Microbicides Acceptability Among Sexually Active Young Women

Completed

• Conditions: HIV Infections
• Interventions: Behavioral: Automated diary system

• Registration Number: NCT00490152
• Lead Sponsor: University of North Carolina, Chapel Hill

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

Study Timeline

• Study First Submitted: 2007-06-21
• Study First Submitted QC: 2007-06-21
• Study First Posted: 2007-06-22
• Study Start: 2007-08
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2016-05
• Last Update Submitted: 2017-02-27
• Last Update Posted: 2017-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 59

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
2	Automated diary system	Participants use VivaGel™ Placebo, applied vaginally twice daily for 14 days, and report their experiences via phone diary and teleconference.
1	Automated diary system	Participants use Vivagel™, applied vaginally twice daily for 14 days, and report their experiences via phone diary and teleconference.
3	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.

Primary Outcome Measures

Name	Time	Method
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 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 adherence as measured by a computerized phone diary	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 in-depth interviews via teleconferences	21 days (through end of study)

Trial Locations

Locations (3)

University of South Florida College of Medicine; 🇺🇸 Tampa, Florida, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

University Pediatric Hospital; 🇵🇷 San Juan, Puerto Rico