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Abstract
Background Using an HIV pretest screening tool to identify children most at risk for HIV infection may be a more efficient and cost-effective approach to identify children living with HIV in resource-limited settings. These tools seek to reduce overtesting of children by increasing the positive predictive value while ensuring a high negative predictive value for those screened for HIV.
Methods This qualitative study in Malawi evaluated acceptability and usability of a modified version of the Zimbabwe HIV screening tool to identify children aged 2–14 years most-at-risk. The tool included additional questions about previous hospitalisations due to malaria and prior documented diagnoses. Sixteen interviews were conducted with expert clients (ECs), trained peer-supporters, which administered the screening tool and 12 interviews with biological and non-biological caregivers of screened children. All interviews were audiorecorded, transcribed and translated. Transcripts were analysed manually using a short-answer analysis, compiling responses for each question by study participant group. Summary documents were generated, identifying common and outlier perspectives.
Results The HIV paediatric screening tool was generally accepted by caregivers and ECs, with both groups seeing the benefit of the tool and promoting its use. The ECs who were primarily responsible for implementing the tool initially struggled with acceptance of the tool but started to accept it after additional training and mentorship was provided. Overall, caregivers accepted having their children tested for HIV, although non-biological caregivers expressed hesitancy in giving consent for HIV testing. ECs reported challenges with the ability for non-biological caregivers to answer some questions.
Conclusion This study found general acceptance of paediatric screening tools in children in Malawi and identified some minor challenges that raise important considerations for tool implementation. These include the need for a thorough orientation of the tools for the healthcare workers and caregivers, appropriate space at the facility, and adequate staffing and commodities.
- HIV
- Qualitative research
Data availability statement
Data are available on reasonable request. Data are available from the study team on reasonable request.
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
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WHAT IS ALREADY KNOWN ON THIS TOPIC
Antiretroviral therapy coverage remains lower in children than adults living with HIV globally, with a key reason for this discrepancy being high rates of undiagnosed HIV infection among children.
It is not cost-effective to test every child for HIV that accesses the outpatient department.
Paediatric HIV screening tools identify children most-at-risk for HIV infection, screening them in for HIV testing, yet risk missing some children living with HIV depending on the sensitivity of a given tool.
WHAT THIS STUDY ADDS
Insights around perceptions of the paediatric screening tool from caregivers and expert clients, with general acceptance of the tool.
Information on successes and challenges with implementation of the tool, such as impact on patient flow and availability of resources.
Considerations to strengthen the implementation of paediatric screening tools, including training and resource needs.
HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY
This study provides insight into the challenges of obtaining information from non-biological caregivers, which may influence how information is collected from caregivers in the future.
These study findings may be helpful for countries considering adopting a paediatric screening tool, identifying important policy and programme considerations for implementation, including human resources (ensure consistent, well-trained staff) and commodities (ensure adequate number of test kits).
As countries prepare to introduce the paediatric screening tool, it is important to ensure effective communication regarding the importance and use of the tool to both facility staff and caregivers.
Introduction
Antiretroviral therapy (ART) coverage remains lower in children than adults living with HIV infection globally, with a key reason for this discrepancy being high rates of undiagnosed HIV infection among children.1 Malawi had an estimated 74 000 children ages 0–14 living with HIV in 20192 of whom, approximately only 63% were receiving ART.3 The WHO recommends provider-initiated testing and counselling for all individuals attending any healthcare facility in high HIV prevalence settings as one strategy to identify undiagnosed people living with HIV.4 However, the extent to which provider-initiated testing and counselling is implemented in primary healthcare facilities is variable, especially for children. Recently, there has been a focus on active index testing,5 though, even with this approach, a number of children may be missed.
Lack of HIV testing in children is due to a variety of factors. Healthcare workers (HCWs) may be unaware that some older children living with HIV (CLHIV) may remain without symptoms or have only mild symptoms,6 and therefore, HIV infection in such children and adolescents may go undetected.7 HCWs may also lack proficiency in paediatric HIV management and communication skills with parents to enable implementation of HIV testing in children outside of the early infant diagnosis setting, and mothers may be concerned regarding confidentiality and disclosure of their HIV status to HCWs.8 Moreover, given resource constraints and the lower prevalence of HIV among children compared with adults (1.6% in those aged 0–14 years vs 10.6% among those 15–64 years of age in Malawi),9 it may not be cost-effective to test every child in the outpatient department setting, especially in very high-volume facilities.
