Viewing Study NCT03132415



Ignite Creation Date: 2024-05-06 @ 10:01 AM
Last Modification Date: 2024-10-26 @ 12:23 PM
Study NCT ID: NCT03132415
Status: COMPLETED
Last Update Posted: 2024-03-18
First Post: 2017-04-24

Brief Title: Get Connected Efficacy Trial
Sponsor: University of Pennsylvania
Organization: University of Pennsylvania

Study Overview

Official Title: Get Connected Linking YMSM to Adequate Care Through a Multilevel Tailored WebApp Intervention
Status: COMPLETED
Status Verified Date: 2023-08
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: None
Brief Summary: Get Connected GC is an online brief intervention that employs individual and systems-level tailoring technology to reduce barriers to HIV prevention care eg HIVSTI testing PrEP for YMSM The deployment of GC through a mobile-friendly WebApp seeks to optimize online interventions acceptability accessibility availability long-term affordability among youth The investigators will enroll self-reported HIV-negative or sero-status unaware sexually active YMSM ages 15-24 across three cities and randomize them into the GC intervention condition or to an attention-control condition Assessments will be collected at 30 days and at 3 6 9 and 12 month follow-up
Detailed Description: The number of HIV infections among men who have sex with men aged 15-24 YMSM has grown significantly in the past decade For YMSM to successfully engage in HIV prevention and care services requires that they navigate a series of multilevel barriers operating at the individual eg risk awareness self-efficacy to get tested systems eg costs medical mistrust lack of culturally competent care and structural eg homelessness costs stigma levels

The investigators developed Get Connected GC as an online brief intervention that employs individual and systems-level tailoring technology to reduce barriers to linkage to competent prevention care eg HIVSTI testing PrEP for YMSM ages 15-24 After a formative phase comprised of assessing HIV testing sites performance via a mystery shopping procedure the investigators will test the efficacy of GC for increasing YMSMs successful engagement in locally appropriate HIV prevention and care using a two-arm randomized controlled trial

The trial will compare the full GC intervention to the GC HIV test locator Participants will be recruited from three cities Houston Philadelphia and Atlanta characterized by high HIV incidence and followed over 12 months Assessments will be collected at 30 days and at 3 6 9 and 12 month follow-up

Specific Aims include

Aim 1 Examine the quality of HIV test counseling and PrEP-related referrals to YMSM within local HIVSTI testing sites in 3 cities Houston Philadelphia Atlanta

Aim 2 Test the efficacy of GC for increasing HIV-negative or HIV-unknown YMSMs successful uptake of HIV prevention services eg routine HIVSTI testing and PrEP awareness and willingness as compared to the attention-control condition over a 12-month period

Aim 3 Qualitatively assess sites satisfaction with performance assessments and their improvements in service delivery when working with YMSM across the three regions

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
Secondary IDs
Secondary ID Type Domain Link
1U19HD089881 NIH None httpsreporternihgovquickSearch1U19HD089881