Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06250504
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2023-12-15
Brief Title:
Long-Acting HIV Pre-Exposure Prophylaxis Integrated With Sexual and Reproductive Health - cRCT
Sponsor:
Africa Health Research Institute
Organization:
Africa Health Research Institute
Study Overview
Official Title:
Long-acting HIV Pre-Exposure Prophylaxis Integrated With Community-based Sexual and Reproductive Health in South Africa LAPIS A Hybrid 1a Cluster Randomised Controlled Phase 3B Trial of Effectiveness and Implementation
Status:
RECRUITING
Status Verified Date:
2024-04
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:
LAPIS
Brief Summary:
The goal of this hybrid 1a Cluster Randomised Controlled Trial phase 3B trial is to evaluate the effectiveness and implementation of offering a choice of HIV Pre-Exposure Products PrEP through community-based sexual and reproductive health services on PrEP uptake and retention and population prevalence of sexually transmissible HIV amongst adolescents and young adults living in rural South Africa
Researchers will compare adding the choice of long-acting PrEP ie two monthly injectable cabotegravir CAB LA or dapiravine vaginal ring and HIV post exposure prophylaxis packs to daily oral PrEP integrated with community-based SRH in the 20 intervention clusters with standard of care SoC daily oral PrEP integrated with community-based SRH in the 20 control clusters on uptake and retention on PrEP We hypothesise that offering a choice of long-acting or oral PrEP and PEP within the community-based delivery of SRH services will overcome the challenges and barriers to effective use of oral daily PrEP and lead to a population-level effect on uptake and retention on PrEP and thus the prevalence of sexually transmissible HIV amongst 15-30 year olds living in rural KwaZulu-Natal South Africa
Researchers will compare adding the choice of long-acting PrEP ie two monthly injectable cabotegravir CAB LA or dapiravine vaginal ring and HIV post exposure prophylaxis packs to daily oral PrEP integrated with community-based SRH in the 20 intervention clusters with standard of care SoC daily oral PrEP integrated with community-based SRH in the 20 control clusters on uptake and retention on PrEP We hypothesise that offering a choice of long-acting or oral PrEP and PEP within the community-based delivery of SRH services will overcome the challenges and barriers to effective use of oral daily PrEP and lead to a population-level effect on uptake and retention on PrEP and thus the prevalence of sexually transmissible HIV amongst 15-30 year olds living in rural KwaZulu-Natal South Africa
Detailed Description:
This is a pragmatic trial of adding in a choice of South African Health Products Registration Authority SAHPRA approved newer PrEP products - APRETUDE cabotegravir 600 mg3 mL DAPIRING Dapivirine 25mg Vaginal Ring5620280979 22112022 - to the current national department of health approved oral daily PrEP with TVFFTC Tenofovir disoproxilemtricitabine Objective 1 To measure the effectiveness of the choice of oral and long-acting PrEP including injectable CAB LA and vaginal ring DapiRing and post exposure prophylaxis PEP on increasing effective uptake adoption retention and adherence of PrEP compared to oral PrEP in young people aged 15-30 in rural South Africa and to estimate the preliminary effect on transmissible HIV and HIV incidence
Objective 2 To understand real-world implementation
21 To explore the acceptability appropriateness preference and reach of CABLA from the perspective of young people aged 15-30 and their communities in rural South Africa 22 To understand the feasibility affordability and scalability of delivering CABLA through community-based PrEP with SRH
23 To identify implementation challenges and practical solutions for CABLA initiation laboratory monitoring eg RNA testing and safe stopping within nurse-led and rural community-based clinical settings 24 To evaluate the safety and tolerability of CABLA compared to oral PrEP
Objective 2 To understand real-world implementation
21 To explore the acceptability appropriateness preference and reach of CABLA from the perspective of young people aged 15-30 and their communities in rural South Africa 22 To understand the feasibility affordability and scalability of delivering CABLA through community-based PrEP with SRH
23 To identify implementation challenges and practical solutions for CABLA initiation laboratory monitoring eg RNA testing and safe stopping within nurse-led and rural community-based clinical settings 24 To evaluate the safety and tolerability of CABLA compared to oral PrEP
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?:
False
Is an FDA AA801 Violation?:
None