Antiretroviral Therapy Programs Research Articles

Diagnosis and clinical outcomes of extrapulmonary tuberculosis in antiretroviral therapy programmes in low- and middle-income countries: a multicohort study.

IntroductionExtrapulmonary tuberculosis (EPTB) is difficult to confirm bacteriologically and requires specific diagnostic capacities. Diagnosis can be especially challenging in under‐resourced settings. We studied diagnostic modalities and clinical outcomes of EPTB compared to pulmonary tuberculosis (PTB) among HIV‐positive adults in antiretroviral therapy (ART) programmes in low‐ and middle‐income countries (LMIC).MethodsWe collected data from HIV‐positive TB patients (≥16 years) in 22 ART programmes participating in the International Epidemiology Databases to Evaluate AIDS (IeDEA) consortium in sub‐Saharan Africa, Asia‐Pacific, and Caribbean, Central and South America regions between 2012 and 2014. We categorized TB as PTB or EPTB (EPTB included mixed PTB/EPTB). We used multivariable logistic regression to assess associations with clinical outcomes.Results and DiscussionWe analysed 2695 HIV‐positive TB patients. Median age was 36 years (interquartile range (IQR) 30 to 43), 1102 were female (41%), and the median CD4 count at TB treatment start was 114 cells/μL (IQR 40 to 248). Overall, 1930 had PTB (72%), and 765 EPTB (28%). Among EPTB patients, the most frequently involved sites were the lymph nodes (24%), pleura (15%), abdomen (11%) and meninges (6%). The majority of PTB (1123 of 1930, 58%) and EPTB (582 of 765, 76%) patients were diagnosed based on clinical criteria. Bacteriological confirmation (using positive smear microscopy, culture, Xpert MTB/RIF, or other nucleic acid amplification tests result) was obtained in 897 of 1557 PTB (52%) and 183 of 438 EPTB (42%) patients. EPTB was not associated with higher mortality compared to PTB (adjusted odd ratio (aOR) 1.0, 95% CI 0.8 to 1.3), but TB meningitis was (aOR 1.9, 95% CI 1.0 to 3.1). Bacteriological confirmation was associated with reduced mortality among PTB patients (aOR 0.7, 95% CI 0.6 to 0.8) and EPTB patients (aOR 0.3 95% CI 0.1 to 0.8) compared to TB patients with a negative test result.ConclusionsDiagnosis of EPTB and PTB at ART programmes in LMIC was mainly based on clinical criteria. Greater availability and usage of TB diagnostic tests would improve the diagnosis and clinical outcomes of both EPTB and PTB.

Rates and predictors of adherence and retention for antiretroviral therapy among HIV-positive adults in Enugu, Nigeria.

HIV infection and AIDS are majorpublic health challenges in Nigeria, a country with one of the highest rates of new infection in sub-Saharan Africa and the second largest HIV epidemic in the world.Non-adherence to medication and defaulting from treatment are the two major challenges faced by anti-retroviral therapy (ART) programs in resource-constrained settings. This study was undertaken to determine the rate and predictors of adherence to medication and retention among people living with HIVin Enugu State, Nigeria. This was a cross-sectionalretrospective study conducted among adults living with HIV(PLHIV) receiving ARTs in eightcomprehensive health facilities in Enugu, Nigeria. We used self-reported adherence and recorded clinic visits to assess adherence and retention, respectively. Descriptive statistics (frequencies, proportions, mean and standard deviation) and regression analysis were then conducted to identify the association between adherence, retention and demographic and health-related factors. The mean age of respondents was 38.5±9.8 years. Predictors of good adherence to medication includedbeing male(adjusted odds ratio [AOR]:2.08; 95% confidence interval [CI]:1.12-3.85), having been on anti-retroviral medications for more than 5 years (AOR:1.92; 95% CI: 1.17-3.16), the non-consumption of alcohol(AOR: 3.67; 95% CI: 2.01-6.70), not usingtraditional medicine (AOR: 2.76; 95% CI:1.33-5.73) and having a baseline CD4count exceeding 500 cells/µl (AOR: 5.67; 95% CI: 1.32-24.32).Adequate retention was predicted by being resident in the urban area (AOR: 1.90; 95% CI: 1.17-3.06). Being away from home (41.8%) and forgetfulness (35.0%) were reported as the major reasons for missing medication. The rates of adherence and retention found in this study were similar to those reported forother resource-limited settings. Health education and behavioural modification interventions should be intensified to reduce the consumption of alcohol and the use of traditional medicine by people living with HIV. Identifying other factors may help to design effective strategies to ensure that people living with HIV adhere to their medications and remain in care.

