Clinical Trials


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

This study has been completed
National Institute on Drug Abuse (NIDA)

Information provided by (Responsible Party)
National Institute on Drug Abuse (NIDA) Identifier

First received: October 30, 2013
Last updated: January 10, 2017
Last Verified: October 2013
History of Changes


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 Intervention
Substance Related Disorders

Behavioral : Enhanced Behavioral Skills Training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Multi-Level HIV Prevention for Pregnant Drug Abusers

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures

  • 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:
  • Drug use risk behavior [ Time Frame: 6 months post intervention ]
Other Outcome Measures:
  • Service utilization, social support, and individual cognitive-behavioral factors [ Time Frame: 6 months post intervention ]

Enrollment: 250
Study Start Date: October 2006
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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


Ages Eligible for Study: 18 Years and older  
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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01976702

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)
More Information

More Information

Responsible Party: National Institute on Drug Abuse (NIDA) Identifier: NCT01976702   History of Changes  
Other Study ID Numbers: DESPR DA021521  
Study First Received: October 30, 2013  
Last Updated: January 10, 2017  

Keywords provided by National Institute on Drug Abuse (NIDA):

HIV risk behaviors
Pregnant drug abusers

Additional relevant MeSH terms:
Substance-Related Disorders processed this data on May 24, 2020
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