In Malawi, children are tested based on HIV exposure or suspicion of infection due to symptoms. For HIV-exposed infants, tests are conducted at 6–8 weeks, 12 months and 24 months. Prior to the introduction of the paediatric HIV screening tool, HIV testing in older children was dependent on HCW suspicion of infection due to the presence of symptoms, resulting in few older children receiving testing.
To address the gap between testing needs and available resources, paediatric HIV screening tools were developed to identify children most at risk for HIV infection, thereby decreasing the overall number of children needing to be tested for HIV, while monitoring the absolute number of CLHIV identified. Such tools, however, must also maximise sensitivity, to reduce the likelihood that a child with HIV infection will miss being tested due to a negative screening test. The ‘cost’ of missing such children is high, as these children are prone to dying earlier from the disease.10 One such screening tool that was designed to be simple and quick to administer is the Zimbabwe HIV risk screening tool (Z-HRST).11 12 This tool can be used by lay cadres in outpatient settings and involves four simple questions about a child’s recent illnesses and family history. This tool was originally tested in non-malaria endemic areas and was shown to be effective.13 However, when applied in malaria endemic areas, the tool was not as successful and this was hypothesised to be primarily due to increased hospitalisation from malaria, resulting in lower sensitivity of hospitalisation as an indicator to identify children at risk for HIV.
In an effort to explore the effectiveness of an adapted paediatric HIV screening tool in a malaria endemic area, the Elizabeth Glaser Paediatric AIDS Foundation (EGPAF), in collaboration with the Malawi Ministry of Health and the Centers for Disease Control and Prevention, tested an adapted version of Z-HRST tool (online supplemental file 1). In addition to the Z-HRST questions, the EGPAF version of the tool asked if the child was admitted to the hospital in the past, and if the hospitalisation was due to malaria, and checked for documented diagnosis for children admitted to the hospital (health passport, discharge summary slip or other records available with the caregiver).
Supplemental material
EGPAF sought to validate the modified paediatric screening tool in children aged 2–14 years and their caregivers receiving outpatient services in 16 high-volume health facilities in Malawi. We undertook a study to understand the acceptability of this screening tool among caregivers and its usability and acceptability among expert clients (ECs) administering the tool.
Methods
Study design
This was a qualitative study design that evaluated the acceptability and usability of a HIV risk-screening tool among children in Malawi.
Site selection
Eleven sites were selected from the southern region of Malawi, which, at the time of the study, had the highest HIV prevalence among children aged 2–14 years.9 High-volume outpatient department services were defined as those having at least 50 children under the age of 15 years receiving outpatient services per day. Sites were also selected to include rural, urban and semiurban locations.
Study population and recruitment
The study population included caregivers attending outpatient clinics, whose children aged 2–14 years were screened with the tool and received an HIV test following the screening, and ECs who administered the tool. ECs are HIV-positive individuals trained in providing advice and support to other HIV-positive individuals, in a peer-support type service with no clinical training. ECs selected for the study were required to have been involved in the administration of the screening tool. ECs had undergone a 5-day training on the tool led by Mothers2Mothers supported by EGPAF. The training included interview methods, human subjects’ research ethics training and standard operating procedures on the implementation of the tool. In addition, the ECs participated in a pilot in non-selected study sites to assess any issues around client flow and linkage to care affected by the tool. Eligible ECs were selected using convenience sampling, based on which of the ECs were working on the days that the qualitative interviews were conducted with caregivers at the selected health facilities. If an EC chose not to participate, another EC present at the facility was invited. This process continued until the sample size of 16 was reached.
Caregivers of the children screened using the tool were asked at the time of screening if they were interested in participating in the qualitative interviews immediately following the screening. Caregivers were purposively selected by the ECs from those who voluntarily expressed interest in participating in the interviews. The study team aimed to have an equal distribution of caregivers that were biological and non-biological, and those with children in 2–9 and 10–14 years old age ranges. In Malawi, it is quite common for non-biological caregivers (such as grandparents and aunts) to take children to health facility while parents are working or unavailable. Therefore, it is necessary to evaluate the tool with this population.
Purposive sampling based on exit interviews with caregivers was used on a ‘first-come, first-serve’ basis until the sample size was met for each stratification. This process continued until the sample size of six caregivers of 2–9-year-old children and six caregivers of 10–14-year-old children was reached. This allowed the research team to ensure that the views of caregivers of younger and older children were equally captured. A sample size of 12 interviews was determined to be sufficient, as previous literature has indicated that saturation may be reached at-10–12 interviews.14
Data collection
Data collection occurred after the tool had been implemented for approximately 1 year. All study staff were trained in research ethics, including confidentiality, administering informed consent, completion of the data collection forms and conducting qualitative interviews, transcribing, as well as roles and responsibilities.
Research assistants obtained written informed consent from all interview participants prior to the interviews. Interviews were conducted by the field supervisor with a research assistant taking notes. The field supervisor conducted the interviews using a paper-based semistructured tool to guide the conversation (online supplemental file 2 and 3). All interviews were audiorecorded with the participant’s consent. Interviews were conducted in Chichewa and lasted approximately 30 min.
Supplemental material
Supplemental material
For the caregivers, demographic information was gathered including their sex, age, sex of their child and their biological relationship with the child. Acceptability was assessed through questions about perceived benefits and challenges of the tool, the ability to answer the questions in the tool and implications for increased identification for HIV among children and adolescents. The interviews with the caregivers were conducted directly after the screening tool was administered and were held at a private location in the facility where the screening took place.
Demographic data collected for the ECs included their sex, age, experience in a healthcare facility and the type of facility they worked in. Acceptability was assessed through questions about how the caregivers responded to questions in the tool, caregiver reaction to having their child screened and about EC’s experience administering the tool. Usability was assessed by the average time taken to complete the screening tool, the impact on client flow, ease of using the screening tool and their recommendations on implementation of the tool.
Analysis
All interviews were audiorecorded and simultaneously transcribed and translated into English in Word documents by the research assistants. The study included an equal balance of biological and non-biological caregivers, and caregivers of children ages 2–9 and 10–14 years old to ensure that the study population was representative of those accessing care. Transcripts from all caregivers were analysed as one unit, and transcripts from those providing care to patients were analysed as one unit. Transcripts from each group were reviewed to ensure saturation by determining that no new data was emerging.
Data were analysed using both an inductive and deductive approach. While the data collection tool is structured, data beyond the predefined topics were explored and additional codes created. Transcripts were analysed by hand using a short-answer analysis. This involved compiling the responses for each question by study participant group (caregiver or EC) in a Word document and reviewing for anticipated and unanticipated information. From the compiled responses, documents were generated, summarising common and outlier perspectives. Themes were identified among the summaries and quotes representative of the themes selected. Similarities and differences between the caregivers and ECs were explored. All data were reviewed by the qualitative lead and two research assistants. Any discrepancies were discussed among the group and repeatedly reviewed until consensus was reached. No additional data beyond the transcripts were reviewed.
Patient and public involvement
Patients and the public were not involved in the study’s design or recruitment of study participants. Results have been shared with site administrators, the Malawi Ministry of Health and Child Care, and local stakeholders.
Results
Twenty-eight in-depth interviews were conducted in October 2019, including 12 interviews with the caregivers and 16 with the ECs. All caregivers were female, had a mean age of 38 years, and half were the biological parent of the screened child. The mean age of the caregivers’ children at the time of the interviews was 7.9 years.
Ten of the 16 ECs were female, the mean age was 38.9 years and the average amount of time in their current position was 5.7 months. Fourteen ECs were employed at a health centre and the remaining two at a district hospital.
The study results were organised into four emerging themes, including perceived benefits, perceived challenges, ease of administering and recommendations to improve the paediatric screening tool.
Perceived benefits of the paediatric screening tool
Caregivers
Most of the caregivers stated that the primary benefit of the tool was being prompted to learn their child’s HIV status. Most of the caregivers reported believing that their child was at risk of HIV, but only half of them had ever considered testing their child. Many caregivers were concerned that their children played with sharp objects and/or condoms, putting them at risk for infection. When asked how they felt about receiving their child’s HIV test results, all but one caregiver reported that they were grateful to learn their child’s HIV status. One caregiver stated:
There is no problem with knowing whether the child has HIV, but there is a benefit that if they do have [HIV] you will know how to take care of them by the counsel that you can get from the clinicians. (Caregiver, age 51, child age 2)
Many caregivers wished to know their child’s HIV status to better understand how to care for them properly. When probed to see if they were fearful of their child’s HIV results being positive, four of the caregivers said yes. Despite their fear, they reported wanting to know their child’s status.
