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

HIV/AIDS Clinical Trial

— BRIDGES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04295876
• Other study ID #: 191314
• Secondary ID: HD15-SD-059
• Status: Completed
• Phase: N/A
• Start date: December 19, 2019
• Est. completion date: January 1, 2021

Study information

• Verified date: September 2021
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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]

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Intervention

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.

Locations

Country	Name	City	State
United States	UCSD Webster Building	San Diego	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Diego	California HIV/AIDS Research Program, Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	ART Adherence	Validated self-report adherence measures, proportion of WLHA attaining HIV viral suppression (<200 copies/mL, assessed by medical record extraction).	6-months post-Baseline
Other	ART Adherence	Validated self-report adherence measures, proportion of WLHA attaining HIV viral suppression (<200 copies/mL, assessed by medical record extraction).	12-months post-Baseline
Primary	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
Primary	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
Primary	Self-Efficacy for ART Adherence	Validated self-report measures of ART regime adherence	3-months post-Baseline
Primary	Self-Efficacy for ART Adherence	Validated self-report measures of ART regime adherence	6-months post-Baseline
Primary	ART Initiation AND/OR Retention	Validated self-report measures of ART regime adherence	3-months post-Baseline
Primary	ART Initiation AND/OR Retention	Validated self-report measures of ART regime adherence	6-months post-Baseline
Primary	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	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.)	6-months post-Baseline
Secondary	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.)	6-months post-Baseline
Secondary	Ancillary Support Service Linkage	Self-Reported Support Service Linkage	3-months post-Baseline
Secondary	Ancillary Support Service Linkage	Self-Reported Support Service Linkage	6-months post-Baseline
Secondary	Ancillary Support Service Access	Self-Reported Support Service Access	6-months post-Baseline