Multi-Level HIV Prevention for Pregnant Drug Abusers

Not Applicable

Completed

• Conditions: Substance Related Disorders

• 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

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