Ignite Creation Date:
2024-05-06 @ 10:12 AM
Last Modification Date:
2024-10-26 @ 12:26 PM
Study NCT ID:
NCT03199027
Status:
COMPLETED
Last Update Posted:
2019-09-04
First Post:
2017-06-23
Brief Title:
Timing of Referral to Adherence Clubs for Antiretroviral Therapy
Sponsor:
University of Cape Town
Organization:
University of Cape Town
Study Overview
Official Title:
Timing of Referral to Adherence Clubs for Antiretroviral Therapy - a Randomised Controlled Trial
Status:
COMPLETED
Status Verified Date:
2019-09
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:
TRAC
Brief Summary:
Following the announcement of the global 90-90-90 strategy there is a huge need in South Africa for effective well-developed scaled-up models of ART anti-retroviral therapy delivery that aim to improve patient adherence and viral suppression The ART adherence club is one such model of service delivery The investigators are conducting a pragmatic randomised control trial to compare virological outcomes 12 months post-ART initiation between arms individuals referred to the Adherence club at 4 months post-ART initiation early referral and individuals referred to the Adherence club at 12 months post-ART initiation delayed referral Individuals with delayed Adherence club referral will continue to attend the ART clinic as per the Standard-of-Care
Detailed Description:
Following on from the huge need for scaled-up models of ART anti-retroviral therapy delivery to improve patient adherence and viral suppression the ART adherence club model was piloted from 2007 with the aim of assessing whether this group-based lay-counsellor led service with an emphasis on social support and adherence could help address retention in care and viral suppression Since the initial pilots the club model has been scaled up rapidly with more than 400 clubs meeting in the Cape Town metro As this model is being scaled-up and implemented rapidly there is an urgent necessity to further assess its effectiveness
Whilst adherence clubs have been shown to be locally implementable popular with buy-in by clinic staff and patients and cost-effective and whilst community-based interventions have been shown to improve retention evidence of local adherence club effectiveness in improving viral suppression and retention has only been observationally obtained This observational evidence is highly subject to selection bias
This trial aims to address this by using a randomised controlled trial design with two arms - ART patients receiving care in clinic as per the Standard-of-Care this arm will have delayed referral to Adherence clubs at 12 months post-initiation and ART patients receiving care in Adherence clubs this arm will have early referral to Adherence clubs at 4 months post-initiation By doing this the investigators hope to generate robust evidence regarding both the effectiveness of clubs and the optimal timing of club referral
Whilst adherence clubs have been shown to be locally implementable popular with buy-in by clinic staff and patients and cost-effective and whilst community-based interventions have been shown to improve retention evidence of local adherence club effectiveness in improving viral suppression and retention has only been observationally obtained This observational evidence is highly subject to selection bias
This trial aims to address this by using a randomised controlled trial design with two arms - ART patients receiving care in clinic as per the Standard-of-Care this arm will have delayed referral to Adherence clubs at 12 months post-initiation and ART patients receiving care in Adherence clubs this arm will have early referral to Adherence clubs at 4 months post-initiation By doing this the investigators hope to generate robust evidence regarding both the effectiveness of clubs and the optimal timing of club referral
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?:
None
Is an FDA AA801 Violation?:
None