Ignite Creation Date:
2024-05-06 @ 7:29 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06027671
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-13
First Post:
2023-08-31
Brief Title:
Structured Peer-delivered ART and Reentry Community Strategy
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Structured Peer-delivered Antiretroviral Therapy ART and Reentry Community Strategy to Overcome Barriers to HIV Care Continuity During Community Re-entry From Incarceration in South Africa
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
SPARCS
Brief Summary:
The overarching goal of this study is to implement both a transition community adherence club strategy Group-SPARCS and an ART provision strategy ART-SPARCS for HIV-positive individuals transitioning from correctional to community settings in South Africa The current proposal will allow for a fully powered effectiveness randomized clinical trial RCT
To compare the effectiveness of Full-SPARCS ART-SPARCS and Group-SPARCS to care as usual and to each other to achieve HIV RNA suppression 6 months following correctional facility release
To assess determinants of implementation of Full-SPARCS ART-SPARCS and Group-SPARCS
To assess the scalability through costing and cost effectiveness analysis of Full-SPARCS ART-SPARCS and Group-SPARCS
To compare the effectiveness of Full-SPARCS ART-SPARCS and Group-SPARCS to care as usual and to each other to achieve HIV RNA suppression 6 months following correctional facility release
To assess determinants of implementation of Full-SPARCS ART-SPARCS and Group-SPARCS
To assess the scalability through costing and cost effectiveness analysis of Full-SPARCS ART-SPARCS and Group-SPARCS
Detailed Description:
Background The South African government has devoted resources towards HIV care in correctional facilities that have resulted in antiretroviral therapy ART coverage of 90 and viral load VL suppression of 80 among incarcerated people living with HIV PLWH However despite free post-release care the investigators previously observed that only an estimated 34 were in care three months post-release The investigators developed tested and manualized the Structured Peer-delivered ART and Re-entry Community Strategy SPARCS to overcome post-incarceration barriers specific to PLWH returning to the community8-10 In the investigators randomized controlled pilot of SPARCS 6-month post-release continuity of care was 61 in the intervention arm compared to 36 in the usual care arm p0001 demonstrating effectiveness Full-SPARCS has two distinct components spanning six months post-release direct provision of ART ART-SPARCS and 12 biweekly peer facilitator-led group sessions Group-SPARCS ART-SPARCS is designed to overcome clinic-level barriers through bimonthly distribution of ART without a group component Group-SPARCS is designed to increase self-efficacy social support and life skills through facilitated group discussion and curriculum including planning problem solving financial literacy and living with HIV without ART distribution The current usual care is a supply of ART and a referral letter at the time of release from incarceration
Methods This research study will be conducted in Gauteng Province Recruitment will occur within correctional facilities of the Department of Correctional Services DCS - Modderbee Kgosi Mampuru II and Johannesburg All study interventions will occur following release in either Ekurhuleni District Tshwane District or Johannesburg District The study population will be comprised of adult 18 years old corrections inmates either male or female with known HIV infection and are receiving ART within the correctional facility and are expected to be released back into the community within 3 months of study enrollment Participants will be randomized 1111 to either the standard of care Full-SPARCS Group-SPARCS or ART-SPARCS using sequential envelopes with study arm determination sealed inside Study staff will contact participants to ascertain care status and update contact information at one week one month three months six months nine months and twelve months from release Participants assigned to Group-SPARCS or ART-SPARCS will be asked to attend biweekly sessions Group-SPARCS activities will include - structured curriculum symptom screening and routine laboratory monitoring ART-SPARCS will include the distribution of pre-packed medication and routine laboratory monitoring Full-SPARCS includes all components of Group-SPARCS and ART-SPARCS
Study sample A total of 640 participants will be randomized to one of the four arms Sixty of the participants will be selected for participation in qualitative in-depth interviews An additional 25 staff involved in Transition community adherence club TCAC referral ART provision implementation coordination will be enrolled for qualitative in-depth interviews
Significance The proposed study is consistent with NIH HIVAIDS highest priority research and the South African National Strategic Plan on HIV Tuberculosis TB and Sexually Transmitted Infections STIs 2017-2022 The research addresses the HIVAIDS Research Priority of retention and engagement in these services and achievement and maintenance of optimal prevention and treatment responses It also addresses health disparities through a focus on recently released inmates a marginalized population The proposal also fits with the South African National Strategic Plan prioritizing inmates as a key population for HIV services
Methods This research study will be conducted in Gauteng Province Recruitment will occur within correctional facilities of the Department of Correctional Services DCS - Modderbee Kgosi Mampuru II and Johannesburg All study interventions will occur following release in either Ekurhuleni District Tshwane District or Johannesburg District The study population will be comprised of adult 18 years old corrections inmates either male or female with known HIV infection and are receiving ART within the correctional facility and are expected to be released back into the community within 3 months of study enrollment Participants will be randomized 1111 to either the standard of care Full-SPARCS Group-SPARCS or ART-SPARCS using sequential envelopes with study arm determination sealed inside Study staff will contact participants to ascertain care status and update contact information at one week one month three months six months nine months and twelve months from release Participants assigned to Group-SPARCS or ART-SPARCS will be asked to attend biweekly sessions Group-SPARCS activities will include - structured curriculum symptom screening and routine laboratory monitoring ART-SPARCS will include the distribution of pre-packed medication and routine laboratory monitoring Full-SPARCS includes all components of Group-SPARCS and ART-SPARCS
Study sample A total of 640 participants will be randomized to one of the four arms Sixty of the participants will be selected for participation in qualitative in-depth interviews An additional 25 staff involved in Transition community adherence club TCAC referral ART provision implementation coordination will be enrolled for qualitative in-depth interviews
Significance The proposed study is consistent with NIH HIVAIDS highest priority research and the South African National Strategic Plan on HIV Tuberculosis TB and Sexually Transmitted Infections STIs 2017-2022 The research addresses the HIVAIDS Research Priority of retention and engagement in these services and achievement and maintenance of optimal prevention and treatment responses It also addresses health disparities through a focus on recently released inmates a marginalized population The proposal also fits with the South African National Strategic Plan prioritizing inmates as a key population for HIV services
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