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Study to Improve Partner Services for STD Prevention

This study has been completed.
Study NCT00207467.   Last updated on September 13, 2005.   Information provided by Centers for Disease Control and Prevention

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Descriptive Information Fields
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
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.

Study Phase Phase II
Study Type  Interventional
Study Design  Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure  Index patient report of partner taking medicine at 6-8 weeks
Secondary Outcome Measure  Index patient re-infection at 6-8 weeks
Cost effectiveness outcomes
Condition  Trichomonas Vaginalis
Urethritis
Intervention  Behavioral: Patient-delivered partner treatment
Behavioral: Booklet-enhanced partner referral
MEDLINE PMIDs 16080084
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  1500
Start Date  December 2001
Completion Date December 2004
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
Gender Both
Ages 16 Years to 44 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00207467
Organization ID CDC-NCHSTP-3196
Secondary IDs †† CA# R30/CCR619143-01
Study Sponsor  Centers for Disease Control and Prevention
Collaborators †† Tulane University School of Medicine
Investigators 
Principal Investigator:     Patty Kissinger, PhD     Tulane University School of Medicine    
Information Provided By Centers for Disease Control and Prevention
Verification Date September 2005
First Received Date  September 13, 2005
Last Updated Date September 13, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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