Thesis (MPH)--University of Limpopo, 2013. / Statistics from Pigg’s Peak Hospital, in Swaziland, continue to show an improvement in the uptake of HIV testing among TB patients, as well as a very high rate of HIV co-infection among the TB patients. The unit’s reports also show a low uptake of antiretroviral therapy among the HIV co-infected TB patients, and high death rates. Most of these deaths occur among HIV co-infected TB patients who have not yet initiated ART despite being on TB treatment. Anecdotal evidence suggests that there is reluctance and refusal by a considerable proportion of TB/HIV co-infected patients to take TB treatment and ART concurrently, and that they prefer to commence ART after completing TB treatment. No study has ever been conducted in Swaziland to determine the reasons for refusal of ART initiation prior to the completion of TB treatment among HIV co-infected TB patients. Aim The aim of this study was to explore the reasons for refusing antiretroviral therapy among HIV co-infected tuberculosis patients, prior to the completion of tuberculosis treatment, at Pigg’s Peak Hospital, in Swaziland. Methods A qualitative descriptive study was conducted in order to generate information on the subjects’ experiences and views on the concurrent taking of tuberculosis and antiretroviral medicines. A sample of nineteen HIV co-infected TB patients was purposefully selected to answer the research question. Results The most common reasons given by the respondents for refusing ART initiation during TB therapy were their un-readiness for ART, especially because ART must be taken for life, the perception that one was still in good health, the fear of adverse outcomes being precipitated by combining ART with TB medicines, a preference of traditional medicines, and health systems-related problems. Other reasons were: a lack of food, substance abuse, a fear of the increased pill burden, a denial of the HIV-positive status, and problems related to treatment supporters. Conclusion In TB/HIV co-infection care settings, comprehensive Pre-ART counseling must be integrated with interventions that address the specific barriers to ART initiation faced by clients; to improve the acceptability of ART initiation during TB therapy to these HIV/TB co-infected patients.

A research report submitted to the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, in partial fulfillment of the requirements for the degree Master of Family Medicine, October 2013 / Botswana has one of the highest HIV prevalence rates in the world, with 32% of pregnant women and 24% of adults in the general population living with HIV. Although antiretroviral therapy (ART) or HIV/AIDS treatment is widely available in the public sector in Botswana, not all treatment-eligible patients utilise the services in a timely manner. The study aims to identify the factors associated with the intention of already screened HIV positive/AIDS patients, who met the government criteria, to enrol into the HIV treatment programme in Lobatse, Botswana. Methods: A Cross-sectional descriptive study was used, conducted at the Infectious Disease Control Clinic, Athlone Hospital, Lobatse over a 6-month period. A questionnaire was administered on systematically sampled participants, who met Botswana National antiretroviral treatment or HIV/AIDS treatment guidelines. Results: A total of 342 participants were enrolled, mostly female (67.3%) and single (50%). Majority of the participants were age 35-44 years (17%), attained up to primary level education (44%) and were mostly unemployed (54%). A majority (59%) intended to enroll into ART or HIV/AIDS treatment programme due to sickness, while others were motivated by voluntary testing and counseling (24%). The majority of the respondents received post-test counseling (97.3%) and most was motivated to seek ART or HIV/AIDS treatment (88.3%). Only (60%) disclosed their status to their relative. Although most participants (59.6%) were willing to be linked to care and support, most (65.1%) were ignorant of support groups and services available for them. Discussion: Although there is increasing access to ART or HIV/AIDS treatment, most participants still wait until they are sick or have symptoms before they enroll into ART. Supportive post-test counseling and conducive family environment were some of the enabling factors. Distance to health facilities and long queues are barriers to accessing care as well as stigma and discrimination. The most significant reasons for not continuing with the treatment were health facilities being far from place of residence and queuing for a long time to see a doctor and or collect medications. Conclusion: Sickness, public education, supportive family environment and effective post-test counseling were found to be significant motivators for intention to enroll into ART. Perceived barriers to accessing treatment include distance and time spent in the health facilities. Interventions are required to reduce stigma, bring health facilities nearer to the people, and increase efficiency in health facilities and increase access and utilization of the care and support groups.

A research report submitted to the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, in partial fulfilment of the requirements for the degree of Master of Science in Pharmaceutical Affairs Johannesburg, 2012 / Objective: To determine the proportion of HIV+ patients who fail treatment on a yearly basis in a 5-year treatment cohort in Tshwane District Hospital and to determine the correlation of treatment failure with variables routinely measured at the clinic namely WHO stage, CD4 count, HIV viral load, age, gender, presence of concomitant diseases, concomitant medication and distance travelled to clinic. Design: A retrospective study with an analytical component was conducted using the hospital records of adult patients receiving antiretroviral therapy in 2004 and followed for 5 years (until 2009) at the Tshwane District Hospital. Methods: All adult patients receiving antiretroviral therapy in 2004 were identified and followed for the next 5 years till 2009 at Tshwane District Hospital. The proportion of patients that failed treatment yearly was calculated. Univariate analysis was used to compare all patients who failed at any time point with the patients who did not fail at all for all variables. A repeated measures logistic regression model was developed to determine the variables that impacted on the binary outcome, namely treatment failure or not. Results: Of the 1104 adult patients who were attending the TDH Immunology clinic in 2004, 870 adults were receiving ARVs. 333 patients (38.28 %) experienced treatment failure throughout the study period. 6.9 % (60/870) of the study population failed virologically. 307 of the 870 patients (35.29 %) failed treatment immunologically. 102 patients (11.72 %) experience treatment failure at the 12 month time point, 37 patients(4.49 %) at the 24 month time point, 57 patients(6.93 %) at 36 month time point, 101 patients(12.27 %) at the 48 month time point and 140 patients (7.01 %) failed treatment at 60 month time point. Univariate analysis showed significant correlation between treatment failure and non-adherer, interrupting treatment, defaulted treatment, viral load at baseline, 12, 24, 36, 48, 60 months, and CD4 count at baseline, 12, 24, 36, 48, 60 months. In the multivariate analysis, there was a significant association between short term stoppage of treatment (STSTOP) (coefficient ratio = 1.41; p<0.001), long term stoppage of treatment (LTSTOP) (coefficient ratio = 3.24; p<0.001), transfers from other health institutions (coefficient ratio = 1.96; p<0.001), regimen (coefficient ratio = -0.1734) and treatment failure. The change in log viral load at 12 months from baseline (LOGVLBL12) (coefficient ratio =-1.7145; p<0.001) was highly significant for reaching the end point - treatment v failure. Older patients were less likely to fail treatment (coefficient ratio = -0.0517, p<0.001) and patients with an advance stage of the disease (WHO stage 3 or 4) were at a lower risk of failing treatment (coefficient ratio = -0.4175; P=0.008). The CD4 count was significant in the univariate analysis P<0.01) and XTGEE (coefficient ratio =- 0.0001; p<0.001). There was no significant correlation between gender, place of residence, employment status and treatment failure. Conclusion: More than one–third of the patients receiving treatment in TDH failed treatment within the 5 year study period. The determinants of treatment failure are age, WHO stage, transfer from other institutions, short term stoppage of treatment, long term stoppage of treatment, CD4 cell count and the level of viral suppression within the first year of treatment (LOGVLBL-12). This study reinforces the need for identifying high risk patients earlier in treatment in order to implement strategies that might strengthen adherence to treatment.

A research report submitted to the Faculty of Medicine, University of the Witwatersrand, in partial fulfillment of the requirements for the Degree of Master of Medicine in the division of Plastic and Reconstructive Surgery. Johannesburg 2014 / With 67% of the world’s human immunodeficiency virus (HIV) infected population existing in Sub-Saharan Africa and recent access to highly active antiretroviral therapy (HAART); demand for plastic surgical intervention in addressing HIV-associated lipodystrophy has expanded dramatically. This study assessed the prevalence of lipodystrophy in a random clinic cohort, the demand for surgical correction, and risk of treatment non-compliance A questionnaire and database cross-sectional review of 554 patients was performed over a three-month period at the Themba Lethu Clinic, Johannesburg, South Africa. A total of 479 patients completed the questionnaire, 83% were female. Nearly 90% of patients were currently being treated, or had been treated with stavudine (d4T). The prevalence of lipodystrophy was 11.7%. Nearly 5.9% of patients had considered stopping treatment due to changes in body morphology following the onset of HAART, 47% of patients interviewed would consider surgery to correct unwanted physical changes following treatment with HAART. Male patients were satisfied by physical changes in their body habitus following treatment (pre-treatment satisfaction 38% vs. post-treatment satisfaction of 94%). Female patients had 6.5 times more breast hypertrophy related symptoms than in their pretreatment state. This study identified a prevalence of 11.7% of patients with HIV-associated lipodystrophy. A total of 3.8% of all patients would consider non-compliance on the basis of this side effect alone. The demand for surgical correction is significant, extends beyond patients diagnosed with HIV-associated lipodystrophy, and needs to be addressed.

