Microbicides Acceptability Among Sexually Active Young Women
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ClinicalTrials.gov Identifier: NCT00490152 |
Recruitment Status
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Completed
First Posted
: June 22, 2007
Last Update Posted
: February 28, 2017
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Sponsor:
University of North Carolina, Chapel Hill
Collaborators:
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
Tracking Information | ||||
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First Submitted Date | June 21, 2007 | |||
First Posted Date | June 22, 2007 | |||
Last Update Posted Date | February 28, 2017 | |||
Study Start Date | August 2007 | |||
Actual Primary Completion Date | November 2009 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Not Provided | |||
Change History | Complete list of historical versions of study NCT00490152 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures | Not Provided | |||
Original Secondary Outcome Measures | Not Provided | |||
Current Other Outcome Measures | Not Provided | |||
Original Other Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Microbicides Acceptability Among Sexually Active Young Women | |||
Official Title | Microbicide-Use Adherence, Acceptability, and Attitudes Among Sexually Active Young Women Participating in a Phase I Microbicide Trial (MTN 004) "Tell Juliana" | |||
Brief Summary | ATN 062 is designed to gain scientific knowledge of microbicide-use adherence, acceptability, and attitudes among sexually active young women | |||
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 | |||
Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
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. | |||
Condition | HIV Infections | |||
Intervention |
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Study Groups/Cohorts |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
59 | |||
Original Estimated Enrollment |
40 | |||
Actual Study Completion Date | November 2009 | |||
Actual Primary Completion Date | November 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 24 Years (Adult) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Puerto Rico, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT00490152 | |||
Other Study ID Numbers | ATN 062 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | University of North Carolina, Chapel Hill | |||
Study Sponsor | University of North Carolina, Chapel Hill | |||
Collaborators |
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Investigators |
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PRS Account | University of North Carolina, Chapel Hill | |||
Verification Date | May 2016 |