Trichomonas VaginalisPhase 2NCT00207467
Study to Improve Partner Services for STD Prevention
A Phase 2 study testing Patient-delivered partner treatment and Booklet-enhanced partner referral in people with Trichomonas Vaginalis and Urethritis, run by Centers for Disease Control and Prevention at 2 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 16 to 44 years
- Conditions the study is for
- Trichomonas Vaginalis, Urethritis
- What is being tested?
- Patient-delivered partner treatment and Booklet-enhanced partner referral
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,500 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2001to Dec 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 44 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Delgado STD Clinic
New Orleans, Louisiana, 99999
Orleans Women's Health Clinic
New Orleans, Louisiana, 99999
About this study
Official title: Prospective Study for Cost-Effectiveness Strategies to Improve Partner Notification: Female Trichomonas and Male Urethritis Studies
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).
Read the 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.
- Conditions
- Trichomonas Vaginalis, Urethritis
- Being tested
- Patient-delivered partner treatment, Booklet-enhanced partner referral
- Keywords
- patient-delivered partner treatment, partner referral, sexually transmitted diseases
- Medical subject headings
- Urethritis, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-delivered partner treatmentBehavioural
Booklet-enhanced partner referralBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Index patient report of partner taking medicine at 6-8 weeks
Secondary outcomes (2)
Index patient re-infection at 6-8 weeks
Cost effectiveness outcomes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startDec 2001
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Trichomonas VaginalisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,500 participants
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Tulane University
- Investigators
- Patty Kissinger, PhD, Principal investigator, Tulane University School of Public Health and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00207467
- Sponsor's protocol ID
- CDC-NCHSTP-3196
- Other IDs
- CA# R30/CCR619143-01
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 21 Sep 2005
- Results posted
- No
Publications
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.
PubMed 16080084
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study for Cost-Effectiveness Strategies to Improve Partner Notification: Female Trichomonas and Male Urethritis Studies
- ClinicalTrials.gov ID
- NCT00207467
- Acronym / sponsor ID
- CDC-NCHSTP-3196
- Conditions
- Trichomonas Vaginalis, Urethritis
- Keywords
- patient-delivered partner treatment, partner referral, sexually transmitted diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,500 participants
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Tulane University
- Study start
- Dec 2001
- Study completion
- Dec 2004
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 16 to 44 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient-delivered partner treatment | Behavioural | – |
| Booklet-enhanced partner referral | Behavioural | – |
Primary outcome
Index patient report of partner taking medicine at 6-8 weeks
2 secondary outcomes
Index patient re-infection at 6-8 weeks
Cost effectiveness outcomes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2005.
- Results publication: PubMed 16080084Kissinger 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.
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Treponema Pallidum Infection, Chlamydia Trachomatis Infection
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Refining Treatment Options for Trichomonas Vaginalis Infection: A Comparative Analysis of Metronidazole and Secnidazole
Trichomonas Vaginitis, Bacterial Vaginitis
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Point-of-care Tests for Vaginal Discharge in Nepal
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Not yet recruitingObservational study
Endosymbionts in Trichomonas Vaginalis Pathogenicity
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patty Kissinger, PhD principal investigator
Tulane University School of Public Health and Tropical Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Patient-delivered partner treatment and Booklet-enhanced partner referral in people with Trichomonas Vaginalis and Urethritis, run by Centers for Disease Control and Prevention at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Index patient report of partner taking medicine at 6-8 weeks. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00207467, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2005.