Study Setting

This study was carried out at Felege-Hiwot Hospital and Gondar University Hospital, Northwest Ethiopia. Each hospital serves a catchment area of 5 million people. In 2005, when free ART was launched in the country, both hospitals began to offer ART. The numbers of patients receiving ART were 4,378 and 6,265, in Gondar University Hospital and Felege-Hiwot Hospital, respectively, at the time of data collection.

Adult patients with HIV-infection and CD4 count less than or equal to 350 cells/mm³ regardless of the clinical symptoms, or with any symptoms indicating a WHO clinical stage of 3 or 4, irrespective of CD4 count, are eligible to start ART. At both hospitals, specific ART nurses provide counseling to patients diagnosed as HIV-positive before and after ART initiation, while the physicians working in the ART clinics initiate ART medication based on patients’ clinical and laboratory findings. Nurses are also responsible for assessing patients’ progress at regular appointments in ART clinics, every month for the initial six months and every three months thereafter. If patients have any complaints, such as opportunistic infections (OIs) and drug side effects, the nurses refer patients to the physician to receive treatment. Furthermore, the study clinics have a peer support program staffed with case managers who themselves take ART. ART nurses refer patients to case managers for adherence counseling and management of ART risk factors. Case managers are certified care providers responsible for managing ART risk factors and locating patients lost to follow-up. They carry out a programmed outreach service to track patients who have been lost to follow-up and are not reachable by phone, and to provide onsite community support.

Inclusion/Exclusion Criteria

Adult patients (≥18 years old) who had been receiving ART in the study clinics for at least a month and could provide informed consent in Amharic were eligible for the interviews. All ART nurses and case managers who had been working in the ART clinics for at least 6 months were invited to participate in the focus group discussions.

Recruitment and Sampling

ART nurses and case managers aware of patients’ treatment histories, supplemented by checking of patients’ medical records, helped to identify and recruit possible participants into the study. The recruitment of patients continued until information saturation was achieved. Research pharmacists working across the two sites invited all ART nurses and case managers to participate.

Ethics Statement

The Tasmanian Social Sciences Human Research Ethics Committee, University of Tasmania, Australia, and College of Medicine and Health Science Ethics committee, Bahir-Dar University, Ethiopia, approved this study. Patient interviews were conducted in private rooms where patients felt safe and stress-free. Focus group discussions were conducted in hospital auditoriums. Focus group participants were required to maintain the confidentiality of the identities of other participants and the content of the discussion. Participants were told either to remove themselves from the room or ask the interviewer to move the interview in another direction if they felt distress during the interview. The purpose of the study was explained to all participants using standard information statements, and written informed consent was obtained before participation. At the end of the session, the participants received 150 birr (∼ $ 7 USD) as compensation for their time and transportation costs. Patients who disclosed non-adherence during interview were referred to case managers in ART clinics for possible intervention. Personal or identifying information was not retained within the transcripts.

Data Collection

Data were collected from 22 February 2013 to 12 July 2013 using semi-structured interview and focus group discussion guides with patients and healthcare providers. The guides were designed to elicit information from the patients’ and healthcare providers’ points of view based on their experience with HIV medication, including factors that facilitate or constrain adherence to HIV medication and reasons for loss to follow-up. Consistent with an inductive approach, guides were updated continuously based on the results of the ongoing data analysis before the next interview or focus group discussion. A trained research pharmacist conducted the interviews and focus groups in the local language, Amharic. Comprehensive notes were taken throughout and after interviews and focus groups, and all sessions were audio-recorded. Participants decided on the times and the locations of the individual interviews. Data were stored in a locked cabinet in locked facilities in the College of Medicine and Health Sciences at the Bahir-Dar University. All electronic records were stored on a secure, password-protected, server at the University of Tasmania. Researchers were able access the data whenever required. Data will be destroyed 5 years following publication. Paper data will be securely shredded and electronic data will be erased at this time.

Data Preparation

Upon completion of each focus group and interview, the research pharmacist produced a complete transcript in Amharic. The transcribed data were read and reviewed to ensure understanding and then compared with the original audio-records for accuracy. The study data were established from the transcripts.

Data Analysis

Analysis of data aimed to describe the barriers to, and facilitators of, adherence to ART including the possible reasons of patients for missing appointments and/or being lost to follow-up at ART clinics. A grounded theory approach was used for analysing the data [18]. The process of data analysis was as shown in figure 1. The documents in Amharic were uploaded into NVivo (QSR, Cambridge, MA) and textual data were coded into themes inductively. Two coders (the research pharmacist and a general practitioner) performed the coding separately and differences were resolved with discussion. Focus groups and interviews were coded and analysed separately, and matched for common themes. The key findings were illustrated by selecting representative quotes.

