Clinical trial NCT00619320: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
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
Pregnant Women
HIV seronegativity
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2008-02-20
Enrollment: 380
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of penetrative unprotected sexual intercourse occasions
timeFrame: baseline, 1 month, 3 months, and 6 months post-randomization follow-up assessment
measure: The proportion of sex episodes involving alcohol or other drugs
timeFrame: baseline, 1 month, 3 months, and 6 months post-randomization follow-up assessment
measure: The proportion of penetrative unprotected sex occasions (of all sex occasions)
timeFrame: baseline, 1 month, 3 months, and 6 months post-randomization follow-up assessment
Secondary outcomes:
measure: Perceived self-efficacy to carry out safer sex and the carrying of condoms
timeFrame: baseline, 1 month, 3 months, and 6 months post-randomization follow-up
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Richmond Behavioral Health Authority (RBHA)
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University, Nelson Womens Health (OB) Clinic
state: Virginia
Study officials:
affiliation: Professor, Department of Psychology, Virginia Commonwealth University
name: Dace S Svikis, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: