Anti-retroviral therapy (ART) prolongs the lives of people living with HIV and Acquired Immune Deficiency Syndrome (AIDS) and enhances their well-being (Steel, Nwokike & Joshi
Since 2002, the government of Botswana has provided ART free of charge to all citizens of Botswana who qualify for treatment. The ART programme aims to suppress viral replication, restore the person's immune response, stop or at least delay the progression of the disease, reduce mortality and enhance the person's quality of life. However, there are concerns that the ART adherence levels might be suboptimal (below 95%), with potentially serious consequences (World Health Organization [WHO]
To achieve effective treatment outcomes and realise the benefits of ART, strict adherence to treatment instructions are critical. Adherence rates of 95% or more are required for optimum virologic suppression (Jani
The overall aim of this study was to identify factors affecting ART adherence levels and the impact on immunologic and virologic responses in adult patients in one rural district in Botswana and, further, to use this knowledge to enhance the ART adherence rate amongst adult patients at the participating clinic, other clinics in Botswana and other sub-Saharan African (SSA) countries.
Specific objectives of this study were to:
Identify factors influencing patients’ adherence levels to ART.
Determine the association between ART adherence levels and immunologic and virologic responses.
Recommend possible interventions in order to improve ART adherence levels.
The assumptions on which the study was based are as follows:
ART adherence would increase CD4 cell counts and suppression of viral loads (VL).
Adherence could be measured by regular collection of ARVs from the pharmacy.
The patients who collected their refills regularly and maintained high adherence rates, were expected to show immunologic recovery and virologic suppression as reflected in their increased CD4 cell counts and undetectable VL, respectively.
The study used routinely collected data recorded on patients’ medical records and pharmacy refill charts.
A cross-sectional survey, using structured interview schedules to collect data, was used in this study. The study was conducted at the Infectious Disease Control Centre (IDCC) clinic located at the district hospital where patients with HIV are reviewed every working day and put on ART.
The study population for this study comprised adult patients who had been on ART at the participating clinic for at least six months by 31 October 2011. Structured interviews were conducted with 300 ART patients between November 2011 and February 2012.
Eligible respondents were selected using systematic sampling during routine consultations until the required sample size of 300 was obtained.
The structured interview schedule, comprising mostly open-ended items but including a few closed-ended questions, was designed specifically for this study. A pilot study was conducted by interviewing 10 patients, who were excluded from participation in the final study. This enabled the two interviewers to identify any potential comprehension and recording problems; and to estimate the time needed to complete each interview. Interviews lasted 22–40 minutes.
The different sections of the interview schedule sought information about the respondents’ demographic variables, health-related aspects, counselling experiences, adherence levels, remembering to take their pills regularly, disclosure issues, side-effects of ARVs and social issues which could influence their adherence levels.
The instrument's content and construct validity were evaluated by five healthcare professionals who provided ART services in Botswana. The reliability of the structured interview schedule was determined by calculating Cronbach's Alpha coefficients. These ranged from 0.79 to 0.85 for different subsections of the instrument, which was deemed acceptable (Burns & Grove
The interviews were conducted in a private room in the clinic. Each respondent's informed consent was obtained before the interview commenced. The interviewers asked the same questions in the same sequence during each interview and recorded every response. Responses to open-ended questions were recorded verbatim. The first author was available if any interviewer required his assistance. Each respondent's pharmacy refill records, CD4 count and VL were recorded from his/her patient file from 01 January 2011 until the date of his/her interview.
The
Some biographic data will be presented initially so that the rest of the results can be contextualised against this background knowledge. The results will address patients’ adherence levels, the correlation between patients’ adherence levels and the CD4, as well as their VL counts and factors affecting patients’ ART adherence levels.
