| • Female, aged 18-34 years, inclusive
• General good health (by history and per clinician discretion) without any clinically significant systemic disease (including, but not limited to significant liver disease/hepatitis, gastrointestinal disease, kidney disease, thyroid disease, osteoporosis or bone disease, and diabetes), uterus, and cervix
• Not pregnant or planning to become pregnant
• Pre-screening (Visit 0) HIV risk score ≤4 (on HIV risk assessment tool developed for women in sub-Saharan Africa (included in Appendix II)
• Currently having regular menstrual cycles (approximately 24-35 days) OR with a history of having regular menstrual cycles before contraceptive use, by report, and resumed some menstruation or spotting (with biochemical confirmation of ovulation)
• Willing to undergo Visual Inspection with Lugol’s Iodine (VILI) for cervical abnormalities during pelvic exam at Visit 1
o Women with an abnormal VILI will be linked directly to cervical cancer screening through Papanicolaou smear testing and will not be eligible for enrollment unless cervical cancer screening is negative
• Willing to abstain from use of vaginal products other than the study product, including tampons (except for during menses) , menstrual cups, vaginally inserted cloths or other materials, spermicides, lubricants, and douches for the whole study
• Willing to abstain from any vaginal intercourse starting 48 hours before CM collection, as possible, and 48 hours before Visits 4 and 7
• Vaginal and cervical anatomy that, in the opinion of the clinician, lends itself to easy genital tract sample collection and is absent of vesicles and ulcers
• No use of hormonal contraceptives within the following periods specified for each type of contraception method:
o Oral contraceptives (combined or progestin-only), contraceptive patch or contraceptive vaginal ring at least two (2) months prior to Visit 1
o Last DMPA injection received at least four (4) months prior to Visit 1 and has resumed re |
• Body mass index (BMI) ≥30 kg/m
• History of hysterectomy
• Currently pregnant or within less than three (3) calendar months of the last pregnancy outcome. Note: If recently pregnant, must have had at least two spontaneous menses since pregnancy outcome
• Currently breastfeeding or having breastfed an infant in the last two (2) months, or planning to breastfeed during the course of the study
• Contraindication to any study products—LNG, TFV, or excipient ingredients
• Contraindication to LNG (detailed in Appendix VI and the standard operating procedures (SOP) manual, which is consistent with WHO guidelines http://apps.who.int/iris/bitstream/10665/181468/1/9789241549158_eng.pdf?ua=1
• In the last three (3) months, diagnosed with or treated for any STI or pelvic inflammatory disease
o Note: Women with a history of genital herpes or condylomata who have been asymptomatic for at least six (6) months may be considered for eligibility if pelvic exam shows no vesicles or open lesions.
• Positive test for HIV-1 (in accordance with national testing algorithm, Appendix IV), syphilis, Trichomonas vaginalis (TV), Neisseria gonorrhea (GC), Chlamydia trachomatis (CT) or HBsAg
o NOTE: Women who test positive for HIV-1, syphilis, TV, GC, or CT will be treated for the STI at no cost at the CRC according to the 2015 Kenya National AIDS and STI Control Programme Algorithms for Managing Common STI Syndromes (https://aidsfree.usaid.gov/sites/default/files/hts_policy_kenya_2015.pdf); they will also receive face-to-face counseling, but will not be eligible to take part in the study.
• Nugent score greater than or equal to 7 or a symptomatic BV clinical diagnosis as defined by Amsel’s criteria
o Must have 3 of the 4 signs for a diagnosis of BV using Amsel’s criteria
Discharge, white & homogeneous
Elevated pH, >4.5
Amine odor present
20% clue cells present on wet mount
• Chronic or acute vulvar or vaginal symptoms (pain, irritation, spotting/bleeding, discharge, etc.) |
Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s) |
18 Year(s) |
34 Year(s) |
Female |