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Study to Improve Partner Services for STD Prevention

Primary Purpose

Trichomonas Vaginalis, Urethritis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Patient-delivered partner treatment
Booklet-enhanced partner referral
Sponsored by
Centers for Disease Control and Prevention
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Trichomonas Vaginalis focused on measuring patient-delivered partner treatment, partner referral, sexually transmitted diseases

Eligibility Criteria

16 Years - 44 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Delgado STD Clinic
  • Orleans Women's Health Clinic

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Index patient re-infection at 6-8 weeks
Cost effectiveness outcomes

Full Information

First Posted
September 13, 2005
Last Updated
September 13, 2005
Sponsor
Centers for Disease Control and Prevention
Collaborators
Tulane University
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1. Study Identification

Unique Protocol Identification Number
NCT00207467
Brief Title
Study to Improve Partner Services for STD Prevention
Official Title
Prospective Study for Cost-Effectiveness Strategies to Improve Partner Notification: Female Trichomonas and Male Urethritis Studies
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
December 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Centers for Disease Control and Prevention
Collaborators
Tulane University

4. Oversight

5. Study Description

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).
Detailed Description
For partner treatment, index women who were diagnosed with trichomonas vaginalis and index men who were diagnosed with urethritis were randomized to one of three study arms: Standard partner referral (PR) - index patients were instructed to tell their partners that they need to go to a clinic for STI evaluation and treatment. Booklet-enhanced partner referral (BEPR) - index patients were given a wallet-sized booklet containing 4 tear-out cards with information for the partner and treatment guidelines for the providers that would see the partners. The partners could then present this card at a clinic to help the clinician better treat them. If index patients had more than 4 partners, they were given additional booklets. Patient delivered partner treatment (PDPT) - index patients were given packages containing 2 gram metronidazole (for TV patients) or azithromycin 1 gram and cefixime 400 mg (for urethritis patients) for up to 4 identified sex partners. When cefixime was no longer available, ciprofloxacin 500 mg was used. These packages contained written instructions about how to take the medication, warnings about side effects and a nurse's pager number to call if there were any questions or if the partner encountered any problems. All medications were distributed in containers with childproof caps and the partner's initial and birthdates were written on the bottle. This was a requirement of the Louisiana State Pharmacy Board. Names were not documented on the index patient's study or medical records.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trichomonas Vaginalis, Urethritis
Keywords
patient-delivered partner treatment, partner referral, sexually transmitted diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1500 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Patient-delivered partner treatment
Intervention Type
Behavioral
Intervention Name(s)
Booklet-enhanced partner referral
Primary Outcome Measure Information:
Title
Index patient report of partner taking medicine at 6-8 weeks
Secondary Outcome Measure Information:
Title
Index patient re-infection at 6-8 weeks
Title
Cost effectiveness outcomes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patty Kissinger, PhD
Organizational Affiliation
Tulane University School of Public Health and Tropical Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Delgado STD Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
99999
Country
United States
Facility Name
Orleans Women's Health Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
99999
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16080084
Citation
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.
Results Reference
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Study to Improve Partner Services for STD Prevention

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