M.Sc. (Epidemiology), Faculty of Health Sciences, University of the Witwatersrand, 2011 / Background and Objectives The advent of Highly Active Antiretroviral Therapy (HAART) has resulted in a significant reduction in HIV/AIDS related morbidity and mortality in sub-Saharan Africa. However, toxicities due to HAART continue to pose challenges to the success of different regimens. Severe hepatotoxicity is one of the significant adverse events occurring in patients on HAART. Information on the incidence and risk factors for severe hepatotoxicity in cohorts from resource poor settings is limited. It is against this background that we undertook the study to determine the incidence and explore factors associated with severe hepatotoxicity following HAART initiation in a South African cohort. Materials and Methods Secondary data analysis of a prospective cohort 9764 HIV-infected adult patients initiated on HAART at the Themba Lethu clinic antiretroviral rollout facility in Johannesburg, South Africa between 1st April 2004 and 30th June 2009 was conducted. Severe hepatotoxicity cases were identified within the first 12 months of initiating HAART as grade 3 or 4 elevation in baseline ALT levels. The incidence rate of severe hepatotoxicity was calculated and potential socio-demographic and clinical predictors were explored using Cox proportional hazard regression modelling. Results At baseline, 91.8% of patients were commenced on an efavirenz-based regimen while only 8.2% were on a nevirapine-based regimen. The median CD4 count at v initiation of HAART for this cohort was 80 cells/ mm3, a figure lower than the Department of Health (DoH) CD4 cut off for initiating HAART of 200 cells/ mm3. The overall incidence rate of severe hepatotoxicity was 10.7 (95% CI: 8.7 – 13.1) cases per 1000 p-yrs of follow-up. The period with the highest risk of severe hepatotoxicity was within 2 months of initiating HAART. Incidence of severe hepatotoxicity was 21.1(95% CI: 12.7 – 34.9) cases per 1000 p-yrs among patients on a nevirapine-based regimen and 9.7 (95% CI: 7.8 – 12.1) cases per 1000 p-yrs in those on an efavirenz-based one. The hazard for severe hepatotoxicity within the first year of initiating HAART was 2.17 times higher in individuals on a nevirapine-based regimen compared to those on an efavirenz-based regimen after adjusting for baseline ALT, baseline CD4, age and gender (HR = 2.17; 95%CI = 1.18 – 3.97; p = 0.013). Though imprecise, the estimate for baseline ALT category suggested an increased risk for severe hepatotoxicity in individuals with a baseline ALT more than 40 I.U/L compared to those with a baseline ALT of less than 40 I.U/L (HR = 1.63; 95%CI = 1.00 – 2.67; p = 0.050). Conclusion The results of the study suggest that severe hepatotoxicity following initiation of HAART in this cohort is low compared to other previously studied cohorts. The high incidence rate of severe hepatotoxicity in the first two months of initiating HAART necessitates the need for more frequent and careful monitoring of ALT levels early during therapy. Patients on a nevirapine-based regimen have a higher risk of developing severe hepatotoxicity when compared to their counterparts on an efavirenz-based regimen, a result consistent with findings from previous studies.

M. Pharm., Faculty of Health Sciences, University of the Witwatersrand, 2011 / Background: According to the 2010 edition of the UNAIDS Report on the global AIDS epidemic, an estimated 320 000 (20%) fewer people died of AIDS-related causes in South Africa in 2009 than in 2004 due to the increase in availability of anti-retroviral medicines.(2) With this positive trend, the mindset should be shifted towards reducing adverse effects of ART. The need for permanent ART treatment and the significant increase in life expectancy have led to the observation of new, frequent, and sometimes severe drug-related adverse effects.(4) One of the most challenging and potentially dangerous side-effects is hyperlactataemia (Hlac) that may evolve to lactic acidosis (LA)(5) ART–associated Hlac may be asymptomatic, or symptomatic which in the extreme case can progress to life threatening acidosis. The latter, i.e. lactic acidosis is a fairly frequent and often misdiagnosed or under diagnosed and potentially fatal side effect of ARTs. (6) Objectives: To explore the relationship between Hlac/LA and gender, weight, dosage CD4 and regimen alterations in HIV patients on ARTs and to compare the earlier regimens to the revised regimens as independent risk factors for Hlac and LA. Sample size would be based on the hypothesis that newer regimens would reduce the incidence of Hlac and LA. Methods: A Retrospective study was conducted by reviewing 3 741 patient files from August 2004 to December 2007. This study was to assess the incidence and risk factors of Hlac/LA. Hlac was defined as a venous lactate measurement of ≥2.3mmol/L and LA was ≥5mmol/L. Immunological, virological, haemotological and biochemical results were recorded for all the patients. A second phase involved a Prospective study. Patients who were on treatment for >12 months were randomly selected from the queue at the clinic between the September 2008 and December 2009. Immunological, virological, haematological and biochemical information was recorded for all patients selected. Analysis involved descriptive statistics, comparison of means, frequency analysis and multivariate analysis. Results: Two-hundred and thirty two patients were identified with elevated lactate levels in the retrospective study. The incidence was 6.2% in this population, with gastro-intestinal symptoms, peripheral neuropathy, abdominal tenderness, rash and upper respiratory tract infection being the significant symptoms. The major risk factor was a low CD4 count. The prospective study included 292 patients with 24.3% with Hlac/LA with peripheral neuropathy (p 0.209), gastrointestinal symptoms (nausea, vomiting) (p 0.148) and abdominal tenderness (p 0.214) were the most significant symptoms. In terms of the hypothesis that newer regimens would lower the incidence of elevated lactate levels by 50%, the observed incidence of 24.3% is no different from previously reported rates. This therefore shows that although regimen changes have been implemented the overall incidence of Hlac appears to be unchanged but the LA rate was found to be significantly lower than before, 6.8 cases per 1000 patient years vs ±19 cases per 1000 person years.(16) Gastro-intestinal symptoms but not peripheral iv neuropathy; with low CD4 count, weight loss and low weight on entry were the significant risk factors, which is most likely representative of advanced disease. Conclusions: Although newer regimens have been introduced, Hlac/LA still exist. Healthworkers need to be on high alert for Hlac/LA particularly if a patient enters into the ART program with a low CD4 count and a low weight

A research report submitted to the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, in partial fulfillment of the requirements for the degree of Masters of Public Health in the field of Health Measurement 22nd February, 2012 / Introduction: Barriers associated with good adherence to Antiretroviral Therapy (ART) among human immunodeficiency virus (HIV) infected adolescents are multiple and complex. Those barriers contribute to low adherence levels putting infected adolescents at risk of developing resistance and decreasing their survival time. Patients care givers psychosocial and demographic variables, medication related factors and health care delivering factors are among the barriers that correlate with non adherence to antiretroviral drugs (ART’s) among HIV infected adolescents. Those barriers vary across individuals within the same population of adolescents. This study was conducted to determine the level of adherence among HIV infected adolescents on ART and to identify barriers associated with non adherence among this population attending the Botswana Baylor Children’s Clinical Center of Excellence (COE) in Gaborone, Botswana. Materials and methods: A cross sectional analytical study using quantitative data was performed. A structured, self administrated questionnaire adapted from the AIDS Clinical Trials Group (ACTG) was used to identify the barriers while the socio-demographic and clinical data were retrieved from study participants’ medical records. The adherence level was estimated using the pharmacy pill count technique. The adolescents aged 13 to 18 years receiving ART for more than 6 months and attending the ART National Program at the time of the study and who did assent and had their care givers consent to participate in the study were included in the analysis. Results: A high adherence level (75.6%) was reported among the study participants. Besides gender, no other socio-demographic and clinical variables showed association with non adherence. Male adolescents were found to be 70% less likely to adhere to their medication than their counterpart females [p= 0.020, OR=0.30, 95% CI (0.10 – 0.85)]. Furthermore adolescents v who missed a dose because their pills were not collected from the pharmacy either by themselves or by their care givers were 77 % less likely to adhere to their ART medication than those who did not miss a dose because they had their medication collected [p= 0.019, OR= 0.23, 95%CI (0.064 – 0.837)]. Conclusion: A high proportion of HIV infected adolescents attending the Baylor Center of Excellence ART National Program were adherent to their medication. Despite the high level adherence to ART among this age group, interventions to improve adherence level should be designed with a focus on male adolescents and to reinforce counseling of care givers and adolescents about the hazards of poor adherence to treatment. Further research is however, needed to elucidate more about the two main barriers that were found to be significantly associated with non adherence among adolescents at Botswana Baylor Children’s Clinical Center of Excellence: male-gender and medication collection from the pharmacy.

