Microbicides Acceptability Among Sexually Active Young Women - Full Text View

Purpose

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

Condition	Intervention
HIV Infections	Behavioral: Automated diary system


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Microbicide-Use Adherence, Acceptability, and Attitudes Among Sexually Active Young Women Participating in a Phase I Microbicide Trial (MTN 004) "Tell Juliana"

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:

Microbicide use adherence as measured by a computerized phone diary [ Time Frame: 21 days(through end of study) ]
Microbicide use adherence as measured by e-mail messages [ Time Frame: 21 days (through end of study) ]
Microbicide use adherence as measured by in-depth interviews via teleconference [ Time Frame: 21 days (through end of study) ]
Microbicide use acceptability as measured by a computerized phone diary [ Time Frame: 21 days (through end of study) ]
Microbicide use acceptability as measured by e-mail messages [ Time Frame: 21 days (through end of study) ]
Microbicide use acceptability as measured by in-depth interviews via teleconferences [ Time Frame: 21 days (through end of study) ]
Microbicide use attitudes as measured by a computerized phone diary [ Time Frame: 21 days (through end of study) ]
Microbicide use attitudes as measured by e-mail messages [ Time Frame: 21 days (through end of study) ]
Microbicide use attitudes as measured by in-depth interviews via teleconferences [ Time Frame: 21 days (through end of study) ]


Enrollment:	59
Study Start Date:	August 2007
Study Completion Date:	November 2009
Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Participants use Vivagel™, applied vaginally twice daily for 14 days, and report their experiences via phone diary and teleconference.	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. Other Names: VivaGel™ 3% w/w SPL7013 Gel
2 Participants use VivaGel™ Placebo, applied vaginally twice daily for 14 days, and report their experiences via phone diary and teleconference.	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. Other Name: VivaGel™ Placebo
3 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 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. Other Names: HEC Placebo Gel HEC Gel

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

Eligibility


Ages Eligible for Study:	18 Years to 24 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

HIV-negative women ages 18 to 24 years old who are non-pregnant, sexually active and enrolled in MTN 004 will be offered the option to enroll in ATN 062. Approximately half of the participants will be recruited in San Juan, PR, and the other half in Tampa, FL.

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00490152

Locations


United States, Florida
University of South Florida College of Medicine
Tampa, Florida, United States, 33606
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Puerto Rico
University Pediatric Hospital
San Juan, Puerto Rico, 00936

Sponsors and Collaborators

University of North Carolina, Chapel Hill

National Institute on Drug Abuse (NIDA)

National Institute of Mental Health (NIMH)

Investigators


Study Chair:	Alex Carballo-Diéguez, PhD	HIV Center for Clinical and Behavioral Studies at the New York State Psychiatric Institute and Columbia University

More Information

Additional Information:

Website for the Adolescent Trials Network for HIV/AIDS Interventions This link exits the ClinicalTrials.gov site


Responsible Party:	University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:	NCT00490152 History of Changes
Other Study ID Numbers:	ATN 062
Study First Received:	June 21, 2007
Last Updated:	February 27, 2017

Keywords provided by University of North Carolina, Chapel Hill:


HIV Microbicide Gel HIV Seronegativity

Additional relevant MeSH terms:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases	Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Anti-Infective Agents

ClinicalTrials.gov processed this record on August 16, 2017