Study of Dapivirine Vaginal Ring (VR) in Adolescents

Exclusion Criteria

• •1. Per participant report at Screening, intends to do any of the following during the study participation period:
• •1. become pregnant
• •2. relocate away from the study site
• •3. travel away from the study site for more than 4 consecutive weeks
• •2. Diagnosed with a urinary tract infection (UTI) and/or reproductive tract infection (RTI) at Screening and/or Enrollment. Note: Otherwise eligible participants diagnosed with UTI during Screening will be offered treatment and may be enrolled after completing treatment and all symptoms have resolved. If treatment is completed and symptoms have resolved within 56 days of obtaining informed consent for Screening, the participant may be enrolled.
• •3. Diagnosed with pelvic inflammatory disease and/or an sexually transmitted infection (STI) requiring treatment per current Centers for Disease Control and Prevention (CDC) guidelines within 60 days of Enrollment (inclusive)
• •4. At Enrollment, has a clinically apparent Grade 2 or higher pelvic exam finding (observed by study staff)\*\* Note: Cervical bleeding associated with speculum insertion and/or specimen collection judged to be within the range of normal according to the clinical judgment of the IoR/designee is considered expected non-menstrual bleeding and is not exclusionary. Note: Otherwise eligible participants with exclusionary pelvic exam findings may be enrolled/randomized after the findings have improved to a non-exclusionary severity grading or resolved. If improvement to a non-exclusionary grade or resolution is documented within 56 days of providing informed consent for screening, the participant may be enrolled.
• •5. Participant report and/or clinical evidence of any of the following:
• •1. Known adverse reaction to any of the study products (ever)
• •2. Known HIV-infected partner
• •3. Non-therapeutic injection drug use in the 12 months prior to Screening
• •4. The use of HIV Post-exposure prophylaxis (PEP) and/or Pre-exposure prophylaxis (PrEP) within the 6 months prior to Enrollment
• •5. Currently breastfeeding
• •6. Last pregnancy outcome within 90 days or less of Screening
• •7. Participation in any other research study involving drugs, medical devices, vaginal products, or vaccines, within 60 days of Screening
• •8. Participant report of 3 or more penile-vaginal sexual partners in the month prior to Screening
• •9. At Enrollment, as determined by the IoR/designee, has any significant uncontrolled active or chronic cardiovascular, renal, liver, hematologic, neurologic, gastrointestinal, psychiatric, endocrine, respiratory, immunologic disorder or infectious disease
• •6. Has any of the following Grade 1 or higher\* laboratory abnormalities at Screening Visit:
• •1. Aspartate aminotransferase (AST) or alanine transaminase (ALT)
• •2. Creatinine
• •3. Hemoglobin
• •4. Platelet count Note: Otherwise eligible participants with an exclusionary test may be re-tested during the screening process. Please see the MTN-023/IPM 030 SSP for additional details.
• •7. Has any other condition that, in the opinion of the IoR/designee, would preclude informed assent/consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
• •* Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 1.0, December, 2004 (Clarification dated August 2009) \*\*Female Genital Grading Table for Use in Microbicide Studies Addendum 1 to the DAIDS Table for Grading Adult and Pediatric Adverse Events, Version 1.0, December 2004 (Clarification dated August 2009)