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
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Depression as assessed by the PROMIS Depression scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Hopkins Bartlett Clinic patient
- •HIV/AIDS positive
- •Self-identify as female
- •Adult (18 years of age or older)
排除标准
- •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
研究组 & 干预措施
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
结局指标
主要结局
Depression as assessed by the PROMIS Depression scale
时间窗: Baseline, 6 and 12 months post baseline
PROMIS Depression 8. Score range 0 to 32; higher score is worse
HIV-related viral load
时间窗: 12 months post baseline
Obtained from Medical Record. Score range 0-\>100,000; higher scores are worse
PTSD Checklist (PCL-6)
时间窗: Baseline, 6 and 12 months post-baseline
PCL-6 - 6 items. Score range: 0-24; higher score is worse
Retrospective HIV adherence
时间窗: Baseline, 6 and 12 months post-baseline
Retrospective Adherence 5-items. Score range 0-15; higher score is worse
HIV Adherence Self-Efficacy
时间窗: Baseline, 6 and 12 months post-baseline
HIV Adherence Self-Efficacy Scale 13-items. Score range 0-39; higher score is better
次要结局
- 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)
- Suicide Behavior(Baseline, 6 and 12 months post-baseline)
- Health and Well-being as assessed by the PROMIS Global Health Scale(Baseline, 6 and 12 months post baseline)