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Multi-Level HIV Prevention for Pregnant Drug Abusers

Multi-Level HIV Prevention for Pregnant Drug Abusers

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01976702
Acronym
PDA
Enrollment
250
Registered
2013-11-06
Start date
2006-10-31
Completion date
2011-05-31
Last updated
2017-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Substance Related Disorders

Keywords

HIV risk behaviors, Pregnant drug abusers

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.

Interventions

BEHAVIORALEnhanced Behavioral Skills Training

Sponsors

National Institute on Drug Abuse (NIDA)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Sexual risk behavior6 months post interventionReduction in HIV sex risk and drug abuse behavior among pregnant substance abusers

Secondary

MeasureTime frame
Drug use risk behavior6 months post intervention

Other

MeasureTime frame
Service utilization, social support, and individual cognitive-behavioral factors6 months post intervention

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026