Echo

ECHO

Title:

The Evidence for Contraceptive Options and HIV Outcomes (ECHO) Trial: A Multi-Center, Open-Label, Randomized Clinical Trial Comparing HIV Incidence and Contraceptive Benefits in Women using Depo Medroxyprogesterone Acetate (DMPA), Levonorgestrel (LNG) Implant, and Copper Intrauterine Devices (IUDs)

Acronym:

ECHO

Site Principal Investigators:
  1. Prof. Elizabeth Bukusi Principal Investigator
  2. Dr. Maricianah Onono Co- Principal investigator
  3. Dr. Stella
Timeline:

2014 – 2016

Status:

 Completed

Funder:

Sponsor: Bill and Melinda gates Foundation.
Coordinated by: FHI 360

Objective:


The Evidence for Contraceptive Options and HIV Outcomes is an open-label randomized clinical trial that compared three highly effective, reversible methods of contraception to evaluate whether there is a link between use of any of these methods and increased risk of acquiring HIV infection.

Brief Description

The Evidence for Contraceptive options and HIV Outcomes is an open-label randomized clinical trial that will compare three highly effective, reversible methods of contraception to evaluate whether there is a link between use of any of these methods and increased risk of acquiring HIV infection.

Background

  • Women worldwide need family planning, and in Africa, the use of hormonal contraception, and especially Depo, provide women with a long-acting, reversible and safe option for birth control.
    More than 150 million women around the world use hormonal contraceptives.
  • African women are at high risk of HIV.
    16 million women aged 15 years and older are living with HIV; 80% live in sub-Saharan Africa
    Young women 15–24 years old in sub-Saharan Africa are twice as likely as young men to be living with HIV.
African countries with HIV prevalence also have high rates of women using hormonal contraception
  • The reasons for this are unclear.
  • There is confusing data about whether there is a link between using some contraceptives and an increased risk of contracting HIV.

Objectives

Primary objective
  • To compare the risks of HIV acquisition between women randomised to DMPA, levonorgestrel (LNG) implants, and copper IUDs
Secondary and tertiary objectives
  • Pregnancy, safety, contraceptive continuation
Why do we need the ECHO Study?
  • For over 25 years, the world has lived with the uncertainty about whether or not use of hormonal contraceptives increases HIV risk.
  • ECHO aims to answer this critical public health question of the possible risks (HIV acquisition) and benefits (pregnancy prevention) of the three commonly-used, effective contraceptive methods among women who desire contraception
     
    Purpose of the ECHO Study
    When comparing women’s use of the contraceptives— Depo, Jadelle and IUD:
    • Is there an increased risk of acquiring HIV when they use one method over the others?
    • Are there more or less side effects of each method?
    • Are the pregnancy rates the same?
    • How well do women stay on each of the three contraceptive methods?
ECHO Sites

The study will take place at 12 sites across Eastern and Southern Africa, including sites in:

  1. Kenya – Kisumu
  2. South Africa
  3. Swaziland
  4. Zambia
Who can participate in the ECHO study
  • Sexually active women 16-35 years old
  • HIV negative and willing to be tested
  • Seeking effective contraception
  • Do not want to become pregnant for the duration of study participation
  • Willing to be randomised to any of the three contraceptives being tested
  • Willing to give consent to participate
Voluntary and confidential
  • All information shared with trial staff will kept confidential.
  • Women are asked to be honest at all times in their answers to staff.
  • Participation is voluntary and women may leave the study at any time they wish.
DMPA or Depo Provera
  • Most widely used progestin-only injectable
  • Given every 3 months as injection in arm
  • Return of fertility is often delayed, by a minimum of four months

Jadelle Implant
  • Consists of two thin, flexible rods filled with synthetic progestin that are inserted just under the skin of a woman’s upper arm
  • Once inserted, lasts up to 5 years, although one can have it removed at any time Rapid return to fertility once removed
Copper IUD (Cu-IUD)
  • The copper-bearing intrauterine device (Cu-IUD) is a small, flexible plastic frame with copper sleeves or wire around it that is inserted in the uterus (womb)
  • Once inserted, lasts up to 10 years, although one can have it removed at any time
  • Return to fertility is immediate

How the study works
Recruitment and Enrolling in the Study
  1. Potential participants will be invited to the trial site to learn about the study
  2. During an initial visit, they will learn about the risks and benefits and also about what is included in the visits (known as informed consent).
  3. Women will learn about the 3 contraceptives being tested and asked if they would be willing to use any of the 3 products
When a woman enrols in ECHO, she will be randomly placed in 1 of 3 groups
  • Participants in all groups will be given the same standard prevention package (condoms, HCT, STI treatment)
  • All women have an equal chance of being placed into each group.
  • Neither she nor the staff can choose which product each participant will receive.
  • Selection into a group is random, like rolling a dice.
  • Once a participant is in a group, she will be encouraged to remain on her assigned method for the duration of the study.

Participant study visits schedule

What happens during study visits?
  • Provide contraceptive counselling
  • Provide HIV counselling and testing
  • Ask questions about sexual behaviour
  • Do a pregnancy test if needed
  • Check health – for STIs and side effects to products
  • Update contact information
  • Schedule next appointment
  • Give reimbursement for transport