Clinical trial NCT04295876: The BRIDGES Project: Bridging Resources to Engage Women in Integrated HIV Care and Support Services
Official title: The BRIDGES Project: Bridging Resources to Engage Women in Integrated HIV Care and Support Services
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Keywords: HIV Care Continuum
Ancillary Support Services
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Stanford University
name: California HIV/AIDS Research Program
First posted: 2020-03-05
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel intervention and control groups.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The BRIDGES Project seeks to test a program intended to help women living with HIV who face specific barriers due to culture, gender, violence, trauma, adverse mental health, and substance use to be able to better access HIV care. This program was created and tried with women living with HIV, as previously studies have indicated that women with these experiences are less likely to have stable HIV care. The BRIDGES Project will use Peer Navigators, who are other women living with HIV who have had similar experiences and have been successful in accessing care, to help other women living with HIV to access HIV care and stay in HIV care. The BRIDGES Project will also provide support to women through group sessions co-facilitated by a licensed clinical therapist and Peer Navigator. Through participation in BRIDGES, women will: (1) build skills to cope with HIV care and treatment barriers (e.g., violence, trauma, adverse mental health, substance use); (2) be connected to HIV treatment and other support services (e.g., domestic violence, mental health, substance use); and (3) learn interpersonal skills to connect with support (e.g., service providers, peers, friends, family) when faced with new or ongoing barriers.

Detailed description: The BRIDGES Project intervention is culturally-tailored intervention for syndemic-affected cis- and transgender women living with HIV/AIDS (WLHA) that aims to: 1) build skills to cope with syndemic-related affective distress, 2) facilitate linkages to both HIV treatment and relevant ancillary service providers (e.g., domestic violence, mental health, substance use), and 3) teach women interpersonal skills to activate social support networks (e.g., service providers, friends, family) when faced with new or ongoing barriers. Participants in the The BRIDGES Project are estimated to demonstrate improvements in HIV care outcomes (i.e., linkage to HIV care, self-efficacy in ART adherence, retention in HIV care) and syndemic-support outcomes (i.e., coping skills, activated social support networks, linkage to and receipt of ancillary support services) compared to HIV-infected women assigned to standard of care (self-guided access and use of Ryan White case management).

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Identify as female, including cis-gender female or transgender female
* Living with HIV/AIDS
* Ability to speak and understand English
* Self-report one or more syndemic factor(s) \[lifetime history of or current: trauma, physical violence and/or sexual violence, PTSD symptoms, substance use, adverse mental health\]
* identification as one of the following: out-of-care or unstable in care, newly diagnosed, never in care, or linked to care but have fallen out of care\]

Primary outcomes:
measure: Linkage to Care
timeFrame: 3-months post-Baseline
measure: Linkage to Care
timeFrame: 6-months post-Baseline
measure: Self-Efficacy for ART Adherence
timeFrame: 3-months post-Baseline
measure: Self-Efficacy for ART Adherence
timeFrame: 6-months post-Baseline
measure: ART Initiation AND/OR Retention
timeFrame: 3-months post-Baseline
measure: ART Initiation AND/OR Retention
timeFrame: 6-months post-Baseline
measure: Retention in Care
timeFrame: 6-months post-Baseline
Secondary outcomes:
measure: Coping Self-Efficacy
timeFrame: 6-months post-Baseline
measure: Social Support Network Activation
timeFrame: 6-months post-Baseline
measure: Ancillary Support Service Linkage
timeFrame: 3-months post-Baseline
measure: Ancillary Support Service Linkage
timeFrame: 6-months post-Baseline
measure: Ancillary Support Service Access
timeFrame: 6-months post-Baseline
Other outcomes:
measure: ART Adherence
timeFrame: 6-months post-Baseline
measure: ART Adherence
timeFrame: 12-months post-Baseline
Locations:
city: San Diego
country: United States
facility: UCSD Webster Building
state: California
Study officials:
affiliation: University of California, San Diego
name: Jamila K. Stockman, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: