BackgroundToday's uncertain HIV funding landscape threatens to slow progress towards treatment goals. Understanding the costs of antiretroviral therapy (ART) will be essential for governments to make informed policy decisions about the pace of scale-up under the 2013 WHO HIV Treatment Guidelines, which increase the number of people eligible for treatment from 17.6 million to 28.6 million. The study presented here is one of the largest of its kind and the first to describe the facility-level cost of ART in a random sample of facilities in Ethiopia, Malawi, Rwanda, South Africa and Zambia.Methods & FindingsIn 2010–2011, comprehensive data on one year of facility-level ART costs and patient outcomes were collected from 161 facilities, selected using stratified random sampling. Overall, facility-level ART costs were significantly lower than expected in four of the five countries, with a simple average of $208 per patient-year (ppy) across Ethiopia, Malawi, Rwanda and Zambia. Costs were higher in South Africa, at $682 ppy. This included medications, laboratory services, direct and indirect personnel, patient support, equipment and administrative services. Facilities demonstrated the ability to retain patients alive and on treatment at these costs, although outcomes for established patients (2–8% annual loss to follow-up or death) were better than outcomes for new patients in their first year of ART (77–95% alive and on treatment).ConclusionsThis study illustrated that the facility-level costs of ART are lower than previously understood in these five countries. While limitations must be considered, and costs will vary across countries, this suggests that expanded treatment coverage may be affordable. Further research is needed to understand investment costs of treatment scale-up, non-facility costs and opportunities for more efficient resource allocation.
BackgroundAround 70% of those living with HIV in need of treatment accessed antiretroviral therapy (ART) in Zambia by 2009. However, sustaining high levels of adherence to ART is a challenge. This study aimed to identify the predictive factors associated with ART adherence during the early months of treatment in rural Zambia.MethodsThis is a field based observational longitudinal study in Mumbwa district, which is located 150 km west of Lusaka, the capital of Zambia. Treatment naive patients aged over 15 years, who initiated treatment during September-November 2010, were enrolled. Patients were interviewed at the initiation and six weeks later. The treatment adherence was measured according to self-reporting by the patients. Multiple logistic regression analysis was performed to identify the predictive factors associated with the adherence.ResultsOf 157 patients, 59.9% were fully adherent to the treatment six weeks after starting ART. According to the multivariable analysis, full adherence was associated with being female [Adjusted Odds Ratio (AOR), 3.3; 95% Confidence interval (CI), 1.2-8.9], having a spouse who were also on ART (AOR, 4.4; 95% CI, 1.5-13.1), and experience of food insufficiency in the previous 30 days (AOR, 5.0; 95% CI, 1.8-13.8). Some of the most common reasons for missed doses were long distance to health facilities (n = 21, 53.8%), food insufficiency (n = 20, 51.3%), and being busy with other activities such as work (n = 15, 38.5%).ConclusionsThe treatment adherence continues to be a significant challenge in rural Zambia. Social supports from spouses and people on ART could facilitate their treatment adherence. This is likely to require attention by ART services in the future, focusing on different social influences on male and female in rural Zambia. In addition, poverty reduction strategies may help to reinforce adherence to ART and could mitigate the influence of HIV infection for poor patients and those who fall into poverty after starting ART.
