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.: PACTR202009758229976 Date of Approval: 01/09/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The WHICH injection study (Part 1)
Official scientific title The Women’s Health, Injectable Contraception and HIV study (Part 1): randomized comparison of immunological, hormonal, physiological, psychological and behavioural effects of NET-EN versus DMPA contraception.
Brief summary describing the background and objectives of the trial Effective contraception is the single most important strategy for reducing maternal and perinatal mortality globally. In countries such as South Africa, depot medroxyprogesterone acetate (DMPA) accounts for the great majority of modern contraceptive usage. Animal, immunological, endocrinological and observational clinical studies have suggested that DMPA may increase susceptibility to HIV. However, the net effect of biological, physiological and behavioural effects is unknown, nor are the relative effects of alternative contraception methods. The international collaborative ECHO study currently being conducted will address the relative effects of DMPA versus the intrauterine device (IUD) and the levonorgestrel (LNG) implant. However, our experience over more than 10 years of providing the IUD and more recently the etonorgestrel implant has indicated that the majority of women in the Eastern Cape and elsewhere in South Africa continue to prefer injectable contraception. Reasons include familiarity as this has been the dominant method in these communities for decades, confidentiality and fear of complications with the IUD and implant. Thus, the most important question in terms of potential public health benefit and implementation, is the relative effects of alternative injectables, norethisterone enanthate (NET-EN) versus DMPA IM. The primary objective of the proposed study (part 1) is to provide robust evidence to inform clinicians, policy-makers, and women about the relative risks and benefits of NET-EN versus DMPA IM with respect to biological, physiological, hormonal, psychological and behavioural effects, and method continuation. This question is relevant for all settings where women prefer injectable contraception.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Early detection /Screening
Anticipated trial start date 01/11/2018
Actual trial start date 05/11/2018
Anticipated date of last follow up 04/10/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 520
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
M180528 University of the WITWATERSRAND Human Research Ethics Committee - Medical
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 Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Medroxyprogesterone acetate (150 mg of medroxyprogesterone acetate (MPA)/ml) administered IM every 12 weeks) 12 Months 3 monthly injection 260 Active-Treatment of Control Group
Experimental Group Norethisterone enanthate administered 200mg/ml IM every 8 weeks 2monthly injection 260
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Requests injectable contraception and intends to continue contraception for at least 18 months. • Aged 18 to 40 years. Legally competent to sign consent according to local regulations.. • Prepared to use either NET-EN or DMPA • Prepared to accept follow-up procedures and able to fulfil these procedures, including routine HIV tests according to national guidelines (see below). • After full counselling, decline to use PrEP • Understands patient information form and signs informed consent. • Received DMPA in previous 6 months or NET-EN in previous 4 months • HIV positive • Planning to move out of study area in next 18 months • Participating in another clinical trial • <6 weeks postpartum or post-abortion • Have Diabetes or High blood pressure • Does not meet MEC criteria or local national guidelines for NET-EN or DMPA use. • Using or intending to use medication which may interfere with biological measurements, for example steroids or drugs affecting renal function such as PrEP. Prospective participants will be fully informed about PrEP, and if interested in using PrEP, will be referred to any available local providers.Participants who, after recruitment, change their minds and decide to access PrEP services, will be kept in the study. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 Year(s) 40 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 17/09/2018 University of Witwatersrand Human Research Ethics Committee Medical
Ethics Committee Address
Street address City Postal code Country
29 Princess of Wales Terrace ,Parktown Johannesburg 2193 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary hormonal outcome will be serum 17β estradiol, and the primary psychological outcome will be depression (BDI-II). Baseline and at 25 weeks
Secondary Outcome Sentinal immune suppression markers (eg CCR5 levels on T cells and CD14+ cells from genital tract samples; plasma interferonγ). Serum sex hormone binding globulin Serum testosterone Serum free testosterone Serum progesterone Additional depression measures Sexual dysfunction Sexual activity including condom use Amenorrhoea Weight change Adherence Baseline and 25 weeks - 28weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Effective Care Research Unit Cecilia Makiwane Hopsitals,Billie Road Mdantsane 5200 South Africa
Match Research Unit 38 Dr A B Xuma Durban 4001 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
South African Medical Research Council GRANTS INNOVATION AND PRODUCT DEVELOPMENT Francie van Zijl Drive. Parow Valley Cape Town South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Fort Hare 50 Church Street East London 5200 South Africa University
COLLABORATORS
Name Street address City Postal code Country
. Prof Janet Patricia Hapgood Molecular and Cell Biology Building ,University Ave.University of Cape Town Cape Town South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mandisa SingataMadliki mandisa.singata@gmail.com 0027824201743 1 Admin Block, Frere Maternity Hospital,Amalinda Drive
City Postal code Country Position/Affiliation
East London 5247 South Africa Co Director Effective Care Research Unit.University of Fort Hare
Role Name Email Phone Street address
Public Enquiries Mandisa SingataMadliki mandisa.singata@gmail.com 0027437092709 Frere Martenity Hospital,Room 1 admin block,Amalinda Drive.Amalinda
City Postal code Country Position/Affiliation
East London 5247 South Africa Principal investigator
Role Name Email Phone Street address
Scientific Enquiries Mandisa SingataMadliki mandisa.singata@gmail.com 0027437092709 Frere Martenity Hospital,Room 1 admin block,Amalinda Drive.Amalinda
City Postal code Country Position/Affiliation
East London 5247 South Africa Principal investigator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The de-identified dataset will be made available after acceptance of the paper. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Available immediately after publication Open access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information