HIV/AIDSBRIDGESNCT04295876
The BRIDGES Project: Bridging Resources to Engage Women in Integrated HIV Care and Support Services
A study testing The BRIDGES Project Intervention in people with HIV/AIDS, run by University of California, San Diego at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- The BRIDGES Project Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2019to 1 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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]
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- HIV/AIDS
- Being tested
- The BRIDGES Project Intervention
- Keywords
- HIV Care Continuum, Ancillary Support Services
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The BRIDGES Project InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: The BRIDGES Project Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 6-months post-Baseline
Self-Efficacy for ART Adherence
Validated self-report measures of ART regime adherence
Measured: 3-months post-Baseline
Self-Efficacy for ART Adherence
Validated self-report measures of ART regime adherence
Measured: 6-months post-Baseline
ART Initiation AND/OR Retention
Validated self-report measures of ART regime adherence
Measured: 3-months post-Baseline
ART Initiation AND/OR Retention
Validated self-report measures of ART regime adherence
Measured: 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
Measured: 6-months post-Baseline
Secondary outcomes (5)
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.)
Measured: 6-months post-Baseline
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.)
Measured: 6-months post-Baseline
Ancillary Support Service Linkage
Self-Reported Support Service Linkage
Measured: 3-months post-Baseline
Ancillary Support Service Linkage
Self-Reported Support Service Linkage
Measured: 6-months post-Baseline
Ancillary Support Service Access
Self-Reported Support Service Access
Measured: 6-months post-Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start19 Dec 2019
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel intervention and control groups.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, California HIV/AIDS Research Program
- Responsible party
- Principal investigator, Jamila K. Stockman, University of California, San Diego
- Investigators
- Jamila K. Stockman, PhD, MPH, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04295876
- Sponsor's protocol ID
- 191314
- Other IDs
- HD15-SD-059
- Acronym
- BRIDGES
- Status last verified
- Sep 2021
- First submitted
- 2 Mar 2020
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No, sensitive research subject information with small population, could compromise anonymity of research subjects.
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The BRIDGES Project: Bridging Resources to Engage Women in Integrated HIV Care and Support Services
- ClinicalTrials.gov ID
- NCT04295876
- Acronym / sponsor ID
- BRIDGES / 191314
- Conditions
- HIV/AIDS
- Keywords
- HIV Care Continuum, Ancillary Support Services
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Stanford University, California HIV/AIDS Research Program
- Study start
- 19 Dec 2019 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 5 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel intervention and control groups.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: The BRIDGES Project InterventionWomen 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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]
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The BRIDGES Project InterventionThe 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. | Behavioural | BRIDGES Arm |
Primary outcome
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
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
Self-Efficacy for ART Adherence
Time frame: 3-months post-Baseline
Validated self-report measures of ART regime adherence
Self-Efficacy for ART Adherence
Time frame: 6-months post-Baseline
Validated self-report measures of ART regime adherence
ART Initiation AND/OR Retention
Time frame: 3-months post-Baseline
Validated self-report measures of ART regime adherence
ART Initiation AND/OR Retention
Time frame: 6-months post-Baseline
Validated self-report measures of ART regime adherence
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
5 secondary outcomes
Coping Self-Efficacy
Time frame: 6-months post-Baseline
Social Support Network Activation
Time frame: 6-months post-Baseline
Ancillary Support Service Linkage
Time frame: 3-months post-Baseline
Ancillary Support Service Linkage
Time frame: 6-months post-Baseline
Ancillary Support Service Access
Time frame: 6-months post-Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
- Individual participant dataSharing planned: No. No, sensitive research subject information with small population, could compromise anonymity of research subjects.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamila K. Stockman, PhD, MPH principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The BRIDGES Project Intervention in people with HIV/AIDS, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linkage to Care (time frame: 3-months post-Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2021.