SummaryBackgroundCross-resistance after first-line antiretroviral therapy (ART) failure is expected to impair activity of nucleoside reverse-transcriptase inhibitors (NRTIs) in second-line therapy for patients with HIV, but evidence for the effect of cross-resistance on virological outcomes is limited. We aimed to assess the association between the activity, predicted by resistance testing, of the NRTIs used in second-line therapy and treatment outcomes for patients infected with HIV.MethodsWe did an observational analysis of additional data from a published open-label, randomised trial of second-line ART (EARNEST) in sub-Saharan Africa. 1277 adults or adolescents infected with HIV in whom first-line ART had failed (assessed by WHO criteria with virological confirmation) were randomly assigned to a boosted protease inhibitor (standardised to ritonavir-boosted lopinavir) with two to three NRTIs (clinician-selected, without resistance testing); or with raltegravir; or alone as protease inhibitor monotherapy (discontinued after week 96). We tested genotypic resistance on stored baseline samples in patients in the protease inhibitor and NRTI group and calculated the predicted activity of prescribed second-line NRTIs. We measured viral load in stored samples for all patients obtained every 12–16 weeks. This trial is registered with Controlled-Trials.com (number ISRCTN 37737787) and ClinicalTrials.gov (number NCT00988039).FindingsBaseline genotypes were available in 391 (92%) of 426 patients in the protease inhibitor and NRTI group. 176 (89%) of 198 patients prescribed a protease inhibitor with no predicted-active NRTIs had viral suppression (viral load <400 copies per mL) at week 144, compared with 312 (81%) of 383 patients in the protease inhibitor and raltegravir group at week 144 (p=0·02) and 233 (61%) of 280 patients in the protease inhibitor monotherapy group at week 96 (p<0·0001). Compared with results with no active NRTIs, 95 (85%) of 112 patients with one predicted-active NRTI had viral suppression (p=0·3) and 20 (77%) of 26 patients with two or three active NRTIs had viral suppression (p=0·08). Over all follow-up, greater predicted NRTI activity was associated with worse viral load suppression (global p=0·0004).InterpretationGenotypic resistance testing might not accurately predict NRTI activity in protease inhibitor-based second-line ART. Our results do not support the introduction of routine resistance testing in ART programmes in low-income settings for the purpose of selecting second-line NRTIs.FundingEuropean and Developing Countries Clinical Trials Partnership, UK Medical Research Council, Institito de Salud Carlos III, Irish Aid, Swedish International Development Cooperation Agency, Instituto Superiore di Sanita, WHO, Merck.
Objective: The aim is to determine the total annual cost per patient treated and total cost per patient retained on antiretroviral therapy in Zambia in conventional care in facilities and across community-based differentiated service delivery (DSD) models. Design: Economic evaluation was conducted using retrospective electronic record review. Twenty healthcare facilities (13 with DSD models and 7 as comparison sites) in six of Zambia's 10 provinces were considered. Methods: All individuals on antiretroviral therapy (ART) >18 years old at the study sites were enrolled in a DSD model or conventional care by site type, respectively, with at least 12 months of follow-up data. Accessing care through DSD models [community adherence groups (CAGs), urban adherence groups (UAGs), home ART delivery and care, and mobile ART services] or facility-based conventional care with 3-monthly visits. Total annual cost per patient treated and the annual cost per patient retained in care 12 months after model enrolment. Retention in care was defined as attending a clinic visit at 12 months ± 3 months. Results: The DSD models assessed cost more per patient/year than conventional care. Costs ranged from an annual $116 to $199 for the DSD models, compared with $100 for conventional care. CAGs and UAGs increased retention by 2 and 14%, respectively. All DSD models cost more per patient retained at 12 months than conventional care. The CAG had the lowest cost/patient retained for DSD models ($140–157). Conclusions: Although they achieve equal or improved retention in care, out-of-facility models of ART were more expensive than conventional care.
Background Facility-based, multimonth dispensing of antiretroviral therapy (ART) for HIV could reduce burdens on patients and providers and improve retention in care. We assessed whether 6-monthly ART dispensing was non-inferior to standard of care and 3-monthly ART dispensing.Methods We did a pragmatic, cluster-randomised, unblinded, non-inferiority trial (INTERVAL) at 30 health facilities in Malawi and Zambia. Eligible participants were aged 18 years or older, HIV-positive, and were clinically stable on ART. Before randomisation, health facilities (clusters) were matched on the basis of country, ART cohort size, facility type (ie, hospital vs health centre), and region or province. Matched clusters were randomly allocated (1:1:1) to standard of care, 3-monthly ART dispensing, or 6-monthly ART dispensing using a simple random allocation sequence. The primary outcome was retention in care at 12 months, defined as the proportion of patients with less than 60 consecutive days without ART during study follow-up, analysed by intention to treat. A 2•5% margin was used to assess noninferiority. This study is registered with ClinicalTrials.gov, NCT03101592.
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