“I think the parent should be there because no one was born alone”: Kenyan adolescents’ perspectives on parental involvement in HIV research

Abstract

Despite a pressing need for adolescent HIV research in sub-Saharan Africa, ethical guidance for conducting research among minor adolescents is lacking. One ethical issue is the degree to which parents should be involved in the research process. The existing discourse is predominantly speculative and focuses on negative consequences of parental involvement. We use empirical data to describe Kenyan adolescents’ perspectives on parental involvement in consent and disclosure of HIV test results within a research study context. We conducted two rounds of focus group discussions with 40 adolescents in Western Kenya to ask about minor adolescent participation in HIV research. We analysed data using codes and matrices. Kenyan adolescents were largely in favour of parental involvement during the research process. Half felt adolescent minors should solicit parental consent to participate, and nearly all said parents should learn adolescent minors’ HIV test results in order to provide necessary support. From their perspective, involvement of parents in research extends beyond obtaining their consent to providing essential support for youth, regardless of HIV status, both during and beyond the research study. Ethical guidelines that prioritize adolescent autonomy in research must take into account reasons to involve parents considered important by adolescents themselves, particularly in low-resource settings.

Introduction

AIDS is the leading cause of death among 10–19 year olds in Africa (All In, 2015), and 4 out of 5 of the 2.1 million adolescents infected with HIV live in sub-Saharan Africa (Idele et al., 2014). Yet there are substantial gaps in knowledge of how to curb the epidemic among adolescents, in part because they are persistently underrepresented in HIV research. Effective interventions for adolescents require a greater understanding of how childhood vulnerabilities affect both HIV risk and treatment (Idele et al., 2014; Slogrove, Mahy, Armstrong, & Davies, 2017). As such, there is growing consensus regarding the necessity to conduct HIV research with youth under age 18 (Katusiime, Parkes-Ratanshi, & Kambugu, 2013; Lall, Lim, Khairuddin, & Kamarulzaman, 2015; Phillips & Mbizvo, 2016). Concurrent with the need to conduct research with adolescents in sub Saharan Africa is a call for consistent and unambiguous guidance on ethical issues pertaining to their involvement in the research (Slack, Strode, Fleischer, Gray, & Ranchod, 2007; Slack, Strode, Grant, & Milford, 2005).

One particular ethical issue regarding research with adolescents is the degree to which parents should be involved in research on sensitive topics. Parents have typically been involved in deciding whether to permit their child to participate in research (Schenk et al., 2014), and in the disclosure of study medical results, in order to maintain key ethical principles in research, including respect for persons and beneficence (Hester, 2004). Minor adolescents (i.e., those adolescents who are under the legal age of consent) are typically considered a vulnerable population of human subjects because of concerns about their developmental capacity to understand the potential risks and benefits of research participation and to receive medical results in a research study (Joint United Nations Programme on HIV/AIDS [UNAIDS], 2012). There are also concerns that adolescents may be easier to coerce into participating in research than other populations (Hester, 2004).

Given these concerns, extra precautions are in place to protect adolescents’ ability to autonomously participate in research so that their risk of harm as participants might be minimized. One such precaution is that researchers are required to obtain consent of a parent or guardian in order for adolescent minors to participate in a research study, unless there is an exception in particular contexts (e.g., such as those in place for individuals below the legal age of consent who are emancipated minors, based on their marital status, parenthood, or some other characteristic) as authorized by national legislation (National AIDS and STI Control Programme [NASCOP] & Kenya Medical Research Institute [KEMRI], 2015; UNAIDS, 2012). Exceptions notwithstanding, researchers are typically expected to obtain parental consent and adolescent assent for individuals under the age of 18 (Hester, 2004).

In HIV research, existing scientific and policy discourse on the requirement of parental consent for adolescent participation is predominantly speculative (DiClemente, Ruiz, & Sales, 2010; Folayan, Haire, Harrison, Fatusi, & Brown, 2014; Jaspan et al., 2008; Pomfret, Karim, & Benatar, 2010; Zuch, Mason-Jones, Mathews, & Henley, 2012) and focuses on two anticipated negative consequences of making parental consent a requirement (Zuch et al., 2012). One negative consequence is that youth who have to involve their parents will not partake in the research, i.e., “obtaining parental consent represents a significant barrier to participation of adolescents in HIV biomedical prevention research” (emphasis added) (DiClemente et al., 2010, page 3). A second negative consequence is that parental consent affects adolescent confidentiality regarding their sexual behaviour and health and their ability to participate freely and fully and therefore infringes on “adolescents’ right to dignity and privacy” (Zuch et al., 2012, page 1) thereby placing “children at odds with their parents” (Mathews et al., 2005, page 1269). While these anticipated negative consequences are typically discussed in relation to obtaining parental consent, they apply to parental involvement in HIV testing and disclosure as well. That is, it is conceivable that adolescents may not participate in a research study where parents will learn about their sexual activity and HIV status during HIV testing (Flicker & Guta, 2008).

What the (largely speculative) scientific and policy discourse does not mention are potential positive aspects of parental involvement in research – even in the highly personal realm of sexual behaviour. Also largely absent are the perspectives of prospective adolescent HIV research participants—especially adolescents living in sub-Saharan Africa. In our own review, we found a few articles on perspectives of sexually active teenagers regarding parental involvement, mostly in the United States (Alexander et al., 2015; Fisher, Arbeit, Dumont, Macapagal, & Mustanski, 2016; Flicker & Guta, 2008; Mustanski, 2011). There was, however, a noticeable gap on the perspectives of African adolescents, particularly beyond South Africa (Jaspan et al., 2010; Mathews et al., 2005), despite recognition that whether or not to obtain parental consent is context specific and the most appropriate approach for determining the degree of parental involvement needs to include the community (Flicker & Guta, 2008; UNAIDS, 2012).

The purpose of this empirical paper is to describe Kenyan adolescents’ perspectives both on obtaining parental consent and on having one’s parent in the room when receiving HIV test results in an HIV research study involving adolescent minors, which in Kenya includes adolescents under the age of 18 who are not legally emancipated (NASCOP & KEMRI, 2015).

Methods

Background and setting

This study is based on the formative phase of a larger empirical study on ethical issues in adolescent HIV research. To solicit community feedback to inform study protocols, we created three adult Community Advisory Boards (CABs) and four Youth Advisory Boards (YABs). From April to August 2015, we conducted two focus group discussions (FGDs) with each CAB/YAB. The current study is limited to data from the YABs.

The study was conducted in Siaya County in western Kenya (formerly part of Nyanza Province). With a prevalence of 17.8%, Siaya County has the third highest HIV prevalence in Kenya (National AIDS Control Council of Kenya, 2014).

Procedures

We recruited participants by consulting staff of institutions working with youth (i.e., schools, youth centres and compassion homes). We purposively sampled youth by sex, age group (15–17 or 18–19), HIV status, and current school enrolment (yes/no). Forty adolescents participated in the FGDs; half were female. Over one-third had completed high school and three-quarters were still in school. One-fifth self-identified as HIV-positive.

We used semi-structured guides for FGDs. In Round 1, we used a vignette to ask questions about a hypothetical minor adolescent named Tom (or Rita, for females) (see Box 1 for the vignette). The vignette, by means of story-telling, worked progressively from general questions about the acceptability of adolescent participation in HIV-related research, to appropriate means of recruiting adolescents, acceptability of joining studies without parental consent, different approaches to HIV testing and disclosure of status, provision of ancillary medical services, and potential community responses to Tom or Rita’s involvement in HIV-related research. Through the vignette, FGD participants were told that: the research study was about HIV; male and female adolescents between 15–17 were being recruited; parents or guardians must give their consent; HIV testing would be involved and both parent/guardians and adolescents would be told the results; and participants (in accordance with Kenyan HIV testing policy) would be offered services such as referrals for HIV treatment (if found HIV-positive) or counselling on sexually transmitted diseases. During the narrative, investigators probed participants how they felt about having to seek parental consent, and how they felt about having their parents learn their HIV test results in the context of a study. In Round 2, we did not use a vignette but instead asked follow up questions about parental involvement and risks and benefits to participation (see Appendix 1 for the FGD guides).

Box 1. Vignette Guiding Focus Group Discussion:

Rita is 16 years old and lives with her mother. She is an orphan having lost her father four years ago. Rita was born in Kogelo and is now in Form 1 at a local day school. She has four siblings and is third born. For the past few months, several activities have been held near Rita’s home to inform the community about an ongoing HIV research study and to recruit female and male adolescents aged 15–19 years for the study. Rita’s mother has seen posters with information about the study at the nearby health facility and on walls at the shopping center. Some researchers also talked about the study at the last baraza at the chief’s camp and told people in the community what to do if they were interested in participating in the study. Announcements about the study were also made at some worship places and fliers with information about the study were given to everyone in the worship place that day. Yesterday, Rita came home with a similar flier about the same study that she was given at school. Rita and her mother decide to go to a meeting at a nearby worship place that adolescents ages 15–17 and their parents or guardians have been invited to attend. At the meeting, research staff provide a brief description of the research. They say that participation in the research study is voluntary. They also say that for an adolescent aged 15–17 to participate in the research study a parent or guardian must give permission and the adolescent must assent. This can be done by signing or putting a thumb print on a form. Attendees were then given an opportunity to ask questions in the group meeting or to consult privately with a research staff. Rita went to speak privately with one of the research staff. She asked the staff why parental permission is required. Rita is still talking to the research staff, who told her that all adolescents who participate in the study will be tested for HIV and told their results. Adolescents who are aged 15–17 years must come with a parent or adult relative for the HIV test. There is no choice. But adolescents can choose whether they want their parent or guardian to be in the room during the testing and disclosure of results.

At each round, we conducted 4 separate FGDs, stratified by age group and gender for a total of 8 FGDs. Each FGD had between 7–11 participants, was facilitated by trained research personnel and lasted approximately 2.5 hours. Facilitators spoke in languages preferred by participants (English, Luo, and Kiswahili); most sessions were conducted using a mixture of the three languages.

Protection of human subjects

Written informed consent was obtained before participation. Specifically, for adolescents younger than 18 years old, parent/guardians provided written consent and youth provided written assent; individuals 18 years or older provided written consent. Participants provided demographic information (including HIV status) individually to research staff before the first session. Youth were advised not to disclose their HIV status during FGDs to maintain confidentiality. The entire study – which included the protocol for and the FGD discussions with the YAB’s – was approved by the institutional review boards of the Pacific Institute for Research and Evaluation (PIRE) and the Kenya Medical Research Institute (KEMRI).

Analysis

FGDs were audio recorded, and a member of the research team took notes. Transcripts were prepared by a research team member who had been present at the FGD and were reviewed by the PI and research team for accuracy. Analysis proceeded in several steps. First, we read transcripts in-depth immediately after each transcription and again once all data were available (Bernard, 2013). Second, we created a codebook containing deductive (e.g., parental consent for participation in study, why there should be parental consent , and exceptions to parental consent) and inductive codes (e.g., negative reaction after learning HIV status and HIV stigma). Third, using Atlas.ti (Muhr, 2004), two authors (AG and BI) coded and compared a single transcript to ensure systematic coding. Subsequently, the first author coded the transcripts and synthesized key findings by writing memos (Birks, Chapman, & Francis, 2008). The co-authors discussed emergent findings on parental involvement and the first author then created matrices (Miles & Huberman, 1994) to compare similarities and differences in perspectives on parental involvement by demographic characteristics. The matrices were organized into three sections, one section included all of the quotes where participants felt parents should provide consent, another section included all of the quotes where participants felt parents should not have to provide consent and a third section where participants described ambiguity in whether parents should provide consent. The co-authors met regularly to further interpret and discuss findings.

Results

There was variability across the 15–19 year old Kenyan adolescents with respect to whether they felt minor adolescents (i.e., those under 18) should have to solicit their parent’s consent to participate in an HIV research study that included HIV testing and counselling. Specifically, half of the participants felt that minor adolescents must seek parental consent, one-quarter had mixed feelings about parental consent and one-quarter felt minor adolescents should not have to solicit parental consent to participate. These findings did not differ based on the age of the focus group participant. There was substantially less variability across the 15–19 year old participants when it came to minor adolescents having their parents with them when they learned their HIV status within the HIV research study: all but one felt that it would be valuable for adolescent minors to have their parents involved. We elaborate on these two main findings below.

Adolescent perspectives on parental consent for minors

More than half of all participants, and a majority of HIV-positive participants, who spoke about consent felt minor adolescents must seek their parents’ consent to participate in HIV research. Participants suggested it was normative for parents to know their whereabouts. As such, if an adolescent minor did not tell their parent they were going to participate in research, there would be consequences:

For example, if I came here and my parent does not know where I am, she can beat me thoroughly when I go back. (HIV-negative, 18–19 female)

While some participants focused on negative repercussions of parents finding out that their child had participated in a research study without consent, others reflected on why parents would want to know. Specifically, they discussed how parents who knew their adolescent minors whereabouts would take care of them if something happened.

Only one participant suggested parents needed to protect minor adolescents from deception while involved in the research study:

If he goes for a meeting he will be free if the mother signed (gave consent). When he is free he can be asked questions and he can answer. Let’s say the mother has not signed. He can be asked a question that is not in the main agenda of the study. (HIV status unknown, 15–17 male)

The other participants either felt conflicted or thought minor adolescents should not have to solicit parental consent to enrol. Those who gave reasons for and against parental consent thought parents might not understand why they were interested but felt their lack of understanding should not preclude them from enrolling. On the other hand, these same participants thought parents should provide consent as legal guardians and also felt that parents could protect adolescent minors (if needed) from community gossip about their involvement in the research study.

About a quarter of participants thought minor adolescents should have the autonomy to enrol without parental consent, as described here:

I think you are the young generation and it is your life. You should participate and know more and be ready for future life. So I think permission is not that important. (HIV-negative, 18–19 male)

These participants focused on the minor adolescents’ right to access information about HIV through research regardless of how parents feel. They were not against parental consent because of fears about sharing information about sexual behaviour with parents. Rather, they felt the adolescent minor should not miss the opportunity to be involved if the parent was not readily available to give consent or refused.

Adolescent perspectives on having the parent present during HIV testing and disclosure

An overwhelming majority of participants felt that parents of minor adolescents should be present for part or all of HIV testing and disclosure, even among those who felt conflicted about or against mandatory parental consent. A smaller portion of participants were less certain parents should be present during HIV testing, and one participant felt that minor adolescents should be able to learn their results alone.

The primary reason participants felt parents should be present for part or all of HIV testing and disclosure was because they felt adolescent minors wanted their support. Such support was perceived as particularly important for those minors receiving an HIV-positive diagnosis during the study, as one participant noted:

When you are positive your parent can counsel you more than the doctor. You can be counselled by the doctor and maybe you are not concentrating to what the doctor is telling you but you can understand your mother better. So it is good for your parent to be there. (HIV-negative, 15–17 female).

Similarly, all HIV-positive participants who spoke about the potential of a minor learning their result during a study felt parents should be present to maximize benefits and minimize harms, as described by these two participants:

Why? This is an adolescent and an adolescent you can’t trust with decisions. He may make wrong or right decisions…He may say this is the end of life and he is going to hang himself and that is how he will end his life. What if he was there with the parents? A parent always wants the best for his or her child. He will take him, take him for the drugs and take care of him. He is guaranteed of everything that will come. So there is need for the parent to be there for the disclosure of the results. (HIV-positive, 18–19 male)

I think she [the parent] should be there because no one was born alone. There is a time you will still need others. So she should be included even during the results. (HIV-positive, 18–19 female)

While many participants focused on the important role that parents would play for HIV-positive adolescent minors, a few also described how parental presence would benefit HIV-negative adolescent minors because their parents could help them remain HIV-negative.

On the other hand, a quarter of the participants, mostly males, felt conflicted about whether or not a parent should be present when an adolescent minor undergoes HIV testing and disclosure. Many of these young men were uncomfortable with the idea of sharing their sexual behaviour and upsetting their parents. Despite these concerns, nearly all also said parents should be involved, as reflected by this participant:

I think going with the parent is good because the parent can know the way to handle you even when there is a problem. If you are sick, he will know how to handle you and the type of services he can give you. And I also think that going with the parent is also not good. Some parents cannot be pleased with the results which they (adolescents) get there. They may know that there are some things you have been hiding from them. (HIV-negative, 15–17 male)

Only one seventeen-year-old, HIV-negative participant who had previously tested without her parents’ knowledge, felt unequivocally that parents should not be present when adolescent minors test for HIV in the context of a research study because it could lead to conflict.

Discussion

Kenyan adolescents in our study were largely in favour of parental involvement in HIV research with minor adolescents. While half of the adolescent focus group participants thought researchers should solicit parental consent, the other half were mixed or against it. However, participants were overwhelmingly in favour of having parents learn minor adolescent’s HIV test results during a research study, even among those conflicted about mandated parental consent to participate. Our findings contrast existing scientific and policy discourse on parental involvement in adolescent research and provide an important contextualized perspective on the potential benefits of such involvement for Kenyan adolescents.

In both our study and the few other qualitative studies asking adolescents about parental involvement in HIV research (many of which have been conducted in North America), there are at least some adolescents who see value in minor adolescents having to obtain parental consent to enrol in studies. On the other hand, in each of these reports, including our own, there are also some adolescents who disagree that adolescent minors should have to seek parental consent (Alexander et al., 2015; Fisher et al., 2016; Guadamuz, Goldsamt, & Boonmongkon, 2015; Mustanski, 2011). Yet the heterogeneity across youth in preferences regarding parental consent tends to be downplayed, and as such, the scientific and policy discourse primarily frames parental consent as an impediment to essential research and development of interventions for adolescents, as well as a potential breach of adolescents’ right to dignity and privacy.

Perhaps more important than the question of parental consent for those under the legal age of consent is the degree to which parents should be involved throughout the research process. This question has been neglected in the scientific and policy discourse. Most participants in our study, regardless of their age, thought minors should have their parents with them when they received their HIV test results because the need for support outweighed the fear of discussing sexual behaviour. In fact, some participants who thought adolescent minors should have the autonomy to consent for themselves for research participation still thought parents should be there when minors received their results. Ethical guidelines that focus on parental involvement specifically for the purpose of enrolling an adolescent minor into a study fail to account for the bigger picture: adolescent minors are embedded in relationships with partners, peers, families and communities (Richter, 2010), and they rely on these relationships for support. Further, these relationships (particularly with family, for minor adolescents) will likely continue long after the research has ended. As such, the ethical issue at hand is not solely about whether parental consent is necessary, but also, how and when in the research process should parents be included in order to maximize the responsible and effective conduct of health research with adolescent minors.

Adolescents in our study described the substantial role parents have in their lives and as such, many thought adolescent minors would desire their support both when receiving their HIV results and thereafter. Our findings align with family-centred care literature, which recognizes and capitalizes on the family as the basic unit of care for children (including adolescents) since they wield extraordinary influence on their child’s health and wellbeing (Donenberg, Paikoff, & Pequegnat, 2006). Our findings are also consistent with empirical literature on the importance of parents in adolescent HIV prevention and care. Specifically, parents can positively impact sexual behaviour for HIV-negative youth (Buzi, Smith, & Weinman, 2009; DiClemente et al., 2001; LaSala, 2007) and early and ongoing caregiver involvement and support is associated with better medication adherence for HIV-positive youth (Adejumo, Malee, Ryscavage, Hunter, & Taiwo, 2015; Denison et al., 2015).

However, there is a dearth of research on parents’ reactions to learning that their adolescent has HIV in sub-Saharan Africa. This gap exists since most research on disclosure with this population focuses on disclosure of vertical transmission (i.e., where the parent discloses to an adolescent that the adolescent acquired HIV from the mother during the perinatal period), and not horizontal transmission (i.e., where the adolescent discloses to their parent that they have been infected as an adolescent through sexual behaviour or intravenous drug use) (Adejumo et al., 2015). One qualitative study in South Africa found that parents were supportive of their pregnant adolescent daughters when learning of their HIV-positive status, which they stated they acquired through heterosexual activity. Parents were initially upset when learning about the pregnancy, but a majority of the young women reported high levels of support after their parents got over the initial shock (Hill, Maman, Groves, & Moodley, 2015).

