Adult Women Living With HIV/AIDSBridgesNCT07553312
Clinic-Community Bridge to Improve Health Outcomes for Abused Women Living With HIV/AIDS
An observational study of Adult Women Living With HIV/AIDS and Intimate Partner Violence, run by Johns Hopkins University at 1 site in United States.
Trial summary
Women living with HIV/AIDS (WLWHA) in Baltimore experience disproportionately high rates of intimate partner violence (IPV), housing instability, and food insecurity, which adversely affect health outcomes. The Bartlett Bridges study is being implemented in partnership with the John G. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adult Women Living With HIV/AIDS, Intimate Partner Violence
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2026to 30 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult female identified patients at Hopkins Bartlett Clinic with diagnosis of HIV/AIDS
Who may be able to join
- Hopkins Bartlett Clinic patient
- HIV/AIDS positive
- Self-identify as female
- Adult (18 years of age or older)
Who cannot join
- Not a Hopkins Bartlett Clinic patient
- HIV/AIDS negative
- Does not identify as female
- Under age of 18 years of age
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Johns Hopkins Bartlett Clinic
Baltimore, Maryland, 21205
About this study
Official title: Clinic-Community Bridge-to-Care Initiative: Trauma and Violence Informed Care (TVIC) With Women Survivors of Intimate Partner Violence (IPV) and Living With HIV/AIDS
Women living with HIV/AIDS (WLWHA) in Baltimore experience disproportionately high rates of intimate partner violence (IPV), housing instability, and food insecurity, which adversely affect health outcomes. The Bartlett Bridges study is being implemented in partnership with the John G. Bartlett Infectious Diseases Specialty Practice (Bartlett Clinic) located at Johns Hopkins Hospital. The Bartlett Clinic provides comprehensive, compassionate and equitable services for infectious disease prevention, diagnosis and care. The study team will adapt and evaluate a trauma and violence-informed care (TVIC) intervention, called Confidentiality, Universal Education and Empowerment and Support (CUES), enhanced with the evidence-based myPlan safety planning app in the Bartlett Clinic to address IPV, health and safety in partnership with community organizations that provide advocacy, housing and social services. This hybrid effectiveness-implementation trial aims to improve HIV and mental health outcomes, increase safety, reduce health disparities, and identify implementation mechanisms to inform future scale-up and sustainability of the intervention in healthcare settings.
Read the detailed description
Objectives Aim 1: Using the ADAPT-ITT framework, the clinic-community partners will collaboratively adapt/design the CUES intervention enhanced with myPlan and connections to community organizations (CUES+) to meet the complex health and safety needs of abused WLWHA. The Hopkins team and members of the investigator's clinic-community advisory board (CAB) will collaborate to adapt and design the CUES+ intervention.
Aim 2: Examine the effectiveness of the CUES+ intervention in reducing health disparities for abused WLWHA. All WLWHA clients will receive CUES+ through the clinic-community partnership. Primary outcomes (ART adherence, missed visits/proportion of visits missed, treatment adherence self-efficacy) and mental health (depression, PTSD) will be measured at baseline, 6-, and 12-months post baseline. The investigators hypothesize IPV(+) WLWHA will have poorer outcomes than IPV(-) WLWHA at baseline. After the CUES+ intervention, outcomes for IPV(+) WLWHA will approach the level of outcomes for IPV(-) WLWHA.
Aim 3: Assess the mechanisms, facilitators, and barriers to implementation of clinic-community CUES+ intervention. Aim 3a: Mechanisms (e.g., safety behaviors/resources, IPV exposure, housing stability, food security) by which CUES+ intervention improves primary outcomes will be examined. The investigators hypothesize the intervention will increase safety behaviors and resources, housing stability and food security and reduce IPV exposure resulting in improvements in primary health outcomes. An understanding of mechanisms will identify clinic-community organizational culture, resources and policies needed to sustain the partnership. Aim 3b: Examine clinic-community-based partners contextual and program factors that facilitate the intervention and are needed to sustain the partnerships. The investigators will also examine barriers and facilitators to the intervention from the perspectives of clinicians and community-based partners to inform future implementation and scale-up.
