Reducing HIV: Safer Sex Skill Building in Pregnant Drug Abusing Women
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00619320 |
Recruitment Status
:
Completed
First Posted
: February 20, 2008
Last Update Posted
: February 12, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections Substance Use | Behavioral: Safer Sex Skills Building (SSB) | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 380 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Reducing HIV: Safer Sex Skill Building in Pregnant Drug Abusing Women |
Study Start Date : | December 2008 |
Actual Primary Completion Date : | August 2012 |
Actual Study Completion Date : | October 2012 |

Arm | Intervention/treatment |
---|---|
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:
|
- Number of penetrative unprotected sexual intercourse occasions [ Time Frame: baseline, 1 month, 3 months, and 6 months post-randomization follow-up assessment ]
- 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 ]
- 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 ]
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00619320
United States, Virginia | |
Richmond Behavioral Health Authority (RBHA) | |
Richmond, Virginia, United States, 23219 | |
Virginia Commonwealth University, Nelson Womens Health (OB) Clinic | |
Richmond, Virginia, United States, 23298 |
Principal Investigator: | Dace S Svikis, Ph.D. | Professor, Department of Psychology, Virginia Commonwealth University |
Responsible Party: | Virginia Commonwealth University |
ClinicalTrials.gov Identifier: | NCT00619320 History of Changes |
Other Study ID Numbers: |
P60MD002256 (Project 2 15378) P60MD002256 ( U.S. NIH Grant/Contract ) |
First Posted: | February 20, 2008 Key Record Dates |
Last Update Posted: | February 12, 2013 |
Last Verified: | February 2013 |
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 Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |