Thesis (MSc(Med)(Pharmacy)) -- University of Limpopo, 2010. / SUMMARY Introduction: The Human Immunodeficiency Virus (HIV) pandemic has become a global "monster" and much effort and funds have been channelled by various stake holders to change the deadly course of this threatening disease. Adherence has been identified as a critical element in optimal treatment of the disease with antiretroviral (ARV) medicines. A literature review was conducted on relevant facets of the HI virus, Acquired Immune Deficiency Syndrome (AIDS), disease prevention and treatment with ARVs, treatment obstacles, the importance of a sustained adherence level of at least 95% and the treatment interventions to promote medication adherence. Objectives: The objectives of this study were to evaluate the e-MuM electronic monitoring system (electronic microprocessor, reminder unit [a specialised wristwatch] and software program) for practicality, impact and effectiveness on ARV adherence, to test the ease of use for the patient and pharmacist, to get feedback from patients and clinic staff and finally to make recommendations concerning possible adaptations and the ideal use of the e¬MuM system. Method: The design was a four phase, prospective, randomised experimental, longitudinal study, conducted at the Tshepang Clinic of the Dr George Mukhari Hospital in Garankuwa using 210 volunteer patients.. After signing a consent form, patients were randomized into test and control groups, balanced according to gender and time on treatment. At the end of the baseline phase (only written adherence data collection), both groups were given their stavudine tablets in an electronic monitoring (e-MuM) container (from the end of the second month). The test group received interventions in the form of a alarm watch reminder unit (end of Phase 1), followed by visual (based on e-MuM generated graphs) and verbal feedback (end of Phases 2, 3 and 4). Other adherence tools used to evaluate and compare adherence in this study included a self-assessment questionnaire for gathering quantitative and qualitative data, visual analogue scale (VAS), 2-day and 7-day recall, tablet counts and the biological markers of the patients at the start and end of the study Results: There was no statistically significant difference between demographic data of the two groups at any point during the study. The mean time on treatment of the test group patients increased relative to baseline by the end of the study, which follows a reported trend that patients who have been on treatment for longer, tend to remain in studies. The e-MuM system revealed a large scattering of adherence results in both groups. Medication taken within an hour of the correct time was regarded as "strict" adherence and that taken at any time on the correct day as "lenient" adherence. The most significant increase in mean strict adherence was from Phase 2 to Phase 4 (after two verbal and visual feedback sessions). The adherence increase for the test group was 18.8% and 14.3% for the control group. The mean strict adherence level was 36.1 % for the test group and 29.8% for the control group for the full period. The mean lenient adherence for the full period was 45.5% for the test group and for the control group it was 36.6%. The difference between the two groups in adherence increase over time, did not reach the statistically significant level of P<0.05. One of the difficulties in the study data interpretation of the self-reported adherence was due to patieilts' decanting habits. Patients were asked to state whether and how often they removed their tablets from the original container into another container (decanting). Decanting habit options included daily, weekly, no decanting and unspecified decanting habits. Patients' decanting habits varied greatly. From decanting data available for a total of 209 patients, a majority (145) reported at least two different types of decanting habits for the study period, while five patients reported every decanting habit. Patients statements on their decanting habits were compared with the data recorded by the e-MuM system, but did not correlate at an individual level and were found not reliable enough to permit adjustment of the adherence levels that were calculated by the e-MuM system. Although self-assessment adherence measures exhibited a high degree of correlation, this was in stark contrast with the data obtained from the e-MuM. The mean adherence according to the Visual Analogue Scale (VAS) for the test group and control group was 87.7% and 88.4% respectively. Some of the study participants (11%) marked their adherence out of bounds on the 10cm solid line used for VAS. Despite frequent explanations from staff, some patients were not able to understand the abstract nature of the VAS. This observation may be related to patient educational level, as the majority of study participants (82%) had an incomplete secondary education or lower. In addition, clinic staff and data collectors commented that patients did not want to admit to being non¬ adherent. The mean stated adherence with the 7-day recall was 93.6% for the test group and 92.8% for the control group patients. The 2-day recall was omitted at the end of Phase 2. Adherence measured with tablet counts could not be used as it was only available in 60% of visits by test group patients and 64% of control group patients, as a result of patients not returning their remaining tablets at follow-up visits. Although positive tendencies in biological markers (CD4 and viral load [VL]) were evident towards the end of the study, differences between the groups did not reach statistical significance. The mean increase in CD4 count in the test group over the full period was 76.2 cells/mm3 and the number of patients in the test group with VL < 400 copies/ml increased from 72% to 89%. The mean increase in CD4 count in the control group was 72.2 cells/mm3 and the number of patients with VL < 400 copies/ml increased from 65% to 75%. Conclusion: The results of the study illustrated that the e-MuM system could be integrated in a normal clinic routine but additional staff and facilities (hardware) would be needed. The e-MuM system could be particularly helpful with new or suspected non¬ adherent patients. The disadvantage of the electronic monitoring system is its ability to monitor only one drug per container. It could be used with a fixed combination single tablet regimen. Patients were positive about the reminder unit as a tool to improve adherence. Doctors had mixed opinions of the usefulness of feedback graphs in monitoring adherence. Some patients disagreed with feedback results and this may reflect the anomalies caused by the range of decanting habits. The test group reached higher average rates of adherence than the control group, as jUdged bye-MuM recorded events, but differences were not statistically significant. The e¬ MuM data do not reflect adherence as such, merely container opening patterns, which makes it difficult to interpret results. In focus groups, patients and staff expressed their views about the use of the e-MuM system. No difficulty in the ease of use was reported by patients or staff. Notwithstanding this, a large portion of patients did decant tablets for various reasons, which made calculation of true adherence rates very difficult. A group of patients suggested routine use of the e-MuM system, to keep them conscious of their medication regimen while staff suggested limited use for new patients and non-adherent patients. The size of the container was the biggest obstacle according to patients and clinic staff and a small, more portable container was suggested. The sturdiness of the e-MuM lid with the microprocessor used for the study was questionable. Recommendations: Based on the results of this study, suggestions to increase adherence and utilise the e-MuM system are offered. The ideal medication dosage interval for patients, whose adherence patterns are being monitored electronically, would be once daily. For the e-MuM system to be practical, the device (container with embedded micro chip) has to be small, portable and sturdy. Patients will have to be educated to take every dose directly from the e-MuM container. For optimal e-MuM data interpretation, patient medication taking behaviour, including decanting of tablets must be accurately identified. A trained, dedicated, sensitive person has to interpret data and give feedback to patients.

Student Number : 9803027N - MA research report - School of Psychology - Faculty of Humanities / The recent introduction of antiretroviral treatment (ART) to the public health sector has meant that for millions of Human Immunodeficiency Virus (HIV)-positive patients this deadly disease has been transformed into a chronic condition. There has been much research done internationally on adherence to ART but in South Africa there has been little investigation in this area. This study aimed to bridge this gap by exploring expert and patient opinions and recommendatio ns regarding adherence to antiretroviral medication. To attain this, four experts and seven patients were interviewed using a semistructured interview schedule. The experts had worked within the HIV field for at least two years while the patients had been chosen from public antiretroviral roll-out programmes and had been on ART for at least six months. These interviews were audio recorded and transcribed. The transcriptions were then explored for themes using thematic content analysis. These themes were categorised and discussed under four broad categories: patients’ perceptions of barriers to adherence, patients’ recommendations for improving adherence, experts’ perceptions of barriers to adherence and experts’ recommendations for improving adherence.

