The proposed study is a multi-centre, open-label crossover study to assess the safety and acceptability of a silicone elastomer vaginal ring (containing no drug) when inserted for a 12 week period in 200 healthy, sexually active women.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
220
silicone elastomer intravaginal ring containing no drug product
Reproductive Health & HIV Research Unit - Sheshisani IPM Clinic
Yeoville, Johannesburg, South Africa
South African Medical Research Council
Durban, KwaZulu-Natal, South Africa
Desmond Tutu HIV Foundation, Masiphumelele
Cape Town, South Africa
Kilimanjaro Reproductive Health Program
Moshi, Tanzania
The primary measure of acceptability will be defined as the proportion of women indicating that they would use the study product if it is found to prevent HIV.
Time frame: 3 months
The primary measure of safety will be the proportion of women who have abnormal observations during the pelvic/speculum examinations and the proportion of women who experience adverse events
Time frame: 3 months
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