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

June 9, 2024 updated by: Guiding Right, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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, and/or 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 (e.g., 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 and/or 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 and/or PTSD that negatively affect sustained engagement in HIV related care and treatment.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73111
        • Recruiting
        • Guiding Right, Inc.
        • Contact:
      • Oklahoma City, Oklahoma, United States, 73112
      • Tulsa, Oklahoma, United States, 74135

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: a) aged 18 years or older, b) cisgender or transgender woman, c) as Black or African American racial/ethnic identity, d) Living with HIV/AIDS, e) able to read, speak, and understand English, e) ever-experienced physical, sexual, and/or psychological abuse by a current or former partner of non-partner, and f) owner of a smartphone with internet browsing capabilities.

-

Exclusion Criteria: a) Unwillingness to participate in the study, b) cognitive impairment that would limit participation with study procedures, c) Male Gender, d) HIV negative serostats

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: LP
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.
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.
Behavioral: LPP+: Mindfulness Meditation Delivered
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preliminary effect of LPP+ to improve HIV care outcomes
Time Frame: 3- and 6-month Post Baseline
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guiding Right, Inc.

Collaborators

University of California, San Diego

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2024

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

January 15, 2025

Study Registration Dates

First Submitted

June 9, 2024

First Submitted That Met QC Criteria

June 9, 2024

First Posted (Actual)

June 13, 2024

Study Record Updates

Last Update Posted (Actual)

June 13, 2024

Last Update Submitted That Met QC Criteria

June 9, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IN-US-985-7186

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No current plan.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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