Multi-Level HIV Prevention for Pregnant Drug Abusers (PDA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01976702
Recruitment Status : Completed
First Posted : November 6, 2013
Last Update Posted : January 11, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Substance Related Disorders Behavioral: Enhanced Behavioral Skills Training Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Multi-Level HIV Prevention for Pregnant Drug Abusers
Study Start Date : October 2006
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Abuse HIV/AIDS

Arm Intervention/treatment
Experimental: 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.
Behavioral: Enhanced Behavioral Skills Training
Active Comparator: Health Promotion Comparison
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

Primary Outcome Measures :
  1. Sexual risk behavior [ Time Frame: 6 months post intervention ]
    Reduction in HIV sex risk and drug abuse behavior among pregnant substance abusers

Secondary Outcome Measures :
  1. Drug use risk behavior [ Time Frame: 6 months post intervention ]

Other Outcome Measures:
  1. Service utilization, social support, and individual cognitive-behavioral factors [ Time Frame: 6 months post intervention ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Responsible Party: National Institute on Drug Abuse (NIDA) Identifier: NCT01976702     History of Changes
Other Study ID Numbers: DESPR DA021521
First Posted: November 6, 2013    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: October 2013

Keywords provided by National Institute on Drug Abuse (NIDA):
HIV risk behaviors
Pregnant drug abusers

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders