Decision point on strategies to promote adherence to TPT
What strategies should national programmes adopt to ensure adherence to the prescribed regimen by all individuals started on TPT?
Adherence to treatment is a complex behaviour that is influenced by many factors such as personal motivation, beliefs about health, risks and benefits from treatment, comorbidities, competing demands that conflict with the taking of medicine, family environment, complexity of the drug regimen, drug toxicity, trust and relationship with the health provider (58). Effective person-centred strategies to promote adherence to TPT may incorporate the following components:
- Ensure confidentiality when seeking a person’s commitment to complete the course before initiating TPT.
- Ensure that the person understands the role of TPT regimen options and the duration required to complete for maximizing protection. Provide information materials in the primary language and at the appropriate literacy level of the person concerned.
- • Involve family members and caregivers in health education when possible. Children often move between households and health facilities; it may be helpful to include additional facility members and caregivers in adherence support.
- Reinforce supportive educational messages at each contact during treatment.
- Give clear information regarding adverse drug reactions (“side-effects”) and triggers on when to stop treatment and contact the health care worker.
- Invite clarification questions and provide clear and simple answers. Provide a telephone number to call for other queries or a need to contact health services for advice.
- Develop a personal adherence plan with the support of family member, caregiver or health worker as per treatment regimen being provided (Box 7.1).
Interventions to ensure adherence and treatment completion should be tailored to the specific needs of risk groups and the local context. It should be recognized that protection from a course of TPT depends upon the level of adherence. However, concerns about perfect adherence should not become a barrier in providing TPT. The 2017 WHO guidelines for treatment of drug-susceptible TB proposes several interventions to support adherence that could be applied to TPT, including digital technologies (74). Similarly, the best practice for the care of TB patients produced by The Union indicates support considerations to enhance adherence to TPT (132). A systematic review conducted for earlier WHO guidance on TPT provided inconclusive results about whether direct observation could improve treatment adherence and completion when compared with self-administered treatment (49).
Supportive messages to improve adherence and treatment completion
Acceptance by a person at risk to take TPT is often influenced by information given by counsellors, nurses, doctors, pharmacists and other health care staff. To help people appreciate fully the rationale behind TPT explain about the following benefits:
- TPT can hold back TB disease from occurring later. TB disease can lead to a long period of severe illness, permanent damage to organs and premature death if untreated.
- It is particularly important for people who have the following conditions to take TPT to reduce their risk of developing TB disease:
– People with recent TB infection such as contacts of people with TB disease, especially children
under five years of age
– People with HIV and other medical conditions that lower immunity
– People taking medication that may lower their immunity such as anti-TNF, steroids.
- TPT with new medicines that shorten the treatment span to three months or less is now recommended by WHO, whereas TB disease requires at least six months of treatment, starting with four medicines.
Providers should also alert people about the risks associated with TPT and the likelihood of their occurring (Chapter 6). A person on TPT should remember that:
- Red discolouration of urine and other body fluids while taking 3HR/3HP/1HP/4R is a normal accompaniment of rifamycin therapy and is harmless.
- Some frequent adverse drug reactions are gastrointestinal disturbances, flu-like symptoms, liver injury (hepatotoxicity) or a rash.
- Persons on TPT should be alerted to:
– Early signs of hepatotoxicity that include weakness, fatigue, loss of appetite, persistent nausea. When identified early, hepatotoxicity is reversible and without permanent sequelae. Late signs of hepatotoxicity include liver tenderness, liver enlargement (hepatomegaly) and jaundice
– Flu-like and other acute symptoms appearing shortly after taking a dose of rifapentinecontaining TPT (most commonly with the third dose), rash, pain or numbness in hands and feet.
If a person on TPT experiences any of the above symptoms or a change in their health situation, they should contact a health care provider for advice and only continue taking preventive treatment if advised to do so.
Furthermore, people on TPT should understand that:
- TB disease can develop during TPT
– While an effort is usually made to exclude TB disease through a symptom screen prior to starting TPT, persons on TPT should be vigilant as they can still develop TB disease while on treatment.
– If they start having a cough, unexplained weight loss, fever and night sweats, they should immediately let the provider know and undergo tests for TB disease. Among younger children other non-specific features such as failure to thrive, lack of playfulness and reduced appetite should be carefully monitored as they may be early pointers to TB disease.
- Pregnancy can occur during TPT
– Women of child-bearing age should be counselled to use barrier methods of contraception while using TPT.
– Safety data for use of regimens containing rifapentine during pregnancy remain sparse. If pregnancy occurs during 3HP or 1HP, it would best be to switch TPT to six months of daily isoniazid.
– The triple combination FDC of isoniazid + cotrimoxazole + B6 may be used for TPT among pregnant and breastfeeding women with HIV along with supportive care and monitoring.
Potential barriers to adherence
Many factors influence a person’s adherence to a recommended treatment regimen. Non-adherence should be recognized and addressed as soon as possible. The following need to be considered as potential barriers for TPT among adults:
- Clinic opening hours conflict with person’s schedule
- Competing priorities, such as work, school, caring for children or elderly
- Long waiting times at clinics
- Cost of clinic visits (transport, time, loss of work)
- Incorrect or insufficient information about:
– TB infection
– treatment regimen
– TB disease
- Real or perceived stigma related to TB infection, disease and treatment
- Health beliefs and practices
- Conviction that TPT is more of a nuisance than useful
- Treatment-related issues:
– coexisting medical conditions
– concomitant use of other medicines, conventional or otherwise, or food supplements that could interfere with adherence or with effectiveness of the medicines
– adverse drug reactions associated with the medicines and a person’s past history of reactions to medicines
– alcohol intake during medication
– difficulty remembering daily or weekly dose
– religious practices such as fasting.
