Trichomonas Vaginalis Repeat Infections Among HIV Negative Women

This study is currently recruiting participants.
Verified March 2014 by Tulane University Health Sciences Center
Sponsor:
Information provided by (Responsible Party):
Patricia Kissinger, Tulane University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT01832480
First received: April 4, 2013
Last updated: March 1, 2014
Last verified: March 2014
  Purpose

The overall goal of this project is to determine the influence of patient treatment, host factors and partner treatment on repeat Trichomonas vaginalis (TV) infections among HIV-negative women


Condition Intervention Phase
Vaginitis Trichomonal or Due to Trichomonas
Partner Communication
Drug: MTZ 250 mg BID
Drug: PDPT
Drug: MTZ 2 g
Other: Partner referral
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Trichomonas Vaginalis Repeat Infections Among HIV Negative Women

Resource links provided by NLM:


Further study details as provided by Tulane University Health Sciences Center:

Primary Outcome Measures:
  • TV negative after treatment with either multi or single dose MTZ [ Time Frame: 1 month post treatment completion ] [ Designated as safety issue: No ]

Estimated Enrollment: 2883
Study Start Date: June 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MTZ 2 g and PDPT
Single dose MTZ and Patient delivered partner treatment
Drug: PDPT
patient delivered partner treatment of MTZ
Other Name: Patient delivered partner treatment
Drug: MTZ 2 g
MTZ 2 g
Other Name: Single dose MTZ
Active Comparator: MTZ 2 g and Partner referral
Single dose MTZ and Partner referral
Drug: MTZ 2 g
MTZ 2 g
Other Name: Single dose MTZ
Other: Partner referral
Partner Referral to seek treatment
Other Name: Partner Referral
Experimental: Metronidazole 250 mg BID and PDPT
Multi dose MTZ and patient delivered partner treatment
Drug: MTZ 250 mg BID
MTZ 250 mg BID
Other Name: Multi-dose
Drug: PDPT
patient delivered partner treatment of MTZ
Other Name: Patient delivered partner treatment
Experimental: MTZ 250 mg BID and Partner referral
Multi dose MTZ and partner referral
Drug: MTZ 250 mg BID
MTZ 250 mg BID
Other Name: Multi-dose
Other: Partner referral
Partner Referral to seek treatment
Other Name: Partner Referral

Detailed Description:

This study is a phase IV two-factorial (dosing and partner treatment) randomized clinical trial. HIV-negative women who test positive for TV at their routine gynecological exam at participating clinics will be referred to the nurse/study coordinator to screen for eligibility, provide a description of the study, and obtain written, informed consent (N=2883). Subjects will undergo an audio computer assisted self- interview (ACASI), and will self-collect a vaginal swab for Gram stain testing and be randomized into one of four arms based on 2 factors; dosing -- metronidazole (MTZ) 2 g single dose (CDC recommended treatment regimen) or MTZ 500 mg BID 7-day dose (CDC alternative treatment regimen); and partner treatment -- patient-delivered partner treatment (PDPT) or partner referral (PR). The four arms are MTZ single dose/PDPT, MTZ single dose/PR, MTZ 7d dose/PDPT, and MTZ 7d dose/PR. All enrolled women will be asked to return for a follow-up visit at one month after baseline (window 4-6 weeks).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • female
  • English speaking
  • >= 18 years old (Crossroads and Delgado); >=19 years old (JCDH)

Exclusion Criteria:

  • HIV-infected
  • unable to provide informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01832480

Contacts
Contact: Patricia Kissinger, PhD kissing@tulane.edu

Locations
United States, Alabama
Jefferson County Dept of Health/STD Specialty Clinic Recruiting
Birmingham, Alabama, United States, 35233
Contact: Christina Muzny, MD    205-975-3298    cmuzny@uab.edu   
Sub-Investigator: Christins Muzny, MD         
United States, Louisiana
Delgado Personal Health Center Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Stephanie Taylor, MD       STaylo2@lsuhsc.edu   
Sub-Investigator: Stephanie Taylor, MD         
United States, Mississippi
Crossroads Clinic Recruiting
Jackson, Mississippi, United States, 39213
Contact: Leandro Mena, MD    601-937-2387    lmena@umc.edu   
Sub-Investigator: Harold Henderson, MD         
Sponsors and Collaborators
Tulane University Health Sciences Center
Investigators
Principal Investigator: Patricia Kissinger, MD Tulane Univeristy
  More Information

Publications:
Responsible Party: Patricia Kissinger, Professor, Tulane University Health Sciences Center
ClinicalTrials.gov Identifier: NCT01832480     History of Changes
Other Study ID Numbers: 4042013
Study First Received: April 4, 2013
Last Updated: March 1, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Tulane University Health Sciences Center:
Trichomonas vaginalis
metronidazole
Patient-delivered partner treatment

Additional relevant MeSH terms:
Trichomonas Vaginitis
Vaginitis
Trichomonas Infections
Protozoan Infections
Parasitic Diseases
Vaginal Diseases
Genital Diseases, Female
Metronidazole
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on April 17, 2014