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Completed

NCT Number: NCT00490152

Microbicides Acceptability Among Sexually Active Young Women

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

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–24 year

Sex eligibility

Female

Study type

Observational

Primary location

University Pediatric Hospital, San Juan, Puerto Rico

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Automated diary system

Behavioral

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

Primary outcomes

  1. Microbicide use adherence as measured by a computerized phone diary

    Time frame: 21 days(through end of study)

  2. Microbicide use adherence as measured by e-mail messages

    Time frame: 21 days (through end of study)

  3. Microbicide use adherence as measured by in-depth interviews via teleconference

    Time frame: 21 days (through end of study)

  4. Microbicide use acceptability as measured by a computerized phone diary

    Time frame: 21 days (through end of study)

  5. Microbicide use acceptability as measured by e-mail messages

    Time frame: 21 days (through end of study)

  6. Microbicide use acceptability as measured by in-depth interviews via teleconferences

    Time frame: 21 days (through end of study)

  7. Microbicide use attitudes as measured by a computerized phone diary

    Time frame: 21 days (through end of study)

  8. Microbicide use attitudes as measured by e-mail messages

    Time frame: 21 days (through end of study)

  9. Microbicide use attitudes as measured by in-depth interviews via teleconferences

    Time frame: 21 days (through end of study)

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jun 22, 2007
Registry last updated
Feb 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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