Abstract Human Immunodeficiency Virus (HIV), a chronic medical condition characterized by cycles of wellness and illness, has the potential to decrease the physical activity levels and functional independence of infected individuals. Although antiretroviral therapy has been credited with improving and maintaining the immune status of infected patients by increasing cluster of differention 4 (CD4) count and suppressing viral load, the short- and long-term side effects of antiretroviral medication and the possible negative impact of these side effects on physical well-being have not yet been fully investigated. Therefore, I assessed the relationship between CD4 count, habitual physical activity levels and functional independence in a group of HIV positive South African adults either taking or not taking antiretroviral medication. I also compared the aerobic capacity, muscle strength and physical activity levels (activity counts) of age-matched black HIV negative females and HIV positive females who were taking antiretroviral medication. For the first part of the study, a Lifestyle and Physical Activity Questionnaire was completed by 186 black* male and female HIV positive outpatients who were recruited from a Johannesburg based antiretroviral roll out site. Of these patients, 121 were on first line antiretroviral treatment (median time of seven months), and 65 patients were not taking any medication. The questionnaire, as well as recording HIV history and current CD4 count, assessed each patient’s ability to independently perform one or more tasks of daily living as well as his/her monthly occupational, household and recreational physical activity levels. From the subjects’ responses, a total metabolic equivalent (MET) score for one month was calculated. The second part of the study assessed the full blood counts, aerobic capacity (submaximal bicycle ergometer test), lower limb strength (isokinetic dynamometry), hand grip strength (hand dynamometer) and seven day physical activity counts (actigraphy) of ten HIV positive black females recruited from the same Johannesburg antiretroviral roll out site. All of these patients had been taking first line antiretroviral treatment for a median time period of seven months. Ten HIV negative age-matched black females acted as their controls. From the questionnaire, significant correlations were observed between CD4 count and length of time on antiretroviral medication (P < 0.0001; r = 0.45), and between CD4 count and total monthly physical activity level (P = 0.0067; r = 0.20). Patients who considered themselves functionally independent had a significantly higher CD4 count that those patients who required help from others (P = 0.0031). The second part of the study revealed no significant difference in aerobic capacity, lower limb muscle strength (peak torque), handgrip strength and seven day physical activity counts between the female HIV positive patients and HIV negative controls. My results show that the use of antiretroviral medication (median time of seven months) increases CD4 count which translates into an increased habitual physical activity level and greater sense of functional independence. I have also shown that HIV positive females who are taking antiretroviral medication have an aerobic capacity, leg strength, handgrip strength and physical activity count which is not statistically different to their HIV negative counterparts. In this sample, the side effects associated with the administration of antiretroviral medication did not negatively impact on physical well-being. However, more research needs to be conducted on the possible physical activity limiting side effects of longer term antiretroviral medication administration, which may limit habitual physical activity levels. * Footnote: Race does not refer to any biological attributes but rather to the compulsory classification of people into the Population Registration Act. Although the act has been amended, these categories are still powerful and commonly used by the South African Government and statistical services.

Introduction: Currently there are approximately 1.2 million people in the United States living with HIV and it is estimated that 25.6% of HIV-positive adults suffer from depression. The purpose of this study is to examine the contribution of depression on substance use and medication adherence specifically among HIV-positive adult Georgians receiving medical care for HIV. Methods: Secondary data with a probability sample of 608 HIV-positive adults who took part in the 2009-2012 Georgia Medical Monitoring Project (MMP) were analyzed. Descriptive analysis and multivariate logistic regression models were conducted to assess relationships between depression with current cigarette smoking, injection drug use, other non-injection drug use, and medication adherence, adjusting for sociodemographic covariates (age, gender, race, and education). All analyses accounted for non-response and complex sampling design and were performed using SAS 9.2 (Cary, NC). Results: Among HIV-positive adults in Georgia, approximately 9.2% met the criteria for major depression; 15.2% of women and 6.9% of men had major depression. Heterosexual adults also had a higher percentage of major depression (11.9%) compared to adults who identified as bisexual (8.3%) or homosexual (6.1%). Major depression was also highest among young adults (17.1%) and adults with high school diploma or GED (13.0%). Major depression was associated with a greater odds of current cigarette smoking (3.04; 95% CI: 1.48, 6.23); injection drug use (5.62; 95% CI: 0.96, 32.81), and other non-injection drug use (2.17; 95% CI: 1.10, 4.25), after adjusting for sociodemographic variables. Major depression was also associated with a greater odds of ART medication non-adherence, 2.52 (95% CI: 1.20, 5.28), after adjusting for gender. Conclusion: As previously found in the general population, we found significant associations between depression and smoking and other non-injection drug use among HIV-positive adults. Major depression was also associated with a greater odds of ART medication non-adherence, which is also consistent with the literature. Because HIV-positive adults have ongoing encounters with healthcare providers, screening and treatment for depression and other co-morbid substance use is needed to reduce an additional health burden in this population.

