Reducing HIV: Safer Sex Skill Building in Pregnant Drug Abusing Women

February 11, 2013 updated by: Virginia Commonwealth University
This study will examine safer sex skills building (SSB), a targeted behavioral HIV prevention and risk reduction group intervention in two samples of pregnant drug abusing women.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

"Safer Sex Skills Building" in Pregnant Women: Dace Svikis, (Psychology, Ob-Gyn, Psychiatry) PI, Diane Langhorst (Social Work) and Nichole Karjane, (OB-Gyn) Co-Investigators). This study will focus on increasing Safer Sex Skills development among pregnant women at high risk for HIV infection. The "Safer Sex Skill Building" (SSB) program developed by El Bassel and Schilling (1991, 1992), has demonstrated efficacy in national studies in reducing sexual risk for HIV and other STD transmission. This manual-driven, gender-specific intervention has proven effective in reducing sexual risk behaviors in both methadone maintenance and outpatient drug-free patients. To date, however, the intervention has not been tested with pregnant drug abusing women who may actually be at increased risk if they stop using condoms or continue drug use during pregnancy. This study will examine SSB, a targeted behavioral HIV prevention and risk reduction intervention in two samples of pregnant drug abusing women. Using a 2x2 design, a randomized clinical trial will compare the five-session SSB group intervention to a one-session standard group HIV Education intervention (SE). Study findings will provide benchmark data on the efficacy of SSB for HIV and STD prevention in a diverse sample of pregnant drug abusing women.

Study Type

Interventional

Enrollment (Actual)

380

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23219
        • Richmond Behavioral Health Authority (RBHA)
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University, Nelson Womens Health (OB) Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 18 years of age and older, pregnant
  • At prenatal care (PCC) site: screen positive for on T-ACE and TWEAK and/or drug CAGE, report drinking 3 or more drinks on at least one occasion and/or using an illicit drug at least once in the 30 days prior to pregnancy awareness, and report at least one incident of unprotected penetrative (vaginal or anal) intercourse with a male partner within the six months prior to baseline assessment.
  • At community treatment (RBHA) site, inclusion criteria are the same except post-partum women (i.e., those who gave birth to a child 2 years of age or less) will also be eligible for study enrollment.

Exclusion Criteria:

Both sites:

  • Unable to provide informed consent due to cognitive impairment, psychiatric instability, or language barriers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Safer Sex Skill Building (SSB)
Safer Sex Skill Building Intervention (SSB) A five session behavioral intervention focused on HIV/STD prevention and safer sex negotiation skills
Behavioral: Safer Sex Skills Building (SSB)
Test the effectiveness of an intervention for reducing sexual risk factors for HIV infection in two samples of pregnant drug-using women. The intervention, Safer Sex Skills Building (SSB)(El Bassel and Schilling (1991, 1992)), is a manual-driven, gender-specific group intervention delivered by mental health counselors. To date, its effectiveness has not been examined in pregnant, drug using women. The proposed study will examine the effectiveness of the intervention in both drug treatment (RBHA, N = 200) and prenatal care (PCC, N = 200) settings. Using a randomized clinical trial design, the study will compare the five-session SSB group intervention to a one-session standard group HIV Education session (ED). Study hypotheses: that women in the SSB intervention will have better outcomes (e.g., fewer unprotected penetrative sexual behaviors) than women in the control group (ED).
Other Names:
  • Experimental - Safer Sex Skill Building (5 sessions)
  • Active Comparator - HIV/STD Education (1 session)
Active Comparator: 2
one group session focused on standard HIV/STD education
Behavioral: Safer Sex Skills Building (SSB)
Test the effectiveness of an intervention for reducing sexual risk factors for HIV infection in two samples of pregnant drug-using women. The intervention, Safer Sex Skills Building (SSB)(El Bassel and Schilling (1991, 1992)), is a manual-driven, gender-specific group intervention delivered by mental health counselors. To date, its effectiveness has not been examined in pregnant, drug using women. The proposed study will examine the effectiveness of the intervention in both drug treatment (RBHA, N = 200) and prenatal care (PCC, N = 200) settings. Using a randomized clinical trial design, the study will compare the five-session SSB group intervention to a one-session standard group HIV Education session (ED). Study hypotheses: that women in the SSB intervention will have better outcomes (e.g., fewer unprotected penetrative sexual behaviors) than women in the control group (ED).
Other Names:
  • Experimental - Safer Sex Skill Building (5 sessions)
  • Active Comparator - HIV/STD Education (1 session)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of penetrative unprotected sexual intercourse occasions
Time Frame: baseline, 1 month, 3 months, and 6 months post-randomization follow-up assessment
baseline, 1 month, 3 months, and 6 months post-randomization follow-up assessment
The proportion of sex episodes involving alcohol or other drugs
Time Frame: baseline, 1 month, 3 months, and 6 months post-randomization follow-up assessment
baseline, 1 month, 3 months, and 6 months post-randomization follow-up assessment
The proportion of penetrative unprotected sex occasions (of all sex occasions)
Time Frame: baseline, 1 month, 3 months, and 6 months post-randomization follow-up assessment
baseline, 1 month, 3 months, and 6 months post-randomization follow-up assessment

Secondary Outcome Measures

Outcome Measure
Time Frame
Perceived self-efficacy to carry out safer sex and the carrying of condoms
Time Frame: baseline, 1 month, 3 months, and 6 months post-randomization follow-up
baseline, 1 month, 3 months, and 6 months post-randomization follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

  • Principal Investigator: Dace S Svikis, Ph.D., Professor, Department of Psychology, Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

February 6, 2008

First Submitted That Met QC Criteria

February 19, 2008

First Posted (Estimate)

February 20, 2008

Study Record Updates

Last Update Posted (Estimate)

February 12, 2013

Last Update Submitted That Met QC Criteria

February 11, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P60MD002256 (Project 2 15378)
  • P60MD002256 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infections

Clinical Trials on Safer Sex Skills Building (SSB)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe