Patient-level benefits associated with decentralization of antiretroviral therapy services to primary health facilities in Malawi and Uganda.

Background: The Lablite project captured information on access to antiretroviral therapy (ART) at larger health facilities ('hubs') and lower-level health facilities ('spokes') in Phalombe district, Malawi and in Kalungu district, Uganda. Methods: We conducted a cross-sectional survey among patients who had transferred to a spoke after treatment initiation (Malawi, n=54; Uganda, n=33), patients who initiated treatment at a spoke (Malawi, n=50; Uganda, n=44) and patients receiving treatment at a hub (Malawi, n=44; Uganda, n=46). Results: In Malawi, 47% of patients mapped to the two lowest wealth quintiles (Q1-Q2); patients at spokes were poorer than at a hub (57% vs 23% in Q1-Q2; p<0.001). In Uganda, 7% of patients mapped to Q1-Q2; patients at the rural spoke were poorer than at the two peri-urban facilities (15% vs 4% in Q1-Q2; p<0.001). The median travel time one way to a current ART facility was 60 min (IQR 30-120) in Malawi and 30 min (IQR 20-60) in Uganda. Patients who had transferred to the spokes reported a median reduction in travel time of 90 min in Malawi and 30 min in Uganda, with reductions in distance and food costs. Conclusions: Decentralizing ART improves access to treatment. Community-level access to treatment should be considered to further minimize costs and time.

Impact of decentralisation of antiretroviral therapy services on HIV testing and care at a population level in Agago District in rural Northern Uganda: results from the Lablite population surveys.

Background: We conducted unlinked cross-sectional population-based surveys in Northern Uganda before and after antiretroviral therapy (ART) provision (including Option B+ [lifelong ART for pregnant/breast-feeding women]) at a local primary care facility (Lira Kato Health Centre [HC]). Prior to decentralisation, people travelled 56-76 km round-trip for ART; we aimed to evaluate changes in uptake of HIV-testing, ART coverage and access to ART following decentralisation. Methods: A total of 2124 adults in 1351 households in two parishes closest to Lira Kato HC were interviewed using questionnaires between March and April 2013 and 2123 adults in 1229 households between January and March 2015. Results: Adults reporting HIV-testing in the last year increased from 1077/2124 (50.7%) to 1298/2123 (61.1%) between surveys (p<0.001). ART coverage increased from 74/136 (54.4%) self-reported HIV-positive adults in 2013 to 108/133 (81.2%) in 2015 (p<0.001). Post-decentralisation, 47/108 (43.5%) of those on ART were in care at Lira Kato HC (including 37 new initiations). Most of the remainder (47/61, 77%) started ART prior to any ART provision at Lira Kato HC; the most common reason given for not accessing ART locally was concern about drug-stock-outs (30/59, 51%). Conclusions: HIV-testing and ART coverage increased after decentralisation combined with Option B+ roll-out. However, patients on ART before decentralisation were reluctant to transfer to their local facility.

Implementation of Antiretroviral Therapy for Life in Pregnant/Breastfeeding HIV+ Women (Option B+) Alongside Rollout and Changing Guidelines for ART Initiation in Rural Zimbabwe: The Lablite Project Experience.

BACKGROUND: Lifelong antiretroviral therapy (ART) for pregnant and breastfeeding women (Option B+) was rolled out in Zimbabwe from 2014, with simultaneous raising of the CD4 treatment threshold to 500 cells per cubic millimeter in nonpregnant/breastfeeding adults and children 5 years and over. METHODS: Lablite is an implementation project in Zimbabwe, Malawi, and Uganda evaluating ART rollout. Routine patient-level data were collected for 6 months before and 12 months after Option B+ rollout at a district hospital and 3 primary care facilities in Zimbabwe (2 with outreach ART and 1 with no ART provision before Option B+). RESULTS: Between September 2013 and February 2015, there were 1686 ART initiations in the 4 facilities: 91% adults and 9% children younger than 15 years. In the 3 facilities with established ART, initiations rose from 300 during 6 months before Option B+ to 869 (2.9-fold) and 463 (1.5-fold), respectively, 0-6 months and 6-12 months after Option B+. Post-Option B+, an estimated 43% of pregnant/breastfeeding women needed ART for their own health, based on World Health Organization stage 3/4 or CD4 ≤350 per cubic millimeter (64% for CD4 ≤500). Seventy-four men (22%) and 123 nonpregnant/breastfeeding women (34%) initiated ART with CD4 >350 after the CD4 threshold increase. Estimated 12-month retention on ART was 79% (69%-87%) in Option B+ women (significantly lower in younger women, P = 0.01) versus 93% (91%-95%) in other adults (difference P < 0.001). CONCLUSIONS: There were increased ART initiations in all patient groups after implementation of World Health Organization 2013 guidelines. Retention of Option B+ women was poorer than retention of other adults; younger women require attention because they are more likely to disengage from care.

Measuring and Valuing Informal Care for Economic Evaluation of HIV/AIDS Interventions: Methods and Application in Malawi.

BACKGROUND: Economic evaluation studies often neglect the impact of disease and ill health on the social network of people living with HIV (PLHIV) and the wider community. An important concern relates to informal care requirements which, for some diseases such as HIV/AIDS, can be substantial. OBJECTIVES: To measure and value informal care provided to PLHIV in Malawi. METHODS: A modified diary that divided a day into natural calendar changes was used to measure informal care time. The monetary valuation was undertaken by using four approaches: opportunity cost (official minimum wage used to value caregiving time), modified opportunity cost (caregiver's reservation wage), willingness to pay (amount of money caregiver would pay for care), and willingness to accept (amount of money caregiver would accept for providing care to someone else) approaches. Data were collected from 130 caregivers of PLHIV who were accessing antiretroviral therapy from six facilities in Phalombe district in southeast Malawi. RESULTS: Of the 130 caregivers, 62 (48%) provided informal care in the survey week. On average, caregivers provided care of 8 h/wk. The estimated monetary values of informal care provided per week were US $1.40 (opportunity cost), US $2.41 (modified opportunity cost), US $0.40 (willingness to pay), and US $2.07 (willingness to accept). CONCLUSIONS: Exclusion of informal care commitments may be a notable limitation of many applied economic evaluations. This work demonstrates that inclusion of informal care in economic evaluations in a low-income context is feasible.

Shifting human resources for health in the context of ART provision: qualitative and quantitative findings from the Lablite baseline study.

BACKGROUND: Lablite is an implementation project supporting and studying decentralized antiretroviral therapy (ART) rollout to rural communities in Malawi, Uganda and Zimbabwe. Task shifting is one of the strategies to deal with shortage of health care workers (HCWs) in ART provision. Evaluating Human Resources for Health (HRH) optimization is essential for ensuring access to ART. The Lablite project started with a baseline survey whose aim was to describe and compare national and intercountry delivery of ART services including training, use of laboratories and clinical care. METHODS: A cross-sectional survey was conducted between October 2011 and August 2012 in a sample of 81 health facilities representing different regions, facility levels and experience of ART provision in Malawi, Uganda and Zimbabwe. Using a questionnaire, data were collected on facility characteristics, human resources and service provision. Thirty three (33) focus group discussions were conducted with HCWs in a subset of facilities in Malawi and Zimbabwe. RESULTS: The survey results showed that in Malawi and Uganda, primary care facilities were run by non-physician clinical officers/medical assistants while in Zimbabwe, they were run by nurses/midwives. Across the three countries, turnover of staff was high especially among nurses. Between 10 and 20% of the facilities had at least one clinical officer/medical assistant leave in the 3 months prior to the study. Qualitative results show that HCWs in ART and non-ART facilities perceived a shortage of staff for all services, even prior to the introduction of ART provision. HCWs perceived the introduction of ART as having increased workload. In Malawi, the number of people on ART and hence the workload for HCWs has further increased following the introduction of Option B+ (ART initiation and life-long treatment for HIV positive pregnant and lactating women), resulting in extended working times and concerns that the quality of services have been affected. For some HCWs, perceived low salaries, extended working schedules, lack of training opportunities and inadequate infrastructure for service provision were linked to low job satisfaction and motivation. CONCLUSIONS: ART has been decentralized to lower level facilities in the context of an ongoing HRH crisis and staff shortage, which may compromise the provision of high-quality ART services. Task shifting interventions need adequate resources, relevant training opportunities, and innovative strategies to optimize the operationalization of new WHO treatment guidelines which continue to expand the number of people eligible for ART.

Identifying Key Drivers of the Impact of an HIV Cure Intervention in Sub-Saharan Africa.

