Multi-Level HIV Prevention for Pregnant Drug Abusers

Substance Related Disorders Clinical Trial

— PDA  

Official title:

Multi-Level HIV Prevention for Pregnant Drug Abusers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01976702
• Other study ID #: DESPR DA021521
• Status: Completed
• Phase: N/A
• First received: October 30, 2013
• Last updated: January 10, 2017
• Start date: October 2006
• Est. completion date: May 2011

Study information

• Verified date: October 2013
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Substance Related Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• Enhanced Behavioral Skills Training

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Service utilization, social support, and individual cognitive-behavioral factors		6 months post intervention	No
Primary	Sexual risk behavior	Reduction in HIV sex risk and drug abuse behavior among pregnant substance abusers	6 months post intervention	No
Secondary	Drug use risk behavior		6 months post intervention	No