NCT00619320

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
380

participants targeted

Target at P75+ for phase_2 hiv-infections

Timeline
Completed

Started Dec 2008

Typical duration for phase_2 hiv-infections

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 20, 2008

Completed
10 months until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

February 12, 2013

Status Verified

February 1, 2013

Enrollment Period

3.7 years

First QC Date

February 6, 2008

Last Update Submit

February 11, 2013

Conditions

HIV InfectionsSubstance Use

Keywords

HIV primary preventionHealth promotionHealth behaviorRisk reduction behaviorSexual behaviorSafe sexWomen's healthMinority healthPregnant WomenHIV seronegativity

Outcome Measures

Primary Outcomes (3)

  • Number of penetrative unprotected sexual intercourse occasions

    baseline, 1 month, 3 months, and 6 months post-randomization follow-up assessment

  • The proportion of sex episodes involving alcohol or other drugs

    baseline, 1 month, 3 months, and 6 months post-randomization follow-up assessment

  • The proportion of penetrative unprotected sex occasions (of all sex occasions)

    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

    baseline, 1 month, 3 months, and 6 months post-randomization follow-up

Study Arms (2)

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

Behavioral: Safer Sex Skills Building (SSB)

2

ACTIVE COMPARATOR

one group session focused on standard HIV/STD education

Behavioral: Safer Sex Skills Building (SSB)

Interventions

Safer Sex Skills Building (SSB)BEHAVIORAL

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).

Also known as: Experimental - Safer Sex Skill Building (5 sessions), Active Comparator - HIV/STD Education (1 session)
2Safer Sex Skill Building (SSB)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Both sites:
  • Unable to provide informed consent due to cognitive impairment, psychiatric instability, or language barriers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Richmond Behavioral Health Authority (RBHA)

Richmond, Virginia, 23219, United States

Location

Virginia Commonwealth University, Nelson Womens Health (OB) Clinic

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

HIV InfectionsSubstance-Related DisordersHealth BehaviorRisk Reduction BehaviorSexual BehaviorSafe Sex

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesChemically-Induced DisordersMental DisordersBehavior

Study Officials

  • Dace S Svikis, Ph.D.

    Professor, Department of Psychology, Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2008

First Posted

February 20, 2008

Study Start

December 1, 2008

Primary Completion

August 1, 2012

Study Completion

October 1, 2012

Last Updated

February 12, 2013

Record last verified: 2013-02

Locations

US(2)