Multi-Level HIV Prevention for Pregnant Drug Abusers

NCT01976702 | Completed DMC

• 1 other identifier: DESPR DA021521
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Substance Related Disorders

Keywords

HIV risk behaviors; Pregnant drug abusers

Outcome Measures

Primary Outcomes (1)

• Sexual risk behavior

  Reduction in HIV sex risk and drug abuse behavior among pregnant substance abusers

  6 months post intervention

Secondary Outcomes (1)

• Drug use risk behavior

  6 months post intervention

Other Outcomes (1)

• Service utilization, social support, and individual cognitive-behavioral factors

  6 months post intervention

Study Arms (2)

Enhanced Behavioral Skills Training

EXPERIMENTAL

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.

Behavioral: Enhanced Behavioral Skills Training

Health Promotion Comparison

ACTIVE COMPARATOR

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.

Behavioral: Enhanced Behavioral Skills Training

Interventions

Enhanced Behavioral Skills Training BEHAVIORAL

Enhanced Behavioral Skills Training; Health Promotion Comparison

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• a recent history (within the past year) of using illicit substances
• 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

You may not qualify if:

• under age 18 years

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2013
• First Posted: November 6, 2013
• Study Start: October 1, 2006
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: January 11, 2017

Record last verified: 2013-10