Ignite Creation Date:
2024-07-17 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06474364
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-05
Brief Title:
HIV Prevention and Care Interventions for Youth in Uganda
Sponsor:
MU-JHU CARE
Organization:
MU-JHU CARE
Study Overview
Official Title:
Using Implementation Science to Understand and Design Stakeholder Informed Innovative Interventions to Improve Youth HIV Prevention and Care Continuums in Rural and Urban Uganda
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
HIPCY
Brief Summary:
Several studies show that Adolescents and Young Adults AYA have poor outcomes along the entire Human Immunodeficiency Virus HIV prevention and care cascades compared to adults The investigators propose to evaluate novel evidence-based HIV prevention and care interventions including Cabotegravir LongActing CABLA to determine implementation outcomes among AYA who are at particularly high risk for HIV acquisition and poor viral suppression in five geographically distinct research performance sites in Uganda The results will provide important evidence to inform Uganda and other regional countries policy on integrated HIV prevention care and treatment for AYA at high risk for HIV and Sexually Transmitted Infections STIs in order to reach the UNAIDS 95-95-95 targets and HIV epidemic control
Detailed Description:
Adolescents and Young Adults AYA have a high HIV incidence and poor outcomes along the entire HIV prevention and care cascades compared to adults Despite the high HIV burden both uptake of oral Pre-Exposure Prophylaxis PrEP HIV negatives and achieving viral suppression HIV positives are sub-optimal among youth in Sub-Saharan Africa Among youth in Uganda uptake and persistence on oral PrEP is low with reasons for discontinuation including pill burden low perceived severity of HIV need for partner or parental approval HIV-related stigma fear of side-effects and health facility barriers Cabotegravir a is new long-acting antiretroviral CABLA and highly efficacious PrEP choice that can mitigate barriers to use of daily oral PrEP The Investigators propose to evaluate evidence-based HIV prevention and care interventions to improve implementation outcomes among high-risk AYA 15-24 years in Uganda The study covers the continuum of care will use novel screening methods for HIV risk will involve teams that are highly experienced in youth-focused clinical trials and Implementation Science ImS will implement Ministry of Health MOH approved community differentiated service delivery models for delivery CABLA will evaluate the implementation of the Sustainable East Africa Research in Community Health SEARCH -Youth SY a multi-component intervention comprising of life-stage based assessment and support to increase viral suppression in high-risk AYA with HIV and will use hybrid effectiveness implementation designs to assess these evidence-based interventions The aims include Aim 1 Using the Consolidated Framework for Implementation Research CFIR the investigators will identify determinants of potential implementation success of two innovations CABLA and SY implementation at the community clinic provider and patient levels in 5 geographically distinct sites in Uganda Aim 2a Using a hybrid effectiveness implementation type II design the investigators will assess the uptake and persistence of CAB-LA The investigators will conduct a randomized prospective study to assess effectiveness for the provision of CABLA among high risk AYA Effectiveness outcome will be proportion of study subjects who have initiated CABLA and persisted at 18 months of follow-up comparing facility and community delivery options Implementation outcomes will be feasibility acceptability adoption and maintenance using Reach Effectiveness Adoption Implementation Maintenance REAIM Aim 2b Using a hybrid effectiveness implementation type III design the investigators will assess implementation feasibility adoption fidelity and sustainment and effectiveness of the SY intervention in increasing long-term virologic suppression 200 cmL at 18 months of follow-up in 5 Clinical Research Performance Sites CRPS using REAIM Aim 3 The investigators will use platforms in aims 1 and 2 to strengthen capacity of ImS and to translate findings into policy and guidelines The study involves solid community and institutional partnerships and builds on a strong multi-disciplinary team highly experienced in innovative methods and implementation science in sub-Saharan Africa The project building on Prevention and Treatment through a Comprehensive Care Continuum for HIV-affected Adolescents in Resource Constrained Settings Implementation Science Network PATC3H and Adolescent HIV prevention and treatment implementation Science Alliance AHISA is responsive to World Health Organizations Ugandas MoH priorities regarding the gap in HIV services for highly vulnerable AYA It will test a novel scalable and integrated approach to initiate and sustain support for high-risk AYA in Low and Middle Income Countries LMICs
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