An interventional study of Chembio HIV/Syphilis rapid POC test in Syphilis and HIV Infections, sponsored by The University of Texas Health Science Center, Houston. Completed at 1 site in United States. Open to female participants aged 14 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Screening
The purpose of this study is to determine if a strategy utilizing the Chembio HIV/syphilis rapid point-of-care (POC) test for diagnosis of HIV and syphilis in pregnant women attending prenatal clinics in Guatemala will increase screening and detection rates thereby resulting in higher rates of treatment during pregnancy and ultimately reducing congenital syphilis and HIV Mother-to-child transmission (MTCT) and to provide knowledge and technical expertise on the use of Point-of-care ultrasound for all pregnant patients testing positive for syphilis during the intervention to evaluate the fetus for evidence of congenital syphilis.
126 studies on the registry are indexed under Syphilis; 34 are open to participants now.
This study's enrollment of 153 is below the median of 354 across 85 interventional studies indexed under Syphilis.
Browse Syphilis studies →The University of Texas Health Science Center, Houston is the lead sponsor of 897 studies on the registry; 214 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 142 (82%) have results posted.
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Exclusion Criteria:
Device: 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
Time frame: end of study (15 minutes after baseline)
Number of Participants That Tested Positive for Syphilis
Time frame: end of study (15 minutes after baseline)
Number of Participants That Tested Positive for HIV
Time frame: end of study (15 minutes after baseline)
Number of Participants That Tested Positive for Syphilis and HIV
Time frame: end of study (15 minutes after baseline)
Number of Participants That Received Treatment
Time frame: end of study (15 minutes after baseline)
| Milestone | Chembio HIV/Syphilis Rapid POC Test |
|---|---|
| Started | 149 |
| Completed | 149 |
| Not completed | 0 |
| Participants | Chembio HIV/Syphilis Rapid POC Test |
|---|---|
| Number of Participants That Completed Screening | 149 |
| Participants | Chembio HIV/Syphilis Rapid POC Test |
|---|---|
| Number of Participants That Tested Positive for Syphilis | 4 |
| Participants | Chembio HIV/Syphilis Rapid POC Test |
|---|---|
| Number of Participants That Tested Positive for HIV | 4 |
| Participants | Chembio HIV/Syphilis Rapid POC Test |
|---|---|
| Number of Participants That Tested Positive for Syphilis and HIV | 1 |
| Participants | Chembio HIV/Syphilis Rapid POC Test |
|---|---|
| Number of Participants That Received Treatment | 8 |
Collected over Up to 25 minutes. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Chembio HIV/Syphilis Rapid POC Test | 0/149 (0%) | 0/149 (0%) | 0/149 (0%) |
| Age, Continuous(years) | Chembio HIV/Syphilis Rapid POC Test |
|---|---|
| Mean | 36.99 ± 12.93 |
| Sex: Female, Male(Participants) | Chembio HIV/Syphilis Rapid POC Test |
|---|---|
| Female | 149 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | Chembio HIV/Syphilis Rapid POC Test |
|---|---|
| Hispanic or Latino | 149 |
| Not Hispanic or Latino | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Chembio HIV/Syphilis Rapid POC Test |
|---|---|
| Guatemala | 149 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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