Tuberculosis preventive treatment preferences among care givers of children in Lesotho: a pilot study

SUMMARY

BACKGROUND:

Shorter-duration regimens for preventing drug-susceptible tuberculosis (TB) have been shown to be safe and efficacious in children, and may improve acceptability, adherence, and treatment completion. While these regimens have been used in children in low TB burden countries, they are not yet widely used in high TB burden countries.

SETTING:

Five health facilities in one district in Lesotho, a high TB burden country.

OBJECTIVE:

Assess the preventive treatment preferences of care givers of child TB contacts.

DESIGN:

Qualitative data were collected using in-depth interviews with 12 care givers whose children completed preventive treatment, and analyzed using grounded theory.

FINDINGS:

Care givers were interested in being involved in the children’s treatment decisions. Pill burden, treatment duration and related frequency of dosing were identified as important factors that influenced preventive treatment preferences among care givers.

CONCLUSION:

Understanding care giver preferences and involving them in treatment decisions may facilitate efforts to implement successful preventive treatment for TB among children in high TB burden countries.

GIVEN THE SIGNIFICANT BURDEN of severe tuberculosis (TB) disease and death in young children,^1,2 the implementation of effective preventive treatment is an important upstream strategy to prevent TB-related morbidity and mortality among children. Six months of isoniazid preventive therapy (IPT) is the standard recommendation for all human immunodeficiency virus (HIV) positive children aged ,15 years and HIV-negative children aged ,5 years who have had close contact with an adult TB case.³ However, a recent systematic review reported poor IPT initiation and completion rates among child contacts in high TB burden countries.⁴

Shorter treatment regimens for the prevention of drug-susceptible TB have been shown to be safe and efficacious in clinical trials among children,⁵ and may potentially improve acceptability, adherence and completion of preventive treatment in this vulnerable group.^6,7 While these shorter-duration preventive treatment regimens have been used in children in low TB burden countries, they are not yet widely used in high TB burden countries.⁶ As the latter countries begin to consider the use of shorter preventive treatment regimens in eligible children, understanding the treatment preferences of care givers is important, as care givers have substantial influence on uptake of, retention in and adherence to such treatment, ultimately impacting treatment outcomes.

Lesotho is a lower middle-income sub-Saharan African country,⁸ with an estimated TB incidence of 724 per 100 000 population, and HIV prevalence of 25.6%, both representing the second highest rates in the world.^9,10 While only 3.3% of reported TB cases in Lesotho are children aged ,15 years,¹¹ this is lower than the expected 10–20% in similar settings,¹² likely reflecting substantial underdiagnosis of this serious condition in children. IPT implementation in Lesotho has been very low due to the lack of standardized tools for IPT management and reporting to date. Using qualitative methods, we aimed to ascertain the priority attributes of preventive treatment regimens according to care givers of child TB contacts and the reasons for these preferences to inform future programmatic design.

DESIGN

A purposive sample of 12 care givers whose children had received IPT from five health facilities was recruited in one district in Lesotho between March and May 2017. Inclusion criteria for care givers were a care giver of a child contact who had completed IPT at a health facility, age ⩾15 years, English- or Sesotho-speaking, and able to provide informed consent.

In-depth interviews were conducted in Sesotho by a trained qualitative interviewer at each participating health facility in a private space on-site to ensure participants’ privacy and confidentiality. The interview guide consisted of open-ended, exploratory questions that were framed in a non-judgmental and culturally sensitive way. Questions relevant to this analysis explored interest in shared decision-making by the care giver and the provider and attributes of preventive treatment regimens, such as pill size, number of pills, dosing frequency, treatment duration, and provider recommendations, that are important to care givers. Care givers were presented with scenarios of different regimens (e.g., 3 months of daily treatment with two medications and vitamin B6, 4 months of daily treatment with one medication) and asked to select what they thought was the best regimen for their child. Care givers were then asked which attributes of preventive treatment regimens led them to pick their chosen regimen. Audio-recorded interviews were transcribed verbatim, translated, anonymized, and entered into Dedoose (University of California Los Angeles, Los Angeles, CA, USA), an internet application for qualitative data analysis.¹³ Participants were compensated for their travel costs to the health facility.

We used grounded theory as the framework for data inquiry and analysis.^14,15 Themes were independently generated from a preliminary review of transcripts by two co-authors (YHM, CW) and cross-checked to enhance consensus on themes and primary codes. An iterative process was used to further refine and contextualize codes through constant and discursive comparative analysis^14,15 within and across transcripts to facilitate a comprehensive understanding of care givers’ perspectives. Once concordance on codes was achieved, all transcripts were coded. We used critical reflexivity to ensure that the findings and interpretations were grounded in participants’ narratives. Typical quotations are used in the present study to illustrate the identified themes.

