Microbicide-Use Adherence, Acceptability, and Attitudes Among Sexually Active Young Women Participating in a Phase I Microbicide Trial (MTN 004) "Tell Juliana"
Sponsor study identifier
observational
59
2 countries
3
Study Start
August 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2009
Actual (reported)Study Completion
November 2009
Actual (reported)ATN 062 is designed to gain scientific knowledge of microbicide-use adherence, acceptability, and attitudes among sexually active young women
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 21, 2007
Actual (reported)June 22, 2007
Actual (reported)August 2007
Date type not reportedThis date has not been verified as actual or estimated.
November 2009
Actual (reported)November 2009
Actual (reported)Microbicide use adherence as measured by a computerized phone diary
21 days(through end of study)
Microbicide use adherence as measured by e-mail messages
21 days (through end of study)
Microbicide use adherence as measured by in-depth interviews via teleconference
21 days (through end of study)
Microbicide use acceptability as measured by a computerized phone diary
21 days (through end of study)
Microbicide use acceptability as measured by e-mail messages
21 days (through end of study)
Microbicide use acceptability as measured by in-depth interviews via teleconferences
21 days (through end of study)
Participants use Vivagel™, applied vaginally twice daily for 14 days, and report their experiences via phone diary and teleconference.
Participants use VivaGel™ Placebo, applied vaginally twice daily for 14 days, and report their experiences via phone diary and teleconference.
Participants use HEC Placebo Gel (HEC Gel), applied vaginally twice daily for 14 days, and report their experiences via phone diary and teleconference.
Participants will use a computerized phone diary to describe their experiences with the study product during the 14 days of the trial. They will have three teleconferences with "Juliana" to discuss the product and the technology used in the study. They will also have the opportunity to send emails to "Juliana" during the course of the study.
HIV-negative women ages 18 to 24 years old who are non-pregnant, sexually active and enrolled in MTN 004 will be offered the option to enroll in ATN 062. Approximately half of the participants will be recruited in San Juan, PR, and the other half in Tampa, FL.
University of South Florida College of Medicine
Tampa, Florida, 33606, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
University Pediatric Hospital
San Juan, 00936, Puerto Rico
Alex Carballo-Diéguez, PhD
HIV Center for Clinical and Behavioral Studies at the New York State Psychiatric Institute and Columbia University
59 participants (actual enrollment reported by the registry).
First Submitted
June 21, 2007
First Posted
June 22, 2007
Study Start
August 2007
Date type not reportedThis date has not been verified as actual or estimated.
C2P Mobilization Intervention (Pilot)
Microbicide use attitudes as measured by a computerized phone diary
21 days (through end of study)
Microbicide use attitudes as measured by e-mail messages
21 days (through end of study)
Microbicide use attitudes as measured by in-depth interviews via teleconferences
21 days (through end of study)
Participants will use a computerized phone diary to describe their experiences with the study product during the 14 days of the trial. They will have three teleconferences with "Juliana" to discuss the product and the technology used in the study. They will also have the opportunity to send emails to "Juliana" during the course of the study.
Participants will use a computerized phone diary to describe their experiences with the study product during the 14 days of the trial. They will have three teleconferences with "Juliana" to discuss the product and the technology used in the study. They will also have the opportunity to send emails to "Juliana" during the course of the study.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
November 2009
Actual (reported)Study Completion
November 2009
Actual (reported)Last Updated
February 28, 2017
Record last verified: 2016-05
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Source: ClinicalTrials.gov.
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