Study to Improve Partner Services for STD Prevention

Urethritis Clinical Trial

Official title: Prospective Study for Cost-Effectiveness Strategies to Improve Partner Notification: Female Trichomonas and Male Urethritis Studies

Status Completed

Clinical Trial 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).

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Trichomonas Infections
• Trichomonas Vaginalis
• Urethritis

• NCT number: NCT00207467
• Study type: Interventional
• Source: Centers for Disease Control and Prevention
• Status: Completed
• Phase: Phase 2
• Start date: December 2001
• Completion date: December 2004