Clinical trial NCT04199052: LinkPositively: A Technology-Delivered Peer Navigation and Social Networking Intervention to Improve HIV Care
Official title: LinkPositively: A Technology-Delivered Peer Navigation and Social Networking Intervention to Improve HIV Care Across the Continuum for Black Women Affected by Interpersonal Violence
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: HIV/AIDS
Keywords: HIV Care Continuum, Mobile Apps
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: San Diego State University
name: National Institute of Mental Health (NIMH)
First posted: 2019-12-13
Enrollment: 70
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: Investigators will develop and pilot test a culturally tailored, trauma-informed smartphone app, called LinkPositively, for Black WLHA 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. The study will be conducted in 2 phases with corresponding aims. In Phase 1 (Aim 1), 4 focus groups with Black WLHA with experiences of interpersonal violence, one focus group with peer navigators, and 4-6 key informant interviews with providers will be conducted to determine which app features, content, and functions are most likely to support downloading, initiating use, and sustaining engagement over time. Aim 1 will culminate in usability testing by Black WLHA affected by interpersonal violence (n=8), to finalize intervention components and procedures. In Phase 2 (Aim 2), investigators will pilot test LinkPositively to assess feasibility and acceptability and determine preliminary effects of the intervention on HIV care outcomes (i.e., retention in care, ART adherence, viral suppression) and mechanism of change variables (i.e., social support, self-efficacy). Through a randomized control trial (RCT), participants will be randomly assigned to either the intervention arm (n=40) or control arm (Ryan White standard of care, n=40), with follow-up at 3- and 6- months. This study will benefit the advancement of HIV prevention science by harnessing technology to promote engagement in HIV care, while improving social support through peers and social networking-all under the auspices of being trauma-informed for Black WLHA with experiences of interpersonal violence.

Detailed description: In the US, Black women living with HIV/AIDS (WLHA) are less likely to be engaged in care, adherent to antiretroviral therapy (ART), and virally suppressed compared to White WLHA. Black women are also disproportionately affected by interpersonal violence - physical, sexual, and/or psychological abuse by a current or former intimate partner or non-intimate partner - which may co-occur with poor mental health and/or substance use, further contributing to ART non-adherence, lower CD4 counts, and reduced viral suppression. Peer Navigation, while highlighted as a successful model of care in improving HIV care outcomes, requires resources that HIV service agencies often lack. A scalable and sustainable solution is the use of mobile health (mHealth) smartphone applications ("apps"). Although there has been an increase in mHealth interventions developed for HIV prevention and care among at-risk and HIV-positive men who have sex with men (MSM) and youth, investigators are unaware of any to improve retention in care, ART adherence, and viral suppression among Black WLHA, nor any mHealth interventions that are responsive to Black women's experiences with interpersonal violence. To address this gap, investigators will develop and pilot test a culturally tailored, trauma-informed smartphone app, called LinkPositively, for Black WLHA 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. Guided by the Theory of Triadic Influences and Syndemic Theory, the study will be conducted in 2 phases with corresponding aims. In Aim 1, 4 focus groups with Black WLHA with experiences of interpersonal violence, one focus group with peer navigators, and 4-6 key informant interviews with providers will be conducted to determine which app features, content, and functions are most likely to support downloading, initiating use, and sustaining engagement over time. Aim 1 will culminate in usability testing by Black WLHA affected by interpersonal violence (n=5), to finalize intervention components and procedures. In Aim 2, investigators will pilot test LinkPositively to assess feasibility and acceptability and determine preliminary effects of the intervention on HIV care outcomes (i.e., retention in care, ART adherence, viral suppression) and mechanism of change variables (i.e., social support, self-efficacy). Participants will be randomly assigned to either the intervention (n=40) or control (Ryan White standard of care, n=40) arm, with follow-up at 3- and 6- months. This study will benefit the advancement of HIV prevention science by harnessing technology to promote engagement in HIV care, while improving social support through peers and social networking - all under the auspices of being trauma-informed for Black WLHA with experiences of interpersonal violence.

Eligibility criteria: Inclusion Criteria:

* Female Gender
* Black or African-American racial/ethnic background
* Aged 18 years or older
* HIV-positive status
* Ever experienced physical, sexual, and/or psychological abuse by a current or former partner or non-partner (e.g., relative, friend, stranger)
* Owner of a smartphone with internet browsing capabilities
* English speaking

Exclusion Criteria:

* Male Gender
* Aged 17 or younger
* HIV-negative status

Primary outcomes:
measure: Change in Retention in HIV Care
timeFrame: 3 Months Post-Baseline
measure: Change in Retention in HIV Care
timeFrame: 6 Months Post-Baseline
measure: Change in ART Adherence
timeFrame: 3 Months Post-Baseline
measure: Change in ART Adherence
timeFrame: 6 Months Post-Baseline
measure: Change in Viral Suppression
timeFrame: 3 Months Post-Baseline
measure: Change in Viral Suppression
timeFrame: 6 Months Post-Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD AntiViral Research Center
state: California
Study officials:
affiliation: University of California, San Diego
name: Jamila K. Stockman, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: San Diego State University
name: Keith J. Horvath, PhD
role: PRINCIPAL_INVESTIGATOR
References: