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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00207467
• Other study ID #: CDC-NCHSTP-3196
• Secondary ID: CA# R30/CCR61914
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: September 13, 2005
• Start date: December 2001
• Est. completion date: December 2004

Study information

• Verified date: September 2005
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 44 Years

Eligibility

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

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

Intervention

Behavioral:
• Patient-delivered partner treatment

• Booklet-enhanced partner referral

Locations

Country	Name	City	State
United States	Delgado STD Clinic	New Orleans	Louisiana
United States	Orleans Women's Health Clinic	New Orleans	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	Tulane University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Index patient report of partner taking medicine at 6-8 weeks
Secondary	Index patient re-infection at 6-8 weeks
Secondary	Cost effectiveness outcomes