Randomized Controlled Trial of Routine Screening for IPV
Status and phase
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Details and patient eligibility
About
This is a randomized controlled trial with three arms to establish the impact of screening and referral to services for women disclosing exposure to IPV.
Full description
Approximately 2675 women* will be enrolled and randomized to one of 3 arms. In the first arm, participants will be screened, and if disclosing IPV, will receive information on available resources in the community. In arms two and three, participants will not be screened, but one group will receive information on available resources in the community and the other will not. All three groups will be assessed for quality of life (SF-12;standardized and validated scale with 12 questions that measure overall health (1 item), physical functioning (2 items), role limitations due to physical health problems (4 items), bodily pain (1 item), energy/fatigue (1 item), social functioning (1 item), psychological distress (1 item), and well being (1 item) in the past 4 weeks; items are summed to form a physical health composite scale and a mental health composite scale; each scale is standardized to have a mean of 50 and a standard deviation of 10 for the U.S. population with a possible range from 0 to 100; higher scores represent a better health state); disability; and utilization of health care and IPV services at baseline and at a 12 month follow-up. A pilot study, also using a randomized controlled trial design, will establish the feasibility, acceptability, and impact on disclosure rates, use of referral resources, and potential harms of three screening and referral strategies.
*sample size calculation based n needed to detect a standardized effect size of 0.3 with an α=.05 (1-tailed)and ß=.20 if there's a 20% IPV (+) rate and 30% lost-to-follow-up rate.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- women attending obstetrics & gynecology (OB-GYN), family planning, general medicine, family medicine or HIV/Sexually transmitted disease (STD) clinic
Exclusion criteria
- non-English speaking other than Spanish speakers
- accompanied by a child >3 years of age without adequate provision for child care;
- Visually- or hearing-impaired women;
- without access to a telephone;
- Severe Mental impairment
Trial design
Primary purpose
Allocation
Interventional model
Masking
2,700 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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