NCT00207467

Brief Summary

The goal of this study was to examine the efficacy of patient-delivered partner treatment (PDPT) compared to standard partner referral (PR) and booklet enhanced partner referral (BEPR).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,500

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2001

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

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

December 1, 2001

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

September 21, 2005

Status Verified

September 1, 2005

First QC Date

September 13, 2005

Last Update Submit

September 13, 2005

Conditions

Keywords

patient-delivered partner treatmentpartner referralsexually transmitted diseases

Outcome Measures

Primary Outcomes (1)

  • Index patient report of partner taking medicine at 6-8 weeks

Secondary Outcomes (2)

  • Index patient re-infection at 6-8 weeks

  • Cost effectiveness outcomes

Interventions

Eligibility Criteria

Age16 Years - 44 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Woman attending Family Planning Clinic or men attending STD clinic
  • Aged 16-44
  • (non-pregnant women) - positive InPouch for trichomonas, or
  • (pregnant women) - positive wet mount or InPouch for Trichomonas vaginalis
  • (men) a complaint of urethritis which is verified on examination
  • Report having \>= 1sex partners in past 60 days
  • Not presumptively treated for trichomonas (women) or urethritis (men)
  • Provide informed consent to be re-contacted by telephone or in person in 14-28 days for a follow-up interview and T vaginalis or CT/GC rescreening

You may not qualify if:

  • Men
  • Prisoner
  • Has taken cefixime or azithromycin in last two weeks
  • Has previously participated in the study
  • All female partners are pregnant and did not have male partners Women
  • client has taken metronidazole in the last two weeks
  • client has been in this study previously
  • women who are asymptomatic and in their first trimester of pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Delgado STD Clinic

New Orleans, Louisiana, 99999, United States

Location

Orleans Women's Health Clinic

New Orleans, Louisiana, 99999, United States

Location

Related Publications (1)

  • Kissinger P, Mohammed H, Richardson-Alston G, Leichliter JS, Taylor SN, Martin DH, Farley TA. Patient-delivered partner treatment for male urethritis: a randomized, controlled trial. Clin Infect Dis. 2005 Sep 1;41(5):623-9. doi: 10.1086/432476. Epub 2005 Jul 19.

MeSH Terms

Conditions

UrethritisSexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Urethral DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesCommunicable DiseasesInfectionsGenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Patty Kissinger, PhD

    Tulane University School of Public Health and Tropical Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

December 1, 2001

Study Completion

December 1, 2004

Last Updated

September 21, 2005

Record last verified: 2005-09

Locations