- Keywords
- Women's Health, HIV, Intimate Partner Violence, AIDS
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Women with HIV/AIDS and IPV | Adult women receiving care at Hopkins Bartlett Clinic diagnosed with HIV/AIDS and report past year intimate partner violence (IPV) | |
| Women with HIV/AIDS, no IPV | Adult women receiving care at Hopkins Bartlett Clinic diagnosed with HIV/AIDS, no past year IPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression as assessed by the PROMIS Depression scale
PROMIS Depression 8. Score range 0 to 32; higher score is worse
Measured: Baseline, 6 and 12 months post baseline
HIV-related viral load
Obtained from Medical Record. Score range 0->100,000; higher scores are worse
Measured: 12 months post baseline
PTSD Checklist (PCL-6)
PCL-6 - 6 items. Score range: 0-24; higher score is worse
Measured: Baseline, 6 and 12 months post-baseline
Retrospective HIV adherence
Retrospective Adherence 5-items. Score range 0-15; higher score is worse
Measured: Baseline, 6 and 12 months post-baseline
HIV Adherence Self-Efficacy
HIV Adherence Self-Efficacy Scale 13-items. Score range 0-39; higher score is better
Measured: Baseline, 6 and 12 months post-baseline
Secondary outcomes (7)
Safety Behaviors survey
Safety Behaviors survey adapted from previous studies. 28 items, Score range 0-28; higher is better.
Measured: Baseline, 6 and 12 months post-baseline
Intimate partner violence (IPV) as assessed by the Composite Abuse Scale
Composite Abuse Scale (CASr-SF). 15 items, Score range 0-75; higher is worse
Measured: Baseline, 6 and 12 months post-baseline
Housing Stability as assessed by the Homelessness Screening Clinical Reminder
Homelessness Screening Clinical Reminder (HSCR). 10 items, Score range 0-10; higher score is worse
Measured: Baseline, 6 and 12 months post-baseline
Food security as assessed by the Food Security in the US Survey
USDA measure. 8 items. score range: 0 to 16; higher score is worse
Measured: Baseline, 6 and 12 months post-baseline
Housing Conditions as assessed by the Property Condition Assessment
HUD definitions, Property Condition Assessment. 2 items, score range 0 to 8; higher score is worse
Measured: Baseline, 6 and 12 months post-baseline
Suicide Behavior
Ideation and attempts. 2 items, score range 0-2; higher score is worse
Measured: Baseline, 6 and 12 months post-baseline
Health and Well-being as assessed by the PROMIS Global Health Scale
PROMIS Global Health Scale. 10 items, score range 4-20; higher score is better
Measured: Baseline, 6 and 12 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 posted28 Apr 2026
- Study start17 Mar 2026
- Primary completion31 Jan 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Women Living With HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Nancy Glass, Principal investigator, Johns Hopkins School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07553312
- Sponsor's protocol ID
- IRB00516061
- Other IDs
- R01NR021528-01
- Acronym
- Bridges
- Status last verified
- Jun 2026
- First submitted
- 20 Apr 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinic-Community Bridge-to-Care Initiative: Trauma and Violence Informed Care (TVIC) With Women Survivors of Intimate Partner Violence (IPV) and Living With HIV/AIDS
- ClinicalTrials.gov ID
- NCT07553312
- Acronym / sponsor ID
- Bridges / IRB00516061
- Keywords
- Women's Health, HIV, Intimate Partner Violence, AIDS
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 17 Mar 2026 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 28 Apr 2026 (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.
Women living with HIV/AIDS (WLWHA) in Baltimore experience disproportionately high rates of intimate partner violence (IPV), housing instability, and food insecurity, which adversely affect health outcomes. The Bartlett Bridges study is being implemented in partnership with the John G. Bartlett Infectious Diseases Specialty Practice (Bartlett Clinic) located at Johns Hopkins Hospital. The Bartlett Clinic provides comprehensive, compassionate and equitable services for infectious disease prevention, diagnosis and care. The study team will adapt and evaluate a trauma and violence-informed care (TVIC) intervention, called Confidentiality, Universal Education and Empowerment and Support (CUES), enhanced with the evidence-based myPlan safety planning app in the Bartlett Clinic to address IPV, health and safety in partnership with community organizations that provide advocacy, housing and social services. This hybrid effectiveness-implementation trial aims to improve HIV and mental health outcomes, increase safety, reduce health disparities, and identify implementation mechanisms to inform future scale-up and sustainability of the intervention in healthcare settings.
