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.: PACTR202102794681952 Date of Approval: 10/02/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title ANTENATAL COUPLES’ COUNSELLING IN UGANDA
Official scientific title ANTENATAL COUPLES’ COUNSELLING IN UGANDA: Feasibility trial
Brief summary describing the background and objectives of the trial Reducing maternal, perinatal and neonatal mortality are Sustainable Development Goals and are key priorities for the Ugandan Ministry of Health. Common avoidable factors leading to death include lack of birth planning (and delivery in an inappropriate place) and unmet need for contraception (Willcox et al. 2018). Progress has been slow on both of these avoidable factors because routine antenatal care has focused only on women. Yet in Uganda, many women are powerless to take important decisions (such as place of delivery and use of contraception) without involving their husbands / partners. The World Health Organization recommends postpartum family planning (PPFP) as a critical component of health care. We conducted a qualitative study of post-partum women and their husbands, and health workers, in South-West Uganda in order to understand their reasons for refusing post-partum contraception (Willcox et al. 2019). Women want to discuss contraception with their husbands before agreeing to use a method, but husbands are rarely present at the time of delivery. Participants suggested the need for counselling of couples during antenatal clinics about post-partum contraception. The aim of this trial is to pilot and to test the feasibility of a trial of a complex community-based intervention to reduce maternal, perinatal and neonatal mortality in Uganda. The intervention will focus on provision of information and counselling to antenatal couples about birth planning and post-partum long-acting reversible contraception. Objectives: 1. To assess feasibility of recruiting pregnant women to a trial of the intervention, following them up and recording key outcomes, in both urban and rural areas. 2. To assess the feasibility of VHTs using smartphones to collect and record data on participants, using a secure data transfer system. 3. To measure current levels of uptake of PPFP and estimate by how much this could be increased after couples' counselling is introduced.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ACCU
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 08/02/2021
Actual trial start date
Anticipated date of last follow up 28/02/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 1400
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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 Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Antenatal Couples Counselling Village Health Teams will visit pregnant women and their partners couple a total of 5x and will attempt to provide counselling on at least the first four visits. They will also encourage couples to attend the health facility for couples' counselling. From the time of recruitment (antenatally) to 12 months after delivery. The intervention arm will receive the complex intervention, consisting of: 1. Training Village Health Teams (VHTs) to provide basic information and counselling to antenatal couples in the community, encouraging them to attend a formal antenatal clinic, deliver in an appropriate place according to their level of risk, attend postnatal care clinic and use postpartum family planning. The information delivered by VHTs will also include birth preparation and complication awareness. They will also be trained to show health education films on their smart phones. If the husband does not want to attend antenatal clinic, they will be given the option of speaking to the health worker to answer any questions over the phone if appropriate. The VHTs will also provide counselling on PPFP at the postnatal visits, if the woman has not yet started it. 2. A training course for health workers, covering general communication skills, couples’ counselling, information and refresher practical training on antenatal risk assessment, birth preparedness and post-partum contraception provision. Health workers will be asked to provide couples' counselling to couples who come together to the antenatal clinic. 3. Payment for health workers’ extra work in providing couples’ counselling at weekends and helping with data collection. 4. Screening of health education films in antenatal clinics and postnatal wards: Health Facilities will be provided with a screen and health education films about the contraceptive implant. They will be asked to screen the films daily. The films will also be shown in the waiting room of the antenatal clinic and of the postnatal clinic, so the couples will see them if and when they attend antenatal and postnatal clinics. These consist of a documentary and a short drama film, both of which have undergone extensive development in Uganda using the person-based approach to intervention development and have been approved by the Ministry of Health. 700
