search
Back to results

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

Primary Purpose

HIV Infections, Substance Use

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Safer Sex Skills Building (SSB)
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV primary prevention, Health promotion, Health behavior, Risk reduction behavior, Sexual behavior, Safe sex, Women's health, Minority health, Pregnant Women, HIV seronegativity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Safer Sex Skill Building (SSB)

2

Arm Description

Safer Sex Skill Building Intervention (SSB) A five session behavioral intervention focused on HIV/STD prevention and safer sex negotiation skills

one group session focused on standard HIV/STD education

Outcomes

Primary Outcome Measures

Number of penetrative unprotected sexual intercourse occasions
The proportion of sex episodes involving alcohol or other drugs
The proportion of penetrative unprotected sex occasions (of all sex occasions)

Secondary Outcome Measures

Perceived self-efficacy to carry out safer sex and the carrying of condoms

Full Information

First Posted
February 6, 2008
Last Updated
February 11, 2013
Sponsor
Virginia Commonwealth University
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
search

1. Study Identification

Unique Protocol Identification Number
NCT00619320
Brief Title
Reducing HIV: Safer Sex Skill Building in Pregnant Drug Abusing Women
Official Title
Reducing HIV: Safer Sex Skill Building in Pregnant Drug Abusing Women
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Substance Use
Keywords
HIV primary prevention, Health promotion, Health behavior, Risk reduction behavior, Sexual behavior, Safe sex, Women's health, Minority health, Pregnant Women, HIV seronegativity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
380 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Safer Sex Skill Building (SSB)
Arm Type
Experimental
Arm Description
Safer Sex Skill Building Intervention (SSB) A five session behavioral intervention focused on HIV/STD prevention and safer sex negotiation skills
Arm Title
2
Arm Type
Active Comparator
Arm Description
one group session focused on standard HIV/STD education
Intervention Type
Behavioral
Intervention Name(s)
Safer Sex Skills Building (SSB)
Other Intervention Name(s)
Experimental - Safer Sex Skill Building (5 sessions), Active Comparator - HIV/STD Education (1 session)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Number of penetrative unprotected sexual intercourse occasions
Time Frame
baseline, 1 month, 3 months, and 6 months post-randomization follow-up assessment
Title
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
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dace S Svikis, Ph.D.
Organizational Affiliation
Professor, Department of Psychology, Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Richmond Behavioral Health Authority (RBHA)
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
Virginia Commonwealth University, Nelson Womens Health (OB) Clinic
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs