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Microbicides Acceptability Among Sexually Active Young Women

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ClinicalTrials.gov Identifier: NCT00490152
Recruitment Status : Completed
First Posted : June 22, 2007
Last Update Posted : February 28, 2017
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
ATN 062 is designed to gain scientific knowledge of microbicide-use adherence, acceptability, and attitudes among sexually active young women

Condition or disease Intervention/treatment
HIV Infections Behavioral: Automated diary system

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 Design
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Study Type : Observational
Actual Enrollment : 59 participants
Observational Model: Cohort
Time Perspective: 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"
Study Start Date : August 2007
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
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.
Other Names:
  • VivaGel™
  • 3% w/w SPL7013 Gel
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.
Other Name: VivaGel™ Placebo
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.
Other Names:
  • HEC Placebo Gel
  • HEC Gel


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Microbicide use adherence as measured by a computerized phone diary [ Time Frame: 21 days(through end of study) ]
  2. Microbicide use adherence as measured by e-mail messages [ Time Frame: 21 days (through end of study) ]
  3. Microbicide use adherence as measured by in-depth interviews via teleconference [ Time Frame: 21 days (through end of study) ]
  4. Microbicide use acceptability as measured by a computerized phone diary [ Time Frame: 21 days (through end of study) ]
  5. Microbicide use acceptability as measured by e-mail messages [ Time Frame: 21 days (through end of study) ]
  6. Microbicide use acceptability as measured by in-depth interviews via teleconferences [ Time Frame: 21 days (through end of study) ]
  7. Microbicide use attitudes as measured by a computerized phone diary [ Time Frame: 21 days (through end of study) ]
  8. Microbicide use attitudes as measured by e-mail messages [ Time Frame: 21 days (through end of study) ]
  9. Microbicide use attitudes as measured by in-depth interviews via teleconferences [ Time Frame: 21 days (through end of study) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 24 Years   (Adult)
Sexes 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
University of North Carolina, Chapel Hill
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
Investigators
Study Chair: Alex Carballo-Diéguez, PhD HIV Center for Clinical and Behavioral Studies at the New York State Psychiatric Institute and Columbia University
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Website for the Adolescent Trials Network for HIV/AIDS Interventions  This link exits the ClinicalTrials.gov site

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00490152     History of Changes
Other Study ID Numbers: ATN 062
First Posted: June 22, 2007    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: May 2016

Keywords provided by University of North Carolina, Chapel Hill:
HIV
Microbicide Gel
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Anti-Infective Agents