An observational study in HIV Infections, sponsored by University of North Carolina, Chapel Hill. Completed at 3 sites in 2 countries. Open to female participants aged 18 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-28.
Sponsored by University of North Carolina, Chapel Hill · Observational
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
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 59 is below the median of 200 across 713 observational studies indexed under HIV Infections.
Browse HIV Infections studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.
Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Participants use Vivagel™, applied vaginally twice daily for 14 days, and report their experiences via phone diary and teleconference.
Behavioral: Automated diary system
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 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.
Also known as: VivaGel™, 3% w/w SPL7013 Gel
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.
Also known as: VivaGel™ Placebo
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.
Also known as: HEC Placebo Gel, HEC Gel
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)
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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University of North Carolina, Chapel Hill