Ignite Creation Date:
2024-05-06 @ 2:03 PM
Last Modification Date:
2024-10-26 @ 1:24 PM
Study NCT ID:
NCT04199052
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-01
First Post:
2019-12-09
Brief Title:
LinkPositively A Technology-Delivered Peer Navigation and Social Networking Intervention to Improve HIV Care
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 n8 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 ie retention in care ART adherence viral suppression and mechanism of change variables ie social support self-efficacy Through a randomized control trial RCT participants will be randomly assigned to either the intervention arm n40 or control arm Ryan White standard of care n40 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 HIVAIDS 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 andor psychological abuse by a current or former intimate partner or non-intimate partner - which may co-occur with poor mental health andor 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 womens 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 n5 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 ie retention in care ART adherence viral suppression and mechanism of change variables ie social support self-efficacy Participants will be randomly assigned to either the intervention n40 or control Ryan White standard of care n40 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R34MH122014-01 | NIH | None | httpsreporternihgovquickSearchR34MH122014-01 |