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Enrolling by Invitation

NCT Number: NCT07553312

Clinic-Community Bridge to Improve Health Outcomes for Abused Women 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.

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Key information

Conditions

Adult Women Living With HIV/AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Intimate Partner Violence Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Johns Hopkins Bartlett Clinic

Baltimore, Maryland, 21205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. HIV-related viral load

    Time frame: 12 months post baseline

    Obtained from Medical Record. Score range 0->100,000; higher scores are worse

  3. 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

  4. Retrospective HIV adherence

    Time frame: Baseline, 6 and 12 months post-baseline

    Retrospective Adherence 5-items. Score range 0-15; higher score is worse

  5. 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

Secondary outcomes

  1. Safety Behaviors survey

    Time frame: Baseline, 6 and 12 months post-baseline

    Safety Behaviors survey adapted from previous studies. 28 items, Score range 0-28; higher is better.

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

    Time frame: Baseline, 6 and 12 months post-baseline

    Composite Abuse Scale (CASr-SF). 15 items, Score range 0-75; higher is worse

  3. Housing Stability as assessed by the Homelessness Screening Clinical Reminder

    Time frame: Baseline, 6 and 12 months post-baseline

    Homelessness Screening Clinical Reminder (HSCR). 10 items, Score range 0-10; higher score is worse

  4. Food security as assessed by the Food Security in the US Survey

    Time frame: Baseline, 6 and 12 months post-baseline

    USDA measure. 8 items. score range: 0 to 16; higher score is worse

  5. Housing Conditions as assessed by the Property Condition Assessment

    Time frame: Baseline, 6 and 12 months post-baseline

    HUD definitions, Property Condition Assessment. 2 items, score range 0 to 8; higher score is worse

  6. Suicide Behavior

    Time frame: Baseline, 6 and 12 months post-baseline

    Ideation and attempts. 2 items, score range 0-2; higher score is worse

  7. Health and Well-being as assessed by the PROMIS Global Health Scale

    Time frame: Baseline, 6 and 12 months post baseline

    PROMIS Global Health Scale. 10 items, score range 4-20; higher score is better

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study 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

Acronym: Bridges

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 28, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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