Status:
ACTIVE_NOT_RECRUITING
Acceptability Research on Integrated Point of Care Sexually Transmitted Infection (STI) Testing and Expedited Partner Therapy (EPT)
Lead Sponsor:
Wits RHI Research Centre Clinical Research Site
Collaborating Sponsors:
University of Washington
Conditions:
Neisseria Gonorrhea
Trichomoniasis Vaginalis
Eligibility:
FEMALE
16-25 years
Brief Summary
This protocol builds on nearly a decade of collaborative HIV/STI prevention research to conduct a prospective cohort study of Adolescent Girls and Young Women (AGYW) eligible for PrEP in South Africa ...
Detailed Description
The study aims to estimate the incidence of STIs (Chlamydia trachomatis, Neisseria gonorrhea, and Trichomoniasis vaginalis) among Adolescent Girls and Young Women (AGYW) initiating PrEP who received p...
Eligibility Criteria
Inclusion
- Cisgender girls and women (16-25 years of age, inclusive)
- Vaginal sex with a cisgender male partner in the last three months
- CT, GC, or TV detected at screening
- Willing to return for quarterly study visits
- Not currently pregnant and not planning to become pregnant in the next 12 months
- Using or willing to initiate a highly effective method of contraception\*
- HIV-uninfected
- Interested in initiating oral PrEP
- No known contraindications to FTC or TDF
Exclusion
- At Screening or Enrollment, participant reports known adverse reaction to FTC or TDF.
- At Screening or Enrollment, has single or dual rapid Antibody positive reactive HIV-1 test.
- At Screening or Enrollment, is already participating in another research study involving drugs, medical devices, or vaccines for STI prevention or treatment.
- As determined by the PIs/designee, any current or historical physical health, mental health or social issue or condition that the site investigator or designee determines should exclude participation.
- Has any other condition that, in the opinion of the PIs/designee, would preclude informed consent, make study participation unsafe, or otherwise interfere with achieving the study objectives.
Key Trial Info
Start Date :
February 11 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2024
Estimated Enrollment :
305 Patients enrolled
Trial Details
Trial ID
NCT06570733
Start Date
February 11 2022
End Date
December 1 2024
Last Update
August 26 2024
Active Locations (1)
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1
Wits RHI Research Centre
Hillbrow, Gauteng, South Africa, 2038