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Microbicides Acceptability Among Sexually Active Young Women

This study has been completed.
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00490152
First received: June 21, 2007
Last updated: September 5, 2011
Last verified: August 2011
History of Changes

June 21, 2007
September 5, 2011
August 2007
November 2009   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00490152 on ClinicalTrials.gov Archive Site
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Microbicides Acceptability Among Sexually Active Young Women
Microbicide-Use Adherence, Acceptability, and Attitudes Among Sexually Active Young Women Participating in a Phase I Microbicide Trial (MTN 004) "Tell Juliana"

ATN 062 is designed to gain scientific knowledge of microbicide-use adherence, acceptability, and attitudes among sexually active young women

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
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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.
HIV Infections
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.
Other Names:
  • VivaGel™
  • VivaGel™ Placebo
  • HEC Placebo Gel (HEC Gel)
  • 1
    Participants use Vivagel™, applied vaginally twice daily for 14 days, and report their experiences via phone diary and teleconference.
    Intervention: Behavioral: Automated diary system
  • 2
    Participants use VivaGel™ Placebo, applied vaginally twice daily for 14 days, and report their experiences via phone diary and teleconference.
    Intervention: Behavioral: Automated diary system
  • 3
    Participants use HEC Placebo Gel (HEC Gel), applied vaginally twice daily for 14 days, and report their experiences via phone diary and teleconference.
    Intervention: Behavioral: Automated diary system
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
59
November 2009
November 2009   (final data collection date for primary outcome measure)

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
Female
18 Years to 24 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00490152
ATN 062
Yes
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute on Drug Abuse (NIDA)
  • National Institute of Mental Health (NIMH)
Study Chair: Alex Carballo-Diéguez, PhD HIV Center for Clinical and Behavioral Studies at the New York State Psychiatric Institute and Columbia University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP