Clinical trial NCT00207467: Study to Improve Partner Services for STD Prevention
Official title: Prospective Study for Cost-Effectiveness Strategies to Improve Partner Notification: Female Trichomonas and Male Urethritis Studies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Trichomonas Vaginalis
Urethritis
Keywords: patient-delivered partner treatment
partner referral
sexually transmitted diseases
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: Tulane University
First posted: 2005-09-21
Enrollment: 1500
Sex: ALL
Minimum age (years): 16
Maximum age (years): 44
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Index patient report of partner taking medicine at 6-8 weeks
Secondary outcomes:
measure: Index patient re-infection at 6-8 weeks
measure: Cost effectiveness outcomes
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Delgado STD Clinic
state: Louisiana
city: New Orleans
country: United States
facility: Orleans Women's Health Clinic
state: Louisiana
Study officials:
affiliation: Tulane University School of Public Health and Tropical Medicine
name: Patty Kissinger, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.