Clinical trial NCT00490152: Microbicides Acceptability Among Sexually Active Young Women
Official title: Microbicide-Use Adherence, Acceptability, and Attitudes Among Sexually Active Young Women Participating in a Phase I Microbicide Trial (MTN 004) "Tell Juliana"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: HIV
Microbicide Gel
HIV Seronegativity
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: National Institute of Mental Health (NIMH)
First posted: 2007-06-22
Enrollment: 59
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

Eligibility 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

Primary outcomes:
measure: Microbicide use adherence as measured by a computerized phone diary
timeFrame: 21 days(through end of study)
measure: Microbicide use adherence as measured by e-mail messages
timeFrame: 21 days (through end of study)
measure: Microbicide use adherence as measured by in-depth interviews via teleconference
timeFrame: 21 days (through end of study)
measure: Microbicide use acceptability as measured by a computerized phone diary
timeFrame: 21 days (through end of study)
measure: Microbicide use acceptability as measured by e-mail messages
timeFrame: 21 days (through end of study)
measure: Microbicide use acceptability as measured by in-depth interviews via teleconferences
timeFrame: 21 days (through end of study)
measure: Microbicide use attitudes as measured by a computerized phone diary
timeFrame: 21 days (through end of study)
measure: Microbicide use attitudes as measured by e-mail messages
timeFrame: 21 days (through end of study)
measure: Microbicide use attitudes as measured by in-depth interviews via teleconferences
timeFrame: 21 days (through end of study)
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida College of Medicine
state: Florida
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: San Juan
country: Puerto Rico
facility: University Pediatric Hospital
Study officials:
affiliation: HIV Center for Clinical and Behavioral Studies at the New York State Psychiatric Institute and Columbia University
name: Alex Carballo-Diéguez, PhD
role: STUDY_CHAIR
References: