S.J. Abah, E. Addo, P.C. Adjei, P. Arhin, A.A.S. Barami, M.A. Byarugaba, C.S. Chibuta, A.K. Chowdhury, L. Dlamini, C.C. Ekezie, J. Essobe, T. Gerrits, L.N. Gitau, J.E.P. Hadiyono, H. Irunde, B. Kafoa, L. Kekana, J. Kgatlwane, G. Kibria, R. Kwasa, R. Laing, A. Lupupa, M.J.P. Machai, H.N. Madaki, U. Mehta, S. Murithi, M.A. Naarendorp, V. Nawadra-Taylor, E. Ngemera Mwemezi, J.K.N. Nyoagbe, R. Ogenyi, E. Osafo, S. Suryawati, H. Zeeman.

This article first appeared in the Essential Drugs Monitor 2005, No. 34.

In this chapter, we present data from an exploratory study on adherence to ARVs undertaken as a field exercise for the Promoting Rational Drug Use in the Community (PRDUC) course (see Chapter 3) held in Pretoria, South Africa, in September 2004. The course was organized by WHO, the University of Amsterdam, the Royal Tropical Institute (KIT) Amsterdam, and the Medical University of South Africa, (MEDUNSA), Pretoria. A major activity of the course was field visits to ARV treatment sites. The report of these visits is included below. A full course report is available at: http://mednet3.who.int/prduc/coursereport/PRDUC Report.pdf

In South Africa in 2002, HIV prevalence in the 15-49 age group was estimated to be almost 30% (National Household HIV Prevalence and Risk Survey of South African Children). The public sector roll-out programme for the prevention of mother-to-child transmission with nevirapine started at 18 pilot sites in 2002. An ARV treatment plan was published in 2003 and roll-out of treatment started at 32 accredited sites in April 2004, aiming to treat all South Africans needing therapy (1.4 million by 2009). Although stigma, discrimination and cultural beliefs still affect voluntary testing and recognition of HIV and AIDS, in 2004 many more patients were initiated on ARV therapy.

A group photograph at the 2004 Promoting Rational Drug Use in the Community course.

Twenty ARV products are currently available in South Africa. Current first-line treatment is a twice-daily triple ARV regimen including two nucleoside reverse transcriptase inhibitors and either nevirapine or efavirenz. At least 95% adherence is required for this regimen to be fully effective and prevent the development of drug-resistance. Achieving this high level of adherence remains a concern. At all the treatment sites, patients are assessed by a multidisciplinary team. Patients are enrolled in the ART programme when they have a CD4 count below 200 and/or WHO stage III or IV AIDS-defining illness, and are committed to following the regimen strictly.

Methodology

Six health facilities which provide ART were included in the qualitative study undertaken over a single day in Gauteng and North-West Provinces. These units consisted of three public clinics - one primary, one secondary and one tertiary - two NGO-based primary clinics, and a private-for-profit primary clinic.

Different qualitative methods were used to study factors influencing sub-optimal or non-adherence to ARV treatment. Thirty-eight ARV users, 22 women and 16 men, were interviewed using exit questionnaires (17 people) and semi-structured interviews (21). These interviews aimed to study: patients' history of ARV treatment; experience in taking medicines; cost of treatment; perception of the quality of care given at the clinics; and availability of social support. In-depth interviews were also conducted with 24 health workers, including five doctors, 11 counsellors, five nurses and three pharmacists. The purpose of the interviews was to study the functioning of the ARV programme, information provided to ARV users, availability of ARVs and other resources, perceived job satisfaction, problems (and possible solutions), and other relevant information. In addition, two focus group discussions were conducted, one with patients and one with health care workers. There were structured observations of 13 consultations to study the interaction between the providers and ARV users. The availability of supplies of ARVs in the six clinics was also assessed. Information was collected on data collection forms and tabulated into a matrix using word processing software. These matrices were then synthesized across facilities to produce summary result tables. The heads of individual facilities, health workers and the patients gave their permission prior to the study.

Patients in the study were between 20 and 60 years old, and their educational backgrounds ranged from those who had reached Grade 3, up to diploma and degree holders. Most lived in areas surrounding the facilities, and the reasons for their visits ranged from initiation of treatment to follow-up and other illness. Among the 21 ARV users interviewed using a semi-structured format, 16 had started therapy in 2004, while five had started more than one year previously. The length of treatment as recorded at the time of the survey ranged from three months to four years. One female patient had not started treatment, despite a diagnosis of AIDS nine months previously, due to a fear of being on ARVs for life. Nineteen of the patients interviewed had never used ARVs and 10 people in the study had been diagnosed in the previous year.

