DISSEMINATION REPORT FOR THE CONSENTING STUDY, HELD ON 28 FEBRUARY 2023 AT MU-JHU.
Participants were contacted and invited for the dissemination meeting including the health workers, pregnant women, male partners, and stakeholders. The activity was successful, with 40 Members attending the meeting including:
- 5 male partners
- 5 Stakeholders
- 30 pregnant and breastfeeding mothers
- 3 staff
Phiona welcomed the participants and thanked them for honoring our invitation and coming for the dissemination meeting.
Prayers were led by the Muslim religious leader, a representative of one of the stakeholders.
The PI thanked the participants for coming and welcomed them to the meeting, asked them to ask questions and be interactive during the session.
Presentation topic: Improving informed consent for clinical vaccine trials in pregnant women in Uganda- Consent study.
- Background – Explained to the participants the background of the study; why the study is being conducted, why consenting for maternal vaccine trials is important, and finding the best option for delivering trial information to pregnant women is critical.
- Aims of the study – Aim was to explore attitudes and experiences of pregnant and breast feeding women and their partners taking part in the maternal vaccine trials, and how the prevention trials can be improved to recruit and retain participants in the clinical trials.
- Key research questions – An explanation of the main research questions was given, including: the level of current understanding of information in existing clinical trials for pregnant women, their families and the wider community, the drivers and barriers to involvement in clinical trials, who should be involved in decision making, the current understanding and experience of the consenting process
- Data Collection: Explained the methods we used for collecting data from study participants, and also explained that we used thematic data analysis to analyze the data.
- Findings- Emerging themes from the study were discussed including: health education, antenatal visits, peer talk and support, decision to join clinical trial, benefits of receiving a vaccine, fears about the vaccines, benefits of taking part in current vaccine trials, challenges to participation, signing consent, role of a witness, information shared, current methods/mode of sharing study information, and confidentiality.
Discussion
Participant were divided into four groups and given 20 minutes to discuss four questions.
Questions of discussion
Question 1: What are some of the important points shared from the presentation of study findings?
Question 2: Are the findings/results presented similar to what you have experienced?
Question 3: Which information can you personally share with other people and pregnant mothers in your community?
Question 4: How can you motivate or encourage another person to participate in a maternal vaccine trial?
| Questions | Group 1 responses | Group 2 responses | Group 3 responses | Group 4 responses |
| What are some of the important points shared from the presentation of study findings? | Child spacing Family planning -Sharing with our husbands Visiting the health workers for family planning (Yellow flowers)
| The impact of using the local herbs. Immunization The outcomes of the study benefit the mother and the baby. You have medical access to every challenge you face. Prevention of the disease they are researching about. To find out your HIV status.
| When men are involved in the study we don’t get domestic violence. The vaccine helps us because we produce children who are healthy. The vaccine boosts the immunity of the mother and the baby The study helped us discover different types of family planning. | Not taking or drinking any medicine we find in the community. We have to be extra careful when using the medicine, the medicine we are given for example checking for the expiry date. We have leant that’s always important to visit the hospitals with our partners.
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| Are the findings/results presented similar to what you have experienced? | Yes, family planning stopped my periods for eight months. Yes, the local herbs help better than the scientific ones. Yes, we received the vaccine and didn’t get any side effects. Yes, family planning is more effective when used better or well as advised by the health workers. Yes, we use the local medicine but we still get Perineal tear while the baby is coming out. | Some of our partners don’t want us to participate in research because there so many visits to the hospital. The medicine has not helped some of us because I personally got a problem with my heart after getting vaccinated. | ||
| Which information can you personally share with other people and pregnant mothers in your community? | To go to hospital and get education about the different ways of keeping healthy like feeding and exercising. To go and get the correct information about family planning and the ways it works. To avoid advice from other people in the community. To get advice on how to use drugs in the right way. To advise the mother to visit the hospitals with their partners. Encourage women to give birth from the hospital. To maintain hygiene and sleep under mosquito nets. | To maintain good balanced diet. You must consent, and have a witness. Advise pregnant mother not to use local herbs when they are pregnant. Visiting health workers for the help and medical advice To advise pregnant mothers to sleep under the mosquito net and to do exercise. To take the medicine as advised by the health workers.
| By advising them to go for vaccination because it protects the mother and the baby during delivery. By showing them the benefits of vaccination to the mother and the baby.
| Pregnant women should start going for antenatal early. To take part in clinical trials when you have all the requirements Those who join the research should try to complete the study, avoid dropping off or withdrawing from the study. Visit hospitals after giving birth, for postnatal.
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| How can you motivate or encourage another person to participate in a maternal vaccine trial? | By telling them the experience you went through. Encouraging them to see medical doctors/workers. It’s always important to join because it saves the unborn baby and the mother from diseases.
| We have understood the different types of family planning and the way they work. We have learned that people in the community should work together to ensure that they take all their children for immunization in order to get rid of diseases in the community.
| Encourage them to get the advice from the doctors. Receiving care from the health workers when you are pregnant and after giving birth. You get a chance to get a full body checkup. Ask the government to bring doctors like those in research to the general hospitals.
| To tell them that it saves money because you don’t spend money. By explaining to the benefits of the study. The health workers give you care and work on you without asking for any money. You have a chance to ask doctors question about anything, any time, whether day or night. They can work on you any time you show up |
Questions/ Reactions
- Why is it that when our women use family planning “they don’t cross the red sea” (they don’t get monthly menstruation? And they lose libido?)
- Is it safe to continue using local herbs for softening the pelvis bones?
- Why is it that they use pregnant women in these clinical trials and no other people?
- Why are the health workers limited to getting pregnant women only in hospital, yet even in the community they are there?
- Why do the health workers visit us at home?
- Why is it the vaccine is not given to the baby at birth instead of vaccinating the baby.
Responses
- Concerning family planning, a number of women gave their views according to what the health workers had taught them, the health workers encourage them to do child spacing.
- Some women support the use of local herbs, like using it for showering, that is okay.
- The stakeholders also responded to some of the questions.
- All the questions were responded to and some of the questions about the study, participants were told to ask the health workers in the study.
Suggestions and Recommendation.
- I suggest that pregnant women should be recruited earlier into the studies so that they don’t ask them many questions in late stages of pregnancy.
- Since participants are negative being home visited, they should talk to the mothers and find out why, if it’s the partners who refuse the mothers to be home visited then the health workers should talk to the mothers and find out which time is suitable to be do the visit without any distractions.
- I would like to encourage pregnant women to go the hospital for check-up before they start using any medication.
- The health workers should also leave the hospitals and go to the communities and sensitize people about vaccine trials, they are so many pregnant women who are willing to join research in the community but they don’t know about it.
- They should continue sensitizing pregnant women about maternal vaccines in the community, because we see very many mothers where we live who are not in good conditions, but through this research they can be helped.
- Home visits should continue because it’s the mothers and the baby who benefit, “My wife was for C-section but I liked it very much when they health workers came to check on her and the baby, I think that’s why we have a healthy child”.
- They should continue telling us about the proper use of family planning, and the different types we should use when we are breast feeding.
- Women should be wise when they are welcoming health workers, for me I used to talk to the health workers and they used to approach me as my other normal visitors’ no one could tell that they are health workers, because they don’t wear uniforms.
- VHT encouraged women to use the family plaining properly to avoid unwanted pregnancies, it’s very helpful in bring up healthy children.
- Appreciated the GBS health workers for being very caring and requested that the government should hire health workers like those in the GBS study.
Closing remarks.
The PI gave closing remarks to the participants and thanked the participants for participating actively in the meeting, the meeting was ended with a closing prayer.
