Ignite Creation Date:
2024-05-06 @ 6:00 PM
Last Modification Date:
2024-10-26 @ 2:39 PM
Study NCT ID:
NCT05509959
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2022-07-26
Brief Title:
Women SHINE Addressing Syndemics and HIV Among Women Through Tech-Based Peer Engagement
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
Women SHINE Addressing Syndemics and HIV Among Women Through Tech-Based Peer Engagement
Status:
RECRUITING
Status Verified Date:
2024-07
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:
A two-arm RCT will be conducted to test the efficacy of Women SHINE a web-based trauma-informed peer navigation-social support intervention Figure 2 A total of 360 women living with HIVAIDS WLHA with a history of adulthood interpersonal violence who have been prescribed ART but are non-adherent 90 ART adherent in the last 4 weeks will be enrolled in the study WLHA will be randomized 11 into one of the following conditions 1 Women SHINE intervention arm n180 or 2 Control arm n180 The Women SHINE intervention arm will receive a four-month intervention including peer navigator PN one-on-one sessions phonetext-based check-ins 7 psychoeducation weekly support group sessions 120 mins co-facilitated by a licensed therapist and PN and access to a static website with resources for HIV care interpersonal violence trauma mental health and substance use The control arm will receive one group session 60 mins on self-care and well-being and access to the aforementioned website with resources Women will complete a video-based survey and mailed hair sample self-collection at baseline 4- 8- and 12-months post-randomization to evaluate improvements in ART adherence Aim 1 emotion regulation and PTSD symptoms Aim 2 Investigators will examine the mediating effect of individual retention in HIV care coping self-efficacy social support ancillary support services use and socio-structural stigma medical mistrust mechanisms of change on the efficacy of Women SHINE Aim 3
Detailed Description:
In the US women living with HIVAIDS WLHA are less likely to be adherent to antiretroviral therapy ART and virally suppressed compared to men living with HIVAIDS Concurrently WLHA experience high rates of interpersonal violence - physical sexual andor psychological abuse in childhood or adulthood - which often results in trauma eg post-traumatic stress disorder PTSD and other adverse mental health further contributing to ART non-adherence Additionally the confluence of syndemic or co-occurring adverse mental health substance use and socio-structural factors eg HIV stigma medical mistrust further contribute to poor HIV outcomes Social support through peer navigation and networks has been shown to counter these effects and improve HIV outcomes among WLHA Likewise psychoeducation addressing affective distress to improve mood and emotion management and relationship skills has been shown to reduce PTSD and depression However limited resources at HIV service agencies combined with socio-structural barriers eg social isolation lack of transportation impede the potential effectiveness of in-person peer navigation A scalable and sustainable solution is the use of technology in the form of web-based video interaction Building on these promising pilot findings investigators propose to conduct a randomized clinical trial of Women SHINE new name to improve ART adherence among WLHA affected by interpersonal violence in California Arizona and Nevada Participants will be randomized to either a the intervention arm n180 where they will receive a 4-month program comprised of video-based peer navigation support via one-on-one sessions 7 psychoeducation weekly support group sessions and access to a static Women SHINE website with statewide resources for HIV care interpersonal violence trauma mental health and substance use or b the control arm n180 where they will receive a single group session on self-care and well-being with access to the static Women SHINE website Women will complete video-based survey assessments and mailed hair sample self-collection at baseline 4- 8- and 12-months post-randomization Compared to the control arm investigators will determine if Women SHINE is associated with improvements in ART adherence Aim 1 and PTSD symptoms and emotion regulation Aim 2 Investigators will also examine individual eg self-efficacy for coping social support networks and socio-structural eg HIV stigma medical mistrust mechanisms of change in the efficacy of Women SHINE Aim 3 If efficacious investigators will conduct subsequent research to determine effective and feasible methods for intervention implementation nationwide to improve HIV outcomes among WLHA
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 |
|---|---|---|---|
| R01MH125785 | NIH | None | httpsreporternihgovquickSearchR01MH125785 |