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NCT Number: NCT01578915

A Case Control Study of Women With Multiple Sexual Partners

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.

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Key information

Age range

16 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Jefferson County Department of Health

Birmingham, Alabama, 35233, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. STI diagnosis

    Time frame: Day of enrollment

Secondary outcomes

  1. Sexual risk behaviors

    Time frame: Up to 3 months prior to enrollment

  2. Substance use (alcohol and drugs)

    Time frame: Up to 30 days prior to enrollment

  3. History of intimate partner violence

    Time frame: At any time prior to enrollment

  4. Depression

    Time frame: Up to 7 days prior to enrollment

  5. Social support

    Time frame: Up to 30 days prior to enrollment

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

A Case Control Study of Women With Multiple Sexual Partners Attending the Jefferson County Department of Health Sexually Transmitted Diseases Clinic

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 17, 2012
Registry last updated
May 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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