There are, of course, potential risks to parental involvement, such as anger or violence over their child’s sexual behaviour or HIV status (Wolf et al., 2014), particularly for youth living in violent households (Baumgartner et al., 2015). Among adolescents in sub Saharan Africa who were not infected perinatally, HIV is primarily acquired through sexual contact (Idele et al., 2014). Thus, it is critical that future research document the specific experiences of adolescents and parents when they learn about the adolescent’s sexual behaviour as part of the HIV testing and disclosure process. Given our gaps in knowledge, continued monitoring of the risks and benefits of parental involvement in future research on disclosure with non-vertically infected youth is needed.

Ethical implications

Our findings do not show that all studies in Kenya involving minor adolescents should require parental consent. Instead, they indicate that a majority of adolescents in this context think there are substantial reasons to involve parents in the process of deciding to join research and throughout the course of research participation. Adolescent minor research participation without parental consent is not unheard of, and sometimes done (Knopf et al., 2017; Schenk et al., 2014; Singh et al., 2006), but seems to be considered undesirable among many of our Kenyan adolescents. This was brought into sharp relief in the specific cases of studies involving HIV testing and disclosure of HIV status in other contexts (Alexander et al., 2015; Fisher et al., 2016; Guadamuz et al., 2015; Mustanski, 2011). Our adolescent participants, and especially those who were HIV-positive, felt that adolescent minors would want parental support when receiving and absorbing the implications of their diagnosis within the context of a research study. This finding provides some support for the position that parents should be involved in all research studies offering HIV testing to minor adolescents since researchers cannot predict who will test positive. The needs of those who test positive will likely be greater than those who test negative because the latter will possibly not have to disclose anything about their sexual behaviour to their parents. However, HIV-positive adolescents will automatically have information about their sexual behaviour revealed (unless they were infected via other routes of transmission). Therefore, there is less at stake for those adolescents who have their parents in the room when they are learning their HIV-negative status because their confidentiality is more likely to be upheld and they are not experiencing a potentially life altering diagnosis.

Our findings differ somewhat from Kenya’s HIV testing guidelines, in which adolescents age 15 and older are permitted to test alone, and in which disclosure to significant others (including parents) is encouraged but not mandated (NASCOP, 2015). Research guidance in Kenya has made explicit provisions for adolescent participation in research without parental consent, at increasingly younger ages, and justifies these provisions by invoking the value of personal autonomy (NASCOP & Kenya Medical Research Institute, 2015). Our findings suggest that the concept of the adolescent as it appears in research ethics guidance (as an ‘autonomous young individual’) is not one which resonated with all adolescent Kenyans in our study. There is a need for more research to understand adolescent minors’ actual experiences participating in biomedical HIV research. There is also a need for research to understand adolescent minors’ experiences with HIV testing and disclosure outside of the research context to fully understand the benefits as well as the risks to parental involvement. Finally, there is a need for ongoing conversation with research ethics’ committee members and policy makers to inform future research guidelines in Kenya. In future iterations of research guidelines, stakeholders should take into account the diverse needs and situations of adolescents, and should craft context-sensitive guidance that neither mandates that parents be involved nor mandates their exclusion in order to promote adolescent autonomy.

Limitations

One limitation of our study is that we did not assess characteristics of youth in our sample beyond their age, gender, education and self-reported HIV status. As such, we do not know whether and how other aspects of their identity (e.g., sexual orientation) and risk behaviour (e.g., sex work or substance use) might influence their feelings on parental involvement in HIV research. A second limitation is that focus group questions were hypothetical and not specific to adolescents’ personal experiences in research due to a need to maintain confidentiality. However, the FGDs were often used as springboards for talking about personal experiences, so some of the latter were captured, albeit imperfectly. A third and related limitation is that conducting focus groups precluded us from eliciting sensitive personal narratives about learning one’s HIV status. One strength of the larger study is that we are enrolling adolescents in a research ethics study to empirically assess the risks and benefits of learning HIV results in the context of a research study. The larger study will build on the current study, which to our knowledge, is the first to elicit the perspectives of Kenyan youth on adolescent HIV research.

Conclusion

There will continue to be debate regarding the degree to which parents should be involved in HIV research with minor adolescents as researchers and ethicists attempt to balance ethical principles of respect for persons and beneficence. Given the concerns that the requirement of parental consent impinges on the ethical principal of respect for persons, ethics guidelines should continue to take into consideration whether and how mandated parental consent affects adolescent minors’ participation in HIV research and subsequent findings. On the other hand, in order to maximize beneficence, or do no harm, ethics guidelines must also be attentive to the potential risks of conducting HIV testing and disclosure research with adolescent minors who do not have adequate support throughout the research process and beyond. While in some contexts, it may be entirely appropriate and necessary for adolescent minors to consent for themselves, it is ethically imperative that researchers recognize and respond to the fact that even in such contexts, adolescent minors, and in particular, HIV-positive adolescent minors, are highly vulnerable. As such, researchers are responsible for ensuring that adolescents have access to appropriate support. For some Kenyan adolescents, this support appears to be best provided by parents.

Focus Group Discussion Guides for Community Advisory Board (CAB) and Youth Advisory Board (YAB) Round 1 and 2 Sessions

ROUND 1 SESSION GUIDE

Moderator

Introduction:

Good morning/good afternoon….

My name is… and my colleague sitting next to me is … We will be leading this discussion together. We have several people who will be taking notes…

We work for KEMRI Center for Global Research and PIRE.

