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

HIV/AIDS Clinical Trial

— LPP Plus  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06458660
• Other study ID #: IN-US-985-7186
• Status: Recruiting
• Phase: N/A
• Start date: April 12, 2024
• Est. completion date: January 15, 2025

Study information

• Verified date: June 2024
• Source: Guiding Right, Inc.
• Contact: Theodore H Noel, BS
• Phone: 405) 733-0771
• Email: tnoel[@]guidingright.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 15, 2025
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS
• Mental Health Issue

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Guiding Right, Inc.	Oklahoma City	Oklahoma
United States	New Hope Wellness Center	Oklahoma City	Oklahoma
United States	Guiding Right, Inc.	Tulsa	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
Guiding Right, Inc.	University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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