Microbicides Acceptability Among Sexually Active Young Women
This study has been completed.
Sponsor:
Collaborators:
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
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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: | 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" |
Resource links provided by NLM:
Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
| 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.
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 Names:
|
|
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:
|
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00490152
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
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
Additional Information:
No publications provided
| Responsible Party: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00490152 History of Changes |
| Other Study ID Numbers: | ATN 062 |
| Study First Received: | June 21, 2007 |
| Last Updated: | September 5, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
|
HIV Microbicide Gel HIV Seronegativity |
Additional relevant MeSH terms:
|
Anti-Infective Agents Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015