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Vivagel.Durex
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Microbicides Acceptability
This study has been completed.
First Received: June 21, 2007 Last Updated: January 11, 2010 History of Changes
Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators: National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
Information provided by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00490152
Purpose
ATN 062 is designed to gain scientific knowledge of microbicide-use adherence, acceptability, and attitudes among sexually active young women
Condition Intervention
HIV Infections
Behavioral: Automated diary system
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Microbicide-Use Adherence, Acceptability, and Attitudes Among Sexually Active Young Women Participating in a Phase I Microbicide Trial (MTN 004) "Tell Juliana"
Resource links provided by NLM:
MedlinePlus related topics: AIDS
U.S. FDA Resources
Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Biospecimen Retention: None Retained
Biospecimen Description:
Enrollment: 59
Study Start Date: August 2007
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Participants use Vivagel™, applied vaginally twice daily for 14 days, and report their experiences via phone diary and teleconference.
Behavioral: Automated diary system
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.
2
Participants use VivaGel™ Placebo, applied vaginally twice daily for 14 days, and report their experiences via phone diary and teleconference.
Behavioral: Automated diary system
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.
3
Participants use HEC Placebo Gel (HEC Gel), applied vaginally twice daily for 14 days, and report their experiences via phone diary and teleconference.
Behavioral: Automated diary system
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.
Detailed Description:
ATN 062 will take place in parallel to another study, MTN 004, "Phase I Study of the Safety and Acceptability of 3% w/w SPL7013 Gel (VivaGel™) Applied Vaginally in Sexually Active Young Women." ATN 062 will use quantitative and qualitative research methods. The quantitative method will consist of a computerized diary used by participants during the 14 days of the gel trial of MTN 004. The qualitative methods will include email messages sent by participants to a research assistant as a supplement to the diaries, as well as in-depth interviews through teleconferences to contextualize the recorded events. All study activities will be timed to coincide with those of MTN 004
Eligibility
Ages Eligible for Study: 18 Years to 24 Years
Genders Eligible for Study: Female
Accepts Healthy Volunteers: Yes
Sampling Method: Non-Probability Sample
Study Population
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.
Criteria
Inclusion Criteria:
Currently enrolled in MTN 004.
Willing and able to provide written informed consent for ATN 062.
Willing to participate as required by protocol, including completion of all assessments and follow-ups.
Exclusion Criteria:
Refuses to have teleconferences audio recorded.
Any social or medical condition that, in the investigator's opinion, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00490152
Locations
United States, Florida
University of South Florida College of Medicine
Tampa, Florida, United States, 33606
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Puerto Rico
University Pediatric Hospital
San Juan, Puerto Rico, 00936
Sponsors and Collaborators
http://clinicaltrials.gov/ct2/show/NCT00490152
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Starpharma - This study has been completed
