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

National Institutes of Health (NIH)

Status: Completed

Conditions: Substance Related Disorders

Treatments: Behavioral: Enhanced Behavioral Skills Training

Study type: Interventional

Funder types: NIH

Identifiers

NCT01976702

DESPR DA021521

Details and patient eligibility

About

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.

Enrollment: 250 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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250 participants in 2 patient groups

Enhanced Behavioral Skills Training

Experimental group

Description:

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.

Treatment:

Behavioral: Enhanced Behavioral Skills Training

Health Promotion Comparison

Active Comparator group

Description:

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.

Treatment:

Behavioral: Enhanced Behavioral Skills Training