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.: PACTR202306677547495 Date of Approval: 15/06/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The Effects of Targeted Health Education on Uptake of Contraceptives among Women of Reproductive Age in Nnewi-City South East Nigeria.
Official scientific title The Effects of Targeted Health Education on Uptake of Contraceptives among Women of Reproductive Age in Nnewi-City South East Nigeria
Brief summary describing the background and objectives of the trial Improving child and maternal health are emphasized in Goal 3 of the Sustainable Development Goals (SDGs) as key targets (United Nations, n.d.). Of the many factors that influence child and maternal health, the uptake of contraceptives is rated highly, resulting in several countries measuring the prevalence of contraceptive use among their reproductive population (Blackstone et al, 2017). The use of contraceptives has been adopted in family planning, which refers to a couple’s conscious effort to limit or space the birth of their children, or completely avoid conceiving children (Ajayi et al, 2018).Of the top-10 countries with high and reasonable Contraceptive Prevalence Rate (CPR) currently using any contraceptive regardless of method (modern or traditional) being used as 80% and above, no African country is listed. However, countries like South Africa, Morocco, Kenya, Mauritius, Tunisia, Algeria, etc., have surpassed 50% CPR. In Nigeria, there is a benchmark of achieving 36% CPR by 2018, which is yet to be achieved even in 2021 (Family Planning, 2020). Statistics on CPR from Africa suggest that just few African countries are within the 75% CPR global benchmark as specified by the SDGs for 2030 (Cahill et al, 2020). Knowledge and awareness about contraceptives contribute to high performing CPR or otherwise (Anate et al, 2020).There has not been any report on the effect of targeted education on the uptake of contraceptives among women in Nnewi Anambra state (Olumide et al, 2020. It is against this backdrop that this study is tailored to investigate the impacts of targeted health education intervention uptake of contraceptives amongst women of reproductive age in Anambra, South-East Nigeria. The specific objectives include; To determine the level of uptake of contraceptives and describe the effect of targeted education on uptake of contraceptives amongst by women of child bearing age (18 – 49 years) in Nnamdi Azikiwe University Teaching Hospital (NAUTH), Nnewi-City.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) CPR SDGs
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial The impact of Targeted Health Education intervention on Uptake of Contraceptives among Women of Reproductive Age in Nnewi-City South East Nigeria.
Anticipated trial start date 01/06/2022
Actual trial start date 06/07/2022
Anticipated date of last follow up 20/09/2022
Actual Last follow-up date 30/09/2022
Anticipated target sample size (number of participants) 275
Actual target sample size (number of participants) 275
Recruitment status Completed
Publication URL https://drive.google.com/file/d/1nLUUSFJwLSgjuVxXZuVDoqbytS84CIvf/view?usp=drivesdk
Secondary Ids Issuing authority/Trial register
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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Targeted Health Education intervention Three days per week (Thrice a week ) Three consecutive weeks (3 weeks) The researcher designed an educative intervention on contraception, drawing from his experience as a medical practitioner. The intervention group participated in a 60-minute oral education on contraceptive basal knowledge and method’s demonstration 3 days per week for a duration of 3 consecutive weeks. This educational intervention was done alongside one of the health workers in the facility, and focused on the various types of modern contraception, their advantages and disadvantages inclusive of side effects, and how effective certain contraceptives can be against STDs. Furthermore, how each contraceptive was used was also taught. Importantly, time was created to entertain conversations on the perceived barriers the targeted women face in a bid to uptake contraception. Room was granted for a question-and-answer session. The intervention was delivered in a large conference room at the hospital. 140