BACKGROUND: It is unknown what properties would be required to make an intervention in low income countries that can eradicate or control human immunodeficiency virus (HIV) without antiretroviral therapy (ART) cost-effective. METHODS: We used a model of HIV and ART to investigate the effect of introducing an ART-free viral suppression intervention in 2022 using Zimbabwe as an example country. We assumed that the intervention (cost: $500) would be accessible for 90% of the population, be given to those receiving effective ART, have sufficient efficacy to allow ART interruption in 95%, with a rate of viral rebound of 5% per year in the first 3 months, and a 50% decline in rate with each successive year. RESULTS: An ART-free viral suppression intervention with these properties would result in >0.53 million disability-adjusted-life-years averted over 2022-2042, with a reduction in HIV program costs of $300 million (8.7% saving). An intervention of this efficacy costing anything up to $1400 is likely to be cost-effective in this setting. CONCLUSIONS: Interventions aimed at curing HIV infection have the potential to improve overall disease burden and to reduce costs. Given the effectiveness and cost of ART, such interventions would have to be inexpensive and highly effective.

Assessment of the Potential Impact and Cost-effectiveness of Self-Testing for HIV in Low-Income Countries.

BACKGROUND: Studies have demonstrated that self-testing for human immunodeficiency virus (HIV) is highly acceptable among individuals and could allow cost savings, compared with provider-delivered HIV testing and counseling (PHTC), although the longer-term population-level effects are uncertain. We evaluated the cost-effectiveness of introducing self-testing in 2015 over a 20-year time frame in a country such as Zimbabwe. METHODS: The HIV synthesis model was used. Two scenarios were considered. In the reference scenario, self-testing is not available, and the rate of first-time and repeat PHTC is assumed to increase from 2015 onward, in line with past trends. In the intervention scenario, self-testing is introduced at a unit cost of $3. RESULTS: We predict that the introduction of self-testing would lead to modest savings in healthcare costs of $75 million, while averting around 7000 disability-adjusted life-years over 20 years. Findings were robust to most variations in assumptions; however, higher cost of self-testing, lower linkage to care for people whose diagnosis is a consequence of a positive self-test result, and lower threshold for antiretroviral therapy eligibility criteria could lead to situations in which self-testing is not cost-effective. CONCLUSIONS: This analysis suggests that introducing self-testing offers some health benefits and may well save costs.

Opportunities for improving the efficiency of paediatric HIV treatment programmes.

OBJECTIVES: To conduct two economic analyses addressing whether to: routinely monitor HIV-infected children on antiretroviral therapy (ART) clinically or with laboratory tests; continue or stop cotrimoxazole prophylaxis when children become stabilized on ART. DESIGN AND METHODS: The ARROW randomized trial investigated alternative strategies to deliver paediatric ART and cotrimoxazole prophylaxis in 1206 Ugandan/Zimbabwean children. Incremental cost-effectiveness and value of implementation analyses were undertaken. Scenario analyses investigated whether laboratory monitoring (CD4 tests for efficacy monitoring; haematology/biochemistry for toxicity) could be tailored and targeted to be delivered cost-effectively. Cotrimoxazole use was examined in malaria-endemic and non-endemic settings. RESULTS: Using all trial data, clinical monitoring delivered similar health outcomes to routine laboratory monitoring, but at a reduced cost, so was cost-effective. Continuing cotrimoxazole improved health outcomes at reduced costs. Restricting routine CD4 monitoring to after 52 weeks following ART initiation and removing toxicity testing was associated with an incremental cost-effectiveness ratio of $6084 per quality-adjusted life-year (QALY) across all age groups, but was much lower for older children (12+ years at initiation; incremental cost-effectiveness ratio = $769/QALY). Committing resources to improve cotrimoxazole implementation appears cost-effective. A healthcare system that could pay $600/QALY should be willing to spend up to $12.0 per patient-year to ensure continued provision of cotrimoxazole. CONCLUSION: Clinically driven monitoring of ART is cost-effective in most circumstances. Routine laboratory monitoring is generally not cost-effective at current prices, except possibly CD4 testing amongst adolescents initiating ART. Committing resources to ensure continued provision of cotrimoxazole in health facilities is more likely to represent an efficient use of resources.

Cost-effectiveness of HIV drug resistance testing to inform switching to second line antiretroviral therapy in low income settings.

BACKGROUND: To guide future need for cheap resistance tests for use in low income settings, we assessed cost-effectiveness of drug resistance testing as part of monitoring of people on first line ART - with switching from first to second line ART being conditional on NNRTI drug resistance mutations being identified. METHODS: An individual level simulation model of HIV transmission, progression and the effect of ART which accounts for adherence and resistance development was used to compare outcomes of various potential monitoring strategies in a typical low income setting in sub-Saharan Africa. Underlying monitoring strategies considered were based on clinical disease, CD4 count or viral load. Within each we considered a strategy in which no further measures are performed, one with a viral load measure to confirm failure, and one with both a viral load measure and a resistance test. Predicted outcomes were assessed over 2015-2025 in terms of viral suppression, first line failure, switching to second line regimen, death, HIV incidence, disability-adjusted-life-years averted and costs. Potential future low costs of resistance tests ($30) were used. RESULTS: The most effective strategy, in terms of DALYs averted, was one using viral load monitoring without confirmation. The incremental cost-effectiveness ratio for this strategy was $2113 (the same as that for viral load monitoring with confirmation). ART monitoring strategies which involved resistance testing did not emerge as being more effective or cost effective than strategies not using it. The slightly reduced ART costs resulting from use of resistance testing, due to less use of second line regimens, was of similar magnitude to the costs of resistance tests. CONCLUSION: Use of resistance testing at the time of first line failure as part of the decision whether to switch to second line therapy was not cost-effective, even though the test was assumed to be very inexpensive.