Results

Facility profiles

All six facilities have treatment guidelines, although their sources varied (e.g. WHO, Catholic Society). Three had diagnostic facilities in their hospital while another three send their specimens elsewhere for analysis. The criteria for all sites for starting ARV treatment are HIV-positive status, a CD4 count of less than 200, and WHO stage III or IV of AIDS. All the clinics have a "preparedness for ARV treatment" programme, which varies in intensity and duration. Some of these programmes work with AIDS patients on an individual basis, while others prepare them in groups. Some clinics require proof of adherence to prophylaxis against opportunistic infections, usually cotrimoxazole and in some cases isoniazid. All the clinics carry out pre-training for new ARV users, which includes history-taking, adherence courses of varying lengths and some form of contract agreement.

Only two clinics have a pharmacist on the staff. Elsewhere, in one clinic the prescription is filled in another facility and a nurse then dispenses the ARVs, while in another clinic a pharmacist comes to dispense ARVs on fixed clinic days. In clinics where a pharmacist is available, the pharmacist counsels the patient and issues leaflets on drug schedules and, in some cases, a leaflet on side-effects and a pill intake card. Counselling was conducted at all clinics, either by medical doctors (in two clinics) or by trained HIV counsellors (in four clinics). Where a nutritionist is available, patients are counselled on dietary needs.

Although ARVs are issued free of charge in all the public clinics visited, ARV users pay a registration fee which ranges from 17-30 Rand per visit. The cost in the private clinic ranges from 800-2000 Rand per visit, most of which was said to be covered by insurance. (Exchange rate at time of interview: US$ 1.00 = R 6.35).

At the time of the survey, all the drugs needed for ART were available and there were no stock-outs reported over the previous two months. With regard to support to health workers, de-briefing sessions are carried out in four clinics, three have in-service training for staff, and one clinic provided no support services.

Quality of care

Perceived quality of care may be a crucial issue affecting adherence to ARV treatment in the long term. Data on this were collected from in-depth and exit interviews with ARV users, and observations on interactions between health workers and patients.

Privacy. In all six clinics visited, patients' right to privacy was respected and they were attended to by health workers in a private setting. In one clinic, privacy was seen as a major issue, even during the study interviews, which were carefully planned so that the patients would not meet each other. The-doctor-in-charge stressed the importance of privacy by giving an example of one person who lived around the corner from the clinic, and had started ARV treatment there, but then decided to continue the treatment elsewhere for fear of meeting someone who knew him. In another clinic ARV users could meet, have tea, and support each other on a daily basis. They felt knowing, supporting and sharing experiences with each other made it easier to follow the treatment. Clearly, the importance of privacy depends on the overall set up of the ARV treatment centres.

Respectful treatment. Almost all ARV users interviewed expressed their satisfaction about the way they are treated by the health workers. Most are greeted cordially and feel that they can express their concerns and ask questions. For example, one woman was pregnant and she asked about the implications of her pregnancy for her treatment, and the risk of transmitting her illness to the baby.

Information given to ARV users. This is reportedly a major influence on increased adherence. In this study the information given to patients on their initial visit was observed, and questions were also asked in the exit interviews. In particular, patients were asked: whether health workers provide information about how the medicines work; how to administer the medicines; why continuous treatment is needed; what possible interactions can occur; what to do when they forget to take medicines; what possible side-effects may occur; and where to get ARV re-supply.

All ARV users interviewed said that they get a substantial amount of information, and this was supported by the findings from observations (Table 1). One patient reported having only received information about the possible interaction of ARVs with alcohol. This person showed low self-esteem and exhibited defensive behaviour.

Table 1.
Components of information received by patients initiating ARV treatment at two different facilities

Waiting time. Avoiding long waiting times is crucial in maintaining high adherence levels over a long period. Waiting times ranged from 30 to 90 minutes, and some ARV users reported that the time they had to spend waiting for treatment was a problem for them.

Waiting times and food were issues raised by some participants in all of the studies carried out. Additional spending on snacks and meals due to long waiting times at treatment centres was one concern. Here a stall outside the hospital in Molepolole, Botswana, sells food items.

Factors influencing adherence

Almost all ARV users reported feeling better. Only one person said that the treatment made him more sick, and another was unsure due to the limited period of treatment. Fifteen out of the 21 patients on ARV treatment reported no missed doses, while six reported missing at least one dose since their last visit.

Both health workers and ARV users mentioned several factors that complicate adherence to treatment, sometimes leading to non-adherence for a period, but often just making adherence more difficult.

Costs. Both ARV users and health workers said that the cost of ARV treatment and blood tests, especially in the private facilities, was a major constraint to adherence. Even the ARV users who are covered by Medical Aid complained of costly treatment since the insurance does not cover all expenses. Cost was found to be a major factor that affects adherence. One man said: "... It can take three months for me before I come back when I don't have money..."

Food. Both the health workers and ARV users reported that food complicates adherence and can also be a cause of non-adherence. In a number of cases treatment with ARVs made people hungrier, but they could not afford the cost of additional food. Some centres recommend and/or provide nutritional food, such as fortified high protein supplements.