Virological outcomes of second-line antiretroviral therapy for HIV-1 patients in center of excellence, Gandhi Hospital, Secundrabad, Telangana

Introduction: In India, ART service was established in 2004 and viral load facility was started in 2009 through National Public Health Laboratory (NPHL). Phased scale-up has been planned to efficiently and successfully expand viral load testing services, taking into account the targets for enrollment of People Living with HIV in to Anti Retroviral Therapy program. Methods: This is an observational study conducted at the Centre of Excellence (COE), Gandhi Hospital Secundrabad. It is a referral centre for evaluation of patients suspected of treatment failure from ART centers. Data of all patients >18 years of age who were started on second line therapy due to failure of first line ART was taken in the study. The data of patients admitted between the time period of January 2009 to January 2010 was included. Results: A total of 147 HIV infected patients received second line ART of which 114 were men and 33 were women. Of these, 147 were treated with regimen TL, ATV/r. The most common cause to switch on second line ART was combined immunological and clinical failure (135) followed by all three failure (12).Mean baseline CD4 count was 220.06 (95% confidence interval [CI]: 243.73-196.38) and mean base line of PVL of patients was 291356.6 cells/mm3 (95% CI: 364843.8-217869.29) copies/ml, respectively. Conclusion: Good long term outcome as well as virological suppression in patients starting second line therapy under programmatic conditions in India. This early mortality can be circumvented by introducing routine virological monitoring in the program which will help in early detection of patients with failure.

Antiretroviral therapy program accessibility across Lesotho districts’ primary health care centers

Most of patients in Lesotho receive health care in primary health care (PHC) facilities which are mostly managed by nurses. PHC facilities, which comprise health center facilities, are settings at which basic health care services (including antiretroviral therapy (ART)) which are affordable and accessible are targeted towards individuals, families, communities or groups. In Lesotho, antiretroviral therapy was initiated in 2001 and the free ART program started in November 2004. As the prevalence of HIV/AIDS remains high in Lesotho (25%), not much is known about the accessibility of the ART program in these settings. The aim of this study was to evaluate the ART program accessibility in PHC settings of Lesotho. A cross-sectional survey was conducted from September to November 2015 and quota sampling was used to select nurses involved in the program. A structured self-report questionnaire was used to collect data from 197 respondents and it was analyzed using SPSS version 23. It was found that 100% of PHC facilities were managed by registered nurses, registered nurse midwives or nurse clinicians and their professional titles did not affect service provision. The nurses spent an average of 4.6 (CI=3.5-4.9) years at the PHC facilities and had an average of 9.7 (CI=8.5-11.4) years in clinical practice. The mean number of patients was 173 (CI=138-175) and they spent on average 2.7 (CI=2.4-3.0) hours seeking the services. ART and prevention of mother to child transmission (PMTCT) services were accessible and offered for 4.5 (CI=4.4-4.7) days every week, but not offered on the same days and in the exact same manner. This was due to nurses’ different preferences resulting from differing staffing patterns and workload. In order to improve the current situation, standardized ART service delivery, driven by coordinated services offered on similar days and performed by staffing patterns in line with patient numbers should be encouraged.

Safety and efficacy of Option B+ ART in Malawi: few severe maternal toxicity events or infant HIV infections among pregnant women initiating tenofovir/lamivudine/efavirenz.

Malawi's Option B+ universal antiretroviral therapy (ART) program for pregnant and breastfeeding women does not include routine laboratory monitoring. We report safety outcomes of pregnant women who initiated ART through Option B+. We analysed 12-month data from an observational cohort study on Option B+ among women newly initiating tenofovir/lamivudine/efavirenz (TDF/3TC/EFV) at a government antenatal clinic in Lilongwe, Malawi. Proportions of women engaged in care, incidence of DAIDS grade≥2 laboratory toxicity, grade≥3 adverse events (AEs), viral suppression (<1000 copies/mL), birth outcomes and infant HIV infections are reported. At ART initiation, participants (n=299) had a median age of 26years (IQR 22-30), median CD4 count of 352cells/μl (IQR 231-520) and 94% were in WHO Stage 1. We noted 76 incident DAIDS Grade≥2 laboratory results among 58 women, most commonly elevated liver function tests (n=30 events) and low haemoglobin (n=27). No women had elevated creatinine. Clinical AEs (n=45) were predominantly infectious diseases and Grade 3. Five participants (2%) discontinued TDF/3TC/EFV due to virologic failure (3) or toxicity (2). Twelve months after ART initiation, most women were engaged in care (89%) and had HIV RNA<1000copies/ml (90%). 8% of pregnancies resulted in preterm birth, 9% were low birthweight (<2500g), and 2% resulted in infant HIV infection at 6weeks post-delivery. Most women remained on ART and were virally suppressed 12months after starting Option B+. Few infants contracted HIV perinatally. While some women experienced adverse laboratory events, clinical symptom monitoring is likely reasonable.