O sucesso indiscutível do uso da terapêutica medicamentosa com os antirretrovirais na redução da morbimortalidade relacionada à AIDS tem provocado alterações nas prioridades para a manutenção da saúde das pessoas vivendo com HIV/AIDS, cuja sobrevida tem aumentado significativamente. Entretanto, surgem as doenças degenerativas e os eventos adversos dos antirretrovirais, tais como as modificações corporais, as alterações do metabolismo das gorduras e da glicose, dentre outras. Estes efeitos colaterais têm gerado estigmatizações, podendo gerar resistência à adesão ao tratamento. Partindo desses pressupostos, o presente estudo teve como objetivos: (01) verificar o perfil sócio-epidemiológico, comportamental e religioso, bem como os impactos da adesão aos antirretrovirais nos indivíduos adultos com HIV/AIDS em acompanhamento; (02) traçar o perfil sócio-epidemiológico dos indivíduos com HIV/AIDS em terapia medicamentosa; correlacionando as crenças religiosas e a adesão à terapia com os antirretrovirais, e (03) observar os impactos da lipodistrofia na aderência do tratamento medicamentoso. Foi um estudo do tipo transversal, de natureza quantitativa, analítica e descritiva. Os dados foram coletados no Centro de Atenção e Apoio à Vida Dr. David Capistrano Filho (CAAV), em Vitória da Conquista BA, a investigação literária foi realizada na Escola Superior de Teologia, de São Leopoldo RS, as variáveis utilizadas foram as sócio demográficas comportamentais, as terapêuticas e as religiosas e os dados foram tratados no EPI-INFO versão 3.5.2. A pesquisa envolveu 31 indivíduos, sendo o gênero feminino o mais alcançado, identificados como pertencentes à faixa etária mais acometida pelo HIV/AIDS os indivíduos entre 30 a 39 anos. Destes, 52,9 % apresentando lipodistrofia associada ao uso do TARV. No entanto, esse efeito colateral não interferiu na adesão à terapia medicamentosa. Dos 90,3 % dos entrevistados que expuseram crença religiosa, 45,2 % são católicos, 22,6 % são evangélicos, 19,4 % de outras religiões, 9,7% são espíritas e 3,2 % são de religiões afro-brasileiras. A pesquisa apontou o suporte religioso como fator relevante no enfretamento da doença e na adesão medicamentosa. / The indisputable success in the use of drug therapy with the antiretroviral medications in the reduction of the mortality related with AIDS has provoked alterations in the priorities of maintenance of the health of the people living with HIV/AIDS, whose survival rate has increased significantly. However, degenerative illnesses and adverse reactions related to the antiretroviral medications are arising such as corporal changes, alterations in the metabolism of the fats and glucose, among others. These collateral effects have generated stigmatizations, which can cause resistance to the adherence to the treatment. Starting from these presuppositions, the current study had as goals: (01) verify the social-epidemiological, behavioral and religious profile as well as the impacts of adhering to the antiretroviral medications in the adult individuals with HIV/AIDS being accompanied; (02) trace the social-epidemiological profile of the individuals with HIV/AIDS in drug therapy; correlating the religious beliefs and the adhesion to the therapy with the antiretroviral medication and (03) observe the impacts of lipodystrophy on the adhesion to the drug treatment. It was a transversal type of study, of a quantitative, analytical and descriptive nature. The data was collected at the Centro de Atenção e Apoio à Vida Dr. David Capistrano Filho (CAAV) [Dr. David Capistrano Filho Center for Attention and Support for Life] in Vitória da Conquista BA, the literary investigation was carried out at the Escola Superior de Teologia in São Leopoldo RS, the variables used were the behavioral, therapeutic and religious social demographic variables and the data was treated in the EPI-INFO 3.5.2 version. The research involved 31 individuals, being that the feminine gender was the one most reached. They were identified as belonging to the age group that is most affected by HIV/AIDS which are the individuals between 30 and 39 years of age. Of these 52.9% presented lipodystrophy associated with the use of the TARV. However, this collateral effect did not interfere in the adhesion to the drug therapy. Of the 90.3% interviewed who expressed a religious belief, 45.2% are Catholic, 22.6% are Evangelical, 19.4% are of other religions, 9.7% are Spiritists and 3.2% are from the Afro Brazilian religions. The research pointed to religious support as a relevant factor in confronting the disease and the drug therapy.