- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01578915
A Case Control Study of Women With Multiple Sexual Partners
A Case Control Study of Women With Multiple Sexual Partners Attending the Jefferson County Department of Health Sexually Transmitted Diseases Clinic
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35233
- Jefferson County Department of Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Cases
Women with 4 or more sexual partners during the past year
|
Controls
Women with only one sexual partner during the past year
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
STI diagnosis
Time Frame: Day of enrollment
|
Day of enrollment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Sexual risk behaviors
Time Frame: Up to 3 months prior to enrollment
|
Up to 3 months prior to enrollment
|
Substance use (alcohol and drugs)
Time Frame: Up to 30 days prior to enrollment
|
Up to 30 days prior to enrollment
|
History of intimate partner violence
Time Frame: At any time prior to enrollment
|
At any time prior to enrollment
|
Depression
Time Frame: Up to 7 days prior to enrollment
|
Up to 7 days prior to enrollment
|
Social support
Time Frame: Up to 30 days prior to enrollment
|
Up to 30 days prior to enrollment
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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. doi: 10.1258/095646205774988037.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- High Risk Women
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sexually Transmitted Diseases
-
Columbia UniversityNational Institute of Allergy and Infectious Diseases (NIAID)RecruitingSTI | Sexually Transmitted Disease (STD) | Sexually Transmitted Infection (STI)United States
-
National Institute of Allergy and Infectious Diseases...Terminated
-
Boston Medical CenterCompletedSexually Transmitted InfectionUnited States
-
University of ChicagoCompletedSexually Transmitted InfectionUnited States
-
Assistance Publique Hopitaux De MarseilleCompletedSexually Transmitted InfectionFrance
-
University of California, San FranciscoNational Institute of Mental Health (NIMH); MRC/UVRI and LSHTM Uganda Research... and other collaboratorsCompletedSexually Transmitted InfectionUganda
-
Boston Medical CenterCompletedSexually Transmitted InfectionUnited States
-
University of Illinois at ChicagoEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedHiv | Sexually Transmitted InfectionSouth Africa
-
Chinese University of Hong KongRecruitingGonorrhea | Sexually Transmitted InfectionHong Kong
-
Sagami Rubber Industries Co., Ltd.Essential Access HealthCompletedContraception | Prevention of Sexually Transmitted InfectionsUnited States