Microbicides Acceptability Among Sexually Active Young Women

Study Overview
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Brief Summary
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ATN 062 is designed to gain scientific knowledge of microbicide-use adherence, acceptability, and attitudes among sexually active young women

Detailed Description
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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

Official Title
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Microbicide-Use Adherence, Acceptability, and Attitudes Among Sexually Active Young Women Participating in a Phase I Microbicide Trial (MTN 004) Tell Juliana

Conditions
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HIV Infections

Intervention / Treatment
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* Behavioral: Automated diary system
* Behavioral: Automated diary system
* Behavioral: Automated diary system


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Participants use Vivagel™, applied vaginally twice daily for 14 days, and report their experiences via phone diary and teleconference. | Behavioral: Automated diary system<br>* 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.<br>* Other names: 3% w/w SPL7013 Gel;|
| 2<br>Participants use VivaGel™ Placebo, applied vaginally twice daily for 14 days, and report their experiences via phone diary and teleconference. | Behavioral: Automated diary system<br>* 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.<br>* Other names: VivaGel™ Placebo;|
| 3<br>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<br>* 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.<br>* Other names: HEC Gel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbicide use adherence as measured by a computerized phone diary |  | 21 days(through end of study) | 
| 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 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Microbicide Gel, HIV Seronegativity