Extending Visit Intervals for Clinically Stable Patients on Antiretroviral Therapy: Multicohort Analysis of HIV Programs in Southern Africa.

The World Health Organization recommends differentiated antiretroviral therapy (ART) delivery with longer visit intervals for clinically stable patients. We examined time trends in visit frequency and associations between criteria for clinical stability and visit frequency in ART programs in Southern Africa. We included adults on ART from 4 programs with viral-load monitoring, 2 programs with CD4 monitoring, and 4 programs with clinical monitoring of ART. We classified patients as clinically stable based on virological (viral load <1000 copies/mL), immunological (CD4 >200 cells/µL), or clinical (no current tuberculosis) criteria. We used Poisson regression and survival models to examine associations between criteria for clinical stability and the rate of clinic visits. We included 180,837 patients. There were trends toward fewer visits in more recent years and with longer ART duration. In all ART programs, clinically stable patients were seen less frequently than patients receiving failing ART, but the strength of the association varied. Adjusted incidence rate ratios comparing visit rates for stable patients with patients on failing ART were 0.82 (95% confidence interval: 0.73 to 0.90) for patients classified based on the virological criterion, 0.81 (0.69 to 0.93) for patients classified based on the clinical criterion, and 0.90 (0.85 to 0.96) for patients classified based on the immunological criterion for stability. Differences in visit rates between stable patients and patients failing ART were variable and modest overall. Larger differences were seen in programs using virological criteria for clinical stability than in programs using immunological criteria. Greater access to routine viral-load monitoring may increase scale-up of differentiated ART delivery.

AIDS-defining causes of death from autopsy findings for HIV-positive individuals in sub-Saharan Africa in the pre- and post-ART era: A systematic review and meta-analyses

Background: The lack of representative data on causes of death in sub-Saharan Africa (SSA) hampers our understanding of the regional burden of HIV and impact of interventions. In spite of the roll-out of antiretroviral therapy (ART) programs, HIV-infected individuals are still dying from complications of AIDS in SSA. We reviewed autopsy findings in SSA to observe whether the prevalence of 14 AIDS-defining illnesses changed from the pre-ART era to the post-ART era. Methods: We conducted a systematic review of autopsy findings in SSA using Medline, CINAHL, Evidence Based Medicine, EMBASE, Scopus, Web of Science, and abstracts from the Conference on Retroviruses and Opportunistic Infections, for literature published between January 1, 1990 and September 30, 2018. We focused on 14 AIDS-defining illnesses as causes of death. Results: In total, 33 studies were identified, including 9 from South Africa, 4 from the Ivory Coast, and the rest from eastern regions of sub-Saharan Africa. Of these, 18 studies were included in the meta-analyses for each of the AIDS-defining illnesses for adults. A ‘mixed group’ of studies that included adults and children was used for separate meta-analyses. Most opportunistic infections (OIs) showed a decrease in prevalence, with the notable exception of tuberculosis (TB), which showed a 13% increase in adult deaths and a 5% increase in mixed population group deaths. Kaposi’s sarcoma and non-Hodgkin’s lymphoma both showed a notable increase in prevalence, and liver disease showed a 10% increase in prevalence in the adult group. Conclusions: Even though ART has reduced the contribution of OIs to causes of death for people infected with HIV in SSA, targeted and strategic efforts are needed in order to strengthen existing prevention, diagnosis, and treatment of TB. More research is required to understand the complex role ARTs have on liver and kidney diseases.

Community-based antiretroviral therapy (ART) delivery for female sex workers in Tanzania: intervention model and baseline findings

ABSTRACTTo increase linkage to and retention in antiretroviral therapy (ART) care, we piloted a community-based, ART service delivery intervention for female sex workers (FSWs). At baseline, we recruited and collected data from 617 FSWs (intervention: 309; comparison: 308) who were HIV positive and not on ART. This paper presents (1) the description of the intervention model, and (2) key descriptive and bivariate-level findings of the baseline FSW cohort. The data showed more than half of FSWs had a non-paying sex partner, and less than one-third used a condom at last sex with paying and non-paying clients, which suggest potentially high levels of HIV transmission. In addition, there is a gap in HIV testing and treatment because one-third learned about their HIV-positive status only at study enrollment, and among FSWs who had known their status for more than a month, half had not registered in care. This substantiates the importance of timely HIV diagnosis and treatment. A community-based ART program may serve as an important strategy in closing the HIV care and treatment gap for FSWs.

