HIV Infections, Syphilis
Conditions
Keywords
Mother-to-child transmission (MTCT), Sexually Transmitted Infections (STI)
Brief summary
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.
Interventions
DEVICEChembio 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
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
14 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* pregnant women at any gestational age * Nonpregnant women may also be included if unsure of pregnancy status and attend clinic for pregnancy care and confirmed to be not pregnant by routine testing such as urine pregnancy tests and/or the absence of an intrauterine pregnancy by ultrasound
Exclusion criteria
* Participants not at clinical sites in Puerto Barrios, Guatemala between 09/27/2025 and 10/03/2025
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants That Completed Screening | end of study (15 minutes after baseline) |
| Number of Participants That Tested Positive for Syphilis | end of study (15 minutes after baseline) |
| Number of Participants That Tested Positive for HIV | end of study (15 minutes after baseline) |
| Number of Participants That Tested Positive for Syphilis and HIV | end of study (15 minutes after baseline) |
| Number of Participants That Received Treatment | end of study (15 minutes after baseline) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORIrene A Stafford, M.D., M.S., M.P.H
The University of Texas Health Science Center, Houston
Participant flow
Pre-assignment details
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."
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 36.99 years STANDARD_DEVIATION 12.93 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 149 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment Guatemala | 149 participants |
| Sex: Female, Male Female | 149 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 149 |
| other Total, other adverse events | 0 / 149 |
| serious Total, serious adverse events | 0 / 149 |
Outcome results
None listed