A Case Control Study of Women With Multiple Sexual Partners

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Christina Muzny, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01578915
First received: March 4, 2012
Last updated: March 23, 2014
Last verified: March 2014
  Purpose

Both population based surveys and more focused research studies indicate that increased numbers of sexual partners and partner concurrency contribute to increased risk for acquisition of sexually transmitted infection (STI), including HIV infection. However, unlike for men, both national and sub-population-based studies consistently find that the great majority of women with or without STIs report only 1-2 sex partners in the preceding year and that a minority of women acknowledge > 3 sex partners over the same period, suggesting that this relatively small proportion of women with higher numbers of sex partners play a disproportionate role in sustaining community STI rates. Despite these observations, surprisingly little is known about women with increased numbers of sexual partners, the factors which contribute to increased partner number, and the potential for those factors to be intervened upon to reduce risk for STI. The implications of these facts for STI/HIV prevention efforts are profound. For instance, interventions that include the implication that target audiences have multiple sex partners might be dismissed as irrelevant by those with single partners. Conversely, interventions targeting women with multiple sex partners may be based on assumptions derived from data which, while representative of the general target audience, may not reflect relevant circumstances for the subset of women with higher numbers of partners.

This study will begin to generate data that will provide critical information on this topic and help inform future development of STI/HIV interventions tailored to womens' individual circumstances and contexts. The investigators hypothesize that women with 4 or more sexual partners during the past year will report higher rates of depression and substance abuse (alcohol and drugs), higher rates of intimate partner violence, less social support, more non-vaginal sex, more same-sex contacts, and higher rates of STIs than women reporting only one sexual partner during the past year.


Condition
Sexually Transmitted Diseases

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Case Control Study of Women With Multiple Sexual Partners Attending the Jefferson County Department of Health Sexually Transmitted Diseases Clinic

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • STI diagnosis [ Time Frame: Day of enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sexual risk behaviors [ Time Frame: Up to 3 months prior to enrollment ] [ Designated as safety issue: No ]
  • Substance use (alcohol and drugs) [ Time Frame: Up to 30 days prior to enrollment ] [ Designated as safety issue: No ]
  • History of intimate partner violence [ Time Frame: At any time prior to enrollment ] [ Designated as safety issue: No ]
  • Depression [ Time Frame: Up to 7 days prior to enrollment ] [ Designated as safety issue: No ]
  • Social support [ Time Frame: Up to 30 days prior to enrollment ] [ Designated as safety issue: No ]

Enrollment: 213
Study Start Date: May 2011
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cases
Women with 4 or more sexual partners during the past year
Controls
Women with only one sexual partner during the past year

Detailed Description:

The objectives of this protocol are: (1) To delineate factors that are important modifiable predictors of sexually transmitted infection (STI) risk in the context of increased numbers of sexual partners, comparing those participants with one sexual partner to those with 4 or more sexual partners during the past year. (2) To define the prevalence of infection with Chlamydia, gonorrhea, trichomoniasis, syphilis, genital herpes, and HIV in women reporting one sexual partner in the past year compared to women reporting 4 or more sexual partners during the past year.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women presenting to the Jefferson County Department of Health Sexually Transmitted Diseases Clinic

Criteria

Inclusion Criteria:

  • female,
  • age 16 years or older,
  • report of either one sexual partner during the past year or 4 or more sexual partners in the past year,
  • able to provide written informed consent

Exclusion Criteria:

  • Drug and/or alcohol intoxication at the time of enrollment,
  • exhibition of any type of disruptive or unsafe behavior that would not be conducive to participating in this study
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01578915

Locations
United States, Alabama
Jefferson County Department of Health
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Christina A Muzny, MD University of Alabama at Birmingham
  More Information

Publications:
Responsible Party: Dr. Christina Muzny, Assistant Professor of Medicine, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01578915     History of Changes
Other Study ID Numbers: High Risk Women
Study First Received: March 4, 2012
Last Updated: March 23, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 24, 2014