Clinic-Community Bridge to Improve Health Outcomes for Abused Women Living With HIV/AIDS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Adult Women Living With HIV/AIDS, Intimate Partner Violence. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Primary outcome measures
- Depression as assessed by the PROMIS Depression scale [Time frame: Baseline, 6 and 12 months post baseline]
- HIV-related viral load [Time frame: 12 months post baseline]
- PTSD Checklist (PCL-6) [Time frame: Baseline, 6 and 12 months post-baseline]
- Retrospective HIV adherence [Time frame: Baseline, 6 and 12 months post-baseline]
- HIV Adherence Self-Efficacy [Time frame: Baseline, 6 and 12 months post-baseline]
Secondary outcome measures (7)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Johns Hopkins Bartlett Clinic — Baltimore
Identifiers
NCT: NCT07553312 · IRB00516061 · R01NR021528-01