Rectal HealthNCT00377221
Anorectal Microbicide Project(AMP): Rectal Health, Behaviors and Microbicide Acceptability
An observational study of Rectal Health and Rectal Behaviors, run by University of California, Los Angeles at 2 sites in United States.
Trial summary
Observational, cross-sectional, single-visit study of 896 men and women in Los Angeles, CA and Baltimore, MD including a computer-assisted interview focusing on the behavioral repertoire surrounding RAI, symptoms, and health seeking behaviors and a multidimensional assessment of behaviors, anorectal examination, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Health, Rectal Behaviors, Anorectal Symptomatology
- How many people
- 896 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2006to not given
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Men and women are eligible who meet all of the following criteria:
- At least 18 years of age
- Willing to be tested for STIs including HIV
- Willing to undergo an anal exam
- Mentally competent to understand study procedures and give informed consent.
- For the NO-RAI groups:
Show all 9Show fewer
- No RAI in the past year for the non-RAI men and women
- For the practicing RAI groups:
- Males: report RAI in the past 30 days Females: report RAI in the past 12 months
Who cannot join
- Less than 18 years of age
- Unwilling to be tested for STIs (and HIV)
- Unwilling to undergo an anal exam
- Unwilling to complete study questionnaire
- Not mentally competent to understand study procedures and give informed consent.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins University
Baltimore, Maryland, 21205
AIDS Research Alliance
Los Angeles, California, 90069
About this study
Official title: Rectal Health, Behaviors and Microbicide Acceptability
Observational, cross-sectional, single-visit study of 896 men and women in Los Angeles, CA and Baltimore, MD including a computer-assisted interview focusing on the behavioral repertoire surrounding RAI, symptoms, and health seeking behaviors and a multidimensional assessment of behaviors, anorectal examination, and testing for sexually transmitted infections (STIs).
- Conditions
- Rectal Health, Rectal Behaviors, Anorectal Symptomatology
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2006 (estimated)
- Study startSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal HealthStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 896 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), AIDS Research Alliance, Johns Hopkins Bloomberg School of Public Health
- Responsible party
- Sponsor
- Investigators
- Pamina Gorbach, DrPH, Principal investigator, University of California, Los AngelesPeter A Anton, MD, Principal investigator, University of California, Los AngelesRoss Cranston, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00377221
- Sponsor's protocol ID
- U19-AI060614:P3 Aim1
- Other IDs
- 05-07-098, H.34.05.08.24, ARA010, U19AI060614
- Status last verified
- Aug 2021
- First submitted
- 14 Sep 2006
- Last updated
- 16 Aug 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rectal Health, Behaviors and Microbicide Acceptability
- ClinicalTrials.gov ID
- NCT00377221
- Acronym / sponsor ID
- U19-AI060614:P3 Aim1
- Conditions
- Rectal Health, Rectal Behaviors, Anorectal Symptomatology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 896 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), AIDS Research Alliance, Johns Hopkins Bloomberg School of Public Health
- Study start
- Sep 2006
- First posted
- 18 Sep 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.
Observational, cross-sectional, single-visit study of 896 men and women in Los Angeles, CA and Baltimore, MD including a computer-assisted interview focusing on the behavioral repertoire surrounding RAI, symptoms, and health seeking behaviors and a multidimensional assessment of behaviors, anorectal examination, and testing for sexually transmitted infections (STIs).
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- At least 18 years of age
- Willing to be tested for STIs including HIV
- Willing to undergo an anal exam
- Mentally competent to understand study procedures and give informed consent.
- For the NO-RAI groups:
Key exclusion criteria (5 listed)
- Less than 18 years of age
- Unwilling to be tested for STIs (and HIV)
- Unwilling to undergo an anal exam
- Unwilling to complete study questionnaire
- Not mentally competent to understand study procedures and give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 16 Aug 2021.
Related trials for Rectal Health
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
RecruitingObservational study
A Multilevel Approach to Connecting Underrepresented Populations to Clinical Trials
Cancer
Active, not recruiting
The PRIME-CRC Trial to Promote CRC Screening in Rural Communities
Colorectal Cancer
Recruiting
Resistance vs Aerobic Prehabilitation Before Colorectal Cancer Surgery
Colorectal Cancer, Colorectal Neoplasms
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.
Pamina Gorbach, DrPH principal investigator
University of California, Los Angeles
Peter A Anton, MD principal investigator
University of California, Los Angeles
Ross Cranston, MD principal investigator
University of California, Los Angeles
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Health and Rectal Behaviors, run by University of California, Los Angeles 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 9 inclusion and 5 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 16 Aug 2021. 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.
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.
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 16 Aug 2021.