Expert clients
The ECs mentioned two main benefits of the tool. First, they noted that it helped to identify the children attending the healthcare facility who were HIV-positive. Six ECs noted that this information helped them to care for HIV-positive children by initiating them on treatment early. Second, the ECs reported that the tool helped them know the health status of their community better. Five ECs said this information could help to inform decisions made by the Malawi government to combat HIV. One EC stated:
Since we started screening, the children that were found positive, most of them looked healthy. There is such a good relationship between us and the child’s parents, they always try to talk to us whenever they come to the hospital. (EC)
Perceived challenges with the paediatric screening tool
Caregivers
The caregivers reported no major challenges with the tool when being screened by the ECs. When probed to see if they experienced any major time delays, the caregivers stated they did not experience significant delays and were assisted in getting other services at the facility by the ECs that screened them. Although no participating caregivers reported any major challenges with the tool, ECs reported that some caregivers declined to participate in the study out of concern of time and losing their spot in the queue for other services.
Expert clients
The ECs reported many challenges with the tool, however, most of those challenges were resolved over time. Initially, there was some interruption to the patient flow through the clinic. Caregivers were recruited at the health facility and pulled from lines where they were waiting. This caused some concern among caregivers over losing their place in line and caused some changes in patient flow from one service to another. It also shifted staff to testing for HIV when more children than usual were sent to be tested after screening positive on the tool. Since this work pulled staff from what they had been doing earlier, it potentially slowed other services and increased the ECs’ workloads. When asked about the challenges experienced with other HCWs, one EC stated:
The way health workers operate has to change, there has to be more health workers doing blood testing, because some day there might be a very long queue of people wanting to be tested the same day, it might not be like we are doing now that we choose that at this particular time, we are only testing children because the number of people wanting to be tested would have gone up and we will just be testing as they come. (EC)
The study also found that there was initial resistance to using this tool from HIV diagnostic assistants (HDAs), a lay cadre responsible for testing the children, because they experienced an increase in children getting tested with negative results. The ECs reported that the HDAs felt that the HIV screening tool was wasting test kits. This issue was resolved over time and with increased understanding of the tool’s purpose. When asked about how the use of the tool affected supplies, one EC stated:
Mainly the HDAs are the ones that complain since they say they are over testing since we send them many children. They say they are over testing and that they are failing to do smart testing because of our study. We told them that you need to discuss with our bosses who told us to be doing this thing. The only problem was that of over testing but now after they discussed with our supervisor, they welcomed it. Now we are able to test people without any problem, (EC)
Some ECs reported that there were also issues with wait times if the queue to receive HIV testing became too long. A couple of ECs said that they had some initial misunderstandings on how to implement the tool, but this was also resolved over time. An EC shared:
At first, we used to have conflicts because they [HCWs] did not understand what we were doing and it was adding to their workload, but after sitting down with them they understood that we are doing a study which will not go on forever but, in the end, it will benefit us all. (EC)
ECs reported that there were some resource limitations that also created challenges. These included an insufficient supply of HIV testing kits and lack of a private space to converse with the caregivers and their children. The increase in testing caused some healthcare facilities to run out of the HIV test kits.
Ease of administering the paediatric screening tool
Caregivers
When caregivers were asked if any of the screening tool’s questions were challenging to answer, none of them reported any difficulty. They felt the questions were simple and easy for them to answer accurately.
In contrast to the participating caregivers’ personal responses, however, the ECs reported perceiving that some caregivers had discomfort discussing their own HIV status and the status of their child due to stigma. One EC explained that HIV was still associated with promiscuity and another EC described how asking about the parent’s HIV status raised concerns among the HIV-positive caregivers about the confidentiality of their HIV status. One EC reported:
Most parents were not comfortable telling us because they thought we will be exposing them [their own HIV status] to other people. Others who were positive were thinking that we are telling them to get tested because we have noticed that they are positive therefore we are thinking their child might be positive as well. (EC)
Much of this discomfort was alleviated after the ECs explained the tool. However, ECs reported that some caregivers refused to have their child tested for HIV because they did not believe their children could be HIV-positive if they themselves were not. An EC explained:
Some would say they are negative therefore their child is also negative they are not supposed to be tested. (EC)
Expert clients
Most ECs reported that implementing the screening tool and HIV testing was easier among children aged 2–9 years because younger children did what their caregivers asked, whereas children aged 10–14 years could refuse HIV testing, even if their parents consented to the testing.
