Acceptability Research on Integrated Point of Care Sexually Transmitted Infection (STI) Testing and Expedited Partner Therapy (EPT)

Active, not recruiting

• Conditions: Neisseria Gonorrhea; Trichomoniasis Vaginalis; Chlamydia Trachomatis Infection

• Registration Number: NCT06570733
• Lead Sponsor: Wits RHI Research Centre Clinical Research Site

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-8-16
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Cisgender girls and women (16-25 years of age, inclusive)<br><br> 2. Vaginal sex with a cisgender male partner in the last three months<br><br> 3. CT, GC, or TV detected at screening<br><br> 4. Willing to return for quarterly study visits<br><br> 5. Not currently pregnant and not planning to become pregnant in the next 12 months<br><br> 6. Using or willing to initiate a highly effective method of contraception*<br><br> 7. HIV-uninfected<br><br> 8. Interested in initiating oral PrEP<br><br> 9. No known contraindications to FTC or TDF<br><br>Exclusion Criteria:<br><br> 1. At Screening or Enrollment, participant reports known adverse reaction to FTC or<br> TDF.<br><br> 2. At Screening or Enrollment, has single or dual rapid Antibody positive reactive<br> HIV-1 test.<br><br> 3. At Screening or Enrollment, is already participating in another research study<br> involving drugs, medical devices, or vaccines for STI prevention or treatment.<br><br> 4. As determined by the PIs/designee, any current or historical physical health, mental<br> health or social issue or condition that the site investigator or designee<br> determines should exclude participation.<br><br> 5. Has any other condition that, in the opinion of the PIs/designee, would preclude<br> informed consent, make study participation unsafe, or otherwise interfere with<br> achieving the study objectives.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
GeneXpert

Secondary Outcome Measures

Name	Time	Method
Osom rapid testing kit