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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00619320
First received: February 6, 2008
Last updated: February 11, 2013
Last verified: February 2013

February 6, 2008
February 11, 2013
December 2008
August 2012   (final data collection date for primary outcome measure)
  • Number of penetrative unprotected sexual intercourse occasions [ Time Frame: baseline, 1 month, 3 months, and 6 months post-randomization follow-up assessment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Number of penetrative unprotected sexual intercourse occasions; the proportion of sex episodes involving alcohol or other drugs; and the proportion of penetrative unprotected sex occasions (of all sex occasions). [ Time Frame: baseline, 1 month, 3 month and 6 month post-randomization follow-up assessment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00619320 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Secondary outcome measures will include: perceived self-efficacy to carry out safer sex and the carrying of condoms. [ Time Frame: baseline, 1 month, 3 month and 6 month post-randomization follow-up ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Reducing HIV: Safer Sex Skill Building in Pregnant Drug Abusing Women
Reducing HIV: Safer Sex Skill Building in Pregnant Drug Abusing Women

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.

"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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • HIV Infections
  • Substance Use
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)
  • 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
    Intervention: Behavioral: Safer Sex Skills Building (SSB)
  • Active Comparator: 2
    one group session focused on standard HIV/STD education
    Intervention: Behavioral: Safer Sex Skills Building (SSB)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
380
October 2012
August 2012   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00619320
P60MD002256 (Project 2 15378)
Yes
Virginia Commonwealth University
Virginia Commonwealth University
National Center on Minority Health and Health Disparities (NCMHD)
Principal Investigator: Dace S Svikis, Ph.D. Professor, Department of Psychology, Virginia Commonwealth University
Virginia Commonwealth University
February 2013

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