Control Group The usual health counselling programs organized once a week by the hospital Once a week ( one day per week) Three weeks ( Three consecutive weeks) The control group participated in the health counselling programs organized once a week by the hospital to enlighten women on health specific issues ranging from family planning, gynecological health to mental health (components of Depression and Anxiety). 135 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult women of reproductive age who accessed healthcare services at Nnamdi Azikiwe University Teaching Hospital (NAUTH) facility Nnewi between February 2021 -August 2022. All women (18-49 years), resident in Nnewi , who voluntarily consented to participate in the research/Study. Women who are not-resident in Nnewi and are below 18 years or above 49 years. Women of reproductive age (18 -49 years) but critically unwell, even if they utilized health services in NAUTH, Nnewi. Women who declined participation in the study were excluded with no consequences for non-participation. Adult: 19 Year-44 Year 18 Year(s) 49 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 05/07/2022 Nnamdi Azikiwe University Teaching Hospital Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Nnewi Onitsha Old Road , Nnewi Anambra State Nnewi PMB 5025 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To describe the effect of targeted education on uptake of contraceptives amongst women of child bearing age in NAUTH, Nnewi City, Southeastern Nigeria. pre-intervention and post-intervention period of the study at two weeks upon completion of 3 weeks of the intervention
Secondary Outcome 1. To determine the level of uptake of contraceptives by women of child bearing age (18 – 49 years) in Nnamdi Azikiwe University Teaching Hospital (NAUTH), Nnewi-City, Southeastern Nigeria. 2. To find out the level of knowledge and perceptions of contraceptives by women of childbearing age in NAUTH, Nnewi City, Southeastern Nigeria. 3. To identify the sources of information on contraceptives amongst women of child bearing age in NAUTH, Nnewi City, Southeastern Nigeria. 4. To determine the level of access to contraceptives amongst women of child bearing age in NAUTH, Nnewi City, Southeastern Nigeria. 5. To identify the factors associated with uptake of contraceptives among women of child bearing age in NAUTH, Nnewi City, Southeastern Nigeria. pre-intervention and post-intervention period of the study.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Nnamdi Azikiwe University Teaching Hospital Nnewi Onitsha Old road Nnewi, Anambra State Nnewi PMB 5025 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Simeone Yanmeer Tyotswam savings Department of Population, Reproductive Health and Community Resource Management, School of Public Health and Applied Human Sciences, Kenyatta University, Nairobi. Nairobi Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Rose Tyotswam Block 105, Flat 3, Queen Amina Street , Phase 2 , Site 2, Kubwa. Abuja Nigeria My Elder sister co-sponsoring my PhD studies at Kenyatta University.
COLLABORATORS
Name Street address City Postal code Country
Dr Rosbella Alungata Iseme Department of Population Health, Medical College, Aga Khan University-East Africa, P.O Box 30270-00100, Nairobi Nairobi Kenya
Dr Eliphas Gitonga Makunyi Department of Population, Reproductive Health and Community Resource Management, School of Public Health and Applied Human Sciences, Kenyatta University, Nairobi. Nairobi Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Yanmeer Simeone Tyotswam yanmeer1@yahoo.com +2349094581836 Department of Population, Reproductive Health and Community Resource Management, School of Public Health, Kenyatta University, Nairobi.
City Postal code Country Position/Affiliation
Nairobi Kenya PHD Student in Reproductive Health
Role Name Email Phone Street address
Public Enquiries Rosebella Alungata Iseme rosebella.ondiek@aku.edu +254745259682 Department of Population Health, Medical College, Aga Khan University-East Africa, P.O Box 30270-00100, Nairobi
City Postal code Country Position/Affiliation
Nairobi Kenya Supervisor
Role Name Email Phone Street address
Scientific Enquiries Gitonga Eliphas Mukunyi gitonga.eliphas@ku.ac.ke +254721406609 Department of Population, Reproductive Health and Community Resource Management, School of Public Health and Applied Human Sciences, Kenyatta University, Nairobii
City Postal code Country Position/Affiliation
Nairobi Kenya Supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Will individual participant data be available (including data dictionaries)? Yes What data in particular will be shared? The shared data will include all raw and explainable/processed ( both pre-interventional and post-interventional data sets inclusive) individual respondent data related to the disclosed results in my study. Informed Consent Form,Study Protocol The time frame for the IPD-sharing is from the time the article is published to 5 years post publication. An investigator who finds the data relevant.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://docs.google.com/spreadsheets/d/12u02Go9kJdGkqQgd8Ci_vsSWx0XArV2-/edit?usp=drivesdk&ouid=108445488121617836368&rtpof=true&sd=true Yes 28/04/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 28/04/2023 Result - 03/06/2023 Result - 14/06/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information