Study to Improve Partner Services for STD Prevention

Phase 2

Completed

• Conditions: Trichomonas Vaginalis; Urethritis

• Registration Number: NCT00207467
• Lead Sponsor: Centers for Disease Control and Prevention

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 Timeline

• Study Start: 2001-12
• Study Completion: 2004-12
• Status Verified: 2005-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Last Update Submitted: 2005-09-13
• Study First Posted: 2005-09-21
• Last Update Posted: 2005-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Delgado STD Clinic; 🇺🇸 New Orleans, Louisiana, United States

Orleans Women's Health Clinic; 🇺🇸 New Orleans, Louisiana, United States