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

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ClinicalTrials.gov Identifier: NCT04295876
Recruitment Status : Recruiting
First Posted : March 5, 2020
Last Update Posted : March 30, 2020
Sponsor:
Collaborators:
Stanford University
California HIV/AIDS Research Program
Information provided by (Responsible Party):
Jamila K. Stockman, University of California, San Diego

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
HIV/AIDS Behavioral: The BRIDGES Project Intervention Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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 : December 19, 2019
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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.




Primary Outcome Measures :
  1. Linkage to Care [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 3-months post-Baseline ]
    Validated self-report measures of ART regime adherence

  4. Self-Efficacy for ART Adherence [ Time Frame: 6-months post-Baseline ]
    Validated self-report measures of ART regime adherence

  5. ART Initiation AND/OR Retention [ Time Frame: 3-months post-Baseline ]
    Validated self-report measures of ART regime adherence

  6. ART Initiation AND/OR Retention [ Time Frame: 6-months post-Baseline ]
    Validated self-report measures of ART regime adherence

  7. Retention in Care [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 3-months post-Baseline ]
    Self-Reported Support Service Linkage

  4. Ancillary Support Service Linkage [ Time Frame: 6-months post-Baseline ]
    Self-Reported Support Service Linkage

  5. Ancillary Support Service Access [ Time Frame: 6-months post-Baseline ]
    Self-Reported Support Service Access


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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female gender identifying
Accepts Healthy Volunteers:   No
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]

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04295876


Contacts
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Contact: Jamila K. Stockman, PhD, MPH 858-822-4652 jstockman@health.ucsd.edu

Locations
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United States, California
UCSD Webster Building Recruiting
San Diego, California, United States, 92103
Contact: Jamila K Stockman, PhD MPH    858-354-0381    jstockman@ucsd.edu   
Contact: KATHERINE M ANDERSON    6194713884    k4anderson@ucsd.edu   
Sponsors and Collaborators
University of California, San Diego
Stanford University
California HIV/AIDS Research Program
Investigators
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Principal Investigator: Jamila K. Stockman, PhD, MPH University of California, San Diego
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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 ( Other Grant/Funding Number: California HIV/AIDS Research Program )
First Posted: March 5, 2020    Key Record Dates
Last Update Posted: March 30, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No, sensitive research subject information with small population, could compromise anonymity of research subjects.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jamila K. Stockman, University of California, San Diego:
HIV Care Continuum
Ancillary Support Services
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases