Contraception
Conditions
Brief summary
Clinical study to determine if hormonal contraceptive use effects cells that fight infection (i.e., immune cells).
Detailed description
Feminization of the HIV pandemic is impetus for better understanding of the risk factors promoting male to female sexual transmission. One putative risk factor is hormonal contraceptive use. Our laboratory recently reported that dendritic cell activation, virus-specific T cell expansion, and memory T cell development were impaired among female mice administered depot-medroxyprogesterone acetate (DMPA) prior to viral infection of mucosal tissue, and we now are enrolling women into a clinical investigation exploring the immunomodulatory effects of several common hormonal contraceptive forms. Completion of this research will provide important comparative evaluation of the capacity of these drugs to modulate host defenses combating genital tract infection, eventually supplying healthcare providers more informed recommendations regarding appropriate hormonal contraceptive choices among women at risk for acquisition of HIV.
Interventions
None listed
Sponsors
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Thomas L. Cherpes
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
* not pregnant * regular menstrual cycle
Exclusion criteria
* use of oral contraceptive or Mirena in 3 months prior to enrollment * use of depot-medroxyprogesterone acetate in 6 months prior to enrollment * diagnosis of sexually transmitted infection in 30 days prior to enrollment * history of cervical malignancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in ectocervical permeability | Baseline and 1 month |
Countries
United States
Outcome results
None listed