ChlamydiaNCT01184157
Randomized Trial of Home Versus Clinic-based Screening for Sexually Transmitted Infections
A study testing Home screening and Clinic screening in people with Chlamydia and Gonorrhea, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This study randomizes women using long-acting reversible methods of contraception to home-based STD screening through the mail compared to screening available in a clinical setting. We hypothesize that women randomized to home-based screening will be more likely to complete screening. Read more about this study
- Who is it for?
- Ages 14 to 45 years, women only
- What is being tested?
- Home screening and Clinic screening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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 14 to 45 years
- Women only
- Child, Adult
Who may be able to join
- Participant in Contraceptive CHOICE cohort study
- Using a long-acting reversible method of contraception
- Completed baseline clinical survey in the Contraceptive CHOICE cohort study
Who cannot join
- Living outside the United States at time of annual STI screening
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63108
About this study
Official title: Randomized Trial of Home Versus Clinic-based Screening for Sexually Transmitted Infections in Long-Acting Reversible Contraceptive Users
This study randomizes women using long-acting reversible methods of contraception to home-based STD screening through the mail compared to screening available in a clinical setting. We hypothesize that women randomized to home-based screening will be more likely to complete screening.
- Being tested
- Home screening, Clinic screening
- Medical subject headings
- Chlamydia Infections, Gonorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home screeningBehavioural
Clinic screeningBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Home | Experimental | Home-based STI screening using self-obtained vaginal swabs and postal return of samples. Receives: Behavioral: Home screening |
| Clinic | Active comparator | Receive STI screening in a clinical setting such as a private physician or clinic. Receives: Behavioral: Clinic screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of tests received
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2010 (estimated)
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 ChlamydiaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Jeffrey Peipert, MD, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01184157
- Sponsor's protocol ID
- 07-0256
- Status last verified
- Aug 2010
- First submitted
- 17 Aug 2010
- Last updated
- 18 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Graseck AS, Secura GM, Allsworth JE, Madden T, Peipert JF. Home compared with clinic-based screening for sexually transmitted infections: a randomized controlled trial. Obstet Gynecol. 2010 Dec;116(6):1311-1318. doi: 10.1097/AOG.0b013e3181fae60d.
PubMed 21099596
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Home Versus Clinic-based Screening for Sexually Transmitted Infections in Long-Acting Reversible Contraceptive Users
- ClinicalTrials.gov ID
- NCT01184157
- Acronym / sponsor ID
- 07-0256
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- First posted
- 18 Aug 2010 (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 randomizes women using long-acting reversible methods of contraception to home-based STD screening through the mail compared to screening available in a clinical setting. We hypothesize that women randomized to home-based screening will be more likely to complete screening.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home | Experimental | Behavioral: Home screeningHome-based STI screening using self-obtained vaginal swabs and postal return of samples. |
| Clinic | Active comparator | Behavioral: Clinic screeningReceive STI screening in a clinical setting such as a private physician or clinic. |
Who may qualify
- Ages
- 14 to 45 years
- Sex
- Female only
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Participant in Contraceptive CHOICE cohort study
- Using a long-acting reversible method of contraception
- Completed baseline clinical survey in the Contraceptive CHOICE cohort study
Key exclusion criteria (1 listed)
- Living outside the United States at time of annual STI screening
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 |
|---|---|---|
| Home screening | Behavioural | Home |
| Clinic screening | Behavioural | Clinic |
Primary outcome
Number of tests received
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 18 Aug 2010.
- Derived from this study: PubMed 21099596Graseck AS, Secura GM, Allsworth JE, Madden T, Peipert JF. Home compared with clinic-based screening for sexually transmitted infections: a randomized controlled trial. Obstet Gynecol. 2010 Dec;116(6):1311-1318. doi: 10.1097/AOG.0b013e3181fae60d.
Related trials for Chlamydia
RecruitingPhase 1
Phase 1 Study of Chlamydia Trachomatis mRNA Vaccine in Adults.
Chlamydia Trachomatis Immunization
Active, not recruitingPhase 4
Periodic Presumptive Treatment vs. doxyPEP for STI Control in Kenyan MSM
Gonorrhea Male, Chlamydia (Male)
Not yet recruitingPhase 4
Evaluation of the Impact of Oral Ivermectin on Musca Sorbens Flies, Putative Vector of Trachoma
Survival of Flies Developing in Faecal Samples
Not yet recruiting
Pilot HIV Self-Testing And Self-collected STI Testing Strategy for Sex Worker Empowerment Study
HIV, Syphilis
Not yet recruitingPhase 3
A Clinical Study to Assess the Efficacy of Weekly Doxycycline Prophylaxis to Reduce Bacterial Sexually Transmitted Infections (STI) in Young African Women
Sexually Transmitted Infection (STI), Gonorrhea
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.
Jeffrey Peipert, MD, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home screening and Clinic screening in people with Chlamydia and Gonorrhea, run by Washington University School of Medicine 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 3 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 18 Aug 2010. 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?
Number of tests received. 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 NCT01184157, 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 18 Aug 2010.