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

NCT04295876 | Completed

• 2 other identifiers: 191314HD15-SD-059
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV/AIDS

Keywords

HIV Care Continuum; Ancillary Support Services

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (5)

• Coping Self-Efficacy

  6-months post-Baseline

• Social Support Network Activation

  6-months post-Baseline

• Ancillary Support Service Linkage

  3-months post-Baseline

• Ancillary Support Service Linkage

  6-months post-Baseline

• Ancillary Support Service Access

  6-months post-Baseline

Other Outcomes (2)

• ART Adherence

  6-months post-Baseline

• ART Adherence

  12-months post-Baseline

Study Arms (2)

Standard of Care

NO INTERVENTION

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.

BRIDGES Arm

EXPERIMENTAL

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

Interventions

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.

BRIDGES Arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female gender identifying
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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\]

Sponsors & Collaborators

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

Study Sites (1)

UCSD Webster Building

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Jamila K. Stockman, PhD, MPH

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Vice Chief of Global Public Health

Model Details: Parallel intervention and control groups.

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 5, 2020
• Study Start: December 19, 2019
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: September 13, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)