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Reducing HIV Risk Among Pregnant Women in Drug Treatment

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00332813
First Posted: June 2, 2006
Last Update Posted: March 28, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by:
Rhode Island Hospital
June 1, 2006
June 2, 2006
March 28, 2013
February 2006
October 2010   (Final data collection date for primary outcome measure)
  • Unprotected vaginal or anal intercourse
  • Sharing of injection drug works
Same as current
Complete list of historical versions of study NCT00332813 on ClinicalTrials.gov Archive Site
Risk Assessment Battery
Same as current
Not Provided
Not Provided
 
Reducing HIV Risk Among Pregnant Women in Drug Treatment
Reducing HIV Risk Among Pregnant Women in Drug Treatment
We propose to develop and pilot test an intervention that addresses both sex- and drug-related HIV risk behavior among pregnant women in drug treatment. In the first phase of the study, we will conduct focus groups with pregnant women in drug treatment, as well as a focus group with their treatment providers, in order to determine key areas of emphasis for an intervention in this population. We will then develop an HIV risk behavior intervention for pregnant women in drug treatment, pilot the intervention with 20 women, and elicit their feedback regarding the intervention. Following refinement of the intervention, we will conduct a small randomized trial (n=60) to examine the impact of the intervention compared to standard care (SC). We expect that, relative to SC, participants randomized to the intervention condition will have lower levels of sex- and drug-related HIV risk behavior.
HIV is a critical and costly health problem for American women. Among pregnant drug abusers, sex- and drug-related HIV risk behavior occur at alarming rates. While motivationally-enhanced HIV risk behavior interventions have demonstrated efficacy with similar populations, very little work has been directed toward pregnant women in drug abuse treatment. The long-term objective of this research program is to reduce HIV risk behavior among pregnant women engaged in drug abuse treatment by developing and establishing the efficacy of an intervention that combines motivational interviewing, psychoeducation, and skill building exercises. Furthermore, we seek to advance knowledge of the mechanism of action by which interventions reduce HIV risk behavior. In the present application, we propose to develop and pilot test an intervention that addresses both sex- and drug-related HIV risk behavior among pregnant women in drug treatment. In the first phase of the study, we will conduct focus groups with pregnant women in drug treatment, as well as a focus group with their treatment providers, in order to determine key areas of emphasis for an intervention in this population. We will then develop an HIV risk behavior intervention for pregnant women in drug treatment, pilot the intervention with 20 women, and elicit their feedback regarding the intervention. Following refinement of the intervention, we will conduct a small randomized trial (n=60) to examine the efficacy of the intervention relative to standard care (SC). We expect that, relative to SC, participants randomized to the intervention condition will have lower levels of sex- and drug-related HIV risk behavior. We will also examine the potential mechanisms by which the intervention produces a reduction in HIV risk behavior. If found to be efficacious, this intervention will help to reduce the acquisition of HIV among pregnant drug abusers, improving health outcomes for the women and their children.Relevance to Public Health: The proposed study is designed to develop and test an intervention to reduce sex- and drug-related behavior that places pregnant drug abusers at risk for HIV infection. If successful, this intervention could reduce the rate of HIV infection in these women and their children.
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
HIV Risk Behavior
Behavioral: HIV Risk Behavior Intervention
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
98
October 2010
October 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:18 years of age or older, less than 32 weeks gestation, drug dependence (other than nicotine), have engaged in sex- or drug-related HIV risk behaviors at least monthly for 3 months prior to recruitment -

Exclusion Criteria:Currently psychotic, unable to provide names and contact information for two people who could serve as locators

Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00332813
DA020930
R01DA020930 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Not Provided
Not Provided
Rhode Island Hospital
National Institute on Drug Abuse (NIDA)
Principal Investigator: Susan E. Ramsey, Ph.D. Brown Medical School/Rhode Island Hospital
Rhode Island Hospital
January 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP