A randomized clinical trial on the effects of progestin contraception in the genital tract of HIV-infected and uninfected women in Lilongwe, Malawi: Addressing evolving research priorities.
Hormonal contraception is central in the prevention of unintended pregnancy; however there are concerns that certain methods may increase the risk of HIV acquisition and transmission. Hormonal contraceptives may modify the genital mucosa in several ways, however the mechanisms are incompletely understood. Few studies have examined genital HIV shedding prospectively before and after initiation of hormonal contraception. The effects of hormonal contraception on genital HIV shedding in the setting of antiretroviral therapy (ART) are also unknown. We designed a pilot clinical trial in which HIV-infected and uninfected women were randomized to either depot medroxyprogesterone acetate (DMPA) injectable or levonorgestrel (LNG) implant in Lilongwe, Malawi. The objectives were to: 1) assess the effect and compare the impact of type of progestin contraception (injectable versus implant) on HIV genital shedding among HIV-infected women, 2) assess the effect and compare the impact of type of progestin contraception on inflammatory/immune markers in the genital tract of both HIV-infected and uninfected women, and 3) assess the interaction of progestin contraception and ART by examining contraceptive efficacy and ART efficacy. An additional study aim was to determine the feasibility and need for a larger study of determinants of HIV transmissibility and acquisition. As injectable contraception is widely used in many parts of the world with high HIV prevalence, this study will provide important information in determining the need for and feasibility of a larger study to address these questions that can impact the lives of millions of women living with or at risk for HIV.
Division of Reproductive Health, Centers for Disease Control and Prevention, Atlanta, GA, United States. Electronic address: apk3@cdc.gov.
Athena P
AP
Kourtis
Division of Reproductive Health, Centers for Disease Control and Prevention, Atlanta, GA, United States.
Lisa
L
Haddad
University of North Carolina Project, Lilongwe, Malawi.
Jennifer
J
Tang
University of North Carolina Project, Lilongwe, Malawi.
Lameck
L
Chinula
Division of Reproductive Health, Centers for Disease Control and Prevention, Atlanta, GA, United States.
Stacey
S
Hurst
Division of Reproductive Health, Centers for Disease Control and Prevention, Atlanta, GA, United States.
Jeffrey
J
Wiener
Division of Reproductive Health, Centers for Disease Control and Prevention, Atlanta, GA, United States.
Sascha
S
Ellington
University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.
Julie A E
JA
Nelson
University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.
Amanda
A
Corbett
University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.
Kristina
K
De Paris
Division of Reproductive Health, Centers for Disease Control and Prevention, Atlanta, GA, United States.
Caroline C
CC
King
University of North Carolina Project, Lilongwe, Malawi.
Mina
M
Hosseinipour
University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.
Irving F
IF
Hoffman
Division of Reproductive Health, Centers for Disease Control and Prevention, Atlanta, GA, United States.
Denise J
DJ
Jamieson
D019380:Anti-HIV Agents / Q000378:metabolism / Q000627:therapeutic use*; D016022:Case-Control Studies; D002584:Cervix Uteri / Q000378:metabolism / Q000821:virology*; D003271:Contraceptive Agents, Female / Q000627:therapeutic use*; D003692:Delayed-Action Preparations; D004343:Drug Implants; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D016912:Levonorgestrel / Q000627:therapeutic use*; D008295:Malawi; D017258:Medroxyprogesterone Acetate / Q000627:therapeutic use*; D009092:Mucous Membrane / Q000378:metabolism / Q000821:virology*; D010865:Pilot Projects; D012106:Research; D016896:Treatment Outcome; D014621:Vagina / Q000378:metabolism; D017201:Virus Shedding
D019380:Anti-HIV Agents; D003271:Contraceptive Agents, Female; D003692:Delayed-Action Preparations; D004343:Drug Implants; D016912:Levonorgestrel; D017258:Medroxyprogesterone Acetate