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

NCT06458660 | Recruiting

• 1 other identifier: IN-US-985-7186
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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 (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.

Conditions

HIV/AIDS; Mental Health Issue

Keywords

HIV, AIDS, Mindfulness Meditation, Women, Care Continuum, mobile app, Violence,

Outcome Measures

Primary Outcomes (1)

• Preliminary effect of LPP+ to improve HIV care outcomes

  The study aims to examine the preliminary effect of LPP+; mindfulness meditation plus PN plus LP app (e.g., social networking platform, education and self-care tips, resource locator, and ART self-monitoring and reminders) to improve HIV care outcomes including improved retention in HIV care, ART adherence, and viral suppression using empirical hair sample analysis (ART adherence) and passive electronic health medical review (viral suppression).

  3- and 6-month Post Baseline

Study Arms (2)

Control Arm: LinkPositively

ACTIVE COMPARATOR

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.

Behavioral: LP

Intervention Arm: LinkPositively+

EXPERIMENTAL

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.

Behavioral: LPP+: Mindfulness Meditation Delivered

Interventions

LPP+: Mindfulness Meditation Delivered BEHAVIORAL

During the 6-week intervention period, participants will receive reminder SMS text messages at a time selected by the participant at 48 and 24-hrs before each scheduled study visit. Within 24 hours after every session, participants will receive an SMS text reminder to complete a session satisfaction survey. If the satisfaction surveys are not completed within 48 hours after each session, participants will receive an additional SMS text message once per day for three consecutive days after each planned study visit. Twenty-four hours before each scheduled study visit after study visit number 1, participants will an SMS text requiring a one-character response (1= yes, 2=no), asking if participants practiced any mindfulness meditation techniques since the last session. Participants who have not interacted with the app during the previous week will receive an accountability call to assess barriers to participation.

Intervention Arm: LinkPositively+

LP BEHAVIORAL

LinkPositively is a culturally tailored, trauma-informed smartphone app for Black women living with HIV/AIDS affected by interpersonal violence. Core components of LinkPositively include: a) Virtual Peer Navigation that includes phone and text check-ins and 4 weekly one-on-one video sessions to build skills to cope with barriers and navigate care; b) Social Networking platform to receive peer support; c) Educational and Self-care database with healthy living and self-care tips; d) GPS-enabled Resource Locator for HIV care and ancillary support service agencies; and e) ART self-monitoring and reminder system.

Control Arm: LinkPositively

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Self-identify as a woman
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Guiding Right, Inc.: lead
• University of California, San Diego: collaborator

Study Sites (3)

Guiding Right, Inc.

Oklahoma City, Oklahoma, 73111, United States

RECRUITING

New Hope Wellness Center

Oklahoma City, Oklahoma, 73112, United States

RECRUITING

Guiding Right, Inc.

Tulsa, Oklahoma, 74135, United States

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Central Study Contacts

Theodore H Noel, BS

CONTACT

405) 733-0771; tnoel@guidingright.org

Jamila K Stockman, PhD, MPH

CONTACT

(858) 822-4652; jstockman@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2024
• First Posted: June 13, 2024
• Study Start: April 12, 2024
• Primary Completion: November 1, 2024
• Study Completion: January 15, 2025
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)