Hendramoorthy Maheswaran

Uptake, Accuracy, Safety, and Linkage into Care over Two Years of Promoting Annual Self-Testing for HIV in Blantyre, Malawi: A Community-Based Prospective Study

Background Home-based HIV testing and counselling (HTC) achieves high uptake, but is difficult and expensive to implement and sustain. We investigated a novel alternative based on HIV self-testing (HIVST). The aim was to evaluate the uptake of testing, accuracy, linkage into care, and health outcomes when highly convenient and flexible but supported access to HIVST kits was provided to a well-defined and closely monitored population. Methods and Findings Following enumeration of 14 neighbourhoods in urban Blantyre, Malawi, trained resident volunteer-counsellors offered oral HIVST kits (OraQuick ADVANCE Rapid HIV-1/2 Antibody Test) to adult (≥16 y old) residents (n = 16,660) and reported community events, with all deaths investigated by verbal autopsy. Written and demonstrated instructions, pre- and post-test counselling, and facilitated HIV care assessment were provided, with a request to return kits and a self-completed questionnaire. Accuracy, residency, and a study-imposed requirement to limit HIVST to one test per year were monitored by home visits in a systematic quality assurance (QA) sample. Overall, 14,004 (crude uptake 83.8%, revised to 76.5% to account for population turnover) residents self-tested during months 1–12, with adolescents (16–19 y) most likely to test. 10,614/14,004 (75.8%) participants shared results with volunteer-counsellors. Of 1,257 (11.8%) HIV-positive participants, 26.0% were already on antiretroviral therapy, and 524 (linkage 56.3%) newly accessed care with a median CD4 count of 250 cells/μl (interquartile range 159–426). HIVST uptake in months 13–24 was more rapid (70.9% uptake by 6 mo), with fewer (7.3%, 95% CI 6.8%–7.8%) positive participants. Being “forced to test”, usually by a main partner, was reported by 2.9% (95% CI 2.6%–3.2%) of 10,017 questionnaire respondents in months 1–12, but satisfaction with HIVST (94.4%) remained high. No HIVST-related partner violence or suicides were reported. HIVST and repeat HTC results agreed in 1,639/1,649 systematically selected (1 in 20) QA participants (99.4%), giving a sensitivity of 93.6% (95% CI 88.2%–97.0%) and a specificity of 99.9% (95% CI 99.6%–100%). Key limitations included use of aggregate data to report uptake of HIVST and being unable to adjust for population turnover. Conclusions Community-based HIVST achieved high coverage in two successive years and was safe, accurate, and acceptable. Proactive HIVST strategies, supported and monitored by communities, could substantially complement existing approaches to providing early HIV diagnosis and periodic repeat testing to adolescents and adults in high-HIV settings.

Effect of Optional Home Initiation of HIV Care Following HIV Self-testing on Antiretroviral Therapy Initiation Among Adults in Malawi: A Randomized Clinical Trial

IMPORTANCE Self-testing for HIV infection may contribute to early diagnosis of HIV, but without necessarily increasing antiretroviral therapy (ART) initiation. OBJECTIVE To investigate whether offering optional home initiation of HIV care after HIV self-testing might increase demand for ART initiation, compared with HIV self-testing accompanied by facility-based services only. DESIGN, SETTING, AND PARTICIPANTS Cluster randomized trial conducted in Blantyre, Malawi, between January 30 and November 5, 2012, using restricted 1:1 randomization of 14 community health worker catchment areas. Participants were all adult (≥16 years) residents (n = 16,660) who received access to home HIV self-testing through resident volunteers. This was a second-stage randomization of clusters allocated to the HIV self-testing group of a parent trial. INTERVENTIONS Clusters were randomly allocated to facility-based care or optional home initiation of HIV care (including 2 weeks of ART if eligible) for participants reporting positive HIV self-test results. MAIN OUTCOMES AND MEASURES The preplanned primary outcome compared between groups the proportion of all adult residents who initiated ART within the first 6 months of HIV self-testing availability. Secondary outcomes were uptake of HIV self-testing, reporting of positive HIV self-test results, and rates of loss from ART at 6 months. RESULTS A significantly greater proportion of adults in the home group initiated ART (181/8194, 2.2%) compared with the facility group (63/8466, 0.7%; risk ratio [RR], 2.94, 95% CI, 2.10-4.12; P < .001). Uptake of HIV self-testing was high in both the home (5287/8194, 64.9%) and facility groups (4433/8466, 52.7%; RR, 1.23; 95% CI, 0.96-1.58; P = .10). Significantly more adults reported positive HIV self-test results in the home group (490/8194 [6.0%] vs the facility group, 278/8466 [3.3%]; RR, 1.86; 95% CI, 1.16-2.97; P = .006). After 6 months, 52 of 181 ART initiators (28.7%) and 15 of 63 ART initiators (23.8%) in the home and facility groups, respectively, were lost from ART (adjusted incidence rate ratio, 1.18; 95% CI, 0.62-2.25, P = .57). CONCLUSIONS AND RELEVANCE Among Malawian adults offered HIV self-testing, optional home initiation of care compared with standard HIV care resulted in a significant increase in the proportion of adults initiating ART. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01414413.