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Figure 1. Data Analysis in Generating Grounded Theory.

https://doi.org/10.1371/journal.pone.0097353.g001

Two bilingual translators translated emerging concepts and categories into English. The two translators discussed their differences and developed a single English version. A third person translated the final English version back into Amharic. A committee, consisting of an expert in English, a pharmacologist, an expert qualitative researcher and the research pharmacist, settled issues of conceptual equivalence and use of words between concepts and categories in Amharic and the final English version.

Study Participants

Twenty-four patients, 15 nurses, and 19 case managers participated in this study. Forty-four face-to-face interviews and 6 focus group discussion sessions were conducted across the two sites.

Characteristics of Study Participants

Theme I: Patient-Related Factors

Patient-related factors such as economic constraints, disclosure of HIV status, social support, use of reminder tools, stigma and discrimination, responsibility to raise children, and religious rituals were the most significant determinants of adherence and loss to follow-up.

Category I: Economic Constraints

Individual interviews and focus groups indicated that movement for seeking employment and food insecurity impaired adherence to ART amongst patients with HIV/AIDS who had started ART. Almost all patients (11 of 12) who had been lost to follow-up were unemployed, daily laborers or waiters working at a low wage rate. They moved from one part of the country to another part of the country searching for a job. Lack of money for transport, unavailability of nearby ART clinic services, and language and communication barriers prevented such patients from remaining in care.

I went to Humera to find a job. I got one time a refill from Humera Hospital. After a while, I crossed the Sudan border with friends. I worked in the farm in a jungle for 2 months. I do not speak the Arabic language (so) I was not able to refill my medicine. On the way back to Ethiopia with friends, looters took all (my) money including (my) ART user identification card. Because of this, I missed my medication for about three months. (26 years, male, patient, casual worker, 008)

To get a job, patients usually move to remote areas where they cannot get access to ART. For instance, those who went to Sudan did not get the treatment there and were lost to follow-up for long period of time. (28 years, female, nurse, FG5)

Patients with HIV/AIDS reported reduced physical strength, especially in the initial phase of ART, and were only able to tolerate reduced work hours. Some patients generated a minimal monthly income not sufficient to cover the costs of their basic needs, including food. Thus, unavailability of food hindered patients from taking their HIV medications. Some of the patients, being dependent on the food supply from ART clinics, left their pill bottles with the nurses when they did not receive their food ration from the clinic. Some others patients believed that they had to consume costly food items to take their HIV medications.

Previously, I was getting (an) additional nutrition supply, plumpy nut, for free from the ART clinic. But the other day, the nurse told me that she would not give it to me anymore. When I heard this, I felt angry and left the medication bottle on the nurse’s desk and went away from the clinic. Due to this I did not take pills for five days. (33 years, male, patient, jobless, 007)

When Non-Governmental Organizations (NGOs) stopped food donations, patients complain about continuing ART. Some of them are even lost to follow-up because of the unavailability of food. (32 years, female, case manager, FG3).

Most people do not have an idea that the medication can be taken eating any food available. They do not know that they can prepare the available food in the house with proper hygiene. They think the medicine will be harmful if they do not eat an expensive diet such as meat and eggs. (30 years, female, case manager, FG3)

Category II: Disclosure of HIV Status and Social Support

Both interview and focus group participants most frequently cited that disclosure of their HIV status to friends, family and neighbors was a facilitator of adherence. Patients who disclosed their HIV status to relatives and close friends did not fear stigma and discrimination to obtain and take drugs.

I have no problem of disclosing my (HIV) status to my family, friends, and others. When I usually introduce myself, I often tell them that I am living with HIV… this helped me to take the pills regularly, without any anxiety, and to recover from my illness as well. (35 years, female, patient, librarian, 015)

Many patients told me that disclosure of their status to neighbors and community helped them to take pills properly. (26 years, female, nurse, FG4)

Disclosing one’s HIV status was found to be essential for receiving social support. Reminders to take pills, cover for transportation and food costs, and emotional backing were commonly reported. The most important way that patients received support was in reminders regarding the time they took pills. Patients received support usually from their partner, who himself/herself was also on ART, and/or children who were living with them. Experienced ART nurses and case managers noticed that transport and food support from NGOs had improved patients’ attendance at ART clinics.

Sometimes when I feel fatigued, am busy with work or sleep at dose time my children remind me to take the pills. They bring me a glass of water and the medication bottle. (36 years, female, patient, casual worker, 004)

Aids from NGOs such as getting cooking oil, wheat, and soap until HIV patients recover from their illness and support themselves is one facilitator for adherence to ART. (46 years, male, case manager, FG1)

Category III: Stigma and Discrimination

Patients and healthcare providers frequently mentioned that stigma and discrimination caused patients trouble in taking, obtaining, and keeping medications. Patients described how they would avoid taking pills in front of others, including family members who did not know their HIV status.

