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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).

Publication ,  Journal Article
Hofmeyr, GJ; Morrison, CS; Baeten, JM; Chipato, T; Donnell, D; Gichangi, P; Mugo, N; Nanda, K; Rees, H; Steyn, P; Taylor, D; ECHO Trial Team,
Published in: Gates open research
January 2017

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 up 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% relative increase 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.

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Published In

Gates open research

DOI

EISSN

2572-4754

ISSN

2572-4754

Publication Date

January 2017

Volume

1

Start / End Page

17

Related Subject Headings

  • 42 Health sciences
  • 32 Biomedical and clinical sciences
 

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Hofmeyr, G. J., Morrison, C. S., Baeten, J. M., Chipato, T., Donnell, D., Gichangi, P., … ECHO Trial Team, . (2017). 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). Gates Open Research, 1, 17. https://doi.org/10.12688/gatesopenres.12775.2
Hofmeyr, G Justus, Charles S. Morrison, Jared M. Baeten, Tsungai Chipato, Deborah Donnell, Peter Gichangi, Nelly Mugo, et al. “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).Gates Open Research 1 (January 2017): 17. https://doi.org/10.12688/gatesopenres.12775.2.
Hofmeyr GJ, Morrison CS, Baeten JM, Chipato T, Donnell D, Gichangi P, Mugo N, Nanda K, Rees H, Steyn P, Taylor D, ECHO Trial Team. 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). Gates open research. 2017 Jan;1:17.

Published In

Gates open research

DOI

EISSN

2572-4754

ISSN

2572-4754

Publication Date

January 2017

Volume

1

Start / End Page

17

Related Subject Headings

  • 42 Health sciences
  • 32 Biomedical and clinical sciences