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

August 11, 2021 updated by: University of California, Los Angeles

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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

896

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90069
        • AIDS Research Alliance
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

Men and women are eligible who meet all of the following criteria:

  1. At least 18 years of age
  2. Willing to be tested for STIs including HIV
  3. Willing to undergo an anal exam
  4. Mentally competent to understand study procedures and give informed consent.

  5. For the NO-RAI groups:

    No RAI in the past year for the non-RAI men and women

  6. For the practicing RAI groups:

Males: report RAI in the past 30 days Females: report RAI in the past 12 months

Exclusion Criteria:

  1. Less than 18 years of age
  2. Unwilling to be tested for STIs (and HIV)
  3. Unwilling to undergo an anal exam
  4. Unwilling to complete study questionnaire
  5. Not mentally competent to understand study procedures and give informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

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

Investigators

  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Study Registration Dates

First Submitted

September 14, 2006

First Submitted That Met QC Criteria

September 15, 2006

First Posted (Estimate)

September 18, 2006

Study Record Updates

Last Update Posted (Actual)

August 16, 2021

Last Update Submitted That Met QC Criteria

August 11, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • U19-AI060614:P3 Aim1
  • 05-07-098
  • H.34.05.08.24
  • ARA010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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