I used to miss pills many times… because people were with me. The guy with me did not know my HIV status. I worry what people think about me if they know about my status while I am taking pills in front of them. (25 years, female, patient, waitress, 020)

Only my mother knows about my HIV status… I fear stigma and discrimination if other family members noticed me taking the pills. (20 years, female, patient, waitress, 006)

Patients also preferred to attend treatment in clinics far away from home to avoid disclosure of their HIV status to their community members.

Fearing disclosure in their residential area…. patients attend ART from Gondar when they have access to it in Bahir-Dar and vice versa. That creates a challenge for patients in picking up their medicine later. (23 years, male, nurse, FG1)

Lack of privacy was a particular challenge for patients working in a private home or organization. Half of the patients were part-time workers, daily laborers or waiters. These patients were forced to work at a low wage rate for long hours to cover their living costs in places where their privacy could not be maintained. They had problems with finding a place to keep and take their medications; they thought that they had to hide their pills from employers and colleagues. Patients felt that they might be dismissed from their job if employers learned of their status.

If the employer learns that I am living with HIV… I fear to be sacked from my job. (26 years, female, patient, casual worker, 019)

When I asked my patient, how she was taking her pills? Whether she kept her time or not… she told me that she is a daily laborer baking injera and abshilo in other people’s houses. If employers learn that she is living with HIV and taking the pills they would stop her working with them. She used to take pills only when they went away from her and she was alone. As the result she does not take her pills on time. (45 years, female, nurse, FG5)

I was working as a cooker in a cement factory compound for Indian employees. For some time, I was taking the pills hiding myself (so as) not to be noticed by anyone. But, later, I became worried thinking that if they knew my status, they might dismiss me from my job. Then I stopped taking the pills. (27 years, female, patient, cohabiting, 018)

Category IV: Responsibility for Raising Children

Patients’ commitment to raise and educate their children facilitated medication taking. Patients with HIV were at the peak of their reproductive lives; 14 out of 24 (mean age 36) had dependent children. They fear passing away with AIDS, leaving their children as orphans. Of 14 patients who were living with their children, 9 were found to be adherent by their ART nurses.

… I have a boy born free of the virus. As long as I am alive, I wish to see him achieving better opportunities. If I am not taking the medication properly or abandoned it altogether, I am ruining his chance. (35 years, male, patient, self-employed, 002)

Patients usually say that if they are not alive, it is difficult to imagine the survival of their children. They told me that the medicine kept them healthy to work and help their children to achieve a better future. (35 years, male, nurse, FG5)

Category V: Reminders

Patients frequently mentioned that setting alarms on watches or mobile phones helped them to remember to take their pills. Seven respondents said they set alarms on their mobile phones or watches. Providers also stressed the benefit of reminders in avoiding pill missing due to hectic daily activity.

To take my pills on time, I set a reminder on my mobile phone…it reminds me of the time of my medication even when I forget it. (41 years, male, patient, casual worker, 016)

Especially use of mobile phones or watch alarm tones is more sustainable for not forgetting taking pills. (27 years, female, case manager, FG6)

Although electronic reminder tools have the aforementioned advantages, some patients did not have their own mobile phone or watch, and some others were too illiterate to use these reminder tools. Eight respondents had no formal education and were not able to write and read. These patients used other alternative reminders such as the position of the sun, length of shadows, entrance and exit time of domestic animals and students, and bells from a church or mosque or factories to take their pills on time. Although such kinds of devices were helpful as pill reminders, they were limited in their ability to indicate the exact time.

I take pills whenever I hear Allah Akbar. (26 years, male, patient, casual worker, 008)

I have an old lady customer who is too illiterate to read a watch and who has no family or relatives living with her…she usually takes her pills looking at students going to school in the morning. (33 years, male, nurse, FG5)

Category VI: Religious Rituals

Religious rituals like fasting and holy water were found to influence medication taking. Both Ethiopian Orthodox Christian followers and Muslims have several fasting days and seasons within a year.

Theme II: Healthcare-Related Factors

Healthcare-related factors, such as patient education and counseling facilitated medication adherence, while busyness of healthcare providers, poor laboratory service, and poor medical record handling impaired adherence and retention.

Category I: Counseling and Education

Education and counseling of patients in the ART clinics motivated them to take their pills. Case managers and ART nurses provided education, which focused on the importance of perfect adherence, strategies to improve adherence, consequences of non-adherence, possible side effects of the medications, and the duration of treatment required.

