Trial Outcomes & Findings for Spotting Syphilis: A Dual Point-of-Care Syphilis Screening Initiative in a Low-Resource Healthcare Setting (NCT NCT07498153)
NCT ID: NCT07498153
Last Updated: 2026-08-28
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
153 participants
Primary outcome timeframe
end of study (15 minutes after baseline)
Results posted on
2026-08-28
Participant Flow
Of the 153 participants enrolled, 4 participants withdrew prior to initiation of study procedures and did not undergo the Chembio HIV/Syphilis rapid point-of-care (POC) test. Therefore, 149 participants underwent the test and continued in the study."
Participant milestones
| Measure |
Chembio HIV/Syphilis Rapid POC Test
Chembio HIV/Syphilis rapid POC test: Participants will undergo the Chembio DPP® HIV-Syphilis rapid POC test by fingerstick. The Chembio test is read by a handheld reader. If positive for syphilis, the participant ill be informed and treated at the same visit with intramuscular (IM) Benzathine penicillin G (BPG) according to clinical stage and will undergo point-of-care ultrasound for the detection of fetal markers for congenital syphilis.If positive for HIV, participant will be started on Bictegravir/Tenofovir Alafenamide (TAF)/Emtricitabine (FTC) per guidelines
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|---|---|
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Overall Study
STARTED
|
149
|
|
Overall Study
COMPLETED
|
149
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Spotting Syphilis: A Dual Point-of-Care Syphilis Screening Initiative in a Low-Resource Healthcare Setting
Baseline characteristics by cohort
| Measure |
Chembio HIV/Syphilis Rapid POC Test
n=149 Participants
Chembio HIV/Syphilis rapid POC test: Participants will undergo the Chembio DPP® HIV-Syphilis rapid POC test by fingerstick. The Chembio test is read by a handheld reader. If positive for syphilis, the participant ill be informed and treated at the same visit with intramuscular (IM) Benzathine penicillin G (BPG) according to clinical stage and will undergo point-of-care ultrasound for the detection of fetal markers for congenital syphilis.If positive for HIV, participant will be started on Bictegravir/Tenofovir Alafenamide (TAF)/Emtricitabine (FTC) per guidelines
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|---|---|
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Age, Continuous
|
36.99 years
STANDARD_DEVIATION 12.93 • n=31 Participants
|
|
Sex: Female, Male
Female
|
149 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
149 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
Guatemala
|
149 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: end of study (15 minutes after baseline)Population: 153 participants were screened but 4 participants withdrew before undergoing Chembio HIV/Syphilis rapid POC test.
Outcome measures
| Measure |
Chembio HIV/Syphilis Rapid POC Test
n=153 Participants
Chembio HIV/Syphilis rapid POC test: Participants will undergo the Chembio DPP® HIV-Syphilis rapid POC test by fingerstick. The Chembio test is read by a handheld reader. If positive for syphilis, the participant ill be informed and treated at the same visit with intramuscular (IM) Benzathine penicillin G (BPG) according to clinical stage and will undergo point-of-care ultrasound for the detection of fetal markers for congenital syphilis.If positive for HIV, participant will be started on Bictegravir/Tenofovir Alafenamide (TAF)/Emtricitabine (FTC) per guidelines
|
|---|---|
|
Number of Participants That Completed Screening
|
149 Participants
|
PRIMARY outcome
Timeframe: end of study (15 minutes after baseline)Outcome measures
| Measure |
Chembio HIV/Syphilis Rapid POC Test
n=149 Participants
Chembio HIV/Syphilis rapid POC test: Participants will undergo the Chembio DPP® HIV-Syphilis rapid POC test by fingerstick. The Chembio test is read by a handheld reader. If positive for syphilis, the participant ill be informed and treated at the same visit with intramuscular (IM) Benzathine penicillin G (BPG) according to clinical stage and will undergo point-of-care ultrasound for the detection of fetal markers for congenital syphilis.If positive for HIV, participant will be started on Bictegravir/Tenofovir Alafenamide (TAF)/Emtricitabine (FTC) per guidelines
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|---|---|
|
Number of Participants That Tested Positive for Syphilis
|
4 Participants
|
PRIMARY outcome
Timeframe: end of study (15 minutes after baseline)Outcome measures
| Measure |
Chembio HIV/Syphilis Rapid POC Test
n=149 Participants
Chembio HIV/Syphilis rapid POC test: Participants will undergo the Chembio DPP® HIV-Syphilis rapid POC test by fingerstick. The Chembio test is read by a handheld reader. If positive for syphilis, the participant ill be informed and treated at the same visit with intramuscular (IM) Benzathine penicillin G (BPG) according to clinical stage and will undergo point-of-care ultrasound for the detection of fetal markers for congenital syphilis.If positive for HIV, participant will be started on Bictegravir/Tenofovir Alafenamide (TAF)/Emtricitabine (FTC) per guidelines
|
|---|---|
|
Number of Participants That Tested Positive for HIV
|
4 Participants
|
PRIMARY outcome
Timeframe: end of study (15 minutes after baseline)Outcome measures
| Measure |
Chembio HIV/Syphilis Rapid POC Test
n=149 Participants
Chembio HIV/Syphilis rapid POC test: Participants will undergo the Chembio DPP® HIV-Syphilis rapid POC test by fingerstick. The Chembio test is read by a handheld reader. If positive for syphilis, the participant ill be informed and treated at the same visit with intramuscular (IM) Benzathine penicillin G (BPG) according to clinical stage and will undergo point-of-care ultrasound for the detection of fetal markers for congenital syphilis.If positive for HIV, participant will be started on Bictegravir/Tenofovir Alafenamide (TAF)/Emtricitabine (FTC) per guidelines
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|---|---|
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Number of Participants That Tested Positive for Syphilis and HIV
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1 Participants
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PRIMARY outcome
Timeframe: end of study (15 minutes after baseline)Population: Only the 8 participants who tested positive for Syphilis or HIV were included in this outcome measure.
Outcome measures
| Measure |
Chembio HIV/Syphilis Rapid POC Test
n=8 Participants
Chembio HIV/Syphilis rapid POC test: Participants will undergo the Chembio DPP® HIV-Syphilis rapid POC test by fingerstick. The Chembio test is read by a handheld reader. If positive for syphilis, the participant ill be informed and treated at the same visit with intramuscular (IM) Benzathine penicillin G (BPG) according to clinical stage and will undergo point-of-care ultrasound for the detection of fetal markers for congenital syphilis.If positive for HIV, participant will be started on Bictegravir/Tenofovir Alafenamide (TAF)/Emtricitabine (FTC) per guidelines
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|---|---|
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Number of Participants That Received Treatment
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8 Participants
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Adverse Events
Chembio HIV/Syphilis Rapid POC Test
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
Irene A Stafford, M.D., M.S., M.P.H
The University of Texas Health Science Center of Houston
Phone: (713) 500-6412
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place