Psychological, behavioural and physiological effects of three long-acting reversible contraception (LARC) methods: protocol for an ancillary study of the ECHO randomised trial

• Published in: BMJ open Vol. 7; no. 11; p. e019205
• Main Authors: Singata-Madliki, Mandisa, Hofmeyr, G Justus, Carayon-Lefebvre d’Hellencourt, Florence, Lawrie, Theresa Anne
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group LTD 01.11.2017; BMJ Publishing Group
• Subjects: Adolescent; Adult; Birth control; Consortia; Copper; Depression - epidemiology; Dysmenorrhea - epidemiology; Evidence-based medicine; Female; Humans; Intrauterine devices; Intrauterine Devices, Copper; IUD; Levonorgestrel - pharmacology; London; Long-Acting Reversible Contraception - adverse effects; Long-Acting Reversible Contraception - classification; Medroxyprogesterone Acetate - pharmacology; Menstruation; Methods; Obstetrics and Gynaecology; Physiology; Postpartum depression; Pregnancy; Pregnancy, Unplanned - psychology; Research Design; Sexual disorders; Sexual Dysfunction, Physiological - epidemiology; South Africa; Transplants & implants; Womens health; Young Adult; South Africa; sexual dysfunction; intrauterine device; long-acting progestogen; contraception
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2017-019205

IntroductionThis is the protocol for an ancillary study to the multicentre Evidence for Contraceptive Options and HIV Outcomes (ECHO) Trial, a three-arm randomised trial comparing the effects of depot medroxyprogesterone acetate (DMPA), the levonorgestrel (LNG) implant and the copper intrauterine device (IUD) on HIV incidence (NCT02550067 pre-results). The ancillary study will compare other non-contraceptive effects of these three long-acting, reversible contraceptions about which there is little existing comparative evidence.Methods and analysisWomen randomised to IUD, DMPA and LNG implant (1:1:1) at one of the ECHO trial sites will be asked to participate in the ancillary study at the 1-month follow-up visit. Research staff will interview women that consent to participate at the 3-month follow-up visit. Primary outcomes are depression, sexual dysfunction and menstrual disturbances. The Beck Depression Inventory will be used to assess depression and the Arizona Sexual Experiences Scale to assess sexual dysfunction. Participants will also be asked to prospectively complete a 28-day symptom diary. The required sample size is 522 participants. Depression scores will be analysed as continuous and categorical variables. Analysis will be by intention to treat.Ethics and disseminationThe ancillary study protocol received ethical approval from the University of the Witwatersrand Committee for Research on Human Subjects on 17 February 2016 (reference no. 14112). The results will be disseminated in a peer-reviewed open-access journal.Trial registration numberPACTR201706001651380.