I want to thank you for taking the time to meet with us today.

The purpose of this study is to learn how to involve adolescents in HIV research in a respectful way, in particular, what you and your communities think about how to recruit young men and women in HIV testing and disclosure in the context of research.

We will be taking notes as well as audio recording to make sure we do not miss anything. We will use your feedback to make improvements in HIV research with adolescents.

Reports will be prepared to be shared with others and your names will not appear on these reports. You can also refuse to answer any questions that make you feel uneasy.

Before we start, we would like to establish some ground rules.

Ground rules:

After the introduction, tell participants the following:

• Please remember there is no right or wrong answer to these questions. We just want to hear your answers in your own words from your own perspective.

• We ask that you all feel free to participate and share your opinion.

• We also ask that you give each other a chance to talk. That means only one person talks at a time. Please do not to interrupt others in the group when they are talking.

• We also ask that you all respect the opinions of others in the group.

• People tell things in a different way even though they may be talking about the same thing. Even though you think someone else has already said something that is in line with your own experiences or thoughts, we would like to hear what you have to say.

• Please be assured that any information you give us is confidential and only authorized research staff will have access to anything you share with us.

• We ask each of you to keep the group participants and the information they share confidential.

Do you have any questions before we begin?

Now we are going to turn on the audio recorder and begin the group discussion.

• In today’s discussion, I will tell you a story about Rita and her mother. I will describe several situations that Rita and her mother experienced when learning about an HIV research study that Rita was eligible to participate in. I will then ask some questions about what you think Rita and her mother will do in each situation and how the community will react to Rita and her mother’s decisions.

Begin the story:

Rita is 16 years old and lives with her mother. She is an orphan having lost her father four years ago. Rita was born in Kogelo and is now in Form 1 at a local day school. She has four siblings and is third born. Now I would like to ask you questions about Rita and people in Rita’s community.

• Do you think it is acceptable or unacceptable for female adolescents like Rita to participate in an HIV research study? (Probe: Ask about HIV status, does it matters and to explain why it matters.)

  • For what reasons do you think it is acceptable/unacceptable?

• Do you think it is acceptable or unacceptable for male adolescents to participate in an HIV research study? (same probes as above)

• Do you think it is acceptable or unacceptable for younger female and male adolescents, under 15 years of age, to participate in an HIV research study? (same probes as above)

Continue the story:

For the past few months, several activities have been held near Rita’s home to inform the community about an ongoing HIV research study and to recruit female and male adolescents aged 15–19 years for the study. Rita’s mother has seen posters with information about the study at the nearby health facility and on walls at the shopping center. Some researchers also talked about the study at the last baraza at the chief’s camp and told people in the community what to do if they were interested in participating in the study. Announcements about the study were also made at some worship places and fliers with information about the study were given to everyone in the worship place that day. Yesterday, Rita came home with a similar flier about the same study that she was given at school.

• What are your thoughts about these strategies for providing adolescents like Rita and their parents with information about an HIV research study? (Probes: Tell me about any concerns you have. Tell me about any preferences you have.)

• What are other ways that adolescents age 15–19, like Rita, can be recruited for an HIV research study? (Probe about adolescents in boarding school and those who have dropped out of school)

• Is it acceptable or unacceptable to include the word “HIV” in the posters, fliers and announcements in worship places?

  • For what reasons do you think it is acceptable/unacceptable?

• Is there other information you think is important to give in flyers or other recruitment materials? ? (Probe what information they would want to know about the study that could be put on a flyer, poster or other recruitment material)

• Is there anything that should NOT be said?

Continue with the story:

Rita and her mother decide to go to a meeting at a nearby worship place that adolescents ages 15–17 and their parents or guardians have been invited to attend. At the meeting, research staff provide a brief description of the research. They say that participation in the research study is voluntary. They also say that for an adolescent aged 15–17 to participate in the research study a parent or guardian must give permission and the adolescent must assent. This can be done by signing or putting a thumb print on a form. Attendees were then given an opportunity to ask questions in the group meeting or to consult privately with a research staff. Rita went to speak privately with one of the research staff. She asked the staff why parental permission is required.

• Do you think adolescents like Rita should be able to participate in an HIV research study without parental permission?

  • (If Yes/No) For what reasons?
• Imagine adolescents aged 15–17 years who are married, are pregnant, have given birth or are total orphans living without adults. Should they be able to participate in an HIV research study without parental permission?

  • If married, what do you think about asking husbands for permission?

• In the local customs and traditions, are there other circumstances when it is acceptable for adolescents to participate in a research study without parental permission? (Probes: Age? What about if an adolescent is concerned that her/his parent will be upset? Other circumstances?)

Continue with the story:

Rita is still talking to the research staff, who told her that all adolescents who participate in the study will be tested for HIV and told their results. Adolescents who are aged 15–17 years must come with a parent or adult relative for the HIV test. There is no choice. But adolescents can choose whether they want their parent or guardian to be in the room during the testing and disclosure of results.

• Tell me what you think about testing and disclosing to adolescents like Rita in this way.

• (Probe) Is it acceptable or not acceptable to disclose HIV test results to adolescents ages 15–17 participating in an HIV research study?

