[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07553312":3,"trial-entities:NCT07553312":109,"trial-summary:NCT07553312":113},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":28,"interventions":31,"primary_outcomes":32,"secondary_outcomes":51,"sex":73,"minimum_age":74,"maximum_age":26,"healthy_volunteers":15,"eligibility_criteria":75,"std_ages":88,"locations":91,"central_contacts":101,"overall_officials":102,"references":107,"see_also_links":108},"NCT07553312","IRB00516061","Clinic-Community Bridge to Improve Health Outcomes for Abused Women Living With HIV\u002FAIDS","Clinic-Community Bridge-to-Care Initiative: Trauma and Violence Informed Care (TVIC) With Women Survivors of Intimate Partner Violence (IPV) and Living With HIV\u002FAIDS","ENROLLING_BY_INVITATION","2028-06-30","2026-06","2026-06-11","2026-03-17","Johns Hopkins University","OTHER",true,"Women living with HIV\u002FAIDS (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.","Objectives Aim 1: Using the ADAPT-ITT framework, the clinic-community partners will collaboratively adapt\u002Fdesign 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.\n\nAim 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\u002Fproportion 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.\n\nAim 3: Assess the mechanisms, facilitators, and barriers to implementation of clinic-community CUES+ intervention. Aim 3a: Mechanisms (e.g., safety behaviors\u002Fresources, 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.",[19,20],"Adult Women Living With HIV\u002FAIDS","Intimate Partner Violence",[22,23,20,24],"Women's Health","HIV","AIDS","OBSERVATIONAL",null,[],{"count":29,"type":30},450,"ESTIMATED",[],[33,37,41,45,48],{"measure":34,"description":35,"timeFrame":36},"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",{"measure":38,"description":39,"timeFrame":40},"HIV-related viral load","Obtained from Medical Record. Score range 0-\\>100,000; higher scores are worse","12 months post baseline",{"measure":42,"description":43,"timeFrame":44},"PTSD Checklist (PCL-6)","PCL-6 - 6 items. Score range: 0-24; higher score is worse","Baseline, 6 and 12 months post-baseline",{"measure":46,"description":47,"timeFrame":44},"Retrospective HIV adherence","Retrospective Adherence 5-items. Score range 0-15; higher score is worse",{"measure":49,"description":50,"timeFrame":44},"HIV Adherence Self-Efficacy","HIV Adherence Self-Efficacy Scale 13-items. Score range 0-39; higher score is better",[52,55,58,61,64,67,70],{"measure":53,"description":54,"timeFrame":44},"Safety Behaviors survey","Safety Behaviors survey adapted from previous studies. 28 items, Score range 0-28; higher is better.",{"measure":56,"description":57,"timeFrame":44},"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",{"measure":59,"description":60,"timeFrame":44},"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",{"measure":62,"description":63,"timeFrame":44},"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",{"measure":65,"description":66,"timeFrame":44},"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",{"measure":68,"description":69,"timeFrame":44},"Suicide Behavior","Ideation and attempts. 2 items, score range 0-2; higher score is worse",{"measure":71,"description":72,"timeFrame":36},"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","FEMALE","18 Years",{"inclusion":76,"exclusion":81,"raw_text":87},[77,78,79,80],"Hopkins Bartlett Clinic patient","HIV\u002FAIDS positive","Self-identify as female","Adult (18 years of age or older)",[82,83,84,85,86],"Not a Hopkins Bartlett Clinic patient","HIV\u002FAIDS negative","Does not identify as female","Under age of 18 years of age","Unable to provide informed consent","Inclusion Criteria:\n\n* Hopkins Bartlett Clinic patient\n* HIV\u002FAIDS positive\n* Self-identify as female\n* Adult (18 years of age or older)\n\nExclusion Criteria:\n\n* Not a Hopkins Bartlett Clinic patient\n* HIV\u002FAIDS negative\n* Does not identify as female\n* Under age of 18 years of age\n* Unable to provide informed consent",[89,90],"ADULT","OLDER_ADULT",[92],{"facility":93,"city":94,"state":95,"zip":96,"country":97,"geoPoint":98},"Johns Hopkins Bartlett Clinic","Baltimore","Maryland","21205","United States",{"lat":99,"lon":100},39.29038,-76.61219,[],[103],{"name":104,"affiliation":105,"role":106},"Nancy Glass","Johns Hopkins School of Nursing","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":110,"biomarkers":112},[111,20],"HIV Infection",[111],{"nct_id":4,"found":114,"summary":26,"prompt_version":26},false]