LinkPositively+ An Enhanced Mobile Health App Delivered Intervention to Improve HIV Care Outcomes Among Black Women Affected by Mental Health and Violence

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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 (i.e., 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 1:1 to either the LP arm or the LPP arm.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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Locations
United States
Oklahoma
Guiding Right, Inc.
RECRUITING
Oklahoma City
New Hope Wellness Center
RECRUITING
Oklahoma City
Guiding Right, Inc.
RECRUITING
Tulsa
Contact Information
Primary
Theodore H Noel, BS
tnoel@guidingright.org
405) 733-0771
Backup
Jamila K Stockman, PhD, MPH
jstockman@health.ucsd.edu
(858) 822-4652
Time Frame
Start Date: 2024-04-12
Estimated Completion Date: 2025-01-15
Participants
Target number of participants: 60
Treatments
Active_comparator: Control Arm: LinkPositively
Women assigned to the LinkPositively arm will have access to all four components of the LinkPositively app. Women will be scheduled for a session with staff to inform them of their assigned virtual Peer Navigator (PN). Staff will train participants on how to download the app, explain the five components, using each component, and contacting their PN. Within the first week after, virtual PNs will complete a one-on-one, in-person or phone intake session with the participant, based on the participant's preference. During this intake session, the PN will conduct a participant needs assessment to connect her to HIV medical care via local health clinics and identify other areas of need, services of need, and assisted referrals (domestic violence services, mental health care, substance abuse treatment, housing and legal support, etc.). PNs will provide trauma-informed emotional and informational support, including guidance on accessing information about referred services.
Experimental: Intervention Arm: LinkPositively+
Women assigned to the LPP+ arm will receive all components of the LP arm plus access to mindfulness videos via the app, in addition to participating in a virtual 6-session weekly, PN led mindfulness meditation enhanced intervention. The sessions will be delivered in real time, by PNs and will involve 1 on 1 discussions on a) the principles and health benefits of mindfulness meditation, b) lived experiences of women living with HIV and intersectional identities of being Black, and doubling identifying as women, c) experiencing trauma in personal relationships, d) ethnic pride, e) sex/gender pride, and f) positive self-affirmations. Sessions will be conducted online, in-app, and include culturally congruent video clips, role playing, and skills building activities that enhance self-pride and coping during stressful situations.
Related Therapeutic Areas
Sponsors
Collaborators: University of California, San Diego
Leads: Guiding Right, Inc.

This content was sourced from clinicaltrials.gov