Control Group Usual care Village Health Teams will visit the couple 5x in total, but purely for data collection. They will not be given any extra training in couples' counselling. From antenatal to 12 months postpartum. Usual care 700 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The health facilities to be included should meet the following criteria; • Offering the continuum of ANC, delivery, and PNC services • Offering antenatal care services to more than 50 mothers per month • Have at least two midwives on the station excluding those on study and / or long-term sick leave. • Providing modern contraceptive methods, including a long-term method such as implants • The facility must be connected to electricity so that they are able to show films • Health workers are willing to be involved in the study • VHTs are active and willing to be involved in the study Individual participants to be included should meet the following criteria: • She is a resident of the area. • The pregnancy is seven months or less (self-reported). • The woman plans to attend ANC and PNC at study health sites. • The pregnant woman is in a relationship with the father of their expected child. It is not required that they live together but they must have been together at least 6 months in a relationship, and see each other as their primary partner. • Are 18 years old and above or they are emancipated minors able to consent. • Informed consent is obtained. An individual will be excluded if she: • Presents with severe medical/physical condition(s) making her unable to answer the questions at the time of the interview • Has known causes of cognitive and functional impairment such as functional psychoses, depression and delirium, alcoholism thus is not able to give informed consent Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 13 Year(s) 50 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 14/08/2020 Mbarara University Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
PO Box 1410 Mbarara NA Uganda
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 21/08/2020 Faculty of Medicine Ethics Committee University of Southampton
Ethics Committee Address
Street address City Postal code Country
Southampton General Hospital, Mailpoint 801, South Academic Block, Tremona Road Southampton SO16 6YD United Kingdom
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome a. % of eligible women who consent to participate and are recruited b. % of included women who can be followed up and provide outcome data on place of delivery and uptake of family planning 1 week, 6 months and 12 months after delivery
Secondary Outcome % of included women who ii. whose partners agreed to participate in the project iii. received individual counselling from the VHT on one or more occasions iv. received couples counselling from the VHT on one or more occasions v. attended the antenatal clinic at the health centre one or more times vi. attended the antenatal clinic at the health centre with their partner one or more times vii. received individual counselling at the antenatal clinic on PPFP viii. received individual counselling at the antenatal clinic on birth planning ix. received couples’ counselling at the antenatal clinic on PPFP x. received couples’ counselling at the antenatal clinic on birth planning xi. were given correct advice on recommended place of delivery (according to their level of risk) xii. watched the health education films, with the VHT / at the antenatal clinic 1 week postpartum
Secondary Outcome % of included couples who i. were offered and attended antenatal clinics and counselling at weekends. ii. were counselled and consented for long-acting reversible methods of post-partum family planning (PPFP) 1 week postpartum
Secondary Outcome % of women / couples attending antenatal clinic who were offered counselling on both birth planning and use of acting reversible methods of post-partum family planning at the same visit. 1 week postpartum
Secondary Outcome Proportion of women / couples counselled who agreed on PPFP in a single session, and proportion of women / couples counselled who agreed after attending extra sessions. 6 and 12 months postpartum
Secondary Outcome % of working days when the films on family planning are screened in antenatal clinics (in intervention areas). 1, 2, 3, 6 and 12 months after start of intervention
Secondary Outcome % of VHT visits when i. Counselling was delivered to the woman / couple about birth planning / family planning ii. Data was correctly entered directly into the COSMOS app on the smartphone 1 week, 6 and 12 months postpartum
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mbarara University of Science and Technology Kabale Road Mbarara Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Medical Research Council UK Polaris House, North Star Avenue Swindon SN2 1FL United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Southampton University Road, Highfield Southampton SO17 1BJ United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Mbarara University of Science and Technology PO Box 1410 Mbarara Uganda
Primary Care Research Centre University of Southampton, Aldermoor Health Centre, Aldermoor Close Southampton SO16 5ST United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Vincent Mubangizi vmubangizi@must.ac.ug +2560772499925 Department of Family Medicine and Community Practice, Mbarara University of Science and Technology
City Postal code Country Position/Affiliation
Mbarara Uganda Head of Department
Role Name Email Phone Street address
Scientific Enquiries Merlin Willcox m.l.willcox@soton.ac.uk +442380591771 University of Southampton, Aldermoor Health Centre, Aldermoor Close
City Postal code Country Position/Affiliation
Southampton SO16 5ST United Kingdom Academic Clinical Lecturer
Role Name Email Phone Street address
Public Enquiries Merlin Willcox m.l.willcox@soton.ac.uk +442380591771 University of Southampton, Aldermoor Health Centre, Aldermoor Close
City Postal code Country Position/Affiliation
Southampton SO16 5ST United Kingdom Academic Clinical Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will upload the study and associated data to the Institutional Repository, eprints.soton.ac.uk. We will remove all the direct identifiers (any village names pseudonymised) so that there should be no issue with sharing the anonymised data. Informed Consent Form,Study Protocol Within 12 months of completion of study The requester will be required to send proof of ethical approval and will need approval by the PI.
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