The Lablite project: a cross-sectional mapping survey of decentralized HIV service provision in Malawi, Uganda and Zimbabwe.

BACKGROUND: In sub-Saharan Africa antiretroviral therapy (ART) is being decentralized from tertiary/secondary care facilities to primary care. The Lablite project supports effective decentralization in 3 countries. It began with a cross-sectional survey to describe HIV and ART services. METHODS: 81 purposively sampled health facilities in Malawi, Uganda and Zimbabwe were surveyed. RESULTS: The lowest level primary health centres comprised 16/20, 21/39 and 16/22 facilities included in Malawi, Uganda and Zimbabwe respectively. In Malawi and Uganda most primary health facilities had at least 1 medical assistant/clinical officer, with average 2.5 and 4 nurses/midwives for median catchment populations of 29,275 and 9,000 respectively. Primary health facilities in Zimbabwe were run by nurses/midwives, with average 6 for a median catchment population of 8,616. All primary health facilities provided HIV testing and counselling, 50/53 (94%) cotrimoxazole preventive therapy (CPT), 52/53 (98%) prevention of mother-to-child transmission of HIV (PMTCT) and 30/53 (57%) ART management (1/30 post ART-initiation follow-up only). All secondary and tertiary-level facilities provided HIV and ART services. In total, 58/81 had ART provision. Stock-outs during the 3 months prior to survey occurred across facility levels for HIV test-kits in 55%, 26% and 9% facilities in Malawi, Uganda and Zimbabwe respectively; for CPT in 58%, 32% and 9% and for PMTCT drugs in 26%, 10% and 0% of facilities (excluding facilities where patients were referred out for either drug). Across all countries, in facilities with ART stored on-site, adult ART stock-outs were reported in 3/44 (7%) facilities compared with 10/43 (23%) facility stock-outs of paediatric ART. Laboratory services at primary health facilities were limited: CD4 was used for ART initiation in 4/9, 5/6 and 13/14 in Malawi, Uganda and Zimbabwe respectively, but frequently only in selected patients. Routine viral load monitoring was not used; 6/58 (10%) facilities with ART provision accessed centralised viral loads for selected patients. CONCLUSIONS: Although coverage of HIV testing, PMTCT and cotrimoxazole prophylaxis was high in all countries, decentralization of ART services was variable and incomplete. Challenges of staffing and stock management were evident. Laboratory testing for toxicity and treatment effectiveness monitoring was not available in most primary level facilities.

The Methodological Challenges for the Estimation of Quality of Life in Children for Use in Economic Evaluation in Low-Income Countries.

OBJECTIVES: The assessment of quality of life (QOL) in children has been underresearched in high- and low-income countries alike. This is partly due to practical and methodological challenges in characterizing and assessing children's QOL. This article explores these challenges and highlights considerations in developing age-specific instruments for children affected by HIV and other health conditions in Africa and other low-income settings. METHODS: A literature search identified works that have 1) developed, 2) derived utilities for, or 3) applied QOL tools for use in economic evaluations of HIV interventions for children. We analyzed the existing tools specifically in terms of domains considered, variations in age bands, the recommended respondents, and the relevance of the tools to African and also other low-income country contexts. RESULTS: Only limited QOL research has been conducted in low-income settings on either adults or children with HIV. A few studies have developed and applied tools for children (e.g., in Thailand, Brazil, and India), but none have been in Africa. The existing methodological literature is inconclusive on the appropriate width or depth by which to define pediatric QOL. The existing instruments include QOL domains such as "physical functioning," "emotional and cognitive functioning," "general behavior (social, school, home)," "health perception," "coping and adaptation," "pain and discomfort," "extended effects," "life perspective," and "autonomy." CONCLUSIONS: QOL assessment in children presents a series of practical and methodological challenges. Its application in low-income settings requires careful consideration of a number of context-specific factors.