Almost all ECs noted that asking biological caregivers questions in the screening tool was easier because non-biological caregivers had knowledge gaps about a child’s past and therefore struggled to answer some questions. An EC elaborated:
The differences that we saw is that if it’s the biological parent, she explains clearly the birth of the child, if there were some diseases, they explain everything. Now the other care givers [non-biological] fail to tell whether the child once became sick, has the child tested before, or if the child was once admitted in hospital, and what was the disease. (EC)
ECs also shared that non-biological caregivers were often hesitant to allow for the child they were overseeing to be tested, stating that they could not make this decision since it was not their child. In many cases, the caregiver was a family member, such as a grandmother, auntie, etc. and had the authority to provide consent for HIV testing. However, they were hesitant to test the child because, if the result was positive, this could have negative consequences for the child and the family regarding potential stigma and additional responsibilities related to the child’s follow-up care. One EC explained:
…when we have talked with them and asked them to have the child tested, they were usually refusing considering that the child was not their own. (EC)
Recommendations to improve the paediatric screening tool
Caregivers
Nearly all caregivers recommended that the tool be available throughout Malawi. Many stated that since HIV is ‘everywhere’, the tool should be made available to everyone. When asked how to improve the tool, the caregivers suggested administering the tool directly in the villages instead of only at healthcare facilities and recommended making the tool available at the facility every day rather than only on certain days of the week. One caregiver stated:
[The tool] should reach the whole Malawi, every part so that everyone should have this chance of going to the hospital and have her child tested so that one day we should all benefit when all children will be well and have no HIV. We shall have adequate care for our children. (Caregiver, age 33, child age 11)
Expert clients
The ECs had three main recommendations for improving the overall performance, use and acceptability of the tool. First, they stated that decreasing community stigmatisation of HIV and normalising HIV testing was essential, as stigma seemed to be the main concern regarding testing. The ECs stated that if the community and HCWs worked together as a team and accepted and encouraged HIV testing, then the tool would work the way it was intended. One EC shared:
The main story for this tool to work, it cannot work on its own without parents accepting it. When parents accept it, then it will work well. We can say that this thing will work well, but if parents come and do not accept it, then it will not do its job well. Again, if clinicians, HDAs and all of us work together, then we can make work easier. (EC)
Second, the ECs recommended strengthening initial communication with all healthcare staff to alleviate any tension, frustration and misunderstanding associated with implementing this new tool. Lastly, they suggested always having access to a private space to discuss the sensitive topic of HIV with caregivers and their children.
Similar to the caregivers, the ECs reported wishing to see this tool used throughout Malawi. One EC stated:
HIV is not selecting areas; it can affect anyone anywhere so this tool can be beneficial to the whole country to have healthy people who have known their status and a living well. (EC)
Discussion
This study found that the paediatric screening tool was accepted by ECs and caregivers whose children were screened. Previous research has documented a preference of caregivers to be aware of their child’s HIV status, despite any perceptions of stigma and shame, so that they are able to care for the child.15 A nationally representative survey in Zimbabwe found that 91% of people thought children could benefit from being tested for HIV and 92% would feel happier if their children were tested.16
The main challenge identified in this study at that facility level was a lack of understanding by facility staff, primarily the HDAs, about the use and purpose of the screening tool. According to the ECs, concerns were raised by the HDAs about the amount of test kits were being used and about the use of limited resources. At the time of the study, testing of children was based on the 2016 Ministry of Health guidelines.17 The testing of infants was based on the mother’s status; if she was HIV-positive or deceased, the child was deemed at risk and tested for HIV. Older children were likely to be tested if the mother was breast-feeding and assessed to be at risk of HIV. In addition, activities were focused on accelerating the identification of CLHIV, in line with ‘90-90-90,’ the Joint United Nations Progamme on HIV/AIDS strategy where 90% of HIV-positive individuals were to be diagnosed by 2020, 90% of whom will be on ART and 90% of whom will achieve sustained virologic suppression.18 As HIV positivity yield is higher among adults compared with children, much of the testing attention was focused on the adult population, hence the concern with the potential ‘wastage’ of test kits, since more tests were needed to diagnose CLHIV. Subsequently, study participants reported that when adequate time was spent educating HDAs and HCWs about the purpose and benefit of the tool, these worries subsided and the tool was generally accepted. Previous studies have documented the challenges of implementing new programmes, with many HCWs wanting ‘motivation,’ often in the form of additional financial reimbursement,19 but, in this Malawi study, the staff were more concerned about preserving the limited supply of HIV test kits than receiving additional forms of reimbursement for their work. Additionally, a comment by an EC, that this was a study and therefore time limited, suggested additional barriers to the potential implementation of a screening tool in routine practice. These barriers may include limited staffing. While we did not explore this potential barrier to implementation, these results highlight the need for a comprehensive introduction to the screening tool before its implementation.
