Anorectal Microbicide Project(AMP): Rectal Health, Behavi... | NCT00377221

Studies
Anorectal Microbicide Project(AMP): Rectal Health, Behaviors and Microbicide Acceptability

NCT00377221

Sponsor

University of California, Los Angeles

Status

Completed

Last Update Posted

Aug 16, 2021Actual

Enrollment

896Estimated

Phase

Not provided

Conditions

Rectal Health
Rectal Behaviors
Anorectal Symptomatology

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 14, 2006

First Submission Date that Met QC Criteria

Sep 15, 2006

First Posted Date

Sep 18, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 11, 2021

Last Update Posted Date

Aug 16, 2021Actual

Name	Class
National Institute of Allergy and Infectious Diseases (NIAID)	NIH
AIDS Research Alliance	OTHER
Johns Hopkins Bloomberg School of Public Health	OTHER

Description Module

Brief 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 testing for sexually transmitted infections (STIs).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

896Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pamina Gorbach, DrPH	University of California, Los Angeles	Principal Investigator
Peter A Anton, MD	University of California, Los Angeles	Principal Investigator
Ross Cranston, MD	University of California, Los Angeles	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AIDS Research Alliance		Los Angeles	California	90069	United States
Johns Hopkins University

ID	Type	Link
05-07-098
H.34.05.08.24
ARA010
U19AI060614	U.S. NIH Grant/Contract	View source