Skip to main content
OpenTrials
Completed

NCT Number: NCT00332813

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

HIV Risk Behavior Intervention

Behavioral

Primary outcomes

  1. Unprotected vaginal or anal intercourse

  2. Sharing of injection drug works

Secondary outcomes

  1. Risk Assessment Battery

Sponsors and collaborators

Lead sponsor

Rhode Island Hospital

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Jun 2, 2006
Registry last updated
Mar 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.