Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06458660
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-09
Brief Title:
LinkPositively A Mobile Health App Delivered Intervention to Improve HIV Care Outcomes Among Black Women Affected by Mental Health and Violence
Sponsor:
Guiding Right Inc
Organization:
Guiding Right Inc
Study Overview
Official Title:
LinkPositively An Enhanced Mobile Health App Delivered Intervention to Improve HIV Care Outcomes Among Black Women Affected by Mental Health and Violence
Status:
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:
LPP Plus
Brief Summary:
The investigative team will conduct a 2-arm randomized control trial to examine the preliminary effect of LinkPositively LPP an enhanced version of LinkPositively LP mobile app on improved HIV care outcomes including improved retention in HIV care ART adherence and viral suppression using hair sample analysis and passive electronic medical record review and secondarily self-reported increased social support via activation of social support networks ie assessed by utilization self-efficacy and utilization of ancillary support services at baseline 3- and 6-month post enrollment Black women living with HIV WLHA with a lifetime history of interpersonal violence who have been linked to care but may have fallen out of care in the past year will be randomized 11 to either the LP arm or the LPP arm
Detailed Description:
In the US Black WLHA are less likely to be engaged in care and adherent to antiretroviral therapy ART than other racial groups Black women account for 61 of diagnoses among all women only 56 are retained in care and 49 are virally suppressed HIV disparities are also observed in Oklahoma state where Black women have HIV diagnosis rates that are 8 times higher than White women Interpersonal violence defined as physical sexual andor psychological abuse by a male intimate or non-intimate partner disproportionately affects Black women and is associated with poor outcomes along the HIV care continuum The confluence of co-occurring adverse mental health and socio-structural barriers eg HIV stigma medical mistrust further contribute to poor HIV care outcomes Social support through informal peer networks and Peer Navigators have been successful in improving HIV care among WLHA by increasing self-efficacy and offsetting socio-structural barriers NIMH-funded LinkPositively LP is a pilot-tested culturally-tailored trauma-informed mHealth intervention responsive to interpersonal violence for Black women LP aims to improve HIV care outcomes including improved retention in HIV care ART adherence and to ultimately achieve viral suppression among Black WLHA residing in EHE jurisdictions California and Oklahoma from baseline and 3- and 6-month post enrollment visits It is hypothesized that this is achieved through increased social support and activation of social support networks self-efficacy and utilization of ancillary support services App components include a social networking platform education and self-care tips resource locator and ART self-monitoring and reminders Participants of LP have expressed unaddressed mental health symptoms indicative of depression andor PTSD Mindfulness meditation has demonstrated success as a stress management tool to mitigate negative mental health outcomes Given this we plan to add and test a mental health component within the LP app for Black WLHA known as LinkPositively to support Black WLHA in addressing mental health symptoms indicative of depression andor PTSD that negatively affect sustained engagement in HIV related care and treatment
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