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.: PACTR202107733292870 Date of Approval: 07/07/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A Health Behaviour Model-Based Intervention to Improve Contraceptive Outcomes in the Northern Region of Ghana; a protocol for quasi-experimental study
Official scientific title A Health Behaviour Model-Based Intervention to Improve Contraceptive Outcomes in the Northern Region of Ghana
Brief summary describing the background and objectives of the trial Family planning in the broad sense refers to any conscious effort by a couple to either limit the number of children or space the period between births. The use of modern contraceptive methods is the cornerstone of family planning. In recent years, there has been a global increase in access to and use of modern contraception and Africa shows similar progress but with wide variation. In Ghana in particular, uptake has been relatively stagnant; with the 2014 DHS recording a modern contraceptive prevalence rate of about 22% and an unmet need of about 30%. The prevalence rate in Northern Region is the lowest (11%) in the DHS with Tolon and Kumbungu Districts recording one of the lowest coverages in the region in the past three years; i.e: averaging 7.9% as compared to regional acceptor rates of 19.4%. The main objective of this study is to design and implement a health behavioural model-based intervention to improve outcomes of modern contraception (including uptake) among couples. The study further goes on to determine socio-cultural, demographic and economic factors influencing modern contraceptive use among couples, determines the effect of supply side factors on contraceptive use, determines whether use of innovative qualitative methods will yield new information, design the intervention based on health behaviour models and qualitative assessment and determines the effect of the designed health behaviour model-based intervention on contraceptive outcomes including uptake.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Psychosocial
Anticipated trial start date 18/05/2018
Actual trial start date 29/05/2020
Anticipated date of last follow up 30/06/2019
Actual Last follow-up date 30/09/2019
Anticipated target sample size (number of participants) 1008
Actual target sample size (number of participants) 1006
Recruitment status Completed
Publication URL
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 Non-randomised 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 Routine 6 months Routine services 518 Uncontrolled
Experimental Group A Health Behaviour Model Based Intervention to Improve Contraceptive Outcomes First and Fourth Month: Community Night Screenings First to Third Months, Sixth Month: Separate Monthly Meetings for Males and Females (Husbands and Wives) Fourth and Five Month: Couples Counselling Sessions Training of Health Workers (professionals) Three Mystery Client Surveys 6 months Intervention is based on issues identified from the quantitative and qualitative baseline data and was premised on two health behaviour model; Elaboration Likelihood Model (ELM)and Social Ecological Model (SEM). ELM postulates that there two modes of persuasion; the Central Mode (based cognitive energy applied to adopt the desired behaviour based on information received and the ease of information comprehension) and Peripheral Mode (based on cues such as humour and credible sources information). These two modes of persuasion informed a 2-part film. The SEM informed the societal levels to be targeted by in the intervention. Therefore at the community level, community night screenings were held, At the intra- and interpersonal level, separate male and female monthly meetings (husbands and wives' meetings). Also at the interpersonal level couples' counselling sessions. At the organisational level, training of health professional and mystery client surveys to ensure that quality services are rendered. 498
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Couples who had been married or in union for one year and more • Married or in-union women between the ages 16-49 years in selected communities whose husbands agreed that they should participate in the study • Husbands of married or in-union women selected for the study aged between 16-59 (GSS, GHS, & ICF, 2015) • Couples with at least two (2) children • Couples who are currently expecting a child • Couples with no child or one child Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 16 Year(s) 59 Year(s) Both
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 19/03/2018 Ghana Health Service Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Research and Development Division, P.O. Box MB 190 Accra 00233 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome • Proportion of participants reporting current use of modern contraception • Intrapersonal: Change in Attitude to Modern Contraception • Intrapersonal: Change in Intention to Use Modern Contraceptives • Intrapersonal: Change in Perceived Behavioural Control • Interpersonal: Change in Subjective Norms • Community/ Interpersonal: Change in Stigma At baseline and Endline
Secondary Outcome • Interpersonal: Change in Interspousal Communication Baseline and Endline
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Northern Regional Health Directorate P.O. Box 99 Tamale 00233 Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Naa Korkor Allotey No. 2 Allotey Lane, New Achimota Accra 00233 Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Naa Korkor Allote No. 2 Allotey Lane, New Achimota Accra 00233 Ghana Individual
Secondary Sponsor Ghana National Petroleum Commission Scholarship PMB Petroleum House Tema 00233 Ghana Charities/Societies/Foundation
Secondary Sponsor School of Public Health University of Ghana p.o Accra 00233 Ghana University
COLLABORATORS
Name Street address City Postal code Country
Northern Regional Health Directorate P.O. Box 99 Tamale 00233 Ghana
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Naa Korkor Allotey naa.korkorallotey@ghsmail.org +233244462747 No. 2 Allotey Lane, New Achimota
City Postal code Country Position/Affiliation
Accra 00233 Ghana PhD student School of Public Health University of Ghana
Role Name Email Phone Street address
Public Enquiries Naa Korkor Allotey naa.korkorallotey@ghsmail.org +233244462747 No. 2 Allotey Lane, New Achimota
City Postal code Country Position/Affiliation
Accra 00233 Ghana Ph.D. School of Public Health University of Ghana
Role Name Email Phone Street address
Scientific Enquiries Quasi Torpey ktorpey@hotmail.com +233244563322 P.o
City Postal code Country Position/Affiliation
Accra 00233 Ghana Supervisor Head of Department School of Public Health University of Ghana
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Yes. Individual participant data that underlie the results reported in this article, after identification(text, tables, figures and appendices Study Protocol Beginning 9 months and ending 36 months following article publication Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 07/07/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 07/07/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information