In addition, there were considerable challenges in implementing the tool among non-biological caregivers, ranging from their lack of ability to answer some of the screening questions, to their discomfort with allowing someone else’s child to be tested for HIV. More considerations could include how to implement this tool, such as requesting a biological parent to be present (when possible), to ensure the screening tool is used effectively and to decrease the number of missed cases.
Concerns about stigma and confidentiality among the caregivers was another challenge when implementing the tool. ECs reported that the main question caregivers were uncomfortable with was about their own HIV status, as this raised questions about the confidentiality of their status and around who had access to their records at the facility. Concerns about confidentiality may have influenced caregivers’ decision about having their child screened. Despite decades of work increasing HIV information in the facilities and communities, stigma remains a prominent barrier to the disclosure of one’s status.20 21 It is well documented that confidentiality is a major concern among people living with HIV.22 23 ECs recommended that more work was needed to ‘normalise’ HIV testing, decrease the stigma around testing and increase its acceptability even among patients attending health facilities.
One study evaluating the implementation of a paediatric HIV screening tool in the community found that participants felt that their confidentiality was better protected at home, without the stigma attached to attending the health facility,24 although some participants reported neighbour gossip arising from community health workers seen at their home. This study also reported suboptimal fidelity to administration of this tool to children and adolescents in the community.24
While qualitative studies are not usually generalisable, we believe our results may be applicable to high volume outpatient healthcare settings in Malawi that are likely to screen children for HIV using a screening tool. This is because the study demonstrates the need to provide a thorough orientation and training of HCWs on a potential tool, and to be able to ensure adequate staffing and resources.
There were several limitations of this study. Only caregivers of those who accepted the paediatric screening tool were interviewed and those who rejected to participate may have had differing opinions. Those who declined to participate may have been from a different socioeconomic class and/or likely to be HIV-positive. In addition, no interviews were conducted with the children that were screened with the tool. The children age 10–14 years who rejected being screened, may have had a different perspective. Since the study required all children to be tested regardless of screening outcome to determine the sensitivity, specificity, PPV and NPV, information on caregiver sentiments about children who would not have been offered an HIV test under programme conditions was not able to be collected.
Conclusion
Paediatric HIV screening tools provide a critical opportunity to identify children infected with HIV, especially in resource-constrained settings where it is not possible to test all children with an undocumented HIV status presenting to outpatient departments, preserving finite resources and providing a high yield of HIV-positive results. As previous research has discussed, screening tools may be improved by collecting maternal serostatus, when available. Screening tools need further evaluation and may require adaption to each environment. This study identified important considerations for the implementation of a paediatric screening tool, including the need for a thorough orientation of the tools to ensure they are fully understood and accepted among HCWs. The study also recognised considerations regarding caregivers’ ability to respond to the questions in the tool and recommendations to improve the receptiveness of caregivers to the tool. In designing any new tool, it is important to consider how the tool will be perceived and how the population will react to its introduction.
Data availability statement
Data are available on reasonable request. Data are available from the study team on reasonable request.
Ethics statements
Patient consent for publication
Ethics approval
Ethical clearance was obtained from National Health Science Research Committee on 12 September 2018, approval number 2130, protocol number 12/09/2131. The study was also reviewed and approved by the Advarra Institutional Review Board (IRB) on 22 March 2019, protocol number Pro00032796. Participants gave informed consent to participate in the study before taking part.
Acknowledgments
The authors would like to thank the study participants and research assistants that collected the data, and the patient advisors.
Supplementary materials
Supplementary Data
This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.
Footnotes
Contributors KK and DK designed the study. TM oversaw data collection in the field. LK, TM, SH, JG and GW drafted the manuscript. All authors were involved in reading and approving the final manuscript. LK is the guarantor.
Funding This research has been supported by the President’s Emergency Plan for AIDS Relief (PEPFAR) through the US Centres for Disease Control and Prevention under the terms of NU2GGH002010.
Disclaimer The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the funding agencies.
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.