  • (If Acceptable/Unacceptable) For what reasons?
• There are different ways to test for HIV in research.

  • The first is like in the clinic when they just take a small drop of blood and Rita would get results right away.
  • The second for research, they might take 5 drops of blood on a card and send that to the lab for testing and Rita may choose to get the results when they are available.
  • The third is to take a tube of blood to be sent to the lab for testing. And it might be for other things besides HIV. And Rita would not get the results, but she may get a voucher to go to the nearest clinic to be tested and learn her status.

• What do you think Rita’s preference would be?

• What do you think would be Rita’s mother’s preference?

• What if test results from the blood sample are not shared with adolescents and/or parents/guardians?

Continue with the story:

When Rita was talking to the research staff she told her that she feels she is old enough to go for HIV testing and learn her results without her mother.

• Do you think parents should be part of the session of HIV testing disclosure of results for adolescents age 15–17 like Rita?

  • (If Yes/No) For what reasons?

    • (Probes) Are there certain circumstances when this would be acceptable/unacceptable? (Age? What about if an adolescent is concerned that her/his parent will be upset? Other circumstances?)

• What venues do you feel are appropriate for adolescent HIV testing and counseling, e.g., clinics, schools, at home?

Continue with the story:

During the informational meeting the researchers also said that Rita will be given services including:

• referrals to HIV treatment and care, if positive

• counselling on other sexually transmitted infections

• information on safe sex practices,

• VMMC referral for boys, and

• Condoms will be available for those who wish to receive them

• Some positive and negative adolescents will be visited 2 more times over the next year and a half

Rita thinks this is a good thing.

• What do you think?

  • What makes you feel that way?

• What do you think Rita’s mother will feel about the services Rita will receive during the research study?

• What do you think other people in the community would feel about the services Rita will receive during the research study?

Continue with the story:

Rita and her mother decide that it will be good for Rita to participate in the study. They both sign the consent form.

• Do you think Rita will face any problems in the community if it is known that she is participating in this HIV research study? (Probe: What kind of problems?)

• Would Rita’s mother face any problems in the community for giving permission for Rita’s participation in the research study? (Probe: What kind of problems?)

• Do you think there will be rumors in the community about the HIV research study when it begins? (Probe: What kind of rumors?)

  • What could be done to address these rumors?

Is there anything else that anyone would like to add?

Thank you for your time.

ROUND 2 SESSION GUIDE

As part of the checking in procedures prior to the start of the focus group discussions:

RAs will ask participants whether they have participated in any other HIV research studies in the past, if they are currently participating in any HIV research studies, and how many studies they have participated/are participating in. RAs will also ask participants if they are/have been on any community advisory board. They will do the same thing for the new focus group (round 1) in the research-naïve area as they are collecting the demographic data.

RAs should tell participants that we are not doing a vignette with an imaginary adolescent this time and they are welcome to share their own personal situations but should not feel that they have to if they do not want to. They should also tell them that if they have an experience but don’t want to share it from their perspective, they can tell the story as if it is about their friend.

Introduction:

Good morning/good afternoon and welcome. Thank you for agreeing to participate in this second group discussion.

It’s nice to see you again… My name is… and my colleague sitting next to me is … We will be leading this discussion together. We have two people who will be taking notes…

We work for KEMRI Center for Global Research and PIRE.

I want to thank you for taking the time to meet with us today.

Let me take this opportunity to remind you that the purpose of this study is to learn how to involve adolescents in HIV research in a respectful way. Today, we are going to start with some follow up questions that arose from our first meeting. We are then going to ask you some new questions about compensation for research participation.

Like we did before, we will be taking notes as well as audio recording to make sure we do not miss anything. We will use your feedback to make improvements in HIV research with adolescents.

Reports will be prepared to be shared with others and your names will not appear on these reports. You can also refuse to answer any questions that make you feel uneasy.

Before we start, let me remind of our ground rules that we had when we first met.

Ground rules:

• Please remember there is no right or wrong answer to these questions. We just want to hear your answers in your own words from your own perspective.

• We ask that you all feel free to participate and share your opinion.

• We also ask that you give each other a chance to talk. That means only one person talks at a time. Please do not to interrupt others in the group when they are talking.

• We also ask that you all respect the opinions of others in the group.

• People say things in a different way even though they may be talking about the same thing. Even though you think someone else has already said something that is in line with your own experiences or thoughts, we would like to hear what you have to say.

• Please be assured that any information you give us is confidential and only authorized research staff will have access to anything you share with us.

• We ask each of you to keep the group participants and the information they share confidential.

• We also ask that you turn your phones off or put them on vibrate. If you need to take a call, please do not take it right outside the door or windows of this room so that you don’t disturb the discussion. Also please make sure you speak up and we want to caution you that the recorders pick noise so please be careful not to knock on the table. We will also remind you about this during the meeting.

Do you have any questions before we begin?

Now we are going to turn on the audio recorder and begin the group discussion.

Interviewer turns on the audio-recorder to begin interview.

1. Research involving adolescents and Parental Permission

   We looked carefully at the responses you gave us last time about an imaginary adolescent, Rita or Tom, and from the answers that many of you gave us we had additional questions to ask you about adolescent HIV research.

   Let us begin by discussing parental permission when it comes to research involving adolescents.