The data summarised in
Sociodemographic characteristics of the respondents (
Variable | Number (N = 300) | Percentage |
---|---|---|
Female | 223 | 74.3 |
Male | 77 | 25.7 |
21–30 | 54 | 18.0 |
31–40 | 118 | 39.3 |
41–50 | 73 | 24.3 |
51–60 | 39 | 13.0 |
> 60 | 16 | 5.3 |
Never married | 195 | 65.0 |
Married | 46 | 15.3 |
Cohabiting | 42 | 14.0 |
Divorced/separated/widowed | 17 | 5.7 |
None | 44 | 14.7 |
Primary | 93 | 31.0 |
Secondary | 136 | 45.3 |
Tertiary | 27 | 9.0 |
Employed | 142 | 47.3 |
Unemployed | 158 | 52.7 |
No income | 170 | 56.7 |
< 1000 | 48 | 16.0 |
1000–1999 | 43 | 14.3 |
2000–2999 | 17 | 5.7 |
≥ 3000 | 22 | 7.3 |
The mean ART adherence, measured by pill counts, was 97.6%, with a standard deviation of 3.7 and a median adherence level of 99.0%. As many as 86.0% (
Of the 223 female respondents, 197 (88.3%) had a high level of adherence and 62 (80.5%) out of 77 male respondents also had high adherence levels. There was, however, no significant association between gender and adherence (χ2 = 2.97;
The three most common reasons, reported by 57 respondents, for missing ART doses were forgetfulness (6.3%;
Of the 141 (47.0%) respondents who lost income whilst attending ART clinics, some did so as a result of taking time off work, or forfeiting part of their income because of ART clinic attendance. Some of the suggestions provided by these 141 respondents to help them to improve their adherence levels without incurring losses of income, included:
Employees should not lose payment for attending the ART clinics (37.6%;
Services should be provided closer to respondents’ homes/jobs (28.4%;
Transport to and from ART clinics should be provided for patients (22.0%;
Jobs should be created for patients on ART (12.2%;
Respondents (70.7%;
The majority of the respondents (87.3%;
The majority of respondents (93.3%;
Side-effects experienced by the respondents included dizziness (30.3%;
The major reasons, reported by respondents, for missing ART doses were: forgetfulness (6.3%;
Adherence partners included respondents’ mothers (20.0%;
Sixty-three per cent (
Low levels of perceived stigma were reported. Only 20.0% (
Most respondents (74.7%;
Only 2.0% (
Sixteen per cent of the respondents (
Permission to carry out the study was granted by the University of South Africa as this study comprised part of the first author's obligations to be fulfilled for his Master's degree in Public Health (MPH). The MOH and the participating healthcare institution's management also gave permission for the study to be conducted at the participating clinic.
Signed informed consent was obtained prior to each interview. Participation was voluntary and refusal to participate in the study had no effect whatsoever. No respondent was coerced to answer any specific question. Every respondent was informed that he/she could terminate the interview at any stage. If any respondent should have terminated an interview, another respondent would be requested to consider participating in the study. Although no respondent terminated any interview, they did not reply to all questions. No remuneration was given. Every signed consent form was sealed in an envelope and placed in a container. Each anonymously-completed interview schedule was placed in another container so that no one could match any completed interview schedule with a specific signed consent form. The first author collected the signed consent forms and completed interview schedules at regular intervals and kept these documents securely locked up. The data entered onto the first author's computer could only be accessed by a secure password. Only the first author and the statistician had access to this data and to the completed interview schedules. Every respondent was assured about the anonymity and confidentiality of the data and was informed that a copy of the research report could be requested from the first author should they wish to do so.
Five healthcare providers, who had undergone training in Botswana's HIV treatment protocols and who were working in HIV clinics, evaluated the items in the structured interview schedules. These five experts agreed that all items were relevant to ART adherence issues, amounting to face validity. Furthermore, they also agreed that the instrument's items addressed constructs in and the content of Botswana's HIV treatment guidelines (MOH 2005), amounting to content and construct validity.
Reliability of the instrument was acceptable because the 10 interviews conducted during the pretesting phase produced information similar to that obtained from 300 interviews conducted to collect data for the actual study. The Cronbach alpha score of 0.85 was accepted as indicating that the instrument's items related to ART adherence issues.
