Bibliographic Details
| Title: |
Rationale and design of a multi-center, open-label, randomised clinical trial comparing HIV incidence and contraceptive benefits in women using three commonly-used contraceptive methods (the ECHO study) [version 1; referees: 2 approved] |
| Authors: |
G. Justus Hofmeyr, Charles S. Morrison, Jared M. Baeten, Tsungai Chipato, Deborah Donnell, Peter Gichangi, Nelly Mugo, Kavita Nanda, Helen Rees, Petrus Steyn, Douglas Taylor, ECHO Trial Team |
| Source: |
Gates Open Research, Vol 1 (2017) |
| Publisher Information: |
F1000 Research Ltd, 2017. |
| Publication Year: |
2017 |
| Collection: |
LCC:Medicine |
| Subject Terms: |
Medicine |
| More Details: |
Background: In vitro, animal, biological and observational clinical studies suggest that some hormonal methods, particularly depot medroxyprogesterone acetate – DMPA, may increase women’s risk of HIV acquisition. DMPA is the most common contraceptive used in many countries worst affected by the HIV epidemic. To provide robust evidence for contraceptive decision-making among women, clinicians and planners, we are conducting the Evidence for Contraceptive Options and HIV Outcomes (ECHO) study in four countries with high HIV incidence and DMPA use: Kenya, South Africa, Swaziland, and Zambia (Clinical Trials.gov identifier NCT02550067). Study design: We randomized HIV negative, sexually active women 16-35 years old requesting effective contraception and agreeing to participate to either DMPA, the copper T 380A intrauterine device or levonorgestrel implant. Participants attend a contraception support visit after 1 month and quarterly visits thereafter for 12 to 18 months. Participants receive a standard HIV prevention package and contraceptive side-effect management at each visit. The primary outcome is HIV seroconversion. Secondary outcomes include pregnancy, serious adverse events and method discontinuation. The sample size of 7800 women provides 80% power to detect a 50% difference in HIV risk between any of the three method pairs, assuming 250 incident infections per comparison. Ethical considerations: Several WHO consultations have concluded that current evidence on HIV risk associated with DMPA is inconclusive and that a randomized trial is needed to guide policy, counselling and choice. Previous studies suggest that women without a specific contraceptive preference are willing to accept randomization to different contraceptive methods. Stringent performance standards are monitored by an independent data and safety monitoring board approximately every 6 months. The study has been conducted with extensive stakeholder engagement. Conclusions: The ECHO study is designed to provide robust evidence on the relative risks (HIV acquisition) and benefits (pregnancy prevention) between three effective contraceptive methods. |
| Document Type: |
article |
| File Description: |
electronic resource |
| Language: |
English |
| ISSN: |
2572-4754 |
| Relation: |
https://gatesopenresearch.org/articles/1-17/v1; https://doaj.org/toc/2572-4754 |
| DOI: |
10.12688/gatesopenres.12775.1 |
| Access URL: |
https://doaj.org/article/1d1de8cd0d9f4b8aabfcb66c29fc202f |
| Accession Number: |
edsdoj.1d1de8cd0d9f4b8aabfcb66c29fc202f |
| Database: |
Directory of Open Access Journals |
