Microbicides Acceptability Among Sexually Active Young Women

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00490152
• Other study ID #: ATN 062
• Status: Completed
• Phase: N/A
• First received: June 21, 2007
• Last updated: February 27, 2017
• Start date: August 2007
• Est. completion date: November 2009

Study information

• Verified date: May 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Puerto Rico	University Pediatric Hospital	San Juan
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	University of South Florida College of Medicine	Tampa	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Mental Health (NIMH), National Institute on Drug Abuse (NIDA)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbicide use adherence as measured by a computerized phone diary		21 days(through end of study)
Primary	Microbicide use adherence as measured by e-mail messages		21 days (through end of study)
Primary	Microbicide use adherence as measured by in-depth interviews via teleconference		21 days (through end of study)
Primary	Microbicide use acceptability as measured by a computerized phone diary		21 days (through end of study)
Primary	Microbicide use acceptability as measured by e-mail messages		21 days (through end of study)
Primary	Microbicide use acceptability as measured by in-depth interviews via teleconferences		21 days (through end of study)
Primary	Microbicide use attitudes as measured by a computerized phone diary		21 days (through end of study)
Primary	Microbicide use attitudes as measured by e-mail messages		21 days (through end of study)
Primary	Microbicide use attitudes as measured by in-depth interviews via teleconferences		21 days (through end of study)

External Links

•   Website for the Adolescent Trials Network for HIV/AIDS Interventions