Clinical Trial on the Effects of Progestin-based Contraception in the Genital Tract of HIV-infected and Uninfected Women

Summary

The purpose of this study is to determine the acceptability of randomization to contraceptive options and estimate the effect of progestin contraception on HIV genital shedding and inflammatory/immune perturbations in women who may or may not be on antiretroviral therapy, as well as in HIV-uninfected women controls. It is hypothesized that progestin-containing contraception will lead to inflammatory changes that may affect the local immune activity, influencing HIV acquisition or transmissibility risk.

Timeline

Start

2014-04-08

Primary completion

2017-03-31

Completion

2017-03-31

Publications

• Haddad LB, Tang JH, Davis NL, Kourtis AP, Chinula L, Msika A, Tegha G, Hosseinipour MC, Nelson JAE, Hobbs MM, Gajer P, Ravel J, De Paris K. Influence of Hormonal Contraceptive Use and HIV on Cervicovaginal Cytokines and Microbiota in Malawi. mSphere. 2023 Feb 21;8(1):e0058522. doi: 10.1128/msphere.00585-22. Epub 2023 Jan 9.
• Zia Y, Tang JH, Chinula L, Tegha G, Stanczyk FZ, Kourtis AP. Medroxyprogesterone acetate concentrations among HIV-infected depot-medroxyprogesterone acetate users receiving antiretroviral therapy in Lilongwe, Malawi. Contraception. 2019 Nov;100(5):402-405. doi: 10.1016/j.contraception.2019.07.144. Epub 2019 Jul 30.
• Chinula L, Nelson JAE, Wiener J, Tang JH, Hurst S, Tegha G, Msika A, Ellington S, Hosseinipour MC, Mataya R, Haddad LB, Kourtis AP. Effect of the depot medroxyprogesterone acetate injectable and levonorgestrel implant on HIV genital shedding: a randomized trial. Contraception. 2018 Sep;98(3):193-198. doi: 10.1016/j.contraception.2018.05.001. Epub 2018 May 8.

Drugs

Indications