TrichomoniasisNCT00334555
Control of Trichomoniasis
A study testing different methods of partner notification, partner delivered meds and field intervention in people with Trichomoniasis, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This study is designed to try to find the best method of partner notification and treatment for partners of women with trichomonas Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Trichomoniasis
- What is being tested?
- different methods of partner notification, partner delivered meds and field intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 599 participants
- Where
- 1 siteUnited States
- Study dates
- May 2003to May 2008
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age {> 15 years} Culture or wet prep proven T. vaginalis infection Willingness to provide informed consent and take part in study procedures
- -
Who cannot join
- Infection with other STD pathogens requiring Health Dept DIS intervention (syphilis or HIV) Pregnancy or currently breast feeding Recent (8 hours) ingestion of alcoholic beverages or intent to do so in the 24 hours following treatment Allergy to metronidazole The presence of a sexual partner in the clinic at the time of enrollment A history of referral by a partner already treated for trichomoniasis Report of more than four sexual partners in the preceding 30 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Jefferson County Department of Health STD Clinic
Birmingham, Alabama, 35294
About this study
Official title: Control of Trichomoniasis - A Paradigm for STD Control
This study is designed to try to find the best method of partner notification and treatment for partners of women with trichomonas
Read the detailed description
To carry out a randomized trial to compare the effectiveness of three methods of partner notification and treatment for sexual partners of women with vaginal trichomoniasis - patient self-referral of partners (the current practice standard), delivery of curative therapy to partners by patients themselves, or public health style Disease Intervention carried out by a specially trained Disease Intervention Specialists (DIS) locating the partners and delivering the medication in the field. Reinfection rates with trichomonas at three months of follow-up among the index women will be the measure of effectiveness.
- Conditions
- Trichomoniasis
- Being tested
- different methods of partner notification, partner delivered meds, field intervention
- Keywords
- trichomoniasis, partner notification
- Medical subject headings
- Trichomonas Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
different methods of partner notificationOther
comparing patient referral, partner delivered medications and field intervention to treat sex partners
partner delivered medsOther
patient given meds to give to her partner
field interventionOther
health worker finds partners
| Study group | Role | What they receive |
|---|---|---|
| usual care | Active comparator | patient told to refer her partner for treatment Receives: Other: different methods of partner notification; Other: partner delivered meds; Other: field intervention |
| partner delivered | Active comparator | patient given medication to deliver to her partners Receives: Other: partner delivered meds; Other: field intervention |
| field intervention | Active comparator | field intervention to find partners Receives: Other: field intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence of trichomonas in the index patient
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2006 (estimated)
- Study startMay 2003
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TrichomoniasisStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 599 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Investigators
- Jane Schwebke, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00334555
- Sponsor's protocol ID
- F020508005
- Other IDs
- R01AI050718
- Status last verified
- Aug 2009
- First submitted
- 7 Jun 2006
- Last updated
- 12 Aug 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Control of Trichomoniasis - A Paradigm for STD Control
- ClinicalTrials.gov ID
- NCT00334555
- Acronym / sponsor ID
- F020508005
- Conditions
- Trichomoniasis
- Keywords
- trichomoniasis, partner notification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 599 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- May 2003
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 8 Jun 2006 (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.
This study is designed to try to find the best method of partner notification and treatment for partners of women with trichomonas
Detailed description
To carry out a randomized trial to compare the effectiveness of three methods of partner notification and treatment for sexual partners of women with vaginal trichomoniasis - patient self-referral of partners (the current practice standard), delivery of curative therapy to partners by patients themselves, or public health style Disease Intervention carried out by a specially trained Disease Intervention Specialists (DIS) locating the partners and delivering the medication in the field. Reinfection rates with trichomonas at three months of follow-up among the index women will be the measure of effectiveness.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| usual care | Active comparator | Other: different methods of partner notification, Other: partner delivered meds, Other: field interventionpatient told to refer her partner for treatment |
| partner delivered | Active comparator | Other: partner delivered meds, Other: field interventionpatient given medication to deliver to her partners |
| field intervention | Active comparator | Other: field interventionfield intervention to find partners |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age {> 15 years} Culture or wet prep proven T. vaginalis infection Willingness to provide informed consent and take part in study procedures
- -
Key exclusion criteria (1 listed)
- Infection with other STD pathogens requiring Health Dept DIS intervention (syphilis or HIV) Pregnancy or currently breast feeding Recent (8 hours) ingestion of alcoholic beverages or intent to do so in the 24 hours following treatment Allergy to metronidazole The presence of a sexual partner in the clinic at the time of enrollment A history of referral by a partner already treated for trichomoniasis Report of more than four sexual partners in the preceding 30 days
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 |
|---|---|---|
| different methods of partner notificationcomparing patient referral, partner delivered medications and field intervention to treat sex partners | Other | usual care |
| partner delivered medspatient given meds to give to her partner | Other | partner delivered, usual care |
| field interventionhealth worker finds partners | Other | field intervention, partner delivered, usual care |
Primary outcome
recurrence of trichomonas in the index patient
Time frame: 6 weeks
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 12 Aug 2009.
Related trials for Trichomoniasis
Recruiting
The Integrated Female Sexually Transmitted Infection Testing for HIV Epidemic Control Through PrEP (IN-STEP) Study
Gonorrhea Female, Chlamydia Females
Recruiting
Improving Maternal and Child Health Through Point-of-care STI Testing
Treponema Pallidum Infection, Chlamydia Trachomatis Infection
RecruitingPhase 3
STI Testing to Enhance PrEP Use in Pregnancy
PrEP Adherence, Sexually Transmitted Infections (STIs)
RecruitingObservational study
Association Between Periodontal Status and the Prevalence of Entamoeba Gingivalis and Trichomonas Tenax
Gingivitis and Periodontal Diseases, Periodontitis
RecruitingPhase 4
Refining Treatment Options for Trichomonas Vaginalis Infection: A Comparative Analysis of Metronidazole and Secnidazole
Trichomonas Vaginitis, Bacterial Vaginitis
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.
Jane Schwebke, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing different methods of partner notification, partner delivered meds and field intervention in people with Trichomoniasis, run by University of Alabama at Birmingham at 1 site 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 2 inclusion and 1 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 12 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
recurrence of trichomonas in the index patient (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2009.