Family support. This is an important factor in supporting adherence, and was mentioned by most of the health workers interviewed. However, ARV users are usually shocked when they first realize they have contracted HIV, and often find it difficult to disclose to family members, and so do not receive support.

Side-effects. Health workers at two centres mentioned side-effects as a serious problem. Some ARV users reported that they had experienced side-effects initially but that these passed with time. Of the 21 people interviewed, 11 reported not experiencing any adverse reactions or side-effects. Others complained about various problems, such as rash, nausea and pain in the feet.

ARV users' knowledge about ART. Some health workers reported limited information about ART, especially the importance of treatment adherence. While this factor, in itself, may lead to failures in adherence, it may be even more problematic in those cases where ARV users have received conflicting information from different sources.

In addition to the factors described above, various health workers from two centres mentioned "depression due to HIV status" as a factor complicating adherence to ARV treatment. Health workers also highlighted the concomitant use of traditional medicines as a factor influencing treatment. In terms of adherence to ART, most health workers observed that females appeared to achieve higher levels of adherence than males, and that people aged over 30 years appeared to achieve better levels of adherence to treatment than those in younger age groups. In addition, the level of education appears to have an impact on adherence. ARV users also admitted that they sometimes simply forgot to take the medicines, especially when beginning the treatment.

Efforts to improve services

All clinics have taken several measures to help improve adherence to ARV treatment. Written information in the form of leaflets is available in all clinics. Follow-up programmes vary in intensity from a daily direct observation of treatment, to weekly and to monthly clinical reviews. Some clinics keep a diary of appointments, while others use phone calls and short messaging services. In one clinic, the pharmacist provides patients with leaflets on the treatment schedule, and in some cases provides a diary card, or an alarm clock.

PRDUC course participants were impressed by the high quality of counselling provided by health workers at all clinics. From the observations of 13 counselling episodes, it was reported that most patients were greeted in a friendly way and were listened to carefully. Results from the exit interviews with 17 ARV users also supported this finding. Most of them were satisfied with the services, and said that they respected and trusted the health workers. In the private clinic, participants admired the efforts to ensure privacy by establishing procedures which minimized the chance of patients meeting each other during the visit.

To support the health workers, most clinics have conducted a pre-service training programme, a Care-for-Carer training programme, or debriefing sessions, which varied in intensity, frequency and length. Interviews with health workers indicated that most of them were extremely enthusiastic and committed, although some health workers complained about the heavy workload and tiring counselling process, low remuneration, or the inadequate recognition by the Government of certain aspects of the work. Some health workers expressed their hope that the Government would help create a more enabling environment for ARV treatment by providing a community-focused sensitization programme, to positively influence the support system needed by people on ART.

Discussion

Although this was a small study, the use of in-depth interviews and observation provided comprehensive information about behaviour and practices. Many of the observations and comments were consistent across the range of different facilities.

Most of the sites visited had been operating an ARV roll-out programme for less than six months and the availability of ARVs did not appear to be a problem. However, factors including sex, age and level of education were observed to influence adherence. The national ARV programme uses a multidisciplinary approach in which different health workers in the team and other patients and support groups care for patients. Written information and materials to reinforce adherence are available.

Although the patients interviewed were generally happy with the outcomes of therapy, in some facilities patients complained about side-effects and the demanding nature of ARV regimens. Patients said they trusted the health care workers and felt that they were listened to, respected and given a chance to ask questions. Health workers were enthusiastic and seemed to enjoy their work.

Transport costs were said to be a burden for some patients and a treatment-related increase in appetite posed an additional challenge, especially for those who were poor. However, the Government provides some nutritional support if needed. At most of the facilities, health workers expressed concern about the expected increase in the number of patients to be treated, which could result in overloading existing facilities and human resources. There was also concern at the lack of Care for Carer programmes to support health care staff at the health facilities.

Other problems highlighted included the shortage of social workers and counsellors in the facilities, the need to expand the range of ARVs to include paediatric formulations, and the need for capacity building to improve service delivery. There was widespread concern about the limited numbers of staff available and their capacity to cope with the anticipated increase in patient load.

Conclusion

This study was undertaken over a single day in a small number of health facilities by participants attending a training course. The facilities visited were among the first to provide ARVs to the general population. The staff were enthusiastic and committed to their patients. The patients appreciated the care they were receiving and generally felt better on therapy. Health workers expressed concern about both the present and anticipated future workload. Patients were concerned about treatment-related hunger and the need to take ARVs regularly and for life.

These are early days for the roll-out of ARV therapy in South Africa but there appears to be hope that many more patients could be treated. Many problems persist, including heavy workloads for health care staff, the need to promote adherence, and treatment-related hunger, especially among ART patients who are poor. However, there is also a feeling of enthusiasm among staff and hope among patients - suggesting that the rollout of ARVs has begun successfully in the health facilities studied.