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

Sponsor
University of California, San Diego (Other)
Overall Status
Completed
CT.gov ID
NCT04295876
Collaborator
Stanford University (Other), California HIV/AIDS Research Program (Other)
24
1
2
12.5
1.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: The BRIDGES Project Intervention
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel intervention and control groups.Parallel intervention and control groups.
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
The BRIDGES Project: Bridging Resources to Engage Women in Integrated HIV Care and Support Services
Actual Study Start Date :
Dec 19, 2019
Actual Primary Completion Date :
Jan 1, 2021
Actual Study Completion Date :
Jan 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Linkage to Care [3-months post-Baseline]

    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

  2. Linkage to Care [6-months post-Baseline]

    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. Self-Efficacy for ART Adherence [3-months post-Baseline]

    Validated self-report measures of ART regime adherence

  4. Self-Efficacy for ART Adherence [6-months post-Baseline]

    Validated self-report measures of ART regime adherence

  5. ART Initiation AND/OR Retention [3-months post-Baseline]

    Validated self-report measures of ART regime adherence

  6. ART Initiation AND/OR Retention [6-months post-Baseline]

    Validated self-report measures of ART regime adherence

  7. Retention in Care [6-months post-Baseline]

    2 clinic visits 90+days apart, or as directed by an ART prescribing provider, assessed by medical record extraction

Secondary Outcome Measures

  1. Coping Self-Efficacy [6-months post-Baseline]

    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.)

  2. Social Support Network Activation [6-months post-Baseline]

    Validated Measure of Social Support, (MMOS-SS; Moser et al. 2012; Scale of 1 to 5 where 5 is greater social support.)

  3. Ancillary Support Service Linkage [3-months post-Baseline]

    Self-Reported Support Service Linkage

  4. Ancillary Support Service Linkage [6-months post-Baseline]

    Self-Reported Support Service Linkage

  5. Ancillary Support Service Access [6-months post-Baseline]

    Self-Reported Support Service Access

Other Outcome Measures

  1. ART Adherence [6-months post-Baseline]

    Validated self-report adherence measures, proportion of WLHA attaining HIV viral suppression (<200 copies/mL, assessed by medical record extraction).

  2. ART Adherence [12-months post-Baseline]

    Validated self-report adherence measures, proportion of WLHA attaining HIV viral suppression (<200 copies/mL, assessed by medical record extraction).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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]

Contacts and Locations

Locations

Site City State Country Postal Code
1 UCSD Webster Building San Diego California United States 92103

Sponsors and Collaborators

  • University of California, San Diego
  • Stanford University
  • California HIV/AIDS Research Program

Investigators

  • Principal Investigator: Jamila K. Stockman, PhD, MPH, University of California, San Diego

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jamila K. Stockman, Associate Professor, Vice Chief of Global Public Health, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT04295876
Other Study ID Numbers:
  • 191314
  • HD15-SD-059
First Posted:
Mar 5, 2020
Last Update Posted:
Sep 13, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jamila K. Stockman, Associate Professor, Vice Chief of Global Public Health, University of California, San Diego
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 13, 2021