LinkPositively: A Technology-Delivered Peer Navigation and Social Networking Intervention to Improve HIV Care
Part of paid clinical trials in San Diego, California.
- Sponsor
- University of California, San Diego
- Study ID
- NCT04199052
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- LinkPositively — BEHAVIORALLinkPositively 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.
Study Details
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.
Key Dates
- Start date
- Sep 14, 2021
- Status verified
- Jun 2025
- Primary completion
- Oct 31, 2023
- Completion
- Oct 31, 2023
Study Design
- Enrollment
- 53 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- No Intervention: Standard of CareWomen 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.
- Experimental: LinkPositively InterventionWomen 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.
Primary Outcome Measure
Number of HIV Care Visits [ Time Frame: 3 Months Post-Baseline ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UCSD AntiViral Research Center | San Diego | California | 92103 | - |
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