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.: PACTR202107891858045 Date of Approval: 09/07/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effect of a community-based intervention on knowledge and uptake of family planning in fishing communities of Lake Victoria, Uganda
Official scientific title A community-based intervention on knowledge and uptake of family planning in fishing communities
Brief summary describing the background and objectives of the trial Family planning use is a requirement for unwanted pregnancy prevention, extensive population growth reduction, and health improvement of women, children, and the population as a whole. To date, maternal and infant mortality remain high in sub-Saharan Africa. In Uganda, an estimated 310–438 women die of pregnancy-related causes per 100,000 live births. Approximately 41 infants per 1,000 births die during or within one month after birth. Additionally, many Ugandan women suffer severe morbidity, often as a result of unsafe abortion following unwanted or unintended pregnancies. Only 39% of married women and 43% of sexually active unmarried women use a modern family planning method. Further still, one in three married women are not using contraceptives even though they do not want to become pregnant. Moreover, data on contraceptive knowledge and use is lacking in some sub-populations like the fishing communities which are remotely located and there is no validated tool to assess FP knowledge. The purpose of this trial was to fill the information gap with regard to contraceptive knowledge and use in the remote- rural fishing communities of Uganda in order to contribute to the urgently needed data to improve contraceptive uptake. Due to the apparent high HIV infection rates in fishing communities, these data will be instrumental in the preparation of this population for future clinical research where contraception is a key requirement. The specific objectives of the trial were: 1) To determine the knowledge of family planning and its correlates among people in the reproductive age group from fishing communities; 2) To determine barriers and facilitators of family planning use among people living in fishing communities; 3) To determine the rate of abortion and how it compares with socio-demographic and other characteristics; and 4) To determine the effectiveness of enhanced family planning education on knowledge and use of family planning.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Family planning knowledge and use
Purpose of the trial Education /Training
Anticipated trial start date 23/02/2017
Actual trial start date 27/02/2017
Anticipated date of last follow up 31/12/2019
Actual Last follow-up date 20/12/2019
Anticipated target sample size (number of participants) 1004
Actual target sample size (number of participants) 1004
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 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
Experimental Group Enhanced family planning education Participants in the intervention arm were educated using a simplified handout extracted from the WHO FP guidance tool once every 6 months and participants in the control arm were counselled using the Uganda MoH Family planning counselling guidelines which constituted the standard of care. One year The study intervention constituted FP education using a simplified handout that was extracted from the WHO FP guidance tool called “Family planning: A global handbook for providers. The handbook contains medical information that helps health care providers deliver FP methods appropriately and effectively to clients. It also contains tools for counseling and education on different FP methods. It covers related health issues that may arise in the context of FP. It provides specific guidance on 20 FP methods, their doses, and contraindications and addresses many of clients’ different needs, from correcting misunderstandings to managing side effects. The handout was designed to have simple short sentences with pictures of the FP methods and it was translated into Luganda 502
Control Group Family planning counselling following Uganda MoH guidelines Family planning counselling conducted once every 6 months one year Participants in the control arm received routine FP counselling as per the Ministry of Health (MoH) FP counselling guidelines. The guidelines constitute information about twelve FP methods in the English language. The information is presented in form of long sentences with no pictures. The sentences are read verbatim to clients regardless of their literacy capacity and no reading materials are given to clients for further reading. 502 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Resident or working in the fishing community for at least six months. Capable and willing to provide written informed consent or assent from non-emancipated minors (Parental/guardian consent required for these minors) Willing to comply with study procedures Willing to provide study samples (blood and urine) Able and willing to provide adequate locator information and willing to be contacted by the study staff Able and willing to complete screening and available for the planned follow-up period for the study Females who are pregnant at screening Participation in another research study (e.g. investigational product/behavioural intervention) Non-sexually active minors Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 16 Year(s) 49 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 21/10/2016 Uganda Virus Research Institute Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Plot 51-59 Nakiwogo road Entebbe 49 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Knowledge of family planning At baseline and after 12 Months
Primary Outcome Use of family planning At baseline and after 12 Months
Secondary Outcome Prevalence and Incidence of HIV At baseline and after 12 Months
Secondary Outcome Prevalence and Incidence of Syphilis At baseline and after 12 Months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
UVRIIAVI HIV Vaccine Program ltd Plot 51-59 Nakiwogo road Entebbe 49 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
International AIDS Vaccine Initiative 125 Broad Street NewYork United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor International AIDS Vaccine Initiative 125 Broad Street NewYrk United States of America Other Collaborative Groups
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Annet Nanvubya ananvubya@iavi.or.ug +256772592717 Plot 51-59 Nakiwogo road
City Postal code Country Position/Affiliation
Entebbe Uganda Clinical Trials Manager
Role Name Email Phone Street address
Public Enquiries Annet Nanvubya ananvubya@iavi.or.ug +256772592717 Plot 51-59 Nakiwogo road
City Postal code Country Position/Affiliation
Entebbe Uganda Clinical Trials Manager
Role Name Email Phone Street address
Scientific Enquiries Annet Nanvubya ananvubya@iavi.or.ug +256772592717 Plot 51-59 Nakiwogo road
City Postal code Country Position/Affiliation
Entebbe Uganda Clinical Trials Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial is available after de-identification. Informed Consent Form,Study Protocol Data are available indefinitely upon request The datasets used and/or analyzed during the trial are available from the corresponding author upon request. A full data set containing the data supporting the study findings in this article can also be obtained from the Program Data Manager, by email to: tnakaweesa@iavi.or.ug or information@iavi.or.ug.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 03/07/2021 23/07/2020
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 03/07/2021 Result - 03/07/2021 Result - 03/07/2021 Result - 03/07/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information