Evaluation of treatment response, drug resistance and HIV-1 variability among adolescents on first- and second-line antiretroviral therapy: a study protocol for a prospective observational study in the centre region of Cameroon (EDCTP READY-study)

BackgroundSub-Saharan Africa (SSA) alone has nine out of every 10 children living with HIV globally and monitoring in this setting remains suboptimal, even as these children grow older. With scalability of antiretroviral therapy (ART), several HIV-infected children are growing towards adolescence (over 2.1 million), with the potentials to reach adulthood. However, despite an overall reduction in HIV-related mortality, there are increasing deaths among adolescents living with HIV (ADLHIV), with limited evidence for improved policy-making. Of note, strategies for adolescent transition from pediatrics to adult-healthcare are critical to ensure successful treatment response and longer life expectancy. Interestingly, with uptakes in prevention of mother-to-child transmission, challenges in ART programs, and high viremia among children in SSA, the success rate of paediatric ART might be quickly jeopardised, with possible HIV-1 drug-resistance (HIVDR) emergence, especially after years of paediatric ART exposure. Therefore, monitoring ART response in adolescents and evaluating HIVDR patterns might limit disease progression and guide on subsequent ART options for SSA ADLHIV.ObjectivesAmong Cameroonian ADLHIV receiving ART, we shall evaluate the rate of immunovirologic failure, acquired HIVDR-associated mutations, HIV-1 subtype distribution, genetic variability in circulating (plasma) versus archived (cellular) viral strains, and HIVDR early warning indicators (EWIs) at different time-points.MethodsA prospective and observational study will be conducted among 250 ADLHIV (10–19 years old) receiving ART in the centre region of Cameroon, and followed-up at 6 and 12 months after enrollment. Following consecutive sampling at enrolment, plasma viral load and CD4/CD8 count will be measured, and genotypic resistance testing (GRT) will be performed both in plasma and in buffy coat for participants experiencing virological failure (two consecutive viremia > = 1000 copies/ml). Plasma viral load and CD4/CD8 will be monitored for all participants at 6 and 12 months after enrolment. HIVDR-EWIs will be monitored and survival analysis performed during the 12 months follow-up. Primary outcomes are rates of virological failure, acquired-HIVDR, and mortality.DiscussionOur findings will provide evidence-based recommendations to ensure successful transition from paediatrics to adult ART regimens and highlight further needs of active ART combinations, for reduced morbidity and mortality in populations of ADLHIV within SSA.

Undernutrition of HEU infants in their first 1000 days of life: A case in the urban-low resource setting of Mukuru Slum, Nairobi, Kenya

BackgroundAccording to the Lancet, the successful chemoprophylaxis and the introduction of lifelong antiretroviral therapy programs to eliminate mother to child transmission of HIV has promoted the rise in number of HIV exposed uninfected (HEU) infants. In resource limited settings, these infants are at an increased risk of undernutrition due to risk factors such as low birth weight, food insecurity, household composition, income and improper feeding patterns. As several other studies have suggested, the risk factors vary from one setting to another. This paper delved into reviewing the predisposing undernutrition factors in relation to HIV exposure among infants within the low resource urban setting of Mukuru Slum, in Nairobi, Kenya. MethodsA retrospective cohort study was performed on 160 mother/guardian-child pairs in Mukuru Slum, Nairobi, Kenya. Growth charts of the HIV exposed uninfected infants were studied against a control group of HIV unexposed uninfected infants (HUU). Interviews to collect information on socio economic status, household composition, HIV exposure, infant feeding practices and food insecurity related challenges were done. Data was analyzed using IBM SPSS version 20 and WHO anthroplus software. Descriptive statistics as well as Chi square, t-tests and multivariate analysis was done. ResultsStunting among the HIV exposed uninfected infants was the most common form of undernutrition. 38.9% of the HEU infants were severely stunted (LFAZ), while 5.6% of them were severely wasted (WFLZ), while 24.4% of them were severely underweight. The mean birth weights of the HEU infants (2.953kg) was lower than the HUU (3.195kg). HIV exposure was associated with lower Weight for Length Z score (WFLZ), Weight for Age Z score (WFAZ), Length for Age Z score (LFAZ), BMI for Age Z score (BAZ) and Middle Upper Arm Circumference Z score (MUACZ) (p<0.001). HEU infants were more likely to live in households with lesser number of adults (p=0.016) and higher number of children (p<0.001) as compared to the HUU. Although exclusive breastfeeding was upheld among all infants, the HEU were more likely to rely on Food by Prescription supplements (p<0.001) to meet their daily energy needs. Households with HEU infants were, however, less likely to receive food (p=0.041). Overall the largest effect sizes on undernutrition of all infants was found to be affected by the age of children (ηp2=0.439; p<0.001), sex (ηp2=0.135; p=0.001), HIV exposure (ηp2=0.351; p<0.001) and food aid (ηp2=0.083; p=0.021). ConclusionThis study concluded that, HIV exposed uninfected infants in Mukuru were faced with a high undernutrition risk that was associated with HIV exposure, household composition, food aid and use of food by prescription supplements. These factors provide an insight when managing undernutrition among such infants in other resource limited settings. This study recommends future operational studies to inform HIV programs on exact ways to eliminate undernutrition among the rising number of HEU infants.

