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. Author manuscript; available in PMC: 2024 Jun 1.
Published in final edited form as: J Pediatr. 2022 Nov 17;257:113271. doi: 10.1016/j.jpeds.2022.11.012
ITEM & QUESTION(S) SCORE QUOTE & EXPLANATION
Understanding U2: Interview on Sensitive Topics
What sorts of things will people have to do if they agree to be in the study?
0= Does not mention the interview/survey
1= Says interview, but unclear about topics
2= Says interview will be on sensitive topics, or lists these topics (e.g. HIV, reproductive health).
2 “When we enter in the tent, the health care worker begins interviewing you. She asks you that are you married? if you are married, then you tell her She asks you that do you have children and then you tell her. If you have three children, you tell her that I have three children. She asks you that how many sexual partners have you had for the past year. Still you tell her. From the year, then she asks you about a month and then week”.
-44 year old female parent
Explanation: Participant clearly stated that interview includes asking about sensitive topics
1 “The questions being asked to the participant.”
-12 year old male adolescent
Explanation: Participant said interview but did not mention that it will be on sensitive topics
0 “I do not know about those. I do not remember them.”
-13 year old female adolescent
Explanation: Participant is unable to answer the question
Understanding U6: Loss of Confidentiality & Sensitive Topics
What are some risks about potentially participating in this study?
0= Does not mention loss of confidentiality with survey or HIV test, nor mention discomfort or sensitive topics
1= Vague answer, cannot provide adequate detail
2= Mentions potential loss of confidentiality and/or discomfort with sensitive topics
2 “If the results are kept well they cannot be known to anyone however, if they are not kept well and people know them it may affect my life”
-12 year old male adolescent
Explanation: The participant mentions confidentiality and how a breach would affect their life
1 “When the person decides not to share the results with other people”
-14 year old male adolescent
Explanation: Participant shows some understanding of privacy but answer is vague and they are unable to elaborate further
0 “Because as a participant, you must have wanted to get involved and consented to participate in the project study and if you want to know your health status, you stay in touch with that project”
-37 year old female parent
Explanation: Participant believes that getting involved in the RCCS negates any discomfort or loss of confidentiality
Appreciation A2: Reasons for Recruitment
Do you believe you have been asked to participate in this study for your personal benefit or for the benefit of society or both?
0= Believes they were personally recruited for personal benefit only
1= vague answer, unsure of answer
2= Understands that they were invited because they met inclusion criteria, and that while they personally may benefit, the ultimate purpose is science OR – says both and connects their personal benefits to the larger research study
2 “Not for personal benefit. This is a program for the project [RHSP]. They want to see a way forward in research. I am expecting feedback on how research has reached. Like the blood sample drawn from us.”
-45 year old male parent
Explanation: Participant stated that they are recruited for research.
1 “It is for both to benefit. Benefiting from the research. I can know my HIV status, and how I can protect myself from HIV” -19 year old male adolescent
Explanation: Participant states both but only describes how they benefit from the research
0 “For personal benefit. I get access to free medical care”
-14 year old female adolescent
Explanation: Participant believes they were recruited just to receive medical care and not for a research study
Appreciation A3: Personal Outcomes
Is it possible you may not benefit or even be harmed from this study? Why or how?
0= Does not know, vague answer, unsure
1= Mentions harm OR benefit
2= Is able to explain how they may or may not personally benefit, AND may even be harmed from participating in the research (e.g. receiving health care, loss of confidentiality, bruising from blood draw)
2 “Researchers are experienced and know what they are doing so I donť expect to get any harm. In addition, after the interview, I get my HIV test results. I might feel bad if someone else gets to know my personal information”
-16 year old male adolescent
Explanation: Participant stated knowing HIV status as a personal benefit, and loss of confidentiality as a potential harm.
1 “No iťs impossible for you not to benefit first of all you will get to know your health status and to me that is very beneficial”
-42 year old male parent
Explanation: Only personal benefit to participate is mentioned. Participant did not explain any potential harm
0 “No iťs impossible not to benefit”
-10 year old female adolescent
Explanation: Parenticipant gives a vague answer, beliving they will always benefit, but cannot elaborate further
Expression C1: Able to express a choice
Do you want to participate in the RCCS? Why or why not?
Whose decision would it be to participate in the RCCS?
(For adolescents) Is participating your choice, your parenťs choice, or both of your choices?
0= Does not state a choice to participate or not participate
1= Uncertain, state more than one choice, says it is someone else's decision
2= Clearly states a choice
2 “Musawo [Lugandan word for healthcare worker] I wanted to know my status whether I am sick or whether I am okay. Yes musawo, I made the decision by myself because at first, I thought about it until when I finally made the decision”
-44 year old female parent
Explanation: Participant clearly stated a choice
2 “I decided for myself after my father and mother had allowed me because they would not take me without my consent. I had to decide for myself”
-18 year old male adolescent
Explanation: Participant describes how they came to a decision and also discussed it with their parents.
1 “Uhhu…, it was all over sudden, I was just told that you are now going to participate in research. I was not present, and my mother registered my name, [during RCCS census exercise]”
“I also decided to join RCCS. The decision for my participation involved both my mother and father”.
-37 year old female guardian
Explanation: Participant did not clearly express their own choice to participate. They mentioned that the decision also involved their parents
0 No participants received a zero on this question
Reasoning R1: Comparative
For participants 15+ years old : You decided to participate in the RCCS. Why is participating in RCCS a better decision for you than not participating in RCCS?
For partiicpants 10 – 14 years old : You said that you wanted/did not want to participate in the RCCS. Why is/is not participating in RCCS a better decision for you than not participating in RCCS?
0= Makes no comparative statements
1= States a comparison, but gives no differences
2= Offers at least 1 statement in the form of a comparison of two options, with the comparison stating at least one specific
2 “You know when I participate in the RCCS research, I can know my HIV status. I can know whether I have syphilis or not and know how I can be helped. However, if I have not participated in the RCCS research, I cannot know my status and I cannot be helped to get medicine”
-47 year old female guardian
Explanation: Participant clearly stated a comparative statement. Identifying why participating in RCCS is a better decision for her than not participating in RCCS
1 “It is good because I get free treatment and I also learn a lot”
-56 year old female parent
Explanation: Participant states the positive. but does not give differences. Answer is also vague - “learn a lot”
0 [Participant stays silent] “I find the question difficult”
-10 year old female adolescent
Explanation: Participant was unable to answer the question
Reasoning R3: Mapping to Daily Life
How might these risks and benefits affect your daily life?
0= Gives no reasonable everyday consequences, even with encouragement
1= States only 1 reasonable possible effect of participating on their everyday life, relationships, or social activities
2= States at least 2 reasonable possible effects on their everyday life, relationships, or social activities
2 “When they test me for HIV and results show that I am negative, I continue to protect myself against HIV… When I swell the vein or get bruises, I might experience pain in the hand which might cause failure to do daily activities very well like lifting heavy things.”
-16 year old male adolescent
1 “They help me to be healthy and not to worrya lot. You may have issues that are worrying you, but if you get counselling all your worries will disappear. When you are not worried your heart will not be affected. Every time you are worried,your heart will be affected. You may even find yourself losing weight. Personally I know that worry is very dangerous it can even lead to death
-44 year old female parent
0 [Participant stays silent]
-13 year old male adolescent
Explanation: Participant was unable to answer the question, even when asked multiple probes