Poor design makes it a battle to get young children with HIV to take their medicine

Approximately half of all children receiving HIV care in Kenya have interruptions in their treatment lasting longer than 48 hours, and almost half are lost to follow-up care within five years. A study recently published in PLOS ONE linked these interruptions to the practical challenges of distributing paediatric medicines to small children. The authors argue that these interruptions, which they link to current paediatric ART formulations, contribute to ART ineffectiveness and poor outcomes for children living with HIV. They call for changes to paediatric medications that would make them much easier to administer and less unpleasant to take.

The study of caregivers of children under the age of ten receiving HIV treatment conducted nine focus groups with a total of 72 caregivers (three in five were parents) caring for children living with HIV who were younger than 10. They also interviewed 30 healthcare providers including clinical officers, mentor mothers, nurses, and community health volunteers. Participants were recruited through three public hospitals in Siaya and Mombasa in Kenya in 2022.

Four in five caregivers were female and three in four were themselves living with HIV. Caregivers included parents (61%), grandparents (20%), aunts (11%) and siblings (4%). While 85% were caring for one child living with HIV, 14% were caring for two. Only one in three were the only people giving medicines to their children. The sample was extremely economically disadvantaged: 45% had a weekly household income of less than 500 Kenyan shillings, or £2.5 pounds sterling, and one in four had a weekly income of between 500-750 Kenyan shillings.

Caregivers and health care providers were aware of the importance of children’s adherence, but faced significant barriers to achieving it. These barriers included the medications’ taste, their complex preparation and administration, challenges with storage, frequent hospital visits and stockouts. Many of these barriers were made even more difficult by caregivers’ limited financial resources (many had to choose between spending money on transport to the hospital, on medication, or on food) and responsibilities outside the home.

Poor taste

Very young children mostly received ART as a syrup, and older children took tablets that were crushed and dissolved in liquid, or, as they got older, swallowed whole. Participants did not describe newer paediatric formulations such as dispersible tablets that can be dissolved in water and granules designed to be mixed with food.

Providers and caregivers cited medications’ bitter taste as a significant barrier to adherence, as children refused the medication (spitting it out, vomiting, or running away). This ‘battle’, which caused both children and caregivers anxiety, stress, and, in caregivers’ case, guilt, both strained the caregiver/child relationship and made adherence difficult. If a child vomited or spat out the medication, the caregiver could not tell how much of it they had received.

“The palatability is not good, and as you know, children love tasteful things and when you give them drugs that are not tasteful, they spit it out. It becomes difficult to administer the drug, so you don’t even know whether the child or children have gotten the correct dosage.” – Provider

While sweetening the medication by mixing it with porridge, honey or syrup was often recommended by the children’s doctors, caregivers could not always afford these mixtures, which children often resisted taking. Caregivers described resorting to bribes, and occasionally threats, to get their child to take the medication – which the caregivers viewed as counterproductive, although necessary at the time.

Preparation and administration

Preparing children’s ART twice daily was complicated and time-consuming, often taking up to an hour to complete. Tablets often needed to be crushed, measured, dissolved, and mixed, with each step done carefully to avoid measurement errors. As the tablets did not always fully dissolve, children found them unpleasant to take. Caregivers with children who were too young to take a full tablet had to cut the tablet in half, but the tablet often did not neatly break in the middle. When this happened, caregivers had to choose between under or over-medicating the child.

“Sometimes it breaks wrongly, forcing you to give ¾ instead of a ½ the tablet and . . .You just give it like that.” – Caregiver

Caregivers often had to rely on others who knew of the child’s HIV status (such as a trusted family member) to prepare and administer the child’s ART, but given the complexities of doing this, and these others’ inexperience, caregivers worried that the medications were incorrectly administered. Healthcare providers shared this concern, noting that children whose caregivers heavily relied on others to administer their HIV medications tended to have higher viral loads at checkups.

Caregivers’ desire to keep their children’s HIV status private from all except close family and friends made traveling with children challenging, as unobtrusively carrying and administering these medications was difficult. Similar dangers of other family members or neighbours learning about their children’s HIV status were introduced by the chance of these others witnessing the ‘battles’ described above or caregivers’ preparing ART. As a result, caregivers felt caught between administering the medications on schedule and inadvertently disclosing their children’s HIV status.

“When there is a funeral at home and you attend it, when it comes time to give the child medication and there are some relatives who are unaware of your status, when you take out the medication to give to the child, they ask a lot of questions. It forces us to skip giving the child their medication to avoid the questions.” – Caregiver

“So, when I want to give the baby the drugs, I always like to be alone and when I hear footsteps approaching; I’d want to know who it is. I just tell them I’m a bit busy and tell them to wait a while until I’m done. Personally, I’m not scared but this is my child’s life and her privacy.” – Caregiver

Administering ART to children became easier, with fewer challenges of poor taste and cooperation,  as the child grew older. Older children could also swallow pills whole, which made preparation much easier. Disclosing their HIV status to the child also helped children understand why they were taking the medication, and the importance of adherence. In fact, children as young as six or seven had, as caregivers explained, begun to take responsibility for their own medication adherence, as well as that of their siblings.

Storage

All of the medications the participants discussed required a cool and dry storage environment that was away from direct sunlight. Syrups required refrigeration. Improper storage made the medications less effective, a topic that healthcare providers interviewed for the study said they had seen in their own practice. Given participants’ living environments, doing this was challenging and required improvisation. Caregivers without refrigeration in their homes stored the medication in whatever cool areas they could easily access, such as a cool jug of water or a sandy hole in the ground, but needed to frequently check that the medications had not become too warm or had been discovered by visitors or other children. While tablets did not need refrigeration and could be transported while travelling, keeping syrups cool added to the difficulties of travel.

ART refill frequency and stockouts

How often caregivers refilled their children’s ART varied by the child’s age and viral load (younger children with high viral loads had appointments every two weeks, while other children had appointments every month or two months). Having to travel to the hospital this often was challenging for several reasons.

“There was a time that every month, my two girls had to miss their classes because of going for the refills, but it reached a point where I started skipping going with them to the clinic. Whenever they ask, I would tell them that, they were sitting for exams.” – Caregiver

This same caregiver noted that the frequency of attending the clinic for ART refills “aroused my neighbours’ curiosity”, threatening her child’s privacy. Other difficulties were finding the money for travel and time off work.

When supplies of paediatric ART ran out, providers had to resort to distributing adult versions of the medications – large, bitter pills that were difficult to accurately dose. Caregivers often had to skip doses, seek out medications from private institutions, or make extra visits to the hospital.. Moreover, how clinics managed shortages – prescribing a syrup and a tablet at the same time or switching between them – led to confusion and to mistakes being made. Some medications could not be properly administered to children. One health provider described:

“a dilemma between giving a whole tablet and the child will refuse to swallow completely and it would go to waste or you crush it and compromise the effectiveness of drug and at least deliver something to this child”.

Recommendations

The authors emphasise the need for new designs of ART that make preparing and giving it to small children easier for the caregiver and less unpleasant for the child. This would increase adherence, decrease stress, and improve the quality of life of children living with HIV and their caregivers. It would involve, for example, reducing the number of daily doses and making each dose easier to take. The authors noted that while many programmes aimed at transitioning children to adult care start at 12, 15, 18 years of age or even older, the caregivers who participated in this study described children as young as six beginning to take responsibility for their own medication adherence. Given how much easier this growing responsibility for self-care makes paediatric ART taking for both child and caregiver, simplifying medications would make it easier for children who are not yet developmentally ready to take on these new responsibilities to adhere to their medication regimens.