The Evidence for Contraceptive Options and HIV Outcomes Trial
Condition: HIV; Contraception
Study type: Interventional

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.
    

Detailed description: 
      Approximately 7800 sexually active, HIV-negative women, 16-35 years old, seeking effective
      contraception, willing to be randomized to any of the study arms, and not desiring pregnancy
      for the duration of study participation will be randomly allocated to one of three study arms
      in a 1:1:1 ratio: depot medroxyprogesterone acetate (DMPA), levonorgestrel (LNG) implant,
      copper intrauterine device (IUD).

      Enrollment will require an estimated 18 months and the total duration of the clinical portion
      of the study is estimated to be 36 months.

      The primary objective is to compare the risks of HIV acquisition between women randomized to
      DMPA, levonorgestrel (LNG) implant, and copper IUDs. Secondary objectives are to compare: 1)
      pregnancy rates among women randomized to DMPA, LNG implant, and copper IUDs, 2) rates of
      serious adverse events among women randomized to DMPA, LNG implant, and copper IUDs, 3) rates
      of adverse events that lead to method discontinuation among women randomized to DMPA, LNG
      implant, and copper IUDs, and 4) contraceptive method continuation rates among women
      randomized to DMPA, LNG implant, and copper IUDs. Tertiary objectives are to evaluate: 1)
      whether age modifies the relationship between the three contraceptive methods and HIV
      acquisition, 2) whether HSV-2 status modifies the relationship between the three
      contraceptive methods and HIV acquisition, and 3) early HIV disease progression among
      sero-converters randomized to DMPA, LNG implant, and copper IUDs. Ancillary studies will
      assess biological mechanisms at the interface of contraceptives and markers of HIV risk.
    

Intervention name(s): DMPA; LNG; Copper IUD
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Women randomized to DMPA, will receive an intramuscular injection of DMPA (medroxyprogesterone acetate sterile aqueous suspension 150 mg per 1 mL) at enrolment. Subsequent injections will be given every 3 months (i.e., at quarterly study visits) at the study site.; Women randomized to implants will receive LNG implants in the arm, at enrolment from trained clinicians.; Women randomized to IUDs will receive their IUDs at enrolment. Trained providers will insert T380a copper IUDs using standard insertion techniques.
Other intervention name(s): Depot medroxyprogesterone acetate; Levonorgestrel implant; Copper T380a IUD
Intervention MeSH terms: Copper; Medroxyprogesterone Acetate; Levonorgestrel; Medroxyprogesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: HIV infection; DepoLevonorgestrel; Contraception; DMPA; Copper IUD; Levonorgestrel implant; IUD