Detailed description
Objectives Aim 1: Using the ADAPT-ITT framework, the clinic-community partners will collaboratively adapt/design the CUES intervention enhanced with myPlan and connections to community organizations (CUES+) to meet the complex health and safety needs of abused WLWHA. The Hopkins team and members of the investigator's clinic-community advisory board (CAB) will collaborate to adapt and design the CUES+ intervention.
Aim 2: Examine the effectiveness of the CUES+ intervention in reducing health disparities for abused WLWHA. All WLWHA clients will receive CUES+ through the clinic-community partnership. Primary outcomes (ART adherence, missed visits/proportion of visits missed, treatment adherence self-efficacy) and mental health (depression, PTSD) will be measured at baseline, 6-, and 12-months post baseline. The investigators hypothesize IPV(+) WLWHA will have poorer outcomes than IPV(-) WLWHA at baseline. After the CUES+ intervention, outcomes for IPV(+) WLWHA will approach the level of outcomes for IPV(-) WLWHA.
Aim 3: Assess the mechanisms, facilitators, and barriers to implementation of clinic-community CUES+ intervention. Aim 3a: Mechanisms (e.g., safety behaviors/resources, IPV exposure, housing stability, food security) by which CUES+ intervention improves primary outcomes will be examined. The investigators hypothesize the intervention will increase safety behaviors and resources, housing stability and food security and reduce IPV exposure resulting in improvements in primary health outcomes. An understanding of mechanisms will identify clinic-community organizational culture, resources and policies needed to sustain the partnership. Aim 3b: Examine clinic-community-based partners contextual and program factors that facilitate the intervention and are needed to sustain the partnerships. The investigators will also examine barriers and facilitators to the intervention from the perspectives of clinicians and community-based partners to inform future implementation and scale-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with HIV/AIDS and IPV | – | –Adult women receiving care at Hopkins Bartlett Clinic diagnosed with HIV/AIDS and report past year intimate partner violence (IPV) |
| Women with HIV/AIDS, no IPV | – | –Adult women receiving care at Hopkins Bartlett Clinic diagnosed with HIV/AIDS, no past year IPV |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult female identified patients at Hopkins Bartlett Clinic with diagnosis of HIV/AIDS
Key inclusion criteria (4 listed)
- Hopkins Bartlett Clinic patient
- HIV/AIDS positive
- Self-identify as female
- Adult (18 years of age or older)
Key exclusion criteria (5 listed)
- Not a Hopkins Bartlett Clinic patient
- HIV/AIDS negative
- Does not identify as female
- Under age of 18 years of age
- Unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Depression as assessed by the PROMIS Depression scale
Time frame: Baseline, 6 and 12 months post baseline
PROMIS Depression 8. Score range 0 to 32; higher score is worse
HIV-related viral load
Time frame: 12 months post baseline
Obtained from Medical Record. Score range 0->100,000; higher scores are worse
PTSD Checklist (PCL-6)
Time frame: Baseline, 6 and 12 months post-baseline
PCL-6 - 6 items. Score range: 0-24; higher score is worse
Retrospective HIV adherence
Time frame: Baseline, 6 and 12 months post-baseline
Retrospective Adherence 5-items. Score range 0-15; higher score is worse
HIV Adherence Self-Efficacy
Time frame: Baseline, 6 and 12 months post-baseline
HIV Adherence Self-Efficacy Scale 13-items. Score range 0-39; higher score is better
7 secondary outcomes
Safety Behaviors survey
Time frame: Baseline, 6 and 12 months post-baseline
Intimate partner violence (IPV) as assessed by the Composite Abuse Scale
Time frame: Baseline, 6 and 12 months post-baseline
Housing Stability as assessed by the Homelessness Screening Clinical Reminder
Time frame: Baseline, 6 and 12 months post-baseline
Food security as assessed by the Food Security in the US Survey
Time frame: Baseline, 6 and 12 months post-baseline
Housing Conditions as assessed by the Property Condition Assessment
Time frame: Baseline, 6 and 12 months post-baseline
Suicide Behavior
Time frame: Baseline, 6 and 12 months post-baseline
Health and Well-being as assessed by the PROMIS Global Health Scale
Time frame: Baseline, 6 and 12 months post baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
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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.
Nancy Glass principal investigator
Johns Hopkins School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adult Women Living With HIV/AIDS and Intimate Partner Violence, run by Johns Hopkins University 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 4 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 11 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Depression as assessed by the PROMIS Depression scale (time frame: Baseline, 6 and 12 months post baseline). The study lists 5 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 11 Jun 2026.