Multi-Level HIV Prevention for Pregnant Drug Abusers

Not Applicable

Completed

• Conditions: Substance Related Disorders
• Interventions: Behavioral: Enhanced Behavioral Skills Training

• Registration Number: NCT01976702
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

Brief Summary

This 5 year study, targeting Pregnant Drug Abusers in treatment, is a randomized trial of an Enhanced Behavioral Skills Training (E-BST) intervention compared to a time-and attention-matched Health Promotion Comparison (HPC) condition. E-BST is an adaptation of the original BST intervention (Eldridge, St. Lawrence et al., 1997), designed to strengthen relationship-based social competency skills of the original BST that were crucial in sustaining adherence to protective behavior.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2013-10
• Study First Submitted: 2013-10-30
• Study First Submitted QC: 2013-10-30
• Study First Posted: 2013-11-06
• Last Update Submitted: 2017-01-10
• Last Update Posted: 2017-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 250

Inclusion Criteria

• 18 years of age or older
• a recent history (within the past year) of using illicit substances
• 12-32 weeks pregnant and not planning to terminate the pregnancy
• able to read English Informed Consent form; understand and provided written informed consent
• have competency in conversational English which is required to complete assessments and to participate in the intervention groups
• have a stable living arrangement and provide contact information
• currently not cognitively impaired since cognitive impairment may compromise the ability to comprehend and participate in the assessment and intervention
• currently not showing symptoms of a major psychiatric disorder/ including psychosis, or a high risk for suicidality
• report at least one episode of unprotected vaginal/anal sex since becoming pregnant
• answer "Yes" to this question: "Do you plan to be in the area for the next 12 months?"
• agree to a urine test at the time of each interview to detect the presence of drugs

Exclusion Criteria

• under age 18 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced Behavioral Skills Training	Enhanced Behavioral Skills Training	The Enhanced Behavioral Skills Training (E-BST) will include four 90-minute group sessions and two 60-minute individual sessions regarding HIV prevention and diminishing risk behavior, enhancing communication skills, improving the use of support services, and enhancing the use of resources in their community.
Health Promotion Comparison	Enhanced Behavioral Skills Training	The Health Promotion Comparison (HPC)condition will receive one video-based HIV prevention session, 3 video-based 90-minute group sessions and an additional 2 60-minute sessions with discussions on relevant topics unrelated to HIV.

Primary Outcome Measures

Name	Time	Method
Sexual risk behavior	6 months post intervention	Reduction in HIV sex risk and drug abuse behavior among pregnant substance abusers

Secondary Outcome Measures

Name	Time	Method
Drug use risk behavior	6 months post intervention