Study to Improve Partner Services for STD Prevention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-12-31

Study Completion Date

2004-12-31

Brief Summary

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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

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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.

Conditions

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Trichomonas Vaginalis Urethritis

Keywords

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patient-delivered partner treatment partner referral sexually transmitted diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Patient-delivered partner treatment

Intervention Type BEHAVIORAL

Booklet-enhanced partner referral

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Maximum Eligible Age

44 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Patty Kissinger, PhD

Role: PRINCIPAL_INVESTIGATOR

Tulane University School of Public Health and Tropical Medicine

Locations

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Delgado STD Clinic

New Orleans, Louisiana, United States

Site Status

Orleans Women's Health Clinic

New Orleans, Louisiana, United States

Site Status

Countries

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United States

References

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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. doi: 10.1086/432476. Epub 2005 Jul 19.

Reference Type RESULT

PMID: 16080084 (View on PubMed)

Other Identifiers

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CA# R30/CCR619143-01

Identifier Type: -

Identifier Source: secondary_id

CDC-NCHSTP-3196