Study to Improve Partner Services for STD Prevention

This study has been completed.
Sponsor:
Collaborator:
Tulane University
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00207467
First received: September 13, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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).


Condition Intervention Phase
Trichomonas Vaginalis
Urethritis
Behavioral: Patient-delivered partner treatment
Behavioral: Booklet-enhanced partner referral
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prospective Study for Cost-Effectiveness Strategies to Improve Partner Notification: Female Trichomonas and Male Urethritis Studies

Further study details as provided by Centers for Disease Control and Prevention:

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

Estimated Enrollment: 1500
Study Start Date: December 2001
Estimated Study Completion Date: December 2004
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.

  Eligibility

Ages Eligible for Study:   16 Years to 44 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00207467

Locations
United States, Louisiana
Delgado STD Clinic
New Orleans, Louisiana, United States, 99999
Orleans Women's Health Clinic
New Orleans, Louisiana, United States, 99999
Sponsors and Collaborators
Tulane University
Investigators
Principal Investigator: Patty Kissinger, PhD Tulane University School of Public Health and Tropical Medicine
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00207467     History of Changes
Other Study ID Numbers: CDC-NCHSTP-3196, CA# R30/CCR619143-01
Study First Received: September 13, 2005
Last Updated: September 13, 2005
Health Authority: United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:
patient-delivered partner treatment
partner referral
sexually transmitted diseases

Additional relevant MeSH terms:
Trichomonas Infections
Urethritis
Protozoan Infections
Parasitic Diseases
Urethral Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 28, 2014