Abstract
Background:
Pediatric HIV testing remains suboptimal. The OraQuick test (saliva-based test [SBT]) is validated in pediatric populations ≥18 months. Understanding caregiver and healthcare worker (HCW) acceptability of pediatric SBT is critical for implementation.
Methods:
A trained qualitative interviewer conducted 8 focus group discussions (FGDs): 4 with HCWs and 4 with caregivers of children seeking health services in western Kenya. FGDs explored acceptability of pediatric SBT and home- and facility-based SBT use. Two reviewers conducted consensus coding and thematic analyses of transcripts using Dedoose.
Results:
Most HCWs but few caregivers had heard of SBT. Prior to seeing SBT instructions, both had concerns about potential HIV transmission through saliva, which were mostly alleviated after kit demonstration. Noted benefits of SBT included usability and avoiding finger pricks. Benefits of facility-based pediatric SBT included shorter client waiting and service time, higher testing coverage, and access to HCWs, while noted challenges included ensuring confidentiality. Benefits of caregivers using home-based SBT included convenience, privacy, decreased travel costs, increased testing, easier administration, and child comfort. Perceived challenges included not receiving counseling, disagreements with partners, child neglect, and negative emotional response to a positive test result. Overall, HCW felt that SBT could be used for pediatric HIV testing, but saw limited utility for caregivers performing SBT without a HCW present. Caregivers saw utility in home-based SBT, but wanted easy access to counseling in case of a positive test result.
Conclusions:
SBT was generally acceptable to HCW and caregivers and is a promising strategy to expand testing coverage.
Keywords: HIV, children, pediatric HIV testing, saliva-based testing
INTRODUCTION
Coverage of pediatric HIV testing services (HTS) in sub-Saharan Africa remains suboptimal. National-level household surveys conducted from 2015–2017 in six countries found that 40% of children with HIV ages 0–14 years were undiagnosed.1
The OraQuick oral mucosal transudate HIV antibody test (saliva-based test [SBT]) has shown to be accurate in adult, adolescent,2–5 and pediatric populations ≥18 months.6 It has been scaled-up for adults and adolescents (≥13 years) as an HIV self-test or healthcare worker (HCW) administered test, and became prequalified by the World Health Organization for children 2–12 years as a HCW-administered test in November 2019.7 Availability of pediatric SBT can improve HTS coverage for children.8
The objective of this study was to assess caregiver and HCW acceptability of caregiver- and HCW-administered SBT for pediatric HIV testing. Caregiver-administered SBT – either facility- or home-based – could address limited HCW availability.9,10 Home-based SBT – either administered by HCW or caregivers – could address caregiver-level barriers including transport costs and time constraints.11 Evaluating caregiver and HCW perceptions of pediatric SBT is necessary to inform pediatric SBT guidelines.
METHODS
Study design and population
Focus group discussions (FGDs) – 4 among caregivers and 4 among HCWs –were conducted at a health center in Kisumu, Kenya. Study staff recruited HCWs from pediatric inpatient or outpatient departments, and caregivers from outpatient departments. HCWs and caregivers ≥18 years were eligible to participate. At the time, pediatric SBT was not included in Kenya HIV testing guidelines. The University of Washington Institutional Review Board and Kenyatta National Hospital/University of Nairobi Ethics and Research Committee approved the study. All study participants provided written informed consent.
Data collection
FGDs were conducted in May 2019 using semi-structured interview guides exploring acceptability of SBT for children 2–12 years of age, home- and facility-based SBT, ideal attributes of SBT instructions, and anticipated changes to clinic operations with pediatric SBT testing. FGDs were conducted in Dholuo, Kiswahili, or English based on participant preferences. Discussions were audio recorded, transcribed verbatim and translated into English by a trained Kenyan research scientist.
Data analysis
JN and MB developed, refined, and tested the codebook. They first coded the same transcripts, and the remaining transcripts were coded by one coder and then reviewed by the other coder with disagreements resolved through discussion. Deductive thematic content analyses were conducted to identify common themes and perspectives within the following key categories: initial concerns and perceived benefits of SBT, facility- and home-based SBT, and disseminating SBT information. Analysis used Dedoose (Version 4.12).
RESULTS
Overall, 32 caregivers and 38 HCW participated in 8 FGDs with 7–10 participants each. Caregivers had an average of 2 children and 11 years of education; HCWs had an average of 2 years of HIV testing experience and 16 years of education (Supplementary Table 1).
