Clinical trial NCT06458660: LinkPositively+ A Mobile Health App Delivered Intervention to Improve HIV Care Outcomes Among Black Women Affected by Mental Health and Violence
Official title: LinkPositively+ An Enhanced Mobile Health App Delivered Intervention to Improve HIV Care Outcomes Among Black Women Affected by Mental Health and Violence
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV/AIDS
Mental Health Issue
Keywords: HIV, AIDS, Mindfulness Meditation, Women, Care Continuum, mobile app, Violence,
Lead sponsor: Guiding Right, Inc.
Sponsor class: OTHER
Collaborators: name: University of California, San Diego
First posted: 2024-06-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Preliminary effect of LPP+ to improve HIV care outcomes
timeFrame: 3- and 6-month Post Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Guiding Right, Inc.
state: Oklahoma
city: Oklahoma City
country: United States
facility: New Hope Wellness Center
state: Oklahoma
city: Tulsa
country: United States
facility: Guiding Right, Inc.
state: Oklahoma
Study officials:
References: