Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06554223
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
The SUSTAIN 2 Study - SUStained HIV Treatment for Adherence After Interruption in Care
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The SUSTAIN 2 Study - SUStained HIV Treatment for Adherence After Interruption in Care
Status:
NOT_YET_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:
None
Brief Summary:
The goal of this clinical trial is to learn if the DSD model SUSTAIN-DSD is effective in improving participants HIV treatment adherence The main questions it aims to answer are
Does the SUSTAIN-DSD intervention significantly improve participants treatment adherence and increase rates of viral suppression
Does the SUSTAIN-DSD intervention help retain people in care at clinics
Does SUSTAIN-DSD intervention help reduce treatment interruptions
Participants will
for 24 months either receive the SUSTAIN-DSD intervention ie be enrolled in an adherence club where they will pick up 6-months of ART medication and have the option to use peer support group sessions and additional counseling and or enhanced standard of care ie visit the clinic for treatment and participate in optional counseling sessions
Visit the adherence club to get their blood drawn for viral load tests at 6 months 12 months and every 12 months for SUSTAIN-DSD participants only
Visit the clinic to get their blood drawn for viral load tests repeated 3 months after restart of ART medication then at 12 months and annually there-after if they are virally suppressed enhanced standard of care participants only
Participate in interviews to discuss their experience with the SUSTAIN-DSD intervention
Does the SUSTAIN-DSD intervention significantly improve participants treatment adherence and increase rates of viral suppression
Does the SUSTAIN-DSD intervention help retain people in care at clinics
Does SUSTAIN-DSD intervention help reduce treatment interruptions
Participants will
for 24 months either receive the SUSTAIN-DSD intervention ie be enrolled in an adherence club where they will pick up 6-months of ART medication and have the option to use peer support group sessions and additional counseling and or enhanced standard of care ie visit the clinic for treatment and participate in optional counseling sessions
Visit the adherence club to get their blood drawn for viral load tests at 6 months 12 months and every 12 months for SUSTAIN-DSD participants only
Visit the clinic to get their blood drawn for viral load tests repeated 3 months after restart of ART medication then at 12 months and annually there-after if they are virally suppressed enhanced standard of care participants only
Participate in interviews to discuss their experience with the SUSTAIN-DSD intervention
Detailed Description:
Differentiated Service Delivery DSD models have been shown to provide equivalent or better retention in healthcare and viral VL suppression for people with HIV than conventional care models However to date DSD models have been offered only to people with HIV PWH considered stable ie retained in care and virally suppressed Thus those at high risk of poor outcomes are ineligible for DSD models In response the investigators will work with the City of Cape Town to provide the data needed to impact policy guidelines The investigators designed SUSTAIN2 SUStained HIV Treatment Adherence After INterruption which will test a scalable evidence-based DSD model SUSTAIN-DSD to address individual social and structural barriers to long-term engagement and to increase VL suppression among PWH with an ART treatment interruption or unsuppressed VL PWH-Gaps
SUSTAIN-DSD is a six-month adherence club model of care that offers flexible services with multi-month dispensing of medication de-linked from clinic processes and support from lay counselors and peers which has been proven to help PWH to sustain retention and viral suppression in the Western Cape The study will implement a Hybrid Type 1 randomized controlled trial RCT to evaluate the effectiveness of SUSTAIN-DSD on viral suppression among PWH-Gaps at 24 months post-enrollment as compared to an enhanced standard-of-care an optimized guidelines-based approach The investigators will recruit 300 participants from their parent study and clinics SUSTAIN R01MH125703 MPI OrrellSabin UCT Ethics Reference 5682021 through which the investigators have identified persistent engagement gaps in 43 of the participants despite adherence counseling to test this model of care The investigators will then assess the mechanisms of intervention impact using mixed methods guided by the Capability Opportunity and Motivation model of Behavior COM-B and determine implementation outcomes using Proctors model
Ultimately the investigators goal is to ensure that PWH are able to achieve and maintain virologic suppression through provision of an effective and efficient model of care which can be used in South Africas efforts to reach the 2030 goals
The investigators central hypothesis is that PWH-Gaps receiving SUSTAIN-DSD will have higher rates of viral suppression than those who receive enhanced routine care The investigators will use a Hybrid Type 1 RCT design to answer the study questions
SUSTAIN-DSD is a six-month adherence club model of care that offers flexible services with multi-month dispensing of medication de-linked from clinic processes and support from lay counselors and peers which has been proven to help PWH to sustain retention and viral suppression in the Western Cape The study will implement a Hybrid Type 1 randomized controlled trial RCT to evaluate the effectiveness of SUSTAIN-DSD on viral suppression among PWH-Gaps at 24 months post-enrollment as compared to an enhanced standard-of-care an optimized guidelines-based approach The investigators will recruit 300 participants from their parent study and clinics SUSTAIN R01MH125703 MPI OrrellSabin UCT Ethics Reference 5682021 through which the investigators have identified persistent engagement gaps in 43 of the participants despite adherence counseling to test this model of care The investigators will then assess the mechanisms of intervention impact using mixed methods guided by the Capability Opportunity and Motivation model of Behavior COM-B and determine implementation outcomes using Proctors model
Ultimately the investigators goal is to ensure that PWH are able to achieve and maintain virologic suppression through provision of an effective and efficient model of care which can be used in South Africas efforts to reach the 2030 goals
The investigators central hypothesis is that PWH-Gaps receiving SUSTAIN-DSD will have higher rates of viral suppression than those who receive enhanced routine care The investigators will use a Hybrid Type 1 RCT design to answer the study questions
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