   • 1.1
     What do you think are the reasons that researchers ask parents for their permission to allow their son or daughter who is under age 18 to participate in research studies?
   • 1.2
     If an adolescent wants to be in a study but fears that the parent will say no, what should the researcher do?

     Probe: Should the researchers allow the adolescent to enroll anyway?

   • 1.3
     If a parent does not give permission and then finds out their adolescent child has been tested and is HIV positive, is the researcher responsible for protecting the adolescent from their parent who is angry because he was not consulted and who assumes that the adolescent has been sexually active?

     Probes: How about if the adolescent is tested and becomes distraught after finding out he or she is HIV positive and the parent is not present, is the researcher responsible? If so, what should the researcher do?

     Probes: How about if someone finds out that the adolescent is HIV positive and people in the community begin to talk, is the researcher in any way responsible? If so, what should the researcher do?

   • 1.4
     Do you think boys or girls would have more difficulty coping if they tested positive for HIV? If so, how do you think they would be different?
2. Research benefits

   • 2.1
     Last time we met, many of you talked about the benefits from participating in research. Does participation in research always involve benefits for the participants?
   • 2.2
     Do you think it should always involve personal benefits?
   • 2.3
     Last time many of you said participating in research would allow adolescents to know their HIV status. However, they can also do that by going to the VCT at the nearby clinic. Is that true? Is being tested in a research study different from going to the VCT clinic?
   • 2.4
     Do you think that being in a research study will give you access to more or better treatment for diseases/health services? Do you think it should?
   • 2.5
     Are there any other benefits to participating in research that we haven’t already discussed?
   • 2.6
     Imagine a research study that may have possible benefits in the future for the community, but no benefits for research participants right now. Would this be acceptable?
   • 2.7
     Some people worry that if research studies provide many benefits, people (especially poor people) will have no choice or will feel compelled to join those studies. What do you think about these concerns?
   • 2.8
     Some people worry that if a research study provides a lot of benefits, then the participants will no longer see or care about possible risks. What do you think about these concerns?
3. Potential risks/harms in research

   Let me now ask you about potential risks or harms in research.

   • 3.1
     In our first discussion, you spoke a lot about the benefits of being in a research study. Have you ever heard of people in research having negative experiences or bad things happen to them? What kind of negative experiences or bad things could happen to adolescents in a HIV study?
   • 3.2
     What do you think about researchers offering condoms to young women (e.g., 15 years old) for the prevention of HIV? How do you think others in the community feel about this?
   • 3.3
     Some people worry that the more benefits you have in a research study, the more you are likely to create conflicts (jealousy) between those who are in a study and those who are not. What do you think about these concerns?
   • 3.4
     Someone in one of our first focus groups mentioned that not all ‘researchers are genuine’. Who is a ‘genuine’ researcher? How could you tell if a researcher is genuine or not genuine?

     Probe: What sort of things would a non-genuine researcher do?

4. Recruitment strategies

   Now I would like to ask you some questions about recruitment strategies.

   • 4.1
     Have you seen or heard of any ways of trying to recruit research participants that you thought were inappropriate, stigmatizing, or disrespectful? Tell me about them.
   • 4.2
     We wanted to show you an example of a flyer we might use (give them each a copy to look at and then them collect before you leave). Would this flyer catch your attention? Why/why not? How would you feel about taking one of these flyers and going with it home?
   • 4.3
     What would you and your friends think about joining this study after seeing this flyer? What do you think would make you and your friends join/not join?
5. Compensation

   As we near the conclusion, I’d like to discuss compensation for research participation.

   • 5.1
     Researchers often give participants money for participating in their research studies. How do you feel about this practice?

     Probes: Should the money be for specific costs? Or should the money be for the time it takes to participate in a research study? Or should the money be based on the burdens of the study procedures? Why do you feel this way?

   • 5.2
     In the context of research with adolescents, should compensation be for parents or for adolescents or both?

     Probes: Why do you feel this way? Do you think there would be any challenges to giving compensation to both parents and adolescents? Tell me about them.

   • 5.3
     How much should parents be compensated for accompanying their adolescent children for HIV testing for a research study?

     Probes: How did you come up with that amount? Would the amount be different if the researchers come to your home vs if you have to travel for testing?

   • 5.4
     How much should parents be compensated in a research study where their participation will involve completing an hour-long interview?

     Probes: How did you come up with that amount? Would you change the amount if the interview was 2 hours or half a day? Would the amount be different if the researchers come to your home vs if you have to travel for the interview? Would the amount change if there was more than one interview or should it be the same for each interview?

   • 5.5
     How much should adolescents be compensated in a research study where their participation will involve testing for HIV and completing an hour-long interview?

     Probes: How did you come up with that amount? Would you change the amount if the interview was 2 hours or half a day? Would the amount be different if the researchers come to your home vs if you have to travel for the testing or interview? Would the amount change if there was more than one interview or should it be the same for each interview?

   • 5.6
     What other forms of compensation, instead of money, would be acceptable/unacceptable for research participation? (Probe: Soap? Blankets? School supplies? Food? T-shirts? Other?)

     Probes: Do you see any problems with giving these to either parents or adolescents as compensation? Tell me in your order of preference for these items.

Is there anything else that anyone would like to add?

Thank you for your time.