HIV Infections
Conditions
Keywords
HIV, Microbicide Gel, HIV Seronegativity
Brief summary
ATN 062 is designed to gain scientific knowledge of microbicide-use adherence, acceptability, and attitudes among sexually active young women
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
Interventions
BEHAVIORALAutomated 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.
Sponsors
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
University of North Carolina, Chapel Hill
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 24 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Microbicide use adherence as measured by e-mail messages | 21 days (through end of study) |
| Microbicide use adherence as measured by in-depth interviews via teleconference | 21 days (through end of study) |
| Microbicide use acceptability as measured by a computerized phone diary | 21 days (through end of study) |
| Microbicide use acceptability as measured by e-mail messages | 21 days (through end of study) |
| Microbicide use adherence as measured by a computerized phone diary | 21 days(through end of study) |
| Microbicide use acceptability as measured by in-depth interviews via teleconferences | 21 days (through end of study) |
| Microbicide use attitudes as measured by a computerized phone diary | 21 days (through end of study) |
| Microbicide use attitudes as measured by e-mail messages | 21 days (through end of study) |
| Microbicide use attitudes as measured by in-depth interviews via teleconferences | 21 days (through end of study) |
Countries
Puerto Rico, United States
Outcome results
None listed