LinkPositively: A Technology-Delivered Peer Navigation and Social Networking Intervention to Improve HIV Care Across the Continuum for Black Women Affected by Interpersonal Violence
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- HIV Adherence Self-Efficacy
Study Overview
Brief Summary
Investigators will develop and pilot test a culturally tailored, trauma-informed smartphone app, called LinkPositively, for Black WLHA affected by interpersonal violence. The goal is to determine preliminary effects of the intervention on HIV care (i.e., retention in HIV care, ART adherence) and mental health outcomes (e.g., PTSD, depression, anxiety). 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) global positioning system-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, investigators will pilot test LinkPositively to assess preliminary effects of the intervention on HIV care (i.e., retention in care and ART adherence) and mental health outcomes (e.g., PTSD, depression, anxiety). 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Investigator)
Masking Description
The investigators were blinded to participant study group assignment.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Standard of Care
Women assigned to the control arm will receive self-directed (non-Virtual Peer Navigator (PN) supported) treatment as usual at the HIV care service provider of choice following the Ryan White standard of care (i.e., referrals to physical, dental and mental health services; case management; and ancillary services. Annual assessments (e.g., updates on insurance, housing, referrals needed, behavioral assessment [e.g., depression, substance use]) are conducted by a case manager. For women who have fallen out of care and re-engage care, case management begins with an interview and assessment of current needs. Goals are set to create an individual care plan related to medical care, housing, and other resources, as needed. Referrals are made to appropriate services (e.g., primary care, housing, benefits counseling, food, support services) based on the intake assessment. It is important to note that the case management approach is self-guided versus intensive virtual PN assistance.
LinkPositively Intervention
Women assigned to the LinkPositively intervention 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.
Intervention: LinkPositively (Behavioral)
Outcomes
Primary Outcomes
HIV Adherence Self-Efficacy
Time Frame: 6 Months Post-Baseline
HIV Adherence Self-Efficacy measured using the HIV Adherence Self-Efficacy Scale, minimum=0, maximum=10; higher scores mean greater self-efficacy to adhere to HIV medication.
Number of Participants With ART Adherence
Time Frame: 6 Months Post-Baseline
Dichotomized into two groups (Greater than or equal to 90% adherence to ART regime (self-report) based on the Wilson 3-item adherence self-report items vs. Less than 90% adherence to ART regime (self-report) based on the Wilson 3-item adherence self-report items)
Number of HIV Care Visits
Time Frame: 6 Months Post-Baseline
Median number of HIV care visits in past 6 months
Number of HIV Care Visits
Time Frame: 3 Months Post-Baseline
Median number of HIV care visits
Number of Participants With ART Adherence
Time Frame: 3 Months Post-Baseline
Dichotomized into two groups (Greater than or equal to 90% adherence to ART regime (self-report) based on the Wilson 3-item adherence self-report items vs. Less than 90% adherence to ART regime (self-report) based on the Wilson 3-item adherence self-report items)
HIV Adherence Self-Efficacy
Time Frame: 3 Months Post-Baseline
HIV Adherence Self-Efficacy measured using the HIV Adherence Self-Efficacy Scale, minimum=0, maximum=10; higher scores mean greater self-efficacy to adhere to HIV medication.
Secondary Outcomes
- Generalized Anxiety Disorder Score(6 Months Post-Baseline)
- National Stressful Events Survey PTSD Short Scale Score(6 Months Post-Baseline)
- Patient Health Questionnaire for Depression Score(6 Months Post-Baseline)
- National Stressful Events Survey PTSD Short Scale Score(3 Months Post-Baseline)
- Generalized Anxiety Disorder Score(3 Months Post-Baseline)
- Patient Health Questionnaire for Depression Score(3 Months Post-Baseline)
Investigators
Jamila K. Stockman
Professor
University of California, San Diego