The study protocol was approved by the Columbia University Medical Center Institutional Review Board, New York, NY, USA (Ref #IRB-AAAN7358), and the National Health Research Ethics Committee, Maseru, Lesotho (Ref #ID78-2015). All participants provided written informed consent before participation. Consent was facilitated by providing potential study participants with a detailed study description and an adequate opportunity to ask questions. Care givers were informed that their study participation was voluntary and that all responses would be kept confidential and anonymized.

FINDINGS

All individuals referred to the study by a provider agreed to participate. The average interview duration was 33 min (range 27–38). The majority (11/12) of participants were female; the average age was 35 years (range 20–52); nearly half (5/12) had less than primary education, and one participant was employed. Most care givers were mothers (10/12), one was a father, and one was an aunt of a child contact.

Shared decision-making

Most care givers expressed a strong interest in shared treatment decision making for the child, several of whom were outspoken about the control they have over their child’s treatment and thus the importance of involving them in treatment decisions.

I would like to be involved in the decision making because the sick child is mine. They should tell me that they want to do this and we should be in agreement… Because they can give me medicines but then when I get home, I can put it aside and not continue with them. The service provider would think that, ‘I have given ‘m’e [the mom] her child’s treatment,’ while when I get home I would be saying, ‘they are burdening my child with medications, etc.,’ and then I put these aside and wouldn’t take action.

[38-year-old mother]

…that decision should be a joint one made by all those people because it is I who have brought the child to the health facility, I am the one who meets the nurse, who explains to me in the absence of the family. When we have reached a common decision, I will still go home to explain to them how the medication works. I would not refuse to take the child’s medication and say I am going to ask those at home if I should take the medication when already I see the need for the child to take the medication.

[52-year-old aunt]

I would like a joint decision so that there could be an understanding, so that there could never be a time that you find that a child is not taking the pills properly or when one gets home he/she finds that a child is not taking the medication because the final decision was made by the nurse. Mhmm, you find that the mother was not happy and when she gets home, she makes her own dangerous decisions.

[26-year-old father]

Some of the care givers interested in shared treatment decision making felt that provider recommendations were very important.

I can consider it [nurse’s advice] because what we need is life… When the child is using medication, you will indeed end up being interested in when he is taking the medication, how and at what time. Because we are his parents, we can take care of him.

[31-year-old mother]

…the nurse’s advice [is important] because they are the ones who know these [TB prevention] things… because if I don’t make a decision that she should drink her medication and the decisions are made for me, I have to agree and understand that they bring life to her.

[37-year-old mother]

[I would like to be involved] because I have seen that this one’s for 6 months, they were fine with me. I have never come across any problem and I am the one giving them these drugs… The nurse [should make the treatment decision]… I think she cannot give me something which is wrong and she knows better.

[32-year-old mother]

However, a few care givers were not interested at all in shared treatment decision making and wanted the provider to make the decision.

Sometimes I will not be able to know things which can be discussed… I think the nurse is the one who knows everything which is being discussed about the child’s medication because as for me, I don’t know anything.

[34-year-old mother]

I don’t know anything about medicines… if I am only told that the child should take medication and if I am told by the person who is qualified for that because it can be difficult for me to make a decision.

[40-year-old mother]

I think that when that person [nurse] tells me like that, that is the way that she has been taught for it to be good.

[31-year-old mother]

Treatment preferences

Pill burden, treatment duration and the related frequency of dosing were considered important factors in treatment preferences. Care givers indicated that they had no concerns regarding possible side effects as long as they were informed about these in advance.

Pill burden

Care givers spoke of difficulties in administering medications to young children, both in terms of the number of pills and their size.

I have realized that children are not the same as us; it is so difficult to give children medication. They cause problems when you give them medication.

[34-year-old mother]

… pills are not like syrup, a child is very sensitive to some things, she does not have the understanding of why some things are important to use… it’s the quantity taken per day [that] is right for someone that age.

[26-year-old father]

A single-drug regimen that does not require taking additional vitamin pills, as is needed with IPT, made it an attractive treatment regimen.

You know it’s just one [medicine]; the other ones are just too many, you know.

[20-year-old mother]

Because one is taken once, a child can give problems at times, I am able to trick him with that one… I choose to give him only one.

[40-year-old mother]

Preventive treatment duration and frequency of dosing

Other important factors that care givers raised were the duration of preventive treatment and frequency of dosing. Care givers were interested in shorter treatment periods and less frequent drug administration.

It’s very important ma’am very much as to how long the child will drink it.

[38-year-old mother]

I think the one which you take only once a week for 3 months so that I don’t forget them.

[38-year-old mother]

However, interest in a shorter-duration treatment regimen was offset by concern about weekly administration, which was considered difficult to remember. Many participants viewed daily dosing as easier to remember and manage compared with less frequent dosing.

… in some days I can forget… It’s true it’s important because it’s a short period but sometimes one may forget, while taking medicine every day can make you remember every day until he has completed, yes.

[37-year-old mother]

I like it [daily regimen] because if it has something wrong or something good, one can notice immediately because it is taken daily. That way one can rush to the facility to find out what is wrong… it gives you the opportunity to point out what could be the cause of the problem.

[26-year-old father]

DISCUSSION

Despite having one of the most severe TB epidemics in the world, very few child contacts of TB cases in Lesotho receive IPT, as recommended by national and global guidelines.³ Shorter-duration preventive treatment regimens may potentially improve treatment acceptance, adherence, and completion, and allow more children to complete preventive treatment in high-burden countries. In low TB burden countries, these regimens were found to be associated with higher treatment initiation and completion rates.¹⁶

Care givers of children are acknowledged to play an important role in determining the uptake and outcomes of various child-targeted interventions. Exploring treatment preferences among care givers of children who are potential candidates for preventive treatment is thus important, as they can affect the treatment outcomes of such children. In this small pilot study, to our knowledge the first to explore preventive treatment preferences among care givers in a high TB burden country, we found that care givers were interested in being involved in the treatment decisions of the children they cared for. Pill burden, treatment duration and the related frequency of dosing were identified as important factors that influenced preventive treatment preferences among care givers.

Patient preference has been increasingly acknowledged as an integral part of treatment decision making.^17–20 When decisions involve multiple potential treatment options and there is a lack of a clearly superior option, incorporating such information in discussions with patients is complex, yet of paramount importance. Many patients prefer to actively engage with providers in decisions concerning their health, especially once they understand the benefits of doing so.^21,22 Systematic reviews have emphasized the importance of shared treatment decision making as a mediator and a moderator of health care quality,²³ as it may enhance the provider-patient relationship and improve the quality and outcome of health care.^24,25

Participation in the treatment decision was important to most care givers in our study. Conferring agency to the care giver via discussion of treatment choices may lead to their empowerment and further engagement in their child’s care, resulting in better treatment outcomes. However, while care givers value the idea of being involved and empowered in treatment decisions, in practice they often defer to providers. Furthermore, there are some practical considerations of implementing shared decision making in the context of an imbalanced power structure, where patients are often reluctant to be completely open about their concerns and preferences during clinical encounters out of fear of being labeled ‘difficult’;^26,27 even when patients do ask questions, providers’ answers vary in their completeness, depending on their judgement of their patients’ capacity to understand the information, and some patients are met with discouraging reactions from unprepared providers.²⁸

Pill burden, treatment duration, and dosing frequency were important factors noted by care givers. It is therefore important to engage care givers in discussions of alternative regimens that balance the preferences they articulate and fit those preferences to each child’s needs. Some of the newer preventive treatment regimens are shorter and require less than daily dosing (e.g., weekly dosing) but carry a larger pill burden, which may be inappropriate for children who struggle with pill ingestion or children and adolescents with HIV who might be facing special challenges due to their need to also take antiretroviral therapy and other HIV-related medications. In addition, shorter weekly preventive treatment regimens may not be the appropriate choice for some children, as such dosing can be challenging for some care givers who find it easier to provide daily dosing to children or in situations in which the children or adolescents are already receiving other daily medications for another health condition. This highlights the need to explore different interventions that support adherence to weekly preventive treatment regimens.

Our study had several strengths. It pursued a novel issue in the context of the challenge of achieving better uptake and completion of preventive treatment for TB among child contacts. It also used a rigorous approach to elicit insights from care givers that could inform the design of appropriate preventive treatment models for TB among children.

However, our study findings were limited by the small sample size, which did not allow us to draw definitive conclusions about care giver preferences regarding preventive treatment for TB. Another potential limitation was that study participants were care givers who had administered IPT to their children for 6 months which, while being informative, may limit the generalizability of the findings to naïve care givers to the issues discussed in our study. Furthermore, we did not use pictures to illustrate what each possible regimen would look like in terms of the number and size of pills, and did not ask about cutting or crushing pills for small children. Generalizability may also be limited by the narrow geographic scope of the study.

Programmatic limitations are a reality in most high TB burden countries, as most countries do not currently offer IPT to child contacts and do not support alternative preventive regimens yet. Further prospective studies are needed to test interventions that simultaneously enhance patient and provider communication by changing both patient and provider behaviors and improving shared decision making, as well as gain an understanding of the extent to which patient involvement in decision making is associated with a greater commitment to the treatment option agreed upon. Care giver perceptions and preferences in decisions regarding preventive treatment regimens need to be known, as the provider’s perspective of the best treatment option may not coincide with that of the care giver’s or reflect the unique needs of each child. An important area for study is a greater in-depth exploration of the treatment preferences of care givers and providers and how each prioritizes the various treatment attributes using a discrete choice experiment design to inform future programmatic approaches.

CONCLUSION

Understanding care giver preferences for the management of child contacts of TB cases may facilitate efforts to operationalize the implementation of preventive treatment for TB in high TB burden countries. This strategy will contribute to the prevention of TB, a condition associated with substantial morbidity and mortality among children.