Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201706001651380 Date of Approval: 25/05/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Physiological, psychological and behavioural effects of long-acting reversible contraception
Official scientific title Physiological, psychological and behavioural effects of long-acting reversible contraception
Brief summary describing the background and objectives of the trial Contraception is a complex intervention involving medical, psychological, behavioural, physiological and personal components. There is currently a lack of robust evidence from randomized trials on which to base health policy planning and individual counselling of women. Contraceptive method discontinuation, often due to side effects, is a common cause of unintended pregnancy in the Eastern Cape. Both depression and sexual dysfunction are possible side effects of contraceptive use; however, there is little robust evidence concerning these effects. This is an ancillary study of the ECHO study where participants are randomly allocated to one of three study arms in a 1:1:1 ratio: depot medroxyprogesterone acetate (DMPA), levonorgestrel (LNG) implant, copper intrauterine device (IUD).Women recruited at the ECRU site will be asked to participate in the ancillary study. We will administer a questionnaire including the Beck Depression Inventory (BDI) and the Arizona sexual functioning scale (ASEX) for women attending the 3 month study visit. They will be asked to complete a 28-day daily diary of symptoms and behaviour, commencing the day after the 3-month visit. The diary will be completed either on a participant-held form, or by daily telephone interview. Parameters measured daily will include: ¿ Menstruation (bleeding and pain) ¿ Libido ¿ Depression ¿ Sexual activity ¿ Condom use
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Depression ,Sexual Dysfunction, menstrual disturbances
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 26/05/2016
Actual trial start date
Anticipated date of last follow up 31/05/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 648
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL http://bmjopen.bmj.com/cgi/content/full/bmjopen-2017-019205?ijkey=eaIjpxdxjyUvf3B&keytype=ref
Secondary Ids Issuing authority/Trial register
Wits HREC ref :141112
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Random allocation has used a 1:1:1 allocation to the 3 arms of the trial, stratified by site. Random block sizes between 15 and 30 has been used. Allocation to arm will be assigned at the time of randomisation using standardised procedures and a predetermined sequence that is concealed from all study staff prior to randomisation (e.g. opaque, numbered envelopes or on-line or telephonic randomisation system). Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group IM injection of DMPA (medroxyprogesterone acetate sterile aqueous suspension 150 mg per 1 mL) 150 mg per 1 m injections will be given every 3 months IM injection of DMPA 216
Experimental Group Levonorgestrel (LNG) Implant consist of two silicone rods; each rod contains 75 mg of LNG 5 years or for 18 Months (Study duration)( Implant 216
Experimental Group Copper IUD (Paragard-T 380A®, Duramed) Stat dose 10 years or for 18 Months (Study duration) Copper Intra-uterine contraceptive device. 216
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
be eligible for the study a woman must meet all of the following criteria: ¿ 18-35 years of age ¿ HIV-seronegative ¿ Wants to use effective contraception ¿ Is able and willing to provide written informed consent ¿ Agrees to be randomised to either DMPA, NET-En, or copper IUD ¿ Agrees to use assigned method for 18 months ¿ Agrees to follow all study requirements ¿ Intends to stay in the study area for the next 18 months, and willing and able to provide adequate locator information ¿ If recently pregnant, is at least 6 weeks post-partum ¿ Is sexually active (has had vaginal sex within the last 3 months) or was pregnant within the last 3 months ¿ Agrees not to participate in studies of drugs or vaccines or any other clinical research study while participating in this study. ¿ Reported medical contraindications (WHO MEC Category 3 or 4) to copper IUDs, NET-En, or DMPA, including: o recent septic abortion o suspicious unexplained vaginal bleeding o breast, cervical, uterine, or ovarian cancer o high BP or heart disease, venous thromboembolism, stroke, or diabetes o liver disease or liver tumours o use of liver enzyme inducing medications (see appendix 9) ¿ Is found to have pelvic tuberculosis or uterine fibroids with distortion of the uterine cavity on pelvic exam ¿ Has untreated mucopurulent cervicitis on exam, untreated pelvic inflammatory disease (PID), or untreated known gonorrhoea or chlamydia ¿ Has used DMPA, Net-En, or an IUD in the last 6 months ¿ Is pregnant or intending to become pregnant in the next 18 months ¿ Has had a hysterectomy or sterilization ¿ Has previously participated in the study ¿ Has any condition (social or medical) which in the opinion of the investigator would make study participation unsafe or complicate data interpretation 18 Year(s) 35 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 17/02/2016 Wits Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
University of the Witwatersrand, Suite 189, Houghton Johannesburg 2041 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1.Depression We will administer a questionnaire including the Beck Depression Inventory (BDI) and the Arizona sexual functioning scale (ASEX) for women attending the 3 month study visit. They will be asked to complete a 28-day daily diary of symptoms and behaviour, commencing the day after the 3-month visit.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Effective Care Research Unit Cecilia Makiwane Hospital,Billie Road,Mdantsane East London 5200 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
South African Medical Research Council Frans van Zijl Drive, Tygerberg Cape Town 7505 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor South African Medical Research Council Frans van Zijl Drive, Tygerberg Cape Town 7505 South Africa Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Professor GJ Hofmeyr Frere Maternity Hospital, Amalinda Drive East London 5247 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mandisa Singata-Madliki mandisa.singata@gmail.com +27 43 7092709 Frere Maternity Hospital, Amalinda Drive
City Postal code Country Position/Affiliation
East London 5247 South Africa Co-Director, ECRU
Role Name Email Phone Street address
Public Enquiries Mandisa Singata-Madliki mandisa.singata@gmail.com +27 43 7092709 Frere Maternity Hospital, Amalinda Drive
City Postal code Country Position/Affiliation
East London 5247 South Africa Co-Director, ECRU
Role Name Email Phone Street address
Scientific Enquiries Mandisa Singata-Madliki mandisa.singata@gmail.com +27 43 7092709 Frere Maternity Hospital, Amalinda Drive
City Postal code Country Position/Affiliation
East London 5247 South Africa Co-Director, ECRU
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information