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

Primary Purpose

HIV/AIDS

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The BRIDGES Project Intervention
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for HIV/AIDS focused on measuring HIV Care Continuum, Ancillary Support Services

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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]

Sites / Locations

  • UCSD Webster Building

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard of Care

BRIDGES Arm

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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
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
Self-Efficacy for ART Adherence
Validated self-report measures of ART regime adherence
Self-Efficacy for ART Adherence
Validated self-report measures of ART regime adherence
ART Initiation AND/OR Retention
Validated self-report measures of ART regime adherence
ART Initiation AND/OR Retention
Validated self-report measures of ART regime adherence
Retention in Care
2 clinic visits 90+days apart, or as directed by an ART prescribing provider, assessed by medical record extraction

Secondary Outcome Measures

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.)
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.)
Ancillary Support Service Linkage
Self-Reported Support Service Linkage
Ancillary Support Service Linkage
Self-Reported Support Service Linkage
Ancillary Support Service Access
Self-Reported Support Service Access

Full Information

First Posted
March 2, 2020
Last Updated
September 9, 2021
Sponsor
University of California, San Diego
Collaborators
Stanford University, California HIV/AIDS Research Program
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1. Study Identification

Unique Protocol Identification Number
NCT04295876
Brief Title
The BRIDGES Project: Bridging Resources to Engage Women in Integrated HIV Care and Support Services
Acronym
BRIDGES
Official Title
The BRIDGES Project: Bridging Resources to Engage Women in Integrated HIV Care and Support Services
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
December 19, 2019 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
January 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
Stanford University, California HIV/AIDS Research Program

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS
Keywords
HIV Care Continuum, Ancillary Support Services

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel intervention and control groups.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
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.
Arm Title
BRIDGES Arm
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
The BRIDGES Project Intervention
Intervention Description
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 Measure Information:
Title
Linkage to Care
Description
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
Time Frame
3-months post-Baseline
Title
Linkage to Care
Description
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
Time Frame
6-months post-Baseline
Title
Self-Efficacy for ART Adherence
Description
Validated self-report measures of ART regime adherence
Time Frame
3-months post-Baseline
Title
Self-Efficacy for ART Adherence
Description
Validated self-report measures of ART regime adherence
Time Frame
6-months post-Baseline
Title
ART Initiation AND/OR Retention
Description
Validated self-report measures of ART regime adherence
Time Frame
3-months post-Baseline
Title
ART Initiation AND/OR Retention
Description
Validated self-report measures of ART regime adherence
Time Frame
6-months post-Baseline
Title
Retention in Care
Description
2 clinic visits 90+days apart, or as directed by an ART prescribing provider, assessed by medical record extraction
Time Frame
6-months post-Baseline
Secondary Outcome Measure Information:
Title
Coping Self-Efficacy
Description
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.)
Time Frame
6-months post-Baseline
Title
Social Support Network Activation
Description
Validated Measure of Social Support, (MMOS-SS; Moser et al. 2012; Scale of 1 to 5 where 5 is greater social support.)
Time Frame
6-months post-Baseline
Title
Ancillary Support Service Linkage
Description
Self-Reported Support Service Linkage
Time Frame
3-months post-Baseline
Title
Ancillary Support Service Linkage
Description
Self-Reported Support Service Linkage
Time Frame
6-months post-Baseline
Title
Ancillary Support Service Access
Description
Self-Reported Support Service Access
Time Frame
6-months post-Baseline
Other Pre-specified Outcome Measures:
Title
ART Adherence
Description
Validated self-report adherence measures, proportion of WLHA attaining HIV viral suppression (<200 copies/mL, assessed by medical record extraction).
Time Frame
6-months post-Baseline
Title
ART Adherence
Description
Validated self-report adherence measures, proportion of WLHA attaining HIV viral suppression (<200 copies/mL, assessed by medical record extraction).
Time Frame
12-months post-Baseline

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Female gender identifying
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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]
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamila K. Stockman, PhD, MPH
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD Webster Building
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No, sensitive research subject information with small population, could compromise anonymity of research subjects.

Learn more about this trial

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

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