Clinical trial NCT03664362: The BSHAPE Intervention Program for Safety and Health of Survivors of Cumulative Trauma
Official title: Cumulative Victimization and Women's Health Risks: Development of an Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Violence
Cumulative Trauma
HIV Risk
Stress
Mental Health
Reproductive Health
Empowerment
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2018-09-10
Enrollment: 144
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of the BSHAPE study is to test a trauma informed, culturally tailored, multicomponent program entitled BSHAPE (Being Safe, Healthy, And Positively Empowered) for immigrant survivors of cumulative trauma.

Detailed description: The central hypothesis is that the BSHAPE intervention will promote immigrant women's safety and health (e.g..,improved mental health, reduced physiological impact of stress and health inequities (especially reproductive-sexual health and HIV)), thus leading to overall empowerment.

The study will:

1. Conduct a feasibility and acceptability evaluation of the BSHAPE intervention.
2. Test the BSHAPE intervention for large scale implementation in community-based clinics and programs serving immigrant women.

The impact of BSHAPE will be evaluated in comparison to usual care in promoting safety and health outcomes among immigrant women with cumulative trauma experiences at post-intervention and at 6 and 12 months follow up.

Eligibility criteria: Inclusion Criteria:

* 18-55 years of age
* Self-identify as a female
* Born in Africa or foreign born from African descent
* Must have a current or past abusive romantic relationship
* Must be a survivor of cumulative trauma
* Clinically significant symptoms of PTSD and/or depression
* At least one sexual HIV risk behavior

Exclusion Criteria:

* Less than 18 years of age or more than age 55
* Self-identify as a male
* Not African-born immigrant or born outside the US
* Is not a survivor of cumulative trauma
* Does not meet clinically significant criteria of PTSD and/or depression
* Does not report at least one sexual HIV risk behavior

Primary outcomes:
measure: Change in depressive symptoms
timeFrame: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
measure: Change in symptoms of post-traumatic stress disorder (PTSD)
timeFrame: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
measure: Change in perceived stress
timeFrame: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
measure: Change in sexual risk behaviors
timeFrame: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)]
measure: Change in empowerment related to safety as assessed by the MOVERS scale
timeFrame: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
Secondary outcomes:
measure: Change in overall empowerment as assessed by the Personal Progress Scale-Revised
timeFrame: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
measure: Change in self-efficacy related to coping with trauma as assessed by the Trauma Coping Self-Efficacy scale
timeFrame: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)]
measure: Change in self-efficacy for HIV/Sexually Transmitted Infection (STI) prevention as assessed by the Self-Efficacy for STI-HIV Scale
timeFrame: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
measure: Change in HIV knowledge using the HIV Knowledge Questionnaire
timeFrame: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
measure: Change in Sexually Transmitted Disease (STD) knowledge using the STD Knowledge Questionnaire
timeFrame: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
measure: Change in attitudes for stress management as assessed by the Inventory of Positive Psychological Attitudes
timeFrame: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
measure: Change in utilization of healthcare services
timeFrame: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
measure: Change in severity and frequency of violence
timeFrame: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
measure: Change in physiological stress responses
timeFrame: Assessment time points, Baseline, 3 months and 6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Bushra Sabri, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sabri B, Vroegindewey A, Hagos M. Development, feasibility, acceptability and preliminary evaluation of the internet and mobile phone-based BSHAPE intervention for Immigrant survivors of cumulative trauma. Contemp Clin Trials. 2021 Nov;110:106591. doi: 10.1016/j.cct.2021.106591. Epub 2021 Oct 7.