PDA: Multi-Level HIV Prevention for Pregnant Drug Abusers

• Sponsor: National Institute on Drug Abuse (NIDA) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT01976702
• Collaborator: (none)
• Enrollment: 250
• Arms: 2
• Duration (Months): 55

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Oct 1, 2006
• Actual Primary Completion Date: May 1, 2011
• Actual Study Completion Date: May 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Sexual risk behavior [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 [6 months post intervention]

Other Outcome Measures

1. Service utilization, social support, and individual cognitive-behavioral factors [6 months post intervention]

Eligibility Criteria

Criteria

• 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

Locations

No locations specified.

Sponsors and Collaborators

• National Institute on Drug Abuse (NIDA)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Institute on Drug Abuse (NIDA)
• ClinicalTrials.gov Identifier: NCT01976702
• Other Study ID Numbers: DESPR DA021521
• First Posted: Nov 6, 2013
• Last Update Posted: Jan 11, 2017
• Last Verified: Oct 1, 2013

• Keywords provided by National Institute on Drug Abuse (NIDA): HIV risk behaviors; Pregnant drug abusers
• Additional relevant MeSH terms: Substance-Related Disorders

Study Results

No Results Posted as of Jan 11, 2017