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

• Status: Completed
• Trial end date: 2017-03-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Centers for Disease Control and Prevention
• Collaborators: Bill and Melinda Gates Foundation; Fogarty International Center of the National Institute of Health; John E. Fogarty International Center (FIC); National Institutes of Health (NIH); United States Agency for International Development (USAID)
• Treatments: Contraceptive Agents; Levonorgestrel; Medroxyprogesterone; Medroxyprogesterone Acetate; Progestins

Criteria

Inclusion Criteria:

• Known HIV status, as documented by at least 2 concordant rapid tests (Determine and Uni-Gold, respectively). If the 2 rapid tests are discordant, then a confirmatory test will be done via Western blot.

• Female, pre-menopausal, age 18 to 45 years

• At least 2 regular, monthly cycles (~21-35 days) in the 3 months preceding study enrollment.

• If on hormonal or intrauterine contraception in the past, they must have been off for at least 6 months. If they were previously using DMPA, their last -injection must have been ≥6 months ago.

• If recently pregnant, they must be at least 6 months postpartum

• Able and willing to provide informed consent

• Be otherwise a good candidate for study participation based on assessment by investigator or designee

• Interested in initiating a family planning method, specifically depot medroxyprogesterone acetate (DMPA) or the LNG implant (Jadelle)

• Willing to be randomized to receive either DMPA or LNG implant (Jadelle)

• Willing to wait 4-6 weeks after enrollment to receive this method and to use non-hormonal and non-intrauterine methods (such as abstinence or condoms) consistently during this period

Exclusion Criteria:

• Pregnancy (by clinical history or a positive urine pregnancy test at screening)

• Women currently using any hormonal contraceptive method

• Desire pregnancy within next 12 months

• Untreated visible genital ulcers or lesions on initial pelvic examination

• Known or suspected genital tract cancer (by clinical history or noted during initial pelvic examination).

• Contraindications to DMPA or LNG implant per the WHO medical eligibility114 criteria or judgment of clinician (contraindications include lactation within first 6 weeks postpartum, acute deep venous thrombosis or pulmonary embolism, lupus, migraine with aura, unexplained vaginal bleeding, current or history of breast cancer, severe cirrhosis, liver tumors, history of stroke, current or history of ischemic heart disease).

• Acute HIV infection (as documented by a known negative HIV test 6 months or less prior to screening).