Estrogen, Probiotics and Vaginal Health to Prevent HIV Infection in ACB Women

Summary

This study will enrol African, Caribbean and Black (ACB) women who are known to have a more diverse vaginal microbiome, higher rates of bacterial vaginosis with lower numbers of protective lactobacilli, and are at increased risk for HIV. The investigators will evaluate the safety, feasibility, effect on the vaginal bacterial microbiome and changes in local immune and inflammatory responses with the administration of vaginal estrogen alone, vaginal estrogen in combination with oral or vaginally administered probiotics, or vaginal probiotics alone.

Timeline

Start

2019-11-04

Primary completion

2021-12-14

Completion

2021-12-14

Publications

• Gill B, Wessels JM, Hayes CL, Ratcliffe J, Wokuri J, Ball E, Reid G, Kaul R, Rana J, Alkhaifi M, Tharao W, Smaill F, Kaushic C. Feasibility, safety and tolerability of estrogen and/or probiotics for improving vaginal health in Canadian African, Caribbean, and Black women: A pilot phase 1 clinical trial. PLoS One. 2025 Jan 21;20(1):e0315576. doi: 10.1371/journal.pone.0315576. eCollection 2025.

Drugs

Indications