Initial beliefs and perceived benefits and concerns of SBT
Many HCWs but few caregivers had previously heard of SBT prior to demonstration. Some caregivers and HCWs felt sample collection could be difficult if large volumes of saliva were required; however, this concern was alleviated after SBT demonstration. The concept of detecting HIV infection through SBT raised concerns about potential transmission of HIV through saliva. These concerns were assuaged for most participants during SBT instruction when participants were informed that the test detects antibodies, not live virus. However, some caregivers and HCWs maintained concerns about caregivers understanding of this concept without education.
Noted benefits of SBT included: avoiding uncomfortable finger pricks for children, making testing more comfortable for caregivers and children; perceived easy use; and safety of administration, minimized risk of accidental HCW exposure, and easier disposal of testing equipment.
The primary noted concern of SBT included caregivers’ lack of familiarity with SBT, which could influence caregiver uptake, proper administration, and interpretation/trust in SBT results. HCWs generally felt that SBT should be administered by HCWs, and not caregivers, to provide caregivers with counseling and ensure correct administration and interpretation. Some caregivers and HCWs noted that SBT could be administered by caregivers with appropriate demonstration or instruction, but commonly felt that post-test counseling by HCWs was still necessary.
Participants commented on a range of 4 scenarios in which caregivers or HCWs administered SBT either at home or at health facilities for pediatric HIV testing.
Facility-based SBT
Benefits of facility-based SBT discussed in FGDs were similar to general benefits of including self-testing while waiting for inpatient/outpatient care. When asked about caregiver-administered SBT in facilities, HCWs and caregivers noted benefits of shorter client time, higher HTS coverage, and access to HCWs. SBT was expected to reduce overall client time at the facility where caregivers or HCWs administer the test while patients are waiting. Some caregivers and HCWs felt that SBT could increase HTS coverage because caregivers might feel encouraged to test if given a comfortable option or choice of test platform. Caregivers and HCWs discussed the importance of having access to HCWs for post-test counseling to understand results and ensure linkage to care.
Noted challenges of SBT at a facility included ensuring confidentiality, need for space and staff to conduct SBT and provide counseling, and potential for increased workload if HCWs are expected to assist with SBT.
Home-based SBT
Benefits of home-based pediatric SBT were similar to benefits of general home-based HIV testing. Home-based SBT was thought to be more convenient by saving caregivers time and transportation costs. Participants also noted that home-based SBT would be more comfortable for children due to the familiar and private setting. A benefit specific to SBT discussed by some caregivers and HCWs was that caregivers could perform the SBT due to the ease of sample collection, especially if provided with adequate instruction. Concerns raised were similar to general concerns of home-based self-testing. Perceived challenges included not receiving pre- and post-test counseling, response to positive results, and inappropriate test administration by caregivers. Lack of SBT demonstration/instruction was believed to impact proper sample collection and results interpretation. Participants expressed concerns over caregivers not bringing their child to the facility for care and treatment if a child tested HIV positive at home.
While caregivers and HCWs raised general concerns of social harms related to home-based, caregiver-administered SBT – including partner conflict and/or violence, child neglect, and risk of suicide, and stigma – most concerns were general to caregiver-administered testing without a HCW present or pediatric HIV testing generally, not specific to SBT testing. Partner conflict and violence was noted as potentially resulting from inadvertent disclosure of maternal HIV status and/or a child testing positive for HIV. Participants discussed that child neglect could result from a child testing HIV positive and caregivers or children could die by suicide if a child tests HIV positive. HIV stigma was discussed specifically related to SBT, as lack of knowledge of SBT could result in misconceptions that HIV can be transmitted through saliva, leading to increased HIV stigma. Caregivers and HCWs felt that counseling would be sufficient to mitigate the impact of hypothetical social harms.
Disseminating SBT information
Caregivers and HCWs urged literacy and translation into multiple languages be considered when disseminating information on SBT and generally favored video, pictorial, or in-person instruction. A video at the facility was discussed by caregivers and HCWs as an acceptable method to deliver information on SBT; however, participants noted that a video requires technology and has limited reach.
DISCUSSION
Overall, HCWs found SBT acceptable, but saw limited utility for caregivers performing home- or facility-based SBT without appropriate instruction/demonstration and post-test counseling support. Caregivers saw utility in caregivers performing SBT at home, but wanted easy access to HCWs to confirm and counsel in case of positive results. A few barriers were unique to SBT, including initial concerns about saliva quantity and lack of knowledge about SBT resulting in confusion around HIV transmission. Many of the noted benefits and drawbacks resonate with known benefits or drawbacks of task-shifting, self-testing, and home-based testing.
