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Study to Improve Partner Services for STD Prevention
This study has been completed.
Study NCT00207467   Information provided by Centers for Disease Control and Prevention
First Received: September 13, 2005   No Changes Posted

September 13, 2005
September 13, 2005
December 2001
 
Index patient report of partner taking medicine at 6-8 weeks
Same as current
No Changes Posted
  • Index patient re-infection at 6-8 weeks
  • Cost effectiveness outcomes
Same as current
 
Study to Improve Partner Services for STD Prevention
Prospective Study for Cost-Effectiveness Strategies to Improve Partner Notification: Female Trichomonas and Male Urethritis Studies

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).

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.

Phase II
Interventional
Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
  • Trichomonas Vaginalis
  • Urethritis
  • Behavioral: Patient-delivered partner treatment
  • Behavioral: Booklet-enhanced partner referral
 
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. Epub 2005 Jul 19.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
1500
December 2004
 

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
Both
16 Years to 44 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00207467
 
CDC-NCHSTP-3196, CA# R30/CCR619143-01
Centers for Disease Control and Prevention
Tulane University School of Medicine
Principal Investigator: Patty Kissinger, PhD Tulane University School of Medicine
Centers for Disease Control and Prevention
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP