated as the difference between those entries, in minutes.
Time frame: Day 1
Population: This outcome measure was not collected. At the start of the study, it was determined that staff would not be able to accurately document the sample processing time in the clinical context, as stopping between sample processing and running or reading the test was not feasible and disrupted the providers' workflow, thus potentially altering the outcomes of other process measures. This change was made after the start of the study but not amended specifically in the protocol.
Secondary
Test-concordant Antibiotic Use for Gonorrhea
Proportion of participants in each arm who recevied gonorrhea-active antibiotics if PCR-based testing (rapid test or MDPH) was positive for gonorrhea, or who did not receive gonorrhea-active antibiotics if PCR-based testing (rapid test or MDPH) was negative for gonorrhea
Time frame: Day 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care | Test-concordant Antibiotic Use for Gonorrhea | 41 Participants |
| Rapid STI Test | Test-concordant Antibiotic Use for Gonorrhea | 46 Participants |
Secondary
Time to Result
The investigators will compare time from specimen collection to availability of test result between the point-of-care gram stain or rapid 30-minute desktop test. Providers will record time of specimen collection and time of result (for point of care gram stain), time of result for the rapid desktop platform will be extracted from the platform; time to result will be calculated as the difference between those times, in minutes.
Time frame: Day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care | Time to Result | 6.5 Minutes |
| Rapid STI Test | Time to Result | 34 Minutes |
Other Pre-specified
Clinic Provider Perspectives on Rapid STI Testing
Clinic provider perspectives will be elicited during a focus group discussion at the conclusion of the clinical study.
Time frame: at study completion: 12 months