Community-Based Antiretroviral Therapy (ART) Delivery for Female Sex Workers in Tanzania: 6-Month ART Initiation and Adherence

We conducted an implementation science study of a community-based ART distribution program for HIV-positive female sex workers (FSW) whereby clients received ART services through community-based mobile and home-based platforms. We compared 6-month treatment-related outcomes in the community-based ART arm (N = 256) to the standard facility-based ART delivery arm (N = 253). Those in the intervention arm were more likely to have initiated ART (100.0% vs. 71.5%; p = 0.04), be currently taking ART at the 6-month visit (100.0% vs. 95.0%; p < 0.01), and less likely to have stopped taking ART for more than 30 days continuously (0.9% vs. 5.7%; p = 0.008) or feel high levels of internalized stigma (26.6% vs. 39.9%; p = 0.001). In the adjusted regression model, internalized stigma (adjusted OR [aOR]: 0.5; 95% CI 0.28–0.83) and receiving community-based ART (aOR: 208.6; 95% CI 12.5–3479.0) were significantly associated with ART initiation. Community-based ART distribution model can improve linkage to and adherence to ART over standard facility-based ART programs for FSWs.

Widespread changes in sexual behaviour in eastern and southern Africa: Challenges to achieving global HIV targets? Longitudinal analyses of nationally representative surveys.

IntroductionSexual behaviour change contributed to reductions in HIV incidence in eastern and southern Africa between 1990 and 2010. More recently, there are indications that non‐regular partnerships have increased. However, the effect of these increases on population‐level risks for HIV and other sexually transmitted infections could have been reduced by simultaneous increases in condom use. We describe recent trends in sexual behaviour and condom use within the region and assess their combined effects on population levels of sexual risk.MethodsNationally representative Demographic and Health Survey data on sexually active males and females (15 to 49 years) were used for 11 eastern and southern African countries (≥3 surveys for each country; 1999 to 2016) to describe trends in sexual behaviour (multiple, non‐regular, and casual sexual partnerships; condom use; age at first sex). Logistic regressions tested for statistical significance of changes. Analyses were stratified by sex.ResultsRecent increases in multiple, non‐regular, and/or casual partnerships can be found for males in 10 countries and, for females, in nine countries; five countries exhibited recent decreases in age of sexual debut. Reduction in sex without condoms with non‐regular partners was observed in six countries for males and eight for females. Changes in the proportion of the overall population reporting condomless sex with non‐regular partners varied between countries, with declines in six countries and increases in three.ConclusionsExtensive change in sexual behaviour occurred across eastern and southern Africa during the period of scale‐up of antiretroviral therapy programmes. This includes increasing multiple and non‐regular partnerships, but their potential effects on population‐level sexual risks were often offset by parallel increases in condom use. Strengthening condom programmes and reintegrating communication about behavioural dimensions into combination prevention programmes could help countries to meet international targets for reductions in HIV incidence.

CD4 count recovery and associated factors among individuals enrolled in the South African antiretroviral therapy programme: An analysis of national laboratory based data.

BackgroundWe describe CD4 count recovery among HIV positive individuals who initiated antiretroviral therapy (ART) with and without severe immune suppression using complete laboratory data from South Africa’s national HIV treatment programme between 2010 and 2014 and discuss implications for CD4 count monitoring.MethodsRetrospective analysis of routinely collected laboratory data from South Africa’s National Health Laboratory Service (NHLS). A probabilistic record linkage algorithm was used to create a cohort of HIV positive individuals who initiated ART between 2010 and 2014 based on timing of CD4 count and viral load measurements. A CD4 count < 50 copies/μl at ART initiation was considered severe immunosuppression. A multivariable piecewise mixed-effects linear regression model adjusting for age, gender, year of starting ART, viral suppression in follow up and province was used to predict CD4 counts during follow up.Results1,070,900 individuals had evidence of starting ART during 2010–2014 and met the criteria for inclusion in the cohort -46.6% starting ART with CD4 < 200 cells/μl and 10.1% with CD4 < 50 cells/ μl. For individuals with CD4 counts < 200 cells/μl, predicted CD4 counts > 200 cells/μl, >350 cells/μl and >500 cells/μl corresponded with mean follow up durations of 1.5 years (standard deviation [s.d] 1.1), 1.9years (s.d 1.2) and 2.1 years (s.d 1.3 years). For those with CD4 counts < 50 cells/μl, predicted CD4 count above these threshold corresponded with mean follow up durations of 2.5 years (s.d 0.9 years), 4.4 years (s.d 0.4 years) and 5.0 years (s.d 0.1years) for recovery to the same thresholds. CD4 count recovery varied mostly with duration on ART, CD4 count at the start of ART and gender.ConclusionFor individuals starting with ART with severe immunosuppression, CD4 recovery to 200cells/μl did not occur or took longer than 12 month for significant proportions. CD4 monitoring and interventions recommended for advanced HIV disease should continue until full recovery.

Virologic and immunologic responses of patients on highly active antiretroviral therapy in a rural community health centre in Limpopo, South Africa: A retrospective study.

BackgroundSouth Africa has a high HIV burden. Despite increased uptake of persons living with HIV into the South African national antiretroviral therapy programme, the incidence of HIV increased between 2013 and 2016. Studies suggest that increased community viral suppression results in reduced HIV incidence in that community ‘independent of unsafe sexual behaviours and sharing used syringes’.ObjectiveThe aim of this study was to investigate the viral and immunologic responses of patients, in a rural community health centre in South Africa, to combination antiretroviral therapy (cART) between January 2004 and July 2016.MethodsThis was a retrospective medical record review conducted in Thohoyandou Community Health Centre. Data analysis was done using SPSS 24.0 and Microsoft Excel. The estimates used were 95% confidence intervals, and a p-value < 0.05 was considered to be statistically significant.ResultsAnalysis was done using 1247 individuals, with 76% of the cohort being female and 98% first-line cART. The proportion of patients with a suppressed viral load (VL) at 6 months post-treatment was 64%, and 72% at 60 months. Fifty-nine per cent had consistent viral suppression over a 6-month period and 14% over at least 54 months. The mean CD4+ cell count at baseline was 227 cells/µL, and 538 cells/µL at 60 months. Multivariate regression analysis revealed that males had poorer immunologic and virologic responses.ConclusionsViral suppression in the study population was inferior to the UNAIDS target of 90%. The sustainability of viral suppression, once attained, was also low. These may have a negative impact on HIV transmission.

Virologic and immunologic responses of patients on highly active antiretroviral therapy in a rural community health centre in Limpopo, South Africa: A retrospective study

Background: South Africa has a high HIV burden. Despite increased uptake of persons living with HIV into the South African national antiretroviral therapy programme, the incidence of HIV increased between 2013 and 2016. Studies suggest that increased community viral suppression results in reduced HIV incidence in that community ‘independent of unsafe sexual behaviours and sharing used syringes’. Objective: The aim of this study was to investigate the viral and immunologic responses of patients, in a rural community health centre in South Africa, to combination antiretroviral therapy (cART) between January 2004 and July 2016. Methods: This was a retrospective medical record review conducted in Thohoyandou Community Health Centre. Data analysis was done using SPSS 24.0 and Microsoft Excel. The estimates used were 95% confidence intervals, and a p -value &lt; 0.05 was considered to be statistically significant. Results: Analysis was done using 1247 individuals, with 76% of the cohort being female and 98% first-line cART. The proportion of patients with a suppressed viral load (VL) at 6 months post-treatment was 64%, and 72% at 60 months. Fifty-nine per cent had consistent viral suppression over a 6-month period and 14% over at least 54 months. The mean CD4+ cell count at baseline was 227 cells/µL, and 538 cells/µL at 60 months. Multivariate regression analysis revealed that males had poorer immunologic and virologic responses. Conclusions: Viral suppression in the study population was inferior to the UNAIDS target of 90%. The sustainability of viral suppression, once attained, was also low. These may have a negative impact on HIV transmission.

The Incremental Cost of Delivering PrEP as a Bridge to ART for HIV Serodiscordant Couples in Public HIV Care Clinics in Kenya

Background In 2016, the Kenyan Ministry of Health (MOH) released guidelines that recommend preexposure prophylaxis (PrEP) for persons with substantial ongoing HIV risk, including those in HIV serodiscordant partnerships. Estimates of the costs of delivering PrEP within Kenyan public health facilities are needed for planning for PrEP scale up. Methods We estimated the incremental annual costs of providing PrEP to HIV uninfected partners as a time-limited “bridge” until the infected partner is virally suppressed on ART within HIV serodiscordant couples as part of routine clinic care in Thika, Kenya. Costs were collected from the Partners Demonstration Project, a prospective evaluation of integrated delivery of preexposure prophylaxis (PrEP) and antiretroviral therapy (ART) to high-risk HIV serodiscordant couples. We conducted time and motion studies to distinguish between activities related to research, routine clinical care, and PrEP delivery. Costs (2015 US dollars) were collected from the MOH perspective and divided into staff, transportation, equipment, supplies, buildings and overhead, and start-up. Results PrEP related activities conducted during the screening, enrollment, and follow-up visits took an average of 13 minutes, 51 minutes, and 12 minutes, respectively. Assuming a staff structure of 3 counselors, 1 nurse, and 2 clinicians, we estimate that 3,178 couples can be screened, 1,444 couples offered PrEP and ART, and 6,138 couples followed up annually in an average HIV care clinic. Using costs incurred by the MOH for personnel, drug, and laboratory tests, we estimate that the incremental cost of offering PrEP to HIV uninfected partners within existing ART programs is $86.79 per couple per year. Personnel and PrEP medication made up the largest portion of the costs. We estimate that the total cost to Ministry of Health of delivering integrated PrEP and ART program in public health facilities is $250.19 per HIV serodiscordant couple per year. Conclusions Time-limited provision of PrEP to the HIV uninfected partner within HIV serodiscordant couples can be an affordable delivery model implemented in HIV care programs in Kenya and similar settings. These costs can be used for budgetary planning and cost effectiveness analyses.

Analysis of mortality and loss to follow-up during the rollout of the second-line antiretroviral therapy: An observational study from South India

Background Assessment of the functioning of Kerala’s second-line component of antiretroviral therapy (ART) program by National AIDS Control Organization (NACO) is attempted. Aims This study aims to evaluate the factors related to mortality and loss to follow-up (LFU) during the second-line ART rollout in Kerala. Materials and Methods Prospective observational cohort study. All patients referred for the second-line ART from September 2011 to June 2013 were included, followed up till December 2013 or till death. Those who were not eligible to attend the State AIDS Clinical Expert Panel (SACEP) were excluded from the study. Descriptive variables were compared using proportions and percentages. Univariate analysis and multivariate logistic regression were done to find out the association. The study was approved by ethical committee and consent was taken from all the interviewed patients. Results Of 238 patients enrolled, 62 died and 25 became LFU. Age &gt;40 years (odds ratio [OR] 2.08; 95% confidence interval [CI]: 1.05, 4.1), HIV concordance between partners (OR 1.53; 95% CI: 0.7, 3.34), and duration of &gt;90 days from last CD4+ to SACEP (OR 2.32; 95% CI: 1.17, 4.5) were significantly associated with death. Only factor affecting LFU was distance &gt;150 km from patient’s home to ART Plus Centre (OR: 2.7; 95% CI: 0.11, 1.85). Limitations We could not consider all factors affecting mortality while initiating second-line ART. Moreover, experience from a low-level epidemic state, with good health-care infrastructure may not reflect rest of India. Conclusions Accessibility to program in terms of distance to the point of care and delayed linkage of patients for the second-line ART is presently the main weaknesses in Kerala. Special attention should be given to concordant couples and older individuals who are more vulnerable. Recent steps by NACO, such as initiation of two ART Plus Centre and provision viral load testing at the point of care, are big leaps toward solution.

HIV viraemia during pregnancy in women receiving preconception antiretroviral therapy in KwaDukuza, KwaZulu-Natal.