Of the 300 respondents, 86.0% (
In this study, it was reported that costs incurred through transport and lost wages to visit ART clinics were major obstacles that had a negative impact on optimal adherence to ART. In another Botswana study (Kip, Ehlers & Van der Wal
In this study, side-effects of ART, such as dizziness, headaches and nausea, were reported – similar to those reported by Kip
Common reminders for taking medicines were alarm clocks, putting pills in visible places and taking pills along when going away from home. Almost all of the respondents (99.7%;
Most respondents (97.6%;
Low levels of perceived stigma did not influence ART adherence levels, which is again consistent with findings from previous studies (Kgatlwane
Most respondents (93.3%;
Respondents’ most recent CD4 cell counts were associated with ART adherence (χ2 = 3.99;
Social and cultural factors influencing antiretroviral therapy adherence levels.
Question | Answer | Frequency | Percent | -value (Fishersa or Chi-squareb) |
---|---|---|---|---|
Having visited a traditional healer since commencing ART | No | 294 | 98.0 | 0.191a (ns) |
Yes | 6 | 2.0 | ||
Taking any traditional medicines concurrently with ARVs | No | 295 | 98.3 | 0.139a (ns) |
Yes | 5 | 1.7 | ||
Considerations that traditional medicines are effective | No | 294 | 98.0 | 0.191a (ns) |
Yes | 6 | 2.0 | ||
Drink alcohol | No | 252 | 84.0 | 0.425a (ns) |
Yes | 48 | 16.0 | ||
Smoking cigarettes? | No | 269 | 90.0 | 0.591a (ns) |
Yes | 31 | 10.0 | ||
Number of sexual partners | None | 81 | 27.0 | 0.850a (ns) |
1 | 215 | 71.7 | ||
2 | 4 | 1.3 | ||
Current sex partner | ≤ 3 months | 16 | 7.3 | 0.282b (ns) |
4–6 months | 16 | 7.3 | ||
7–12 months | 19 | 8.6 | ||
2–5 years | 53 | 24.1 | ||
> 5 years | 116 | 52.7 | ||
HIV status of sex partner | Positive | 99 | 33.0 | 0.546b (ns) |
Negative | 86 | 28.7 | ||
Unknown | 37 | 12.3 | ||
No response | 78 | 26.0 |
ART, antiretroviral therapy; ARVs, antiretroviral drugs; ns, not significant.
Correlations between selected factors and adherence.
Variables | Age | CD4 | VL copies | CD4 current | Adh avg |
---|---|---|---|---|---|
Age: Correlation coefficient | 1.000 | -0.045 | −0.115 |
0.009 | 0.044 |
Significance (2-tailed) | - | 0.296 | 0.027 | 0.844 | 0.351 |
300 | 300 | 300 | 299 | 300 | |
CD4: Correlation coefficient | −0.045 | 1.000 | −0.043 | 0.209 |
0.042 |
Significance (2-tailed) | 0.296 | - | 0.356 | 0.000 | 0.321 |
300 | 300 | 300 | 299 | 300 | |
VL copies: Correlation coefficient | −0.115 |
−0.043 | 1.000 |
−0.197 |
-0.246 |
Significance (2-tailed) | 0.027 | 0.356 | - | 0.000 | 0.000 |
300 | 300 | 300 | 299 | 300 | |
CD4 current: Correlation coefficient | 0.009 | 0.209 |
−0.197 |
1.000 | 0.022 |
Significance (2-tailed) | 0.844 | 0.000 | 0.000 | - | 0.612 |
299 | 299 | 299 | 299 | 299 | |
Adh Avg: Correlation coefficient | 0.044 | 0.042 | −0.246 |
0.022 | 1.000 |
Significance (2-tailed) | 0.351 | 0.321 | 0.000 | 0.612 | - |
300 | 300 | 300 | 299 | 300 | |
Age: Correlation coefficient | 1.000 | −0.061 | −0.129 |
0.012 | 0.055 |
Significance (2-tailed) | - | 0.296 | 0.026 | 0.835 | 0.345 |
300 | 300 | 300 | 299 | 300 | |
CD4: Correlation coefficient | −0.061 | 1.000 | −0.054 | 0.310 |
0.058 |
Significance (2-tailed) | 0.296 | - | 0.352 | 0.000 | 0.314 |
300 | 300 | 300 | 299 | 300 | |
VL copies: Correlation coefficient | −0.129 |
-0.054 | 1.000 | −0.243 |
0.279 |
Significance (2-tailed) | 0.026 | 0.352 | - | 0.000 | 0.000 |
300 | 300 | 300 | 299 | 300 | |
CD4 current: Correlation coefficient | 0.012 | 0.310 |
−0.243 |
1.000 | 0.031 |
Significance (2-tailed) | 0.835 | 0.000 | 0.000 | - | 0.593 |