Evaluating the responsiveness of the Warwick Edinburgh Mental Well-Being Scale (WEMWBS): Group and individual level analysis

BackgroundMental well-being now features prominently in UK and international health policy. However, progress has been hampered by lack of valid measures that are responsive to change. The objective of this study was to evaluate the responsiveness of the Warwick Edinburgh Mental Well-being Scale (WEMWBS) at both the individual and group level.MethodsSecondary analysis of twelve different interventional studies undertaken in different populations using WEMWBS as an outcome measure. Standardised response mean (SRM), probability of change statistic (P̂) and standard error of measurement (SEM) were used to evaluate whether WEMWBS detected statistically important changes at the group and individual level, respectively.ResultsMean change in WEMWBS score ranged from −0.6 to 10.6. SRM ranged from −0.10 (95% CI: -0.35, 0.15) to 1.35 (95% CI: 1.06, 1.64). In 9/12 studies the lower limit of the 95% CI for P̂ was greater than 0.5, denoting responsiveness. SEM ranged from 2.4 to 3.1 units, and at the threshold 2.77 SEM, WEMWBS detected important improvement in at least 12.8% to 45.7% of participants (lower limit of 95% CI>5.0%).ConclusionsWEMWBS is responsive to changes occurring in a wide range of mental health interventions undertaken in different populations. It offers a secure base for research and development in this rapidly evolving field. Further research using external criteria of change is warranted.

Starting a Home and Mobile HIV Testing Service in a Rural Area of South Africa

Objective: To compare users of a home and mobile HIV counseling and testing service implemented in rural KwaZulu-Natal, South Africa. Methods: Communities of similar population size and density were allocated HIV counseling and testing provision be either home or mobile services. Uptake of services was compared, including results from a brief questionnaire. Results: Majority of individuals proceeded to test. Mobile services reported a higher proportion of clients who were male (41% vs. 31%; P < 0.001), younger than 25 years (53% vs. 28%; P < 0.001), single (66% vs. 40%; P < 0.001), and never previously tested (62% vs. 56%; P = 0.003). Home services reported a higher proportion of clients older than of 35 years (56% vs. 35%; P < 0.001) and married/partner (43% vs. 30%; P < 0.001). HIV prevalence amongst clients of the 2 services was comparable, with both services testing more clients daily than the local primary health care clinics, but similar to the local hospital. Conclusions: The numbers tested, different populations reached, and high detection rates suggest both modalities have an important role to play, especially in rural communities where cost of transport may be a deterrent.

Cost-effectiveness of left ventricular assist devices (LVADs) for patients with advanced heart failure: Analysis of the British NHS bridge to transplant (BTT) program

BACKGROUND A previous cost-effectiveness analysis showed that bridge to transplant (BTT) with early design left ventricular assist devices (LVADs) for advanced heart failure was more expensive than medical management while appearing less beneficial. Older LVADs were pulsatile, but current second and third generation LVADs are continuous flow pumps. This study aimed to estimate comparative cost-effectiveness of BTT with durable implantable continuous flow LVADs compared to medical management in the British NHS. METHODS AND RESULTS A semi-Markov multi-state economic model was built using NHS costs data and patient data in the British NHS Blood and Transplant Database (BTDB). Quality-adjusted life years (QALYs) and incremental costs per QALY were calculated for patients receiving LVADs compared to those receiving inotrope supported medical management. LVADs cost £80,569 (

Comparative cost-effectiveness of the HeartWare versus HeartMate II left ventricular assist devices used in the United Kingdom National Health Service bridge-to-transplant program for patients with heart failure

127,887) at 2011 prices and delivered greater benefit than medical management. The estimated probabilistic incremental cost-effectiveness ratio (ICER) was £53,527 (

Estimating EQ-5D utility values for major health behavioural risk factors in England

84,963)/QALY (95%CI: £31,802-£94,853;

Cost and quality of life analysis of HIV self-testing and facility-based HIV testing and counselling in Blantyre, Malawi

50,479-

Self-reported health and socio-economic inequalities in England, 1996–2009: Repeated national cross-sectional study

150,560) (over a lifetime horizon). Estimates were sensitive to choice of comparator population, relative likelihood of receiving a heart transplant, time to transplant, and LVAD costs. Reducing the device cost by 15% decreased the ICER to £50,106 (

Intensive Case Finding and Isoniazid Preventative Therapy in HIV Infected Individuals in Africa: Economic Model and Value of Information Analysis

79,533)/QALY. CONCLUSIONS Durable implantable continuous flow LVADs deliver greater benefits at higher costs than medical management in Britain. At the current UK threshold of £20,000 to £30,000/QALY LVADs are not cost effective but the ICER now begins to approach that of an intervention for end of life care recently recommended by the British NHS. Cost-effectiveness estimates are hampered by the lack of randomized trials.