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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00619320
• Other study ID #: P60MD002256 (Project 2 15378)
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 6, 2008
• Last updated: February 11, 2013
• Start date: December 2008
• Est. completion date: October 2012

Study information

• Verified date: February 2013
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: October 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections
• Substance Use

Intervention

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).

Locations

Country	Name	City	State
United States	Richmond Behavioral Health Authority (RBHA)	Richmond	Virginia
United States	Virginia Commonwealth University, Nelson Womens Health (OB) Clinic	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of penetrative unprotected sexual intercourse occasions		baseline, 1 month, 3 months, and 6 months post-randomization follow-up assessment	No
Primary	The proportion of sex episodes involving alcohol or other drugs		baseline, 1 month, 3 months, and 6 months post-randomization follow-up assessment	No
Primary	The proportion of penetrative unprotected sex occasions (of all sex occasions)		baseline, 1 month, 3 months, and 6 months post-randomization follow-up assessment	No
Secondary	Perceived self-efficacy to carry out safer sex and the carrying of condoms		baseline, 1 month, 3 months, and 6 months post-randomization follow-up	No