The first goal of this two-part research study is to understand whether aging affects vaginal health differently in menopausal women living with and without HIV. We want to determine if having HIV is associated with accelerated vaginal aging including earlier changes in the amount and types of vaginal bacteria and inflammation.
Some menopausal women develop a condition known as vaginal atrophy, which causes uncomfortable symptoms such as irritation, pain with sex, dryness and itching. The second part of this study it to determine whether treatment with vaginal estradiol improves these vaginal symptoms and measures of vaginal health in menopausal women living with HIV.
We will study whether menopausal women with HIV have improvement in vaginal atrophy symptoms and aging associated changes in the vagina (bacteria, inflammation) after using a vaginal estradiol tablet (Vagifem® 10 μg) for 12 weeks.
Participants in this part of the study will be randomly assigned to receive treatment with Vagifem or no treatment. An estradiol tablet placed inside the vagina may prevent or delay the aging process, lead to fewer changes in the types of bacteria present in the vagina, improve vaginal atrophy symptoms and ultimately keep the vagina healthier for a longer period of time.
This is especially important for women with HIV as they are living longer, healthier, sexually active lives because the virus is controlled with medication. Vagifem is safe, effective, and FDA approved for the treatment of symptomatic vaginal atrophy.
Procedures: Participation in both parts of the study involves answering questions about your medical and sexual history, surveys, blood draws, pelvic exam, vaginal biopsies, and vaginal swabs. Participation in Part 2 also involves using an estradiol vaginal tablet for 12 weeks.
Compensation: Participants will be compensated commensurate with the parts in which they enroll. Participants who only complete Part 1 will be reimbursed $125. Participants who only complete Part 2 will be reimbursed $250. Participants who complete all study visits (Part 1 and Part 2) will be reimbursed $300.