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

NCT ID: NCT00377221

Last Updated: 2021-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

896 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-09-30

Brief Summary

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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

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Conditions

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Rectal Health Rectal Behaviors Anorectal Symptomatology

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Los Angeles

OTHER

Sponsor Role lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

AIDS Research Alliance

OTHER

Sponsor Role collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role collaborator

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pamina Gorbach, DrPH

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Peter A Anton, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Ross Cranston, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

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AIDS Research Alliance

Los Angeles, California, United States

Site Status

Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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05-07-098

Identifier Type: -

Identifier Source: secondary_id

H.34.05.08.24

Identifier Type: -

Identifier Source: secondary_id

ARA010

Identifier Type: -

Identifier Source: secondary_id

U19AI060614

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U19-AI060614:P3 Aim1

Identifier Type: -

Identifier Source: org_study_id

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