The Evidence for Contraceptive Options and HIV Outcomes Trial

• Status: Completed
• Trial end date: 2018-10-31
• Target enrollment: 0
• Participant gender: Female

Summary

The ECHO Study is an open-label randomized clinical trial that will compare three highly effective, reversible methods of contraception (including a non-hormonal method) to evaluate whether there is a link between use of any of these methods and increased risk of acquiring HIV infection. A randomized clinical trial among about 7,800 women in four countries, ECHO will deliver evidence to support and guide individual, policy and programmatic decisions on contraception for women at risk of acquiring HIV infection.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: FHI 360
• Collaborators: Effective Care Research Unit; Emavundleni Research Centre; Family Life Association of Swaziland; ICAP Columbia University; Kenya Medical Research Institute; Madibeng Centre for Research; Maternal Adolescent and Child Health Research; Qhakaza Mbokodo Research Clinic; Setshaba Research Centre; The Aurum Institute NPC; University of North Carolina at Chapel Hill Division of Global Women’s Health; University of North Carolina, Chapel Hill; University of Washington; Wits Reproductive Health and HIV Institute; World Health Organization
• Treatments: Contraceptive Agents; Copper; Levonorgestrel; Medroxyprogesterone; Medroxyprogesterone Acetate

Criteria

Inclusion Criteria:

• 16-35 years of age (previously pregnant 16 and 17 year olds, where permissible by national regulations and local IRB approval)

• HIV-seronegative

• Wants to use effective contraception

• Is able and willing to provide written informed consent

• Agrees to be randomized to either DMPA, LNG implant, or copper IUD

• Agrees to use assigned method for 18 months

• Agrees to follow all study requirements

• Intends to stay in the study area for the next 18 months, and willing and able to provide adequate locator information

• If has had a recent third trimester birth, is at least 6 weeks postpartum

• Is sexually active (has had vaginal sex within the last 3 months) or was pregnant within the last 3 months

• Agrees not to participate in studies of drugs or vaccines or any other clinical research study while participating in this study.

Exclusion Criteria:

• Reported medical contraindications (WHO MEC Category 3 or 4) to DMPA, LNG implant, or copper IUDs, including: recent septic abortion; suspicious unexplained vaginal bleeding; breast, cervical, uterine, or ovarian cancer; high BP or heart disease, venous thromboembolism, stroke, or diabetes; liver disease or liver tumours; use of liver enzyme inducing medications

• Is found to have pelvic tuberculosis or uterine fibroids with distortion of the uterine cavity on pelvic exam

• Has untreated mucus and purulent cervicitis on exam, untreated pelvic inflammatory disease (PID), or untreated known gonorrhea or chlamydia

• Has received a DMPA or NET-En injection in the last 6 months

• Has used an implant or an IUD in the last 6 months

• Is pregnant or intending to become pregnant in the next 18 months

• Has had a hysterectomy or sterilization

• Has previously participated in the study

• Has any condition (social or medical) which in the opinion of the investigator would make study participation unsafe or complicate data interpretation.