Strategies to improve adherence and treatment completion
To improve the chances of adherence and regimen completion, the following needs to be considered when providing guidance to individuals receiving TPT.
- Explore and unpack an individual’s understanding about TB, TPT and elicit support from family members or a companion in a similar situation (“treatment buddy”).
- Explain the importance of taking treatment at a fixed scheduled time of the day or time/day every week (3HP). The exact timing does not matter but it is easier to remember if the same time is retained.
- Explain the importance of completing the full course of treatment for optimum protection from TB
- In case of adverse drug reactions, even mild ones, stress the importance of informing and seeking care from the provider. In most cases symptomatic treatment will suffice without the need to stop or defer TPT.
- Taking all medications together at once and not dividing the dose over a few hours or a few days. Pills can be separated if the whole dose can be taken within 30 minutes.
- Use reminders to help take medication regularly such as daily/weekly events
– Electronic reminders on cell phones: bidirectional SMS and voice calls can improve communication with the caregiver, such as on suspected toxicities
– Take medication with one of the meals or before sleeping every night (daily) or around Sunday/Saturday/Friday prayers (weekly)
– Be cautious about overreliance on a TV or radio show to remember when to take a dose given that a programme may be rescheduled, moved to a different time slot or there may be electricity outages.
Options that can be used for supporting adherence
- Align TPT delivery and follow-up with TB/HIV/other services that the person may be receiving simultaneously, including use of DSD models, and motivational counselling through trained providers.
- Identify an appropriate treatment supporter such as a family member, neighbour, colleague.
- Record additional information about the person on TPT – such as contact numbers at home, work and cellphone numbers, and email address, as well as names and contact details of close friends, or relatives living in the same city, or same country – with a clear commitment of confidentiality from the providers. The treatment supporter should be counselled in detail with regards to care and provided supportive supervision.
- Schedule in-person encounters for individuals whose treatment has been interrupted or who often miss appointments for medication refills. Digital adherence technologies, such as electronic medical monitors (pill boxes equipped with SIM cards) and video supported therapy may help to ensure adherence when in-person visits are not feasible.
- Provide incentives to encourage or motivate individuals depending on acceptability within the country context and availability of funds (such as airtime/grocery store coupons/food parcels or supplements). While these are commonly used, their link to improved adherence has not been clearly demonstrated (133).
- Provide enablers such as reimbursement of transport cost and phone calls, to make it easier to keep appointments depending on acceptability within the country context and availability of staff resources and funds.
- Develop an adherence plan with the person on TPT and discuss it at each visit. Such a plan may include information on:
– motivators for the person to want to be TB free
– using the person’s individual and family routines and their variations to identify best time to take the medicines
– taking medicines with food to reduce nausea and vomiting or at night three/four hours after dinner.
Special considerations for adherence among children
Infants and children are dependent on caregivers for medication administration, and therefore the barriers faced by their adult caregivers can contribute to missing doses for children. The considerations laid out above would apply to caregivers of children and infants on preventive treatment.
Potential barriers for children
- The absence of child-friendly formulations makes medication more difficult to administer and increases the chances that the child refuses treatment with crushed pills.
- Lack of conviction among the caregiver about importance of TPT. Only if both the caregiver and health care worker are invested in the successful completion of TPT, will the adherence of child be ensured.
- Family factors
– Not having one or more appropriate caregivers among relatives. Given that young children may move around different homes within the family, the involvement of multiple caregivers (grandparents, father’s family) may be necessary
– Caregivers lack of knowledge
– Age and developmental stage at which children can take more responsibility for taking their own medications while still being supervised by an adult
– Changes in routine for the family or child (such as school vacations) that disrupts administration schedule.
Strategies for managing and enhancing adherence among children
- Explain and emphasize to the caregiver and child why they must take the full course of treatment.
- For dispersible FDCs, child-friendly formulations, ensure that the health care workers can explain and provide clear instructions to caregivers regarding how to dissolve the FDCs in water.
- Provide a person-friendly schedule for appointments for drug refills.
- Take note of risk factors for poor adherence and attempt to address them: such as long distance/ transport; orphans (especially if the mother has died); past adverse reactions to medicines or primary caregiver being unwell.
- Provide adolescents with education and adherence support directly, especially if they are living with HIV.
- For young children refusing to take medicine:
– change the food type so as to better mask the taste or place crushed medicines in the centre of solid food that is easy to swallow as alternatives to mixing with water
– provide a treat as reward for taking medication completely
– if a child vomits within 30 minutes of a dose, ensure that a new dose is given to the child. This means families are given a few extra doses every month (the programme should estimate the extent of such losses and reflect the same in procurement plans).
- Prepare an adherence plan with the caregiver and ask that it be shared with other caregivers.
- Review the adherence plan at each encounter especially if there is a new caregiver present.
- Review knowledge and barriers at each visit. Examples of questions to be asked are listed below.
– Who is the primary caregiver (parent, grandparent, aunt/uncle, other child)?
– Does the child sometimes sleep in another family member’s home?
– Is the caregiver aware that the treatment is daily (isoniazid, 3HR) or once weekly (3HP) for three months?
– Is the caregiver aware of dose/pill number at each time?
Is the caregiver being counselled regarding the need for adherence, adverse drug reactions, when to seek health care worker’s advice, and what to do when the child vomits after medication (repeating dose)?