Thesis(MSc(Med)(Pharmacy))--University of Limpopo (Medunsa Campus), 2011. / High levels of adherence to ART are essential for maximal suppression of viral replication and avoidance of drug resistance. Pill counts are an indirect, objective method of assessing adherence. Patients can invalidate pill counts by manipulating the number of tablets returned. This paper describes a pilot study which investigated the ability of ‘mixed’ pill counts to detect deliberate masking of non-adherence to ART at a public sector ARV Clinic in Pretoria, South Africa. Seventy-eight adult patients on a first line regimen of ART were recruited. At the first return visit, a standard pill count was performed and adherence (% of tablets taken) was calculated. For the repeat prescription, three days’ extra supply was dispensed without the patients’ knowledge. At the second return visit, a ‘mixed’ pill count was performed and adherence was calculated. Patients were grouped into three categories based on calculated adherence: truthfully non-adherent (<100% adherence), adherent (100% adherence) and ‘over-compliant’ (>100% adherence, i.e. returning to the clinic with fewer tablets than required). Exploratory interviews were conducted with truthfully nonadherent and over-compliant patients to obtain explanations for discrepancies in pill counts. Twenty-nine (37%) patients completed the study. Reasons for drop-out or discontinuation from the study included the issue of prescriptions for 2-3 months’ ARV supply, missed appointments, regimen changes and failure to return remaining tablets to the clinic. Eleven patients (38%) were identified as over-compliant in one or more of the ARVs in their regimen. Nine of these patients agreed to be interviewed, of which three admitted to manipulating their tablet numbers. Reasons for manipulation included: being ’fine now’ and not in need of ARVs; changes in body shape; possibility of the social grant being terminated if non-adherent; getting a new supply and no need for remaining ARVs; knowing that the tablets would be counted for the study. This pilot study indicated that the ‘mixed’ pill count method is capable of detecting deliberate masking of non-adherence. Applying this method to a larger sample may better estimate the frequency of pill count manipulation by patients and help gain insight to reasons for this behaviour and the extent of actual non-adherence. Key words: dumping, manipulation, masking, over-compliance, HAART

Thesis (MPH)University of Limpopo (Medunsa Campus), 2011. / INTRODUCTION: Antiretroviral therapy (ART) has been proven to significantly improve the quality and quantity of lives of patients infected with HIV. However, several barriers exist that prevent children from being initiated on treatment on time. Studies in adults have shown that the timing of treatment influence outcomes of ART; but little is known about this in children. Hence, the need for this study. The purpose of this study was to characterize the outcomes of late initiation of ART in HIV- positive children seen at the Mildmay Jajja Home center. METHODOLOGY: The study was a cross-sectional survey involving all children who were initiated at the Mildmay Jajja Home in 2005 and had had been on ART for at least 18 months. Two sets of data were collected, for the children on ART: their age and sex were recorded. In addition, based on the Ugandan clinical guidelines for ART, children were grouped into two groups; those 6 six years and below; and those above 6 years. Clinical variables recorded were baseline and repeated measurements of bodyweights, and CD4 counts; weight and CD4 counts at the time of initiation of ART, at 12 months and at 18 months. For the care providers: their age, gender, education level, relationship to the child was recorded. Three outcomes of treatment were assessed, adherence level by the 12th month on treatment; hospitalisation by the 12th month (during the first 12 months of treatment); and survival or death at by the 12th and 18th month on treatment. RESULTS: In total, 114 children were included in the sample. Among them, 54.4% of children were initiated late. Based on age, children 6 years old and younger were more likely and significantly initiated late as compared to those over 6 years old as about 70% of them were actually initiated late. Based on sex, female children older than 6 years were significantly initiated late as compared to boys. The characteristics of care providers that were associated