HIV InfectionsNCT00490152
Microbicides Acceptability Among Sexually Active Young Women
An observational study of HIV Infections, run by University of North Carolina, Chapel Hill at 3 sites in 2 countries.
Trial summary
ATN 062 is designed to gain scientific knowledge of microbicide-use adherence, acceptability, and attitudes among sexually active young women Read more about this study
- Who is it for?
- Ages 18 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Automated diary system
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 59 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Aug 2007to Nov 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
University of South Florida College of Medicine
Tampa, Florida, 33606
About this study
Official title: 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
Read the 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
- Conditions
- HIV Infections
- Being tested
- Automated diary system
- Keywords
- HIV, Microbicide Gel, HIV Seronegativity
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated diary systemBehavioural
Also called VivaGel™, 3% w/w SPL7013 Gel
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.
Automated diary systemBehavioural
Also called VivaGel™ Placebo
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.
Automated diary systemBehavioural
Also called HEC Placebo Gel, HEC Gel
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Participants use Vivagel™, applied vaginally twice daily for 14 days, and report their experiences via phone diary and teleconference. Receives: 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. Receives: 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. Receives: Behavioral: Automated diary system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbicide use adherence as measured by a computerized phone diary
Measured: 21 days(through end of study)
Microbicide use adherence as measured by e-mail messages
Measured: 21 days (through end of study)
Microbicide use adherence as measured by in-depth interviews via teleconference
Measured: 21 days (through end of study)
Microbicide use acceptability as measured by a computerized phone diary
Measured: 21 days (through end of study)
Microbicide use acceptability as measured by e-mail messages
Measured: 21 days (through end of study)
Microbicide use acceptability as measured by in-depth interviews via teleconferences
Measured: 21 days (through end of study)
Microbicide use attitudes as measured by a computerized phone diary
Measured: 21 days (through end of study)
Microbicide use attitudes as measured by e-mail messages
Measured: 21 days (through end of study)
Microbicide use attitudes as measured by in-depth interviews via teleconferences
Measured: 21 days (through end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2007 (estimated)
- Study startAug 2007
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Alex Carballo-Diéguez, PhD, Study chair, HIV Center for Clinical and Behavioral Studies at the New York State Psychiatric Institute and Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00490152
- Sponsor's protocol ID
- ATN 062
- Status last verified
- May 2016
- First submitted
- 21 Jun 2007
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbicide-Use Adherence, Acceptability, and Attitudes Among Sexually Active Young Women Participating in a Phase I Microbicide Trial (MTN 004) "Tell Juliana"
- ClinicalTrials.gov ID
- NCT00490152
- Acronym / sponsor ID
- ATN 062
- Conditions
- HIV Infections
- Keywords
- HIV, Microbicide Gel, HIV Seronegativity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
- Study start
- Aug 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 22 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Behavioral: Automated diary systemParticipants use Vivagel™, applied vaginally twice daily for 14 days, and report their experiences via phone diary and teleconference. |
| 2 | – | Behavioral: Automated diary systemParticipants use VivaGel™ Placebo, applied vaginally twice daily for 14 days, and report their experiences via phone diary and teleconference. |
| 3 | – | Behavioral: Automated diary systemParticipants use HEC Placebo Gel (HEC Gel), applied vaginally twice daily for 14 days, and report their experiences via phone diary and teleconference. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automated diary systemAlso: VivaGel™, 3% w/w SPL7013 GelParticipants 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. | Behavioural | 1 |
| Automated diary systemAlso: VivaGel™ PlaceboParticipants 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. | Behavioural | 2 |
| Automated diary systemAlso: HEC Placebo Gel, HEC GelParticipants 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. | Behavioural | 3 |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
- Website for the Adolescent Trials Network for HIV/AIDS InterventionsLink provided by the sponsor.
Related trials for HIV Infections
Not yet recruitingPhase 1
huCART19-IL18-CD428z Cells for the Treatment of Patients With HIV With CD19+ Cancers
Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia
Enrolling by invitation
Evaluating the Efficacy of Annual CHTC Retesting Among Male Couples at High Risk of HIV Infection
HIV Infections
RecruitingPhase 1/2
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
Tuberculosis
Enrolling by invitation
Intervention to Reduce HIV Related Stigma Among Pregnant and Postpartum Women
HIV, HIV - Human Immunodeficiency Virus
Not yet recruitingPhase 4
Study of BIC/LEN FDC Versus Stable Baseline Regimens in Virologically Suppressed People With HIV
HIV-1 Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alex Carballo-Diéguez, PhD study chair
HIV Center for Clinical and Behavioral Studies at the New York State Psychiatric Institute and Columbia University
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by University of North Carolina, Chapel Hill at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbicide use adherence as measured by a computerized phone diary (time frame: 21 days(through end of study)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2017.