The BRIDGES Project: Bridging Resources to Engage Women in Integrated HIV Care and Support Services (BRIDGES)

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.

Study Overview

• Status: Completed
• Conditions: HIV/AIDS
• Intervention / Treatment: Behavioral: The BRIDGES Project Intervention

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).

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92103
      • UCSD Webster Building

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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]

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care; Women assigned to the control arm will receive self-directed (non-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.
Experimental: BRIDGES Arm; Women assigned to The BRIDGES Project intervention arm will be connected with and receive Ryan White HIV/AIDS Program services (see above as described under Control Arm), as well as receive Peer Navigation support via one-on-one sessions, phone/text-based check-ins, and 6 unique syndemic-responsive 120 -minute group sessions designed to build coping skills (3 sessions) and assertive communication and behavior (3 sessions).	Behavioral: The BRIDGES Project Intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Linkage to Care	Documentation of a clinical visit date with an ART-prescribing provider (yes, no), assessed by medical record extraction; days to first clinical visit since baseline (continuous), assessed by medical record extraction	3-months post-Baseline
Linkage to Care	Documentation of a clinical visit date with an ART-prescribing provider (yes, no), assessed by medical record extraction; days to first clinical visit since baseline (continuous), assessed by medical record extraction	6-months post-Baseline
Self-Efficacy for ART Adherence	Validated self-report measures of ART regime adherence	3-months post-Baseline
Self-Efficacy for ART Adherence	Validated self-report measures of ART regime adherence	6-months post-Baseline
ART Initiation AND/OR Retention	Validated self-report measures of ART regime adherence	3-months post-Baseline
ART Initiation AND/OR Retention	Validated self-report measures of ART regime adherence	6-months post-Baseline
Retention in Care	2 clinic visits 90+days apart, or as directed by an ART prescribing provider, assessed by medical record extraction	6-months post-Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coping Self-Efficacy	Validated Measure of Coping Self-Efficacy (Coping Self Efficacy, Chesney et al 2006; Scale of 1 to 10 where 10 is greater coping self-efficacy.)	6-months post-Baseline
Social Support Network Activation	Validated Measure of Social Support, (MMOS-SS; Moser et al. 2012; Scale of 1 to 5 where 5 is greater social support.)	6-months post-Baseline
Ancillary Support Service Linkage	Self-Reported Support Service Linkage	3-months post-Baseline
Ancillary Support Service Linkage	Self-Reported Support Service Linkage	6-months post-Baseline
Ancillary Support Service Access	Self-Reported Support Service Access	6-months post-Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
ART Adherence	Validated self-report adherence measures, proportion of WLHA attaining HIV viral suppression (<200 copies/mL, assessed by medical record extraction).	6-months post-Baseline
ART Adherence	Validated self-report adherence measures, proportion of WLHA attaining HIV viral suppression (<200 copies/mL, assessed by medical record extraction).	12-months post-Baseline

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: Stanford University; California HIV/AIDS Research Program
• Investigators: Principal Investigator: Jamila K. Stockman, PhD, MPH, University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2019
• Primary Completion (Actual): January 1, 2021
• Study Completion (Actual): January 1, 2021

Study Registration Dates

• First Submitted: March 2, 2020
• First Submitted That Met QC Criteria: March 2, 2020
• First Posted (Actual): March 5, 2020

Study Record Updates

• Last Update Posted (Actual): September 13, 2021
• Last Update Submitted That Met QC Criteria: September 9, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: HIV Care Continuum; Ancillary Support Services
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: 191314; HD15-SD-059 (Other Grant/Funding Number: California HIV/AIDS Research Program)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No, sensitive research subject information with small population, could compromise anonymity of research subjects.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No