UMPALA is a research study to look at the effect of four different, approved contraceptives on the cervical and vaginal tissues as well as on factors in the blood. Participants will have a baseline examination then receive one of four approved, marketed contraceptive products. Cervico-vaginal assessments will take place 4 weeks after contraceptive initiation and 3 months after to assess changes in mucosal safety after use of various contraceptive products in young, healthy, HIV uninfected women.
This clinical study will complete approximately 12 healthy, non-pregnant, HIV-uninfected women aged 18-50 years per contraceptive arm, who are at low risk for sexually transmitted infections (STIs) at two clinical sites, for a total of approximately 96 completed participants. The study will examine changes from baseline, pre-contraceptive dosing to post contraceptive dosing of cervico-vaginal mucosal safety and adverse events. Participants at each site will be randomized (1:1:1:1) to one of four, marketed, approved contraceptive dosing forms: Levonorgestrel (LNG) 52 mg. Intrauterine System (IUS), Copper Intrauterine Device (IUD), etonogestrel (ETG, Nexplanon, Implanon) contraceptive implant, or DMPA SC contraceptive injection. Enrollment is expected to take approximately 8 months and each participant is expected to complete the study within 4 months.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
112
Participants randomized to Copper IUD will receive Paragard IUD at Visit 2.
Participants randomized to ETG implant will receive the implant at Visit 2.
Participants randomized to LNG intrauterine system will receive the IUS at Visit 2.
Eastern Virginia Medical School
Norfolk, Virginia, United States
KEMRI
Thika, Central, Kenya
Number of participants with changes to mucosal function
Evaluate mucosal factors and microbiome changes from baseline associated with mucosal function and reproductive health, including vaginal glycogen, pH, lactic acid, soluble markers and immune cells.
Time frame: 4 weeks and 3 months after product use
Number of participants with changes to mucosal health
Evaluate mucosal factors and microbiome changes from baseline associated with mucosal function and reproductive health, including vaginal glycogen, pH, lactic acid, soluble markers and immune cells.
Time frame: 4 weeks and 3 months after product use
Number of participants with systemic inflammation
Evaluate changes from baseline in systemic factors associated with reproductive health, including C reactive protein and hormone concentrations.
Time frame: 4 weeks and 3 months after product use
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Participants randomized to DMPA SC will receive the injection at Visit 2.