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

NCT06570733 | Active Not Recruiting

• 1 other identifier: ARISE
• Study Type: observational
• Target: 305
• Locations: 1 country
• Sites: 1

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 in which we will assess the acceptability of point-of-care STI testing plus Expedited Partner Therapy (EPT) and its impact on the incidence of common curable STIs over 12 months of follow-up. The social-behavioral scientist will undertake qualitative interviews with participants and their male partners to identify facilitators and barriers to EPT uptake and conduct a comparative cost analysis to estimate the cost per person tested using point-of-care STI testing with and without EPT incremental to the cost of standard of care. Findings from the proposed research will provide essential knowledge for national policymakers to advance approaches to STI screening and treatment that will lead to improvements in AGYW sexual reproductive health and reductions in STIs. The data generated from this project are essential to inform efforts to reduce the burden of STIs and HIV-1 in women and achieve the 2030 Sustainable Development Goals, which includes substantial reductions in HIIV and STIs in key at-risk populations. This project will support global efforts to substantially reduce STIs in key populations.

Conditions

Neisseria Gonorrhea; Trichomoniasis Vaginalis; Chlamydia Trachomatis Infection

Outcome Measures

Primary Outcomes (1)

• GeneXpert

  A PCR instrument used to diagnose chlamydia trachomatis and gonorrhea.

  2 years

Secondary Outcomes (1)

• Osom rapid testing kit

  2 years

Eligibility Criteria

• Age: 16 Years - 25 Years
• Gender Eligibility Details: Participants should be cisgender female.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Approximately 400 non-pregnant, HIV-negative, cis-gender AGYW aged 16-25, who have recently initiated oral PrEP or who are interested in initiating oral PrEP and are diagnosed with an STI at screening (C. trachomatis, N. gonorrhoeae, or T. vaginalis).

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wits RHI Research Centre Clinical Research Site: lead
• University of Washington: collaborator

Study Sites (1)

Wits RHI Research Centre

Hillbrow, Gauteng, 2038, South Africa

Location

Biospecimen

Retention: SAMPLES WITH DNA

Biological specimens such as blood samples and vaginal fluid for use in future studies.

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Trials

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: August 26, 2024
• Study Start: February 11, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)