Every morning in the waiting room nurses and case managers teach us the consequences of not taking pills properly and the benefits of disclosure to family and the community. That helps me a lot to adhere to the treatment and improves my health condition. (36 years, female, patient, self-employed, 014)

If the healthcare provider who initiated ART gives comprehensive education, including how long the medications will be taken, the possible side effects of the medications, the importance of the treatment, whether it cures or not, and checks patients’ understanding at the end, it will help patients to continue their treatment without interruption. (28 years, female, nurse, FG5)

Category II: Fatigue of Healthcare Providers

In contrast, healthcare providers were fatigued with a high load of patients; this impaired the quality of the service delivered. Sometimes, it was felt that ART nurses did not have empathy and rushed when writing prescriptions, without addressing patients’ concerns about their treatment. This impaired the ART nurse-patient relationship and patients did not enjoy coming to the clinics.

They abuse you, they do not accept you in good terms, and I feel bad about these (things). Even, I feel my illness more when I come to the clinic and see their faces. I feel as if I went to a police station and was interrogated as a criminal. (38 years, female, patient, secretary, 023)

…The hospital is crowded … it has many patients… professionals are fatigued with it. (52 years, male, case manager, FG3)

Category III: Poor Laboratory Service

The ART clinics have large numbers of patients; there are queues to receive services. Patients were instructed to come to ART clinics early in the morning and line up to have their CD4 counts checked. Some of them were too busy to do so and unable to attend to their treatment properly.

I came (to the ART clinic) early in the morning at 5 am to get a CD4 test. We were forced to struggle with the coldness and thieves at this time. This is the reason why I did not check my CD4 count regularly and attend my treatment properly. (38 years, female, patient, secretary, 023)

The result of CD4 count tests are delayed up to one day after the test; this needs to be corrected. (28 years, female, case manager, FG6)

Category IV: Poor Medical Record Handling

Several patients and healthcare providers mentioned that there have been serious problems in handling of patients’ medical records in the hospitals. Many patients experienced loss of their medical record and were forced to start a new medical record, losing all their previous data. Sometimes patients were forced to repeat CD4 count measures when the laboratory report was lost from the medical record and was therefore unavailable to inform medical decisions.

My chart was lost from the chart room…the nurse told me to I needed a new chart but I was not voluntary to have a new one…I left the clinic citing the need for my previous documents for prescribing of my medications. (35 years, male, patient, self-employed, 002)

There is problem of chart loss. Sometimes you find the empty cover of the chart while all the documents are lost. Patients were forced to repeat CD4 tests as a result. (36 years, female, case manager, FG2)

Theme III: Medication-Related Factors

Improvements of health on ART and medication side effects were the two consistent and contrasting themes related to medication. Improvement of health on ART facilitated adherence to HIV medication, while medication side effects was among the reasons for patients to be non-adherent or lost to follow-up.

Category I: Improved Health on ART

Most patients had been confirmed as HIV-positive after suffering a long-term sickness. They had seen the devastating effect of HIV on their bodies and had vivid illnesses and stories. A significant improvement of health witnessed soon after initiating ART heightened trust in the medications.

Both patients and providers highlighted being healthy, improved appetite, increased weight and CD4 count, and prolonged lives as positive treatment outcomes. Patients were no longer bedridden, had strength, resumed work, and increased their incomes. These improvements inspired them to continue taking their medicines.

I have decided to be more committed towards the treatment because I have seen the benefits of antiretrovirals. My appetite has improved, I was bedridden, but now I am healthy and I usually find myself at the field for work…. I achieved all this because of the pills. Hence, I should not stop taking the pills. (35 years, male, patient, farmer, 016)

… Improvement of health after treatment of OIs, being able to live longer and progressive increments of CD4 counts were the major factors strengthening medication taking. (24 years, male, nurse, FG5)

Category II: Adverse Effects

Patients who experienced unanticipated and/or intolerable side effects, like nightmares and psychosis, missed doses or discontinued therapy altogether. This was particularly likely among patients who had started ART when asymptomatic as they considered the medications had worsened their health.

I was not conscious (after taking the medications), I was mad, as neighbors told me. I went to a neighbor’s house and shouted, calling on a certain woman, blaming her for being evil eye and making me sick. After that I stopped taking the pills. (26 years, female, patient, casual worker, 019)

When I phoned a lost patient who was on TDF/3TC/EFV, for tracking, he told me that he could not come back unless the regimen changed. That was because he had developed nightmares due to the efavirenz. (33 years, male, case manager, FG2)

At the beginning of my treatment, I experienced vomiting. As the result, I missed some doses, until I adapted to the medication. (30 years, female, patient, waitress, 009)