Clinic-Community Bridge to Improve Health Outcomes for Abused Women Living With HIV/AIDS (Bridges)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Intimate Partner Violence; Adult Women Living With HIV/AIDS

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 Type: Observational
• Enrollment (Estimated): 450

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins Bartlett Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adult female identified patients at Hopkins Bartlett Clinic with diagnosis of HIV/AIDS

Description

Inclusion Criteria:

• Hopkins Bartlett Clinic patient
• HIV/AIDS positive
• Self-identify as female
• Adult (18 years of age or older)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression as assessed by the PROMIS Depression scale	PROMIS Depression 8. Score range 0 to 32; higher score is worse	Baseline, 6 and 12 months post baseline
HIV-related viral load	Obtained from Medical Record. Score range 0->100,000; higher scores are worse	12 months post baseline
PTSD Checklist (PCL-6)	PCL-6 - 6 items. Score range: 0-24; higher score is worse	Baseline, 6 and 12 months post-baseline
Retrospective HIV adherence	Retrospective Adherence 5-items. Score range 0-15; higher score is worse	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	Baseline, 6 and 12 months post-baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Behaviors survey	Safety Behaviors survey adapted from previous studies. 28 items, Score range 0-28; higher is better.	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	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	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	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	Baseline, 6 and 12 months post-baseline
Suicide Behavior	Ideation and attempts. 2 items, score range 0-2; higher score is worse	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	Baseline, 6 and 12 months post baseline

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Nancy Glass, Johns Hopkins School of Nursing

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: April 20, 2026
• First Submitted That Met QC Criteria: April 20, 2026
• First Posted (Actual): April 28, 2026

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: HIV; AIDS; Women's Health; Intimate Partner Violence
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: IRB00516061; R01NR021528-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No