Reducing HIV: Safer Sex Skill Building in Pregnant Drug Abusing Women - Full Text View

Sponsors and Collaborators:	Virginia Commonwealth University National Center on Minority Health and Health Disparities (NCMHD)
Information provided by:	Virginia Commonwealth University
ClinicalTrials.gov Identifier:	NCT00619320

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 II Phase III

MedlinePlus related topics: AIDS Women's Health

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Reducing HIV: Safer Sex Skill Building in Pregnant Drug Abusing Women

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 ]

Estimated Enrollment:	400
Study Start Date:	December 2008
Estimated Study Completion Date:	October 2012
Estimated Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 5 group session Safer Sex Skill Building 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).
2: Active Comparator 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).

Arms

Assigned Interventions

1: Experimental

5 group session Safer Sex Skill Building 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).

2: Active Comparator

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).

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

Contacts

Contact: Diane M Langhorst, Ph.D.	804-827-2524	dlanghorst@vcu.edu
Contact: Danielle Terrell, BS	804-827-1153	dterrell@vcu.edu

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

National Center on Minority Health and Health Disparities (NCMHD)

Investigators

Principal Investigator:

Dace S Svikis, Ph.D.

Professor, Department of Psychology, Virginia Commonwealth University

More Information

No publications provided

Responsible Party:	Virginia Commonwealth Iniversity ( Dace Svikis, Ph.D., Professor of Psychology )
Study ID Numbers:	P60MD002256 (Project 2 15378)
Study First Received:	February 6, 2008
Last Updated:	October 22, 2008
ClinicalTrials.gov Identifier:	NCT00619320 History of Changes
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

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on May 07, 2009