Findings from this study indicated that home-based SBT was acceptable to caregivers, which is consistent with findings from other HIV self-testing studies. While studies have found that HIV testing preferences vary by population,12 SBT has been preferred over blood-based testing for self-testing among adult populations.2,13 Benefits of SBT self-testing among adults include convenience, privacy, painlessness, and usability,4,13,14 similar to those noted in this study. A study among adolescents and caregivers in Zimbabwe found that the privacy afforded by SBT self-testing could address important barriers to pediatric and adolescent HIV testing, such as fear of stigma and discrimination.15 SBT has been approved for use in children 2 years and older7 and has specifically been recommended by PEPFAR for caregiver-administered testing to promote pediatric HIV screening during the COVID-19 pandemic.16
Key concerns about self-testing in adults include inaccurate administration and/or result interpretation,3,13 concerns which were noted by caregivers and adolescents in Zimbabwe15 and caregivers and HCWs in this study. A study among caregivers in Zimbabwe, however, found that the vast majority of caregivers correctly collected SBT with and without provider demonstration (97% and 87%, respectively) and correctly interpreted results with and without provider demonstration (98% and 97%, respectively).17 While HCWs and caregivers may have concerns about caregiver administration, observational data do not support this as a large-scale concern. Providing caregivers with effective instruction on SBT could facilitate accurate caregiver-administered SBT. In our study, participants felt that disseminating information through video, in-person, or pictorial instructions could increase knowledge of SBT test administration.
In this study, potential social harms – including partner violence, stigma, child neglect, and risk of suicide – were noted by participants. Similarly, adolescents and caregivers from a study in Zimbabwe expressed concerns about child neglect and reactions to a positive result.15 In that study, over half of adolescents discussed concerns about other adolescents dying by suicide after receiving a positive HIV test; however, no caregivers discussed risk of suicide.15 Many harms discussed in our study are not specific to the sample collected with a caregiver-administered SBT, but rather are concerns with general pediatric HIV testing or home-based testing. In the current SBT self-testing literature, concerns about social harms exist, but limited existing observational data reveal that there are few unique risks to SBT, and limited evidence does not indicate increased harm.18–23 Implementers should design programs that track child testing and results and actively look for social harms and intervene when needed.
Several self-testing studies also reported that participants expressed interest in accessing a HCW or counseling.3,4,13,14 The study among adolescents and caregivers in Zimbabwe noted that counseling and access to an HCW could address concerns related to harms.15 HIV SBT approaches involving digital supports for HIV self-testing – including web- and phone-based strategies – that allow counseling could be effective models for increasing HIV testing.24
Enhancing facility-based HIV testing services are essential for achieving high coverage of pediatric HIV diagnosis.9,25 A systematic review found that inpatient and outpatient provider-initiated HIV testing had high acceptance rates (86% and 70%, respectively) and testing yield (12% and 3%, respectively).25 Among children diagnosed late in Kenya and Uganda, nearly half of children were diagnosed in outpatient departments.26 Barriers to facility-based provider-initiated HIV testing and counseling include shortage of HCWs and overcrowding of clinics.27 A recent study found that HIV self-testing in facilities resulted in higher uptake of HIV testing in outpatient settings among adolescents and adults.28 Facility-based or other SBT approaches that involve post-test counseling could reduce concerns about SBT self-testing and ensure that caregivers receive appropriate counseling.
Participants for this study were recruited from one facility in Western Kenya and thus may not be generalizable to other settings. However, HIV prevalence in Kisumu is 17.5%, much higher than the national prevalence 4.9%;29 the benefits of pediatric SBT may be higher in this setting. Caregivers enrolled may be systematically different from caregivers who did not to participate.
In conclusion, caregivers and HCWs found SBT acceptable, but HCWs had reservations about administration by caregivers at home. Child comfort, ease of use, and child and HCW safety were noted benefits of SBT compared to blood-based testing. Concerns about knowledge of SBT, SBT administration, interpretation of results, and linkage to care could be overcome by HCW availability for counseling during SBT or HCW administration of SBT.
Supplementary Material
Figure 1.
Results of Healthcare worker and Caregiver Focus Group Discussions
SBT: oral mucosal transudate test; HCW: healthcare worker
Table 1.
