Microbicides Acceptability Among Sexually Active Young Women

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

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

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Behavioral: Automated diary system

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

• Study Type: Observational
• Enrollment (Actual): 59

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 24 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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: HEC Placebo Gel; HEC 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 Names: HEC Placebo Gel; HEC Gel
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: 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

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: June 21, 2007
• First Submitted That Met QC Criteria: June 21, 2007
• First Posted (Estimate): June 22, 2007

Study Record Updates

• Last Update Posted (Actual): February 28, 2017
• Last Update Submitted That Met QC Criteria: February 27, 2017
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: HIV Seronegativity; HIV; Microbicide Gel
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: ATN 062