The Evidence for Contraceptive Options and HIV Outcomes Trial

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.

Conditions

• HIV
• Contraception

Interventions

DRUG

DMPA

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.

DRUG

LNG

Women randomized to implants will receive LNG implants in the arm, at enrolment from trained clinicians.

DRUG

Copper IUD

Women randomized to IUDs will receive their IUDs at enrolment. Trained providers will insert T380a copper IUDs using standard insertion techniques.

Sponsors & Collaborators

• University of Washington

  collaborator OTHER

• Wits Reproductive Health and HIV Institute

  collaborator OTHER

• World Health Organization

  collaborator OTHER

• Madibeng Centre for Research

  collaborator OTHER

• Maternal Adolescent and Child Health Research

  collaborator UNKNOWN

• Qhakaza Mbokodo Research Clinic

  collaborator UNKNOWN

• The Aurum Institute NPC

  collaborator OTHER

• Effective Care Research Unit

  collaborator OTHER

• Emavundleni Research Centre

  collaborator UNKNOWN

• Setshaba Research Centre

  collaborator UNKNOWN

• University of North Carolina, Chapel Hill

  collaborator OTHER

• Family Life Association of Swaziland

  collaborator UNKNOWN

• ICAP Columbia University

  collaborator UNKNOWN

• Kenya Medical Research Institute

  collaborator OTHER

• FHI 360

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

35 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-12-14

Primary Completion

2018-10-31

Completion

2018-10-31

Countries

• Eswatini
• Kenya
• South Africa
• Zambia

Study Locations