Back to Search
Start Over
Psychological, behavioural and physiological effects of three long-acting reversible contraception (LARC) methods: protocol for an ancillary study of the ECHO randomised trial
- Source :
- BMJ Open
- Publication Year :
- 2017
- Publisher :
- BMJ Publishing Group, 2017.
-
Abstract
- Introduction This 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 analysis Women 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 dissemination The 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 number PACTR201706001651380.
- Subjects :
- Adult
Long-Acting Reversible Contraception
Adolescent
Depression
Pregnancy, Unplanned
Levonorgestrel
Medroxyprogesterone Acetate
intrauterine device
Intrauterine Devices, Copper
Sexual Dysfunction, Physiological
South Africa
Young Adult
contraception
Dysmenorrhea
sexual dysfunction
Pregnancy
Research Design
long-acting progestogen
Obstetrics and Gynaecology
London
Protocol
Humans
Female
Subjects
Details
- Language :
- English
- ISSN :
- 20446055 and 02550067
- Volume :
- 7
- Issue :
- 11
- Database :
- OpenAIRE
- Journal :
- BMJ Open
- Accession number :
- edsair.pmid..........1f00f318e2c663265b389cc96ab67118