Themes and notable quotes
| Theme | Excerpt | |
|---|---|---|
| Perceived Overall Benefits of SBT | ||
| Avoid finger pricks | “I can say that testing using saliva is easier than using blood because let’s say this child, if they want to get blood then they will have to prick the child, this will affect the child and the child will cry, but for saliva, I feel that it is easier than that of blood” – CG-02 | |
| Safer for children and HCWs | “It will also reduce the chances of pricking himself because there is no pricking of self, the accidents when collecting the sample.” – HCW-03 “It’s a rapid test that can be done by an individual at their own comfort and it is safe because there is no pricking, there is no interaction with blood and so even disposal like for sharps, so like for blood we have to do it in the hospital yeah, but for saliva it can be done at the comfort of the patient” – HCW-04 |
|
| Usability | “I think that the saliva self-testing kit is advantageous over blood test because there is minimal error in the technique because in the pricking in the blood some people may pick inadequate sample and also may put the buffer a few drops or even more. So, I think in Oraquick this error is minimized.” – HCW-01 | |
| Increase testing | “Me I think it might increase our clients because when a client hears maybe you are not pricking the child, the mother might agree, most of them may agree with the services than when tell the mother that you want to prick the child to take the sample.” – HCW-01 | |
| Perceived Overall Concerns about SBT | ||
| Saliva volume | Initial concerns | “For one to get enough saliva to detect HIV, can a child produce that?” – CG-01 |
| Alleviated concerns | “I think it will work because I thought it would use a lot of saliva but we have seen that it is using just a little amount of saliva” – CG-01 | |
| HIV transmission through saliva | Initial concerns | “HIV can now be tested through saliva and misconceptions are, now if it can be tested through saliva, it can also be transmitted through saliva. So, if my child uses a spoon and this mother comes and borrow my spoon, definitely my child will get HIV, so they don’t…” – HCW-02 |
| Persistent and alleviated concerns | “Caregiver 1: I am saying this, some caregivers cannot agree because it has been said that saliva does not have the virus, so if they take the child there and saliva is collected and put in the – for testing HIV, they will not accept because they will say that this thing just shows a little, it cannot show full? Caregiver 2: But as per what we have been told I think some people will accept, not all will accept, not all will go to heaven, a few will enter, some will accept, some will refuse. And if they are taught, all can accept.” – CG-04 |
|
| Knowledge of SBT | Initial concerns | “I think that we should be taught first because it seems that it is something new, even me, I have not heard a lot about it” – CG-04 |
| Alleviated concerns | “Us here we have been taught on how it tests but there are others who have not been taught, if you give those parents that thing, they will not be able to use it, they will ask themselves how is this thing used to test” – CG-02 | |
| Persistent concerns | “…I think there would be two categories of people here, there is a health professional or somebody with understanding and then there is that layman who does not actually understand how the oraquick works. For us, we will not be concerned but for the lay people I think there will be a lot of concern.” – HCW-02 | |
| Facility-based SBT | ||
| Benefits | Shorter client time | “Time, on time management let’s say you come to the facility, you will not have to line you just get in, you go through the test and then you get the results. It will not be time consuming to these mothers.” – HCW-03 |
| Higher HTS coverage | “It will create more chance for testing the children, options that the mother prefers the child is going to cry or be uncomfortable prick. So, there is an option, just a saliva test. That will be good and it will encourage them…” – HCW-03 | |
| Access to HCWs | “…on my side, counseling must be done so first of all counseling has to be done. Thinking of people’s reaction, you cannot know what people’s intentions. Sometimes in my house, we do not have the disease and then you test a child and the child turns positive, they can neglect the child because they don’t have counseling. So, the first thing, if a person is to be given that kit then the person has to be done for counseling, I think that should be there.” – CG-01 | |
| Reduces workload | “It reduces the workload… Because the… saliva HIV testing, even the parent can do it to their children, yes, a health worker can do or the parent can do” – HCW-04 | |
| Concerns | Confidentiality | “…privacy is very important. So, if it is in the hospital, in a public hospital we can provide a private room so that after you have been given that kit you go to that room to the testing without people around you” – CG-02 |
| Available resources (i.e. space, workforce) | “Yes, we need a room, the counselling room… Our nurses also, they can do it, but they don’t have that room, so that’s why we have our HTS, that’s why we have given them that responsibility, yes.” – HCW-01 | |
| Increased workload | “In… paediatric ward… counselling will have to be involved, meaning counselling to be done per day more work for the care provider. Every person you are going to test their child you’ll have to counsel them, that is work.” – HCW-02 | |
| Home-based SBT | ||
