Microbicides Acceptability Among Sexually Active Young Women

University of North Carolina (UNC)

Status: Completed

Conditions: HIV Infections

Treatments: Behavioral: Automated diary system

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00490152

ATN 062

Details and patient eligibility

About

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

Full 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

Enrollment: 59 patients

Sex: Female

Ages: 18 to 24 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

59 participants in 3 patient groups

1

Description:

Participants use Vivagel™, applied vaginally twice daily for 14 days, and report their experiences via phone diary and teleconference.

Treatment:

Behavioral: Automated diary system

Behavioral: Automated diary system

Behavioral: Automated diary system

2

Description:

Participants use VivaGel™ Placebo, applied vaginally twice daily for 14 days, and report their experiences via phone diary and teleconference.

Treatment:

Behavioral: Automated diary system

Behavioral: Automated diary system

Behavioral: Automated diary system

3

Description:

Participants use HEC Placebo Gel (HEC Gel), applied vaginally twice daily for 14 days, and report their experiences via phone diary and teleconference.

Treatment:

Behavioral: Automated diary system

Behavioral: Automated diary system

Behavioral: Automated diary system