BackgroundPreconception antiretroviral therapy (PCART) followed by sustained viral suppression is effective in preventing mother-to-child transmission of HIV. The rates of persistent and transient viraemia in such patients have not been prospectively assessed in South Africa.ObjectivesWe determined the prevalence of transient and persistent viraemia in HIV-positive women entering antenatal care on PCART and studied variables associated with viraemia.MethodsWe performed a prospective cross-sectional observational study of HIV-positive pregnant women presenting to a primary healthcare facility in KwaZulu-Natal. All had received at least 6 months of first-line PCART. Viral load (VL) was measured, patients were interviewed, adherence estimated using a visual analogue scale and adherence counselling provided. Viral load was repeated after 4 weeks where baseline VL exceeded 50 copies/mL.ResultsWe enrolled 82 participants. Of them, 59 (72%) pregnancies were unplanned. Fifteen participants (18.3%) were viraemic at presentation with VL > 50 copies/mL. Of these, seven (8.5%) had viral suppression (VL < 50 copies/mL), and eight remained viraemic at the second visit. Adherence correlated significantly with viraemia at baseline. Level of knowledge correlated with adherence but not with lack of viral suppression at baseline. Socio-economic indicators did not correlate with viraemia. No instances of vertical transmission were observed at birth.ConclusionsApproximately 20% of women receiving PCART may demonstrate viraemia. Half of these may be transient. Poor adherence is associated with viraemia, and efforts to encourage and monitor adherence are essential. The rate of unplanned pregnancies is high, and antiretroviral therapy programmes should focus on family planning needs of women in the reproductive age group to prevent viral non-suppression prior to pregnancy.KeywordsPreconception Antiretroviral Therapy; HIV; Viraemia; Antenatal Care; Adherence.

Outcomes of patients lost to follow-up after antiretroviral therapy initiation in rural north-eastern South Africa.

ObjectiveThe vital status of patients lost to follow‐up often remains unknown in antiretroviral therapy (ART) programmes in sub‐Saharan Africa because medical records are no longer updated once the patient disengages from care. Thus, we aimed to assess the outcomes of patients lost to follow‐up after ART initiation in north‐eastern South Africa.MethodsUsing data from a rural area in north‐eastern South Africa, we estimated the cumulative incidence of patient outcomes (i) after treatment initiation using clinical records, and (ii) after loss to follow‐up (LTFU) using data from clients that have been individually linked to Agincourt Health and Demographic Surveillance System (AHDSS) database. Aside from LTFU, we considered mortality, re‐engagement and migration out of the study site. Cox proportional hazards regression was used to identify covariates of these patient outcomes.ResultsBetween April 2014 and July 2017, 3700 patients initiated ART and contributed a total of 6818 person‐years of follow‐up time. Three years after ART initiation, clinical record‐based estimates of LTFU, mortality and documented transfers were 41.0% (95% CI: 38.5–43.4%), 1.9% (95% CI 1.0–3.2%) and 0.1% (95% CI 0.0–0.9%), respectively. Among those who were LTFU, the cumulative incidence of re‐engagement, out‐migration and mortality at 3 years were 38.1% (95% CI 33.1–43.0%), 49.4% (95% CI 43.1–55.3%) and 4.7% (95% CI 3.5–6.2%), respectively. Pregnant or breastfeeding women, foreigners and those who initiated ART most recently were at an increased risk of LTFU.Conclusion LTFU among patients starting ART in north‐eastern South Africa is relatively high and has increased in recent years as more asymptomatic patients have initiated treatment. Even though this tendency is of concern in light of the prevention of onwards transmission, we also found that re‐engagement in care is common and mortality among persons LTFU relatively low.

Evaluation of the early warning indicators of HIV drug resistance surveillance system in Manicaland province, Zimbabwe

More than 1.1 million people currently receive lifelong antiretroviral treatment in Zimbabwe following the adoption of the test and treat strategy in 2017. The huge numbers of people on antiretroviral therapy (ART), combined with HIV’s error-prone replication, increases the probability of HIV drug resistance (HIVDR) developing. HIVDR in resource-limited settings like Zimbabwe has significant human and financial implications. The early warning indicators of HIV drug resistance surveillance system was set up to monitor the ART programme and to identify factors that could raise the risk of HIVDR. Fifty-one health workers at 12 health facilities were interviewed in a cross-sectional study that sought to describe how the system operates and also to identify gaps (knowledge, perceived system usefulness, sensitivity) within the system. The system was seen to have multiple weaknesses including inadequate training, difficulties navigating the system, long duration of data abstraction, and poor feedback mechanisms. Opportunities observed during the evaluation centered on integration and incorporation of indicators into the electronic patient monitoring system and strengthening ownership of the programme.