A Case Control Study of Women With Multiple Sexual Partners

Sexually Transmitted Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01578915
• Other study ID #: High Risk Women
• Status: Completed
• Phase: N/A
• First received: March 4, 2012
• Last updated: May 14, 2017
• Start date: May 2011
• Est. completion date: November 2013

Study information

• Verified date: May 2017
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sexually Transmitted Diseases

Locations

Country	Name	City	State
United States	Jefferson County Department of Health	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

References & Publications (5)

DiClemente RJ, Crosby RA, Wingood GM, Lang DL, Salazar LF, Broadwell SD. Reducing risk exposures to zero and not having multiple partners: findings that inform evidence-based practices designed to prevent STD acquisition. Int J STD AIDS. 2005 Dec;16(12):816-8. — View Citation

Muzny CA, Austin EL, Harbison HS, Hook EW 3rd. Sexual partnership characteristics of African American women who have sex with women; impact on sexually transmitted infection risk. Sex Transm Dis. 2014 Oct;41(10):611-7. doi: 10.1097/OLQ.0000000000000194. — View Citation

Muzny CA, Harbison HS, Austin EL, Schwebke JR, Van Der Pol B, Hook EW 3rd. Sexually Transmitted Infection Risk among Women Is Not Fully Explained by Partner Numbers. South Med J. 2017 Mar;110(3):161-167. doi: 10.14423/SMJ.0000000000000621. — View Citation

Santelli JS, Brener ND, Lowry R, Bhatt A, Zabin LS. Multiple sexual partners among U.S. adolescents and young adults. Fam Plann Perspect. 1998 Nov-Dec;30(6):271-5. — View Citation

Van Wagoner NJ, Harbison HS, Drewry J, Turnipseed E, Hook EW 3rd. Characteristics of women reporting multiple recent sex partners presenting to a sexually transmitted disease clinic for care. Sex Transm Dis. 2011 Mar;38(3):210-5. doi: 10.1097/OLQ.0b013e3181f6fe42. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	STI diagnosis		Day of enrollment
Secondary	Sexual risk behaviors		Up to 3 months prior to enrollment
Secondary	Substance use (alcohol and drugs)		Up to 30 days prior to enrollment
Secondary	History of intimate partner violence		At any time prior to enrollment
Secondary	Depression		Up to 7 days prior to enrollment
Secondary	Social support		Up to 30 days prior to enrollment