DNA Clearance of Uncomplicated Trichomonas Vaginalis Infections in HIV Negative Women

NCT01874158 | Completed

• 1 other identifier: 8115
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to screen treated Trichomonas vaginalis (TV) positive women weekly using culture and Polymerase Chain Reaction (PCR) to determine how long TV DNA is detectable post treatment and to examine potential confounders to clearance such as bacterial vaginosis.

Conditions

Trichomonas Vaginitis

Keywords

Trichomonas vaginalis

Outcome Measures

Primary Outcomes (1)

• TV negative by PCR, post treatment

  Women are assessed for TV at each weekly visit by PCR. They are considered cleared of the remnant DNA after PCR is negative.

  4 weeks

Study Arms (1)

TV postive women

All women who are TV positive by wet prep or in-pouch and meet the inclusion exclusion requirements.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

English speaking HIV- women over the age of 18 who are TV positive

You may qualify if:

• English speaking females
• \>18 years old
• HIV-negative
• a patient at the Delgado Personal Health Center

You may not qualify if:

• HIV+ women

Sponsors & Collaborators

• Tulane University Health Sciences Center: lead
• Louisiana State University Health Sciences Center in New Orleans: collaborator

Study Sites (1)

Delgado Personal Health Center

New Orleans, Louisiana, 70112, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

1 vaginal swab collected at screening for In-pouch 3 vaginal swabs collected at enrollment, PCR, gram stain, and future microbiome study At each of 3 follow-up visits, 3 vaginal swabs, PCR, In-pouch, and future microbiome study At the 4th follow-up visit, 4 vaginal swabs, PCR, In-pouch, gram stain, and future microbiome study. All swabs, except at screening, are self-collected.

MeSH Terms

Conditions

Trichomonas Vaginitis

Condition Hierarchy (Ancestors)

Trichomonas Infections; Protozoan Infections; Parasitic Diseases; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Patricia J Kissinger, PhD

  Tulane University School of Public Health and Tropical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 6, 2013
• First Posted: June 10, 2013
• Study Start: November 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: December 19, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)