Ignite Creation Date:
2024-10-25 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06570733
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-08-16
Brief Title:
Acceptability Research on Integrated Point of Care Sexually Transmitted Infection STI Testing and Expedited Partner Therapy EPT
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Acceptability Research on Integrated Point of Care Sexually Transmitted Infection STI Testing and Expedited Partner Therapy EPT
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARISE
Brief Summary:
This protocol builds on nearly a decade of collaborative HIVSTI 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
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 point-of-care STI testing plus Expedited Partner Therapy EPT and those who received point-of-care STI testing but declined EPT To assess the acceptability of point-to-care STI testing plus EPT for AGYW initiating oral PrEP and its impact on exposure to social harms To assess the male partners response and acceptability among those who received EPT Estimate the cost of implementing rapid point-of-care diagnostic STI testing and EPT for AGYW in South Africa using PrEP compared to standard syndromic management The study design aims to conduct a prospective cohort study among adolescent girls and young women AGYW and assess the incidence of select STIs detected by point-of-care testing including Ctrachomatis N gonorrhea or T vaginalis over 12 months of follow-up Moreover to assess the acceptability of expedited partner treatment offered to AGYW with an STI and their partners who received EPT To 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 standard cost
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None