HIV InfectionsPhase 2/3NCT00619320
Reducing HIV: Safer Sex Skill Building in Pregnant Drug Abusing Women
A Phase 2/3 study testing Safer Sex Skills Building (SSB) in people with HIV Infections and Substance Use, run by Virginia Commonwealth University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Substance Use
- What is being tested?
- Safer Sex Skills Building (SSB)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2008to Oct 2012
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Both sites:
- Unable to provide informed consent due to cognitive impairment, psychiatric instability, or language barriers
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Richmond Behavioral Health Authority (RBHA)
Richmond, Virginia, 23219
Virginia Commonwealth University, Nelson Womens Health (OB) Clinic
Richmond, Virginia, 23298
About this study
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.
Read the 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.
- Conditions
- HIV Infections, Substance Use
- Being tested
- Safer Sex Skills Building (SSB)
- Keywords
- HIV primary prevention, Health promotion, Health behavior, Risk reduction behavior, Sexual behavior, Safe sex, Women's health, Minority health, Pregnant Women, HIV seronegativity
- Medical subject headings
- HIV Infections, Substance-Related Disorders, Health Behavior, Risk Reduction Behavior, Sexual Behavior, Safe Sex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safer Sex Skills Building (SSB)Behavioural
Also called Experimental - Safer Sex Skill Building (5 sessions), Active Comparator - HIV/STD Education (1 session)
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).
| Study group | Role | What they receive |
|---|---|---|
| Safer Sex Skill Building (SSB) | Experimental | Safer Sex Skill Building Intervention (SSB) A five session behavioral intervention focused on HIV/STD prevention and safer sex negotiation skills Receives: Behavioral: Safer Sex Skills Building (SSB) |
| 2 | Active comparator | one group session focused on standard HIV/STD education Receives: Behavioral: Safer Sex Skills Building (SSB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of penetrative unprotected sexual intercourse occasions
Measured: baseline, 1 month, 3 months, and 6 months post-randomization follow-up assessment
The proportion of sex episodes involving alcohol or other drugs
Measured: baseline, 1 month, 3 months, and 6 months post-randomization follow-up assessment
The proportion of penetrative unprotected sex occasions (of all sex occasions)
Measured: baseline, 1 month, 3 months, and 6 months post-randomization follow-up assessment
Secondary outcomes (1)
Perceived self-efficacy to carry out safer sex and the carrying of condoms
Measured: baseline, 1 month, 3 months, and 6 months post-randomization follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2008 (estimated)
- Study startDec 2008
- Primary completionAug 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Dace S Svikis, Ph.D., Principal investigator, Professor, Department of Psychology, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00619320
- Sponsor's protocol ID
- P60MD002256 (Project 2 15378)
- Other IDs
- P60MD002256
- Status last verified
- Feb 2013
- First submitted
- 6 Feb 2008
- Last updated
- 12 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing HIV: Safer Sex Skill Building in Pregnant Drug Abusing Women
- ClinicalTrials.gov ID
- NCT00619320
- Acronym / sponsor ID
- P60MD002256 (Project 2 15378)
- Conditions
- HIV Infections, Substance Use
- Keywords
- HIV primary prevention, Health promotion, Health behavior, Risk reduction behavior, Sexual behavior, Safe sex, Women's health, Minority health
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- Dec 2008
- Primary completion
- Aug 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 20 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Safer Sex Skill Building (SSB) | Experimental | Behavioral: Safer Sex Skills Building (SSB)Safer Sex Skill Building Intervention (SSB) A five session behavioral intervention focused on HIV/STD prevention and safer sex negotiation skills |
| 2 | Active comparator | Behavioral: Safer Sex Skills Building (SSB)one group session focused on standard HIV/STD education |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Unable to provide informed consent due to cognitive impairment, psychiatric instability, or language barriers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Safer Sex Skills Building (SSB)Also: Experimental - Safer Sex Skill Building (5 sessions), Active Comparator - HIV/STD Education (1 session)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). | Behavioural | 2, Safer Sex Skill Building (SSB) |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dace S Svikis, Ph.D. principal investigator
Professor, Department of Psychology, Virginia Commonwealth University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Safer Sex Skills Building (SSB) in people with HIV Infections and Substance Use, run by Virginia Commonwealth University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of penetrative unprotected sexual intercourse occasions (time frame: baseline, 1 month, 3 months, and 6 months post-randomization follow-up assessment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2013.