299 | 299 | 299 | 299 | 299 | |
Adh Avg: Correlation coefficient | 0.055 | 0.058 | −0.279 |
0.031 | 1.000 |
Significance (2-tailed) | 0.345 | 0.314 | 0.000 | 0.593 | - |
300 | 300 | 300 | 299 | 300 |
ART, antiretroviral therapy; CD4, CD4 count (when the patients commenced ART); CD4 current, the patients’ CD4 counts at the time of data collection; VL, viral load;
*, correlation is significant at the 0.05 level (2-tailed); **, correlation is significant at the 0.01 level (2-tailed)
There was no association between employment, loss of income, education status, marital status, monthly income, age and ART adherence levels.
The study was conducted at one clinic where 300 ART patients were interviewed. All these patients lived within the catchment area of the clinic. This limits the generalisability of the findings. Interviews were only conducted with the patients and did not include their relatives and the healthcare providers at the clinic. These persons might have had different ideas about factors influencing the patients’ adherence levels to their ART. However, experiences of the patients themselves comprised the data for this study.
In order to enhance patients’ ART adherence levels at the participating clinic, the following recommendations were made:
Regular assessments of ART adherence should be done at the clinic and suboptimal adherence levels must be addressed so as to avoid virologic and immunologic failures as well as drug resistance.
In order to reduce costs, patients on ART could be issued with three months’ supplies of ARVs instead of one month's supply when they come for review.
Future research studies should involve patients from more than one clinic.
Qualitative in-depth interviews should be conducted with patients, their close family members and healthcare providers in order to provide different insights into factors influencing patients’ ART adherence behaviours.
Free supply of ARVs to eligible persons in Botswana does not ensure sufficiently high levels of ART adherence to both achieve and maintain VL suppression beyond detectable limits as well as increases in CD4 counts. Adherence might be enhanced if ARV supplies could be issued for three months at every clinic visit rather than for one month only.
In conclusion, the findings of this study showed that motivators of ART adherence included disclosure of one's HIV-positive status to more than one person, self-efficacy and adherence partners. Barriers to ART adherence included forgetfulness, transportation costs to and from ART clinics, as well as income lost because of absence from work to visit ART clinics. This then implies that these aspects had a negative influence on the respondents’ adherence levels. In addition, there was a positive correlation between respondents’ ART adherence levels, increased CD4 counts and undetectable VLs.
We thank the University of South Africa, the Ministry of Health (Botswana) and the management of the participating clinic for granting permission to conduct this study and all patients who agreed to be interviewed.
The authors declare that they have no financial or personal relationship(s) that may have inappropriately influenced them in writing this article.
E.T.T. (University of South Africa) was the principal investigator and project coordinator. V.J.E. (University of South Africa) was the supervisor of the research project; helped to analyse and interpret the data; and wrote and revised the article. E.T.T. wrote the initial draft of the article, then V.J.E. reviewed the draft and wrote the subsequent revised versions as the corresponding author.