NCT01578915

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
213

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 17, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

May 16, 2017

Status Verified

May 1, 2017

Enrollment Period

2.5 years

First QC Date

March 4, 2012

Last Update Submit

May 14, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • STI diagnosis

    Day of enrollment

Secondary Outcomes (5)

  • Sexual risk behaviors

    Up to 3 months prior to enrollment

  • Substance use (alcohol and drugs)

    Up to 30 days prior to enrollment

  • History of intimate partner violence

    At any time prior to enrollment

  • Depression

    Up to 7 days prior to enrollment

  • Social support

    Up to 30 days prior to enrollment

Study Arms (2)

Cases

Women with 4 or more sexual partners during the past year

Controls

Women with only one sexual partner during the past year

Eligibility Criteria

Age16 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jefferson County Department of Health

Birmingham, Alabama, 35233, United States

Location

Related Publications (5)

  • 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.

    PMID: 20966829BACKGROUND
  • 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.

    PMID: 9859017BACKGROUND
  • 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.

    PMID: 16336765BACKGROUND
  • 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.

    PMID: 25211257BACKGROUND
  • 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.

    PMID: 28257539BACKGROUND

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Christina A Muzny, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

March 4, 2012

First Posted

April 17, 2012

Study Start

May 1, 2011

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

May 16, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations