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OpenTrials
Completed

NCT Number: NCT04295876

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

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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]

Treatment and study plan

The BRIDGES Project Intervention

Behavioral

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 outcomes

  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 outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • California HIV/AIDS Research Program
  • Stanford University

Registry information

Acronym: BRIDGES

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 5, 2020
Registry last updated
Sep 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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