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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| National Institute of Mental Health (NIMH) | NIH |
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ATN 062 is designed to gain scientific knowledge of microbicide-use adherence, acceptability, and attitudes among sexually active young women
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 (VivaGelâ„¢) 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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Participants use Vivagelâ„¢, applied vaginally twice daily for 14 days, and report their experiences via phone diary and teleconference. |
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| 2 | Participants use VivaGelâ„¢ Placebo, applied vaginally twice daily for 14 days, and report their experiences via phone diary and teleconference. |
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| 3 | Participants use HEC Placebo Gel (HEC Gel), applied vaginally twice daily for 14 days, and report their experiences via phone diary and teleconference. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Alex Carballo-Diéguez, PhD | HIV Center for Clinical and Behavioral Studies at the New York State Psychiatric Institute and Columbia University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Florida College of Medicine | Tampa | Florida | 33606 | United States | ||
| University of Pittsburgh Medical Center |
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| Label | URL |
|---|---|
| Website for the Adolescent Trials Network for HIV/AIDS Interventions | View source |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| C480351 | astodrimer |
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|
| 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. |
|
|
| 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. |
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| Pittsburgh |
| Pennsylvania |
| 15213 |
| United States |
| University Pediatric Hospital | San Juan | 00936 | Puerto Rico |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |