Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06350682
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-02-20
Brief Title:
Resilient HIV Implementation Science With SGM Youths Using Evidence
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Resilient HIV Implementation Science With SGM Youths Using Evidence
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
RISE
Brief Summary:
The Resilient HIV Implementation Science with SGM Youths using Evidence RISE Clinical Research Center will use a Type 2 hybrid-effectiveness-implementation study to evaluate the effectiveness and implementation of HMP a youth-tailored digital health platform It is hypothesized that SGM youths in the HMP intervention group will demonstrate improved PrEP initiation and viral load suppression over 12 months compared to the delayed HMP group
Detailed Description:
RISE is a randomized control trial where participants are randomized 11 to either healthMPower HMP exposure for a 12 month period or delayed access to the HMP within 8 strata based on the serostatus group HIV seropositive and HIV seronegative at risk age group 15 to 17 or 18 to 24 years of age and country either Nigeria Kenya Malawi or Zambia Within the strata of serostatus age and country participants will be randomly assigned to the next treatment allocation from a randomly permuted block sequencing using block size of four
750 Participants will be randomly assigned to the HMP exposure while the other 750 participants will have delayed access to HMP The HMP is a culturally adapted status neutral mobile app that works to address HIV prevention to care continuum PHCC for SGM youth at each of the CBSPs
Participants who are delayed access for 12 months will be granted Open access for 12 months thereafter when compared to participants who were provided access for 12 months then provided 12 months of access called continued access without other external support Therefore participants will either be provided access for 12 or 24 months depending on the randomization
Primary outcome clinical effectiveness endpoint for HIV seronegative at risk young will be the uptake of PrEP and for HIV seropositive viral load suppression Secondary outcome PHCC pathway characterized for HIV seronegative at risk youth such as PrEP education and continuation and for HIV seropositive HIV testing linkage and ART initiation
750 Participants will be randomly assigned to the HMP exposure while the other 750 participants will have delayed access to HMP The HMP is a culturally adapted status neutral mobile app that works to address HIV prevention to care continuum PHCC for SGM youth at each of the CBSPs
Participants who are delayed access for 12 months will be granted Open access for 12 months thereafter when compared to participants who were provided access for 12 months then provided 12 months of access called continued access without other external support Therefore participants will either be provided access for 12 or 24 months depending on the randomization
Primary outcome clinical effectiveness endpoint for HIV seronegative at risk young will be the uptake of PrEP and for HIV seropositive viral load suppression Secondary outcome PHCC pathway characterized for HIV seronegative at risk youth such as PrEP education and continuation and for HIV seropositive HIV testing linkage and ART initiation
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