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

NCT07553312 | Enrolling By Invitation DMC

• 2 other identifiers: IRB00478390R01NR021528-01
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Intimate Partner Violence; Adult Women Living With HIV/AIDS

Keywords

Women's Health; HIV; Intimate Partner Violence; AIDS

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (7)

• Safety Behaviors survey

  Baseline, 6 and 12 months post-baseline

• Intimate partner violence (IPV) as assessed by the Composite Abuse Scale

  Baseline, 6 and 12 months post-baseline

• Housing Stability as assessed by the Homelessness Screening Clinical Reminder

  Baseline, 6 and 12 months post-baseline

• Food security as assessed by the Food Security in the US Survey

  Baseline, 6 and 12 months post-baseline

• Housing Conditions as assessed by the Property Condition Assessment

  Baseline, 6 and 12 months post-baseline

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Johns Hopkins Bartlett Clinic

Baltimore, Maryland, 21205, 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

• Nancy Glass

  Johns Hopkins School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: April 28, 2026
• Study Start: March 17, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

US (1)