The BSHAPE Intervention Program for Safety and Health of Survivors of Cumulative Trauma

Johns Hopkins University

Status: Completed

Conditions: HIV Risk; Cumulative Trauma; Reproductive Health; Violence; Empowerment; Mental Health; Stress

Treatments: Behavioral: The BSHAPE Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03664362

K99HD082350 (U.S. NIH Grant/Contract)

IRB00101882

R00HD082350 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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144 participants in 2 patient groups

The BSHAPE Intervention

Experimental group

Description:

Participants in the BSHAPE intervention attend a 9 sessions program post-assessments which is a combination of individualized and group-based sessions.

Treatment:

Behavioral: The BSHAPE Intervention

Usual care or no treatment control

No Intervention group

Description:

Participants in the control arm either are receiving no services or are engaged in usual care provided by community-based/health care organizations