NCT00490152

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2007

Typical duration for all trials

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 22, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

February 28, 2017

Status Verified

May 1, 2016

Enrollment Period

2.3 years

First QC Date

June 21, 2007

Last Update Submit

February 27, 2017

Conditions

HIV Infections

Keywords

HIVMicrobicide GelHIV Seronegativity

Outcome Measures

Primary Outcomes (9)

  • 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)

Study Arms (3)

1

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

Behavioral: Automated diary system

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

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

Interventions

Automated diary systemBEHAVIORAL

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.

Also known as: VivaGel™, 3% w/w SPL7013 Gel
1

Eligibility Criteria

Age18 Years - 24 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of South Florida College of Medicine

Tampa, Florida, 33606, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

University Pediatric Hospital

San Juan, 00936, Puerto Rico

Location

Related Links

MeSH Terms

Conditions

HIV Infections

Interventions

astodrimer

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Alex Carballo-Diéguez, PhD

    HIV Center for Clinical and Behavioral Studies at the New York State Psychiatric Institute and Columbia University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2007

First Posted

June 22, 2007

Study Start

August 1, 2007

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

February 28, 2017

Record last verified: 2016-05

Locations

US(2)PR(1)