| Benefits | Caregiver time | “I think it will save the caregiver time. The time which the caregiver could have taken in the hospital waiting for another client to leave the room, so they just pick and walk away. So that she can walk away and do other things, then he can do it at his/her own time.” – HCW-01 |
| Convenience | “The good thing to them they will be doing them at their convenient time, seeing their results on their own at least for confidentiality, confidential on their side.” – HCW-01 | |
| Privacy | “I think if they [caregiver] are well counselled and they go home do it to their own child, there will be privacy, confidentiality and they will be able to bring the check up rate to bring back he child to the clinic for further testing so that further management can be taken up from there…” – HCW-03 | |
| Decreased costs | “I will have saved fare to the hospital, I will have saved time because I test and put it there, I am just in the house, I do not have that stress of leaving to go and test the child at the hospital.” – CG-02 | |
| Increased testing | “Do the test at home, yes… when we give them and take them at home and use them, the numbers can also at least increase.” – HCW-02 | |
| Easy administration | “I think also because the caregiver and the child have a bond, trust, it will be easier for them to administer the test compared to a stranger because this child can really trust the parent to be able to collect that sample easily compared to us” – HCW-04 | |
| Child comfort | “I think at home, the anxiety and change of environment that the baby was in is off and when they are at home, they are calmer and the parent is able to do the test in a convenient way without any disruptions.” – HCW-02 | |
| Concerns | Lack of counseling | “When they are given those things to go and test at home, it would be good to do counseling for them first, so that if they are found to be positive, then there would be a way to counsel them so that they take things positive.” – CG-04 |
| Inappropriate test administration | “I also think that sample collection is of priority here because you know it is saliva based but you are not supposed to have some things like food in the mouth. So, in case there is wrong sample collection then the results cannot be trusted. The timing of the interpretation can also not be trusted and so the disadvantages will come in because the healthcare worker is not there to supervise the test as it is administered.” – HCW-04 | |
| Missed opportunity for linkage to care | “So, it means that we can trust the parents to go and do the test at home and bring us back the results but you will find that in some instances, the parents cannot be trusted to bring back the results when we want them because we want to make a decision. So, again, as much as it is easy, you might still need to do it in the hospital” – HCW-04 | |
| Partner conflict | “It can bring disagreement with the partner, sometimes he knows that his children are negative and then you get different results” – CG-04 | |
| Stigma | “a lot of discrimination to this child will come up because they feel if this thing can be tested through saliva, it might turn positive, this child if they share spoon, plates, this child might infect my kids.” – HCW-01 | |
| Child neglect | “If I had five children and one of them turns positive, you know if the others get to know that that one is sick, it can bring issues because – you know the child does not know anything, she/he can abuse the sibling that ‘you are sick, don’t play with us’ that can be a problem.” – CG-04 | |
| Responses to positive test results (including risk of suicide) | “I had a thought of preparedness, are the parents prepared to know the status of the children. Preparedness first because if I am going to do it myself and I am not psychologically prepared, chances are if the results turn positive, I might even get a shock.” – HCW-02 | |
ACKNOWLEDGEMENTS
The authors thank the STEP-UP study staff and participants.
J.K.N., M.A.B., I.N.N., and A.D.W. developed the first draft of the manuscript; J.K.N. and M.A.B. conducted the data analysis with mentorship from I.N.N. and A.D.W. A.D.W., I.N.N., J.K.N., G.C.J.-S., J.A.S., D.A.K., G.O. and D.C.W. developed the protocol. A.D.W. and I.N.N. obtained grant funding. E.A., A.O., and V.O. collected study data. A.D.W., I.N.N., E.A., and J.K.N. developed study material and supervised data collection. All co-authors revised and approved the final draft of this manuscript.
Funding:
The Saliva Testing and Video Information to Expand Uptake of Pediatric HIV Testing (STEP-UP) study was funded by the National Institutes of Health (NIH; P30 AI027757 [CFAR New Investigator Award; PI: A.D.W.]) and the Thrasher Research Foundation (A119882; PI: A.D.W.). I.N.N., J.K.N., and A.D.W. were supported by P30 AI027757. A.D.W. was also supported by A119882. I.N.N. was supported by Fogarty International Centre (FIC) D43TW009783 and 1K43TW011422-01A1. This publication was supported by the University of Washington Global Center for the Integrated Health of Women, Adolescents, and Children (Global WACh). This publication was funded in part by the University of Washington/Fred Hutch Center for AIDS Research, and NIH funded program under award number AI027757, which is supported by the following NIH Institutes and Centers: NIAID, NCI, NIMH, NIDA, NICHD, NHLBI, NIA, NIGMS, NIDDK. The content of this publication is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Footnotes
Conflicts of interests: Authors have no conflicts of interest to disclose.
Meetings at which parts of the data were presented: 23rd International AIDS Conference, virtual, July 6–10, 2020. Poster presentation. PEC0582
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