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

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:
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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:
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- Microbicide use adherence as measured by a computerized phone diary [ Time Frame: 21 days(through end of study) ]
- Microbicide use adherence as measured by e-mail messages [ Time Frame: 21 days (through end of study) ]
- Microbicide use adherence as measured by in-depth interviews via teleconference [ Time Frame: 21 days (through end of study) ]
- Microbicide use acceptability as measured by a computerized phone diary [ Time Frame: 21 days (through end of study) ]
- Microbicide use acceptability as measured by e-mail messages [ Time Frame: 21 days (through end of study) ]
- Microbicide use acceptability as measured by in-depth interviews via teleconferences [ Time Frame: 21 days (through end of study) ]
- Microbicide use attitudes as measured by a computerized phone diary [ Time Frame: 21 days (through end of study) ]
- Microbicide use attitudes as measured by e-mail messages [ Time Frame: 21 days (through end of study) ]
- Microbicide use attitudes as measured by in-depth interviews via teleconferences [ Time Frame: 21 days (through end of study) ]

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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 |
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

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
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 |
Study Chair: | Alex Carballo-Diéguez, PhD | HIV Center for Clinical and Behavioral Studies at the New York State Psychiatric Institute and Columbia University |
Additional Information:
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 |