with children being initiated late were being male, less than 40 years old, with a primary school level of education, and not knowing their own HIV status. With regard to outcomes of the treatment, adherence, hospitalisation, and survival were assessed. Overall, 59.4% of children achieved an adherence level of 90% or more; 17.3% of children had been hospitalised at least once; and the mortality was 17.5% during the 2 year period covered by the study. Adherence was influenced slightly by the timing of the start of the treatment since less than half (46.34%) of those initiated late achieved an adherence level of 90% or more as compared to over 53% among those initiated timely. Though there was not statistically significant difference, adherence was slightly better in children whose care providers were biological parents, whose HIV status was known as positive, and female. With regard to hospitalisation, children less than 6 years were significantly more hospitalised than the older ones; their care providers were relatives, not educated, and of unknown HIV status. Those initiated late were significantly more hospitalised than those initiated timely (63.15% versus 36.84%, p=0.03). With regard to survival, the majority of children who died were over 6 years old, and female. The majority of their care providers were female, under 40 years old, and known HIV-positive. In children initiated late, the mortality was 50% (n=14) and 83.3% (n=6) respectively by the 12th and 18th month of treatment as compared to those initiated timely. In conclusion, 54.4% of children were initiated late. Late initiation was associated with negative outcomes such as low adherence to treatment as less than half of them achieved a adherence level of 90% or more; hospitalisation as those initiated late were significantly more hospitalised than those initiated timely; and high mortality since among those who died, 50% and 83.3% of deaths occurred respectively by the 12th and 18th month of treatment among those initiated late. In order to minimize the probability that the majority of children are initiated late, a general awareness campaign should be directed at the general public so that they can be sensitized to the need to bring children to medical attention as soon as possible

A dissertation submitted to the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, in partial fulfilment of the requirements for the Degree of Master of Science in Epidemiology and Biostatistics. Johannesburg, November 2017. / Introduction Viral load is the most reliable indicator of poor adherence to anti-retroviral therapy (ART). However, this assay is difficult to implement in resource-limited settings due to financial and technical constraints. Laboratory markers, combined with the patient’s demographic and clinical details, have been described as better proxies of adherence than the current self-reported adherence measures. However, the real diagnostic value of these biomarkers remains unknown. Therefore, the aim of this study was to assess the usefulness of a composite marker to identify poor adherence to ART defined as a detectable plasma viral load in HIV-positive patients on first-line regimen at Themba Lethu Clinic (TLC) in Johannesburg, South Africa Materials and Methods: This study was retrospective cohort analysis of data collected on HIV-positive ART naïve adults initiating first line antiretroviral regimen at TLC following the 2010 South African antiretroviral treatment guidelines. The data collection was carried out as part of the low-cost monitoring (LCM) study at Themba Lethu Clinic in Johannesburg from February 2012 to 2014. The LCM cohort which aims to look at low cost monitoring of HIV treatment in resource limited settings was initiated in 2009 in Johannesburg, South Africa. The study or treatment outcome was failure to suppress viral load (VL ≥ 400 copies/ml) at 6 and at 12 months. Adherence to antiretroviral treatment was assessed using four (4) self-reported adherence (SRA) measures namely: a self-reporting questionnaire, a Visual Analogue Scale (VAS), a pill identification test (PIT) and the Simplified Medication Adherence Questionnaire (SMAQ). The result of each self-reported measure was classified as either positive or negative given a conventional threshold. In our study three (3) self-reported adherence (SRA) measures were combined into a multi-method approach tool which included self-reports combined with VAS and the pill identification test (PIT). Continuous variables were summarized by median with interquartile range. Categorical variables were summarized by giving their frequencies. To compare continuous variables, we used an unpaired t-test if the variable was normally distributed. When continuous variables were compared from baseline to the previous 6 months, a paired t-test was done. In the case of skewed distribution, we used a non-parametric variant of the t-test such as the Mann-Whitney U-test. To compare categorical variables, we used cross-tables with corresponding chi-square test or Fisher exact test. A Modified Poisson Generalized Linear Model (GLM) with robust variance was used to estimate adjusted relative risks (aRR) of failing to suppress viral load at 6 and at 12 months adjusting for age age, gender, self-reported adherence measures, changes in laboratory markers and missed appointments at 6 and 12 months after ART initiation. As there was missing values in the covariatess and the outcome, we performed a multiple imputation technique under missing at random (MAR) assumption in order to compare the robustness of the estimations between the complete case analysis and the imputation model under MAR after imputing missing values. with the imputed dataset. Additionally, we calculated the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for each self-reported adherence measure using viral load as the reference standard. Thus, we derived two diagnostic risk scores from rounding and adding together the adjusted regression coefficients used to estimate adjusted relative risk and following the Spiegelhalter and Knill-Jones approach, at 6 and at 12 months. The Receiver Operating characteristic (ROC) curves were computed to see the overall discriminative value of each continuous risk score. To assess the clinical usefulness of the continuous riskscores we dichotomized them from 2 ≥ vs < 1 to 5 ≥ vs < 5 and calculated the sensitivity (Se), specificity (Sp), positive predictive value (PPV) and negative predictive value (NPV) at each cut-off, taking detectable viral load as a gold standard. Results: There were 353 HIV-positive patients initiated on first line ART at TLC for the LCM cohort study. Of these, 80.7% did not suppress viral load after 6 months while 30.1% did not suppress viral load at 12 months. The proportion of patients classified as being highly adherent was 86.7% but this proportion decreased to 60% at 12 months. By 6 months, after adjusting for gender and age, the variables that were significantly associated with detectable viral load included: having missed at least two ARV visits by ≥ 7 days (aRR: 2.35 95% CI: 1.08 -5.11); platelet count < 150 cells/mm3 (aRR: 2.73 95% CI: 1.04 -7.18) and VAS ≤ 95% (aRR: 1.65. 95% CI: 1.01-2.71). At 12 months, the estimates showed a positive relationship only with age group and unemployment. There were no similarities in the results found using complete case analysis and analysis with imputed datasets. However, the largest standard errors were obtained from the complete case analysis. At 6 months, the AUC ROC curve was calculated as 0.63 (95% CI, 0.53 - 0.72) while, for the visual analogue scale, the AUC decreased to 0.55 (95% CI, 0.49 - 0.62); for the Simplified Medication Adherence Questionnaire (SMAQ), the AUC decreased to 0.52 (95%CI, 0.45 - 0.60), while for the multi-method approach, it decreased to 0.53 (95% CI, 0.46 - 0.58). The optimal diagnostic accuracy was obtained with the score 5 (≥5 vs <5 Se: 64% and a Sp: 50.0%) followed by a risk score of 4 (Se of 76.0%, Sp of 34.7%). At 12 months, the AUC of the diagnostic risk score was calculated as 0.44 (95%CI, 0.40 - 0.60) while for the three self-reported adherence methods, it decreased to 0.48 (95% CI, 0.40 - 0.60), 0.51 (95%CI, 0.40 - 0.60) and 0.50 (95%CI, 0.41 - 0.59) respectively for the visual analogue scale, the SMAQ and the multi-method approach method respectively. Conclusion. This study shows that after ART initiation, the 6-month’s adherence can be better diagnosed using laboratory markers combined with patient’s information and traditional self-reported adherence measures at Themba Lethu Clinic. The advantage of this proposed method is that it is based on routine and accessible informations collected during HIV-positive patient visits, thus incurring no additional cost for its implementation. An external validation of this diagnostic risk score is needed for its translation into clinical practice in resource-limited settings. / LG2018