Reducing HIV: Safer Sex Skill Building in Pregnant Drug Abusing Women
This study has been completed.
Sponsor:
Virginia Commonwealth University
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections Substance Use |
Behavioral: Safer Sex Skills Building (SSB) |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Reducing HIV: Safer Sex Skill Building in Pregnant Drug Abusing Women |
Resource links provided by NLM:
Further study details as provided by Virginia Commonwealth University:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 380 |
| Study Start Date: | December 2008 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
|
|
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:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00619320
Locations
| United States, Virginia | |
| Virginia Commonwealth University, Nelson Womens Health (OB) Clinic | |
| Richmond, Virginia, United States, 23298 | |
| Richmond Behavioral Health Authority (RBHA) | |
| Richmond, Virginia, United States, 23219 | |
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
| Principal Investigator: | Dace S Svikis, Ph.D. | Professor, Department of Psychology, Virginia Commonwealth University |
More Information
No publications provided
| Responsible Party: | Virginia Commonwealth University |
| ClinicalTrials.gov Identifier: | NCT00619320 History of Changes |
| Other Study ID Numbers: | P60MD002256 (Project 2 15378) |
| Study First Received: | February 6, 2008 |
| Last Updated: | February 11, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Virginia Commonwealth University:
|
HIV primary prevention Health promotion Health behavior Risk reduction behavior Sexual behavior |
Safe sex Women's health Minority health Pregnant Women HIV seronegativity |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on May 16, 2013