Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06176859
Status:
RECRUITING
Last Update Posted:
2023-12-20
First Post:
2023-04-22
Brief Title:
Delivery Optimization for Pre-Exposure Prophylaxis DO PrEP Study
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Delivery Optimization for Pre-Exposure Prophylaxis DO PrEP Study A Prospective Interventional Randomized Study of Community-based PrEP Initiation Delivery and Monitoring in South Africa
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The overall goal is to determine whether an end-to-end decentralized delivery service for PrEP is more effective safe acceptable and cost-effective than facility-based PrEP delivery
Detailed Description:
Optimizing pre-exposure prophylaxis PrEP delivery with a focus on priority populations is critical to realize the enormous potential of PrEP for HIV prevention HIV incidence remains relentlessly high among young women and sexual minority men and primary prevention is critical to achieving control of the HIV epidemic With effective and persistent use oral pre-exposure prophylaxis PrEP for HIV prevents 75-100 of HIV cases among cisgender women and men gay and bisexual men and transgender women Despite the high efficacy uptake throughout the PrEP prevention cascade remains low
South Africa is expanding PrEP provision but requires evidence-based strategies on how to achieve access effective use and persistence The current clinic-based requirement of PrEP to persons at risk for HIV acquisition requires that clients self-identify their exposure to HIV and visit the clinic regularly for initiation monitoring and refills Barriers to PrEP access include clinic level factors ie staff training brief visits and individual level factors including logistics such as transportation for clinic visits The priority is to determine how to deliver PrEP in a scalable way and achieve high PrEP access and effective persistent use
PrEP is a highly efficacious HIV prevention strategy but requires effective strategies that streamline delivery and engage users for scale-up Community-based strategies for HIV testing ART initiation and monitoring successfully reach people living with HIV for treatment and have made marked improvements to viral suppression
This protocol describes a randomized clinical study to test an end-to-end decentralized delivery service for PrEP It aims to safely increase PrEP access and use among priority populations in South Africa Participants will include 16-30 year old HIV negative women and sexual minority men at high risk for acquiring HIV As a critical component of decentralized delivery we will also evaluate the safety and efficacy of HIV self-testing compared to rapid diagnostic tests
South Africa is expanding PrEP provision but requires evidence-based strategies on how to achieve access effective use and persistence The current clinic-based requirement of PrEP to persons at risk for HIV acquisition requires that clients self-identify their exposure to HIV and visit the clinic regularly for initiation monitoring and refills Barriers to PrEP access include clinic level factors ie staff training brief visits and individual level factors including logistics such as transportation for clinic visits The priority is to determine how to deliver PrEP in a scalable way and achieve high PrEP access and effective persistent use
PrEP is a highly efficacious HIV prevention strategy but requires effective strategies that streamline delivery and engage users for scale-up Community-based strategies for HIV testing ART initiation and monitoring successfully reach people living with HIV for treatment and have made marked improvements to viral suppression
This protocol describes a randomized clinical study to test an end-to-end decentralized delivery service for PrEP It aims to safely increase PrEP access and use among priority populations in South Africa Participants will include 16-30 year old HIV negative women and sexual minority men at high risk for acquiring HIV As a critical component of decentralized delivery we will also evaluate the safety and efficacy of HIV self-testing compared to rapid diagnostic tests
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None