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      Community-led delivery of HIV self-testing to improve HIV testing, ART initiation and broader social outcomes in rural Malawi: study protocol for a cluster-randomised trial

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          Abstract

          Background

          Prevention of new HIV infections is a critical public health issue. The highest HIV testing gaps are in men, adolescents 15–19 years old, and adults 40 years and older. Community-based HIV testing services (HTS) can contribute to increased testing coverage and early HIV diagnosis, with HIV self-testing (HIVST) strategies showing promise. Community-based strategies, however, are resource intensive, costly and not widely implemented. A community-led approach to health interventions involves supporting communities to plan and implement solutions to improve their health. This trial aims to determine if community-led delivery of HIVST can improve HIV testing uptake, ART initiation, and broader social outcomes in rural Malawi.

          Methods

          The trial uses a parallel arm, cluster-randomised design with group village heads (GVH) and their defined catchment areas randomised (1:1) to community-led HIVST or continue with the standard of the care (SOC). As part of the intervention, informal community health cadres are supported to plan and implement a seven-day HIVST campaign linked to HIV treatment and prevention. Approximately 12 months after the initial campaign, intervention GVHs are randomised to lead a repeat HIVST campaign. The primary outcome includes the proportion of adolescents 15–19 years old who have tested for HIV in their lifetime. Secondary outcomes include recent testing in adults 40 years and older and men; ART initiation; knowledge of HIV prevention; and HIV testing stigma. Outcomes will be measured through cross-sectional surveys and clinic registers. Economic evaluation will determine the cost per person tested, cost per person diagnosed, and incremental cost effectiveness ratio.

          Discussion

          To the best of our knowledge, this is the first trial to assess the effectiveness of community-led HTS, which has only recently been enabled by the introduction of HIVST. Community-led delivery of HIVST is a promising new strategy for providing periodic HIV testing to support HIV prevention in rural communities. Further, introduction of HIVST through a community-led framework seems particularly apt, with control over healthcare concurrently devolved to individuals and communities.

          Trial registration

          Clinicaltrials.gov registry ( NCT03541382) registered 30 May 2018.

          Electronic supplementary material

          The online version of this article (10.1186/s12879-019-4430-4) contains supplementary material, which is available to authorized users.

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          Most cited references 42

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          Process evaluation of complex interventions: Medical Research Council guidance

          Process evaluation is an essential part of designing and testing complex interventions. New MRC guidance provides a framework for conducting and reporting process evaluation studies
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            Effect of a participatory intervention with women's groups on birth outcomes in Nepal: cluster-randomised controlled trial.

            Neonatal deaths in developing countries make the largest contribution to global mortality in children younger than 5 years. 90% of deliveries in the poorest quintile of households happen at home. We postulated that a community-based participatory intervention could significantly reduce neonatal mortality rates. We pair-matched 42 geopolitical clusters in Makwanpur district, Nepal, selected 12 pairs randomly, and randomly assigned one of each pair to intervention or control. In each intervention cluster (average population 7000), a female facilitator convened nine women's group meetings every month. The facilitator supported groups through an action-learning cycle in which they identified local perinatal problems and formulated strategies to address them. We monitored birth outcomes in a cohort of 28?931 women, of whom 8% joined the groups. The primary outcome was neonatal mortality rate. Other outcomes included stillbirths and maternal deaths, uptake of antenatal and delivery services, home care practices, infant morbidity, and health-care seeking. Analysis was by intention to treat. The study is registered as an International Standard Randomised Controlled Trial, number ISRCTN31137309. From 2001 to 2003, the neonatal mortality rate was 26.2 per 1000 (76 deaths per 2899 livebirths) in intervention clusters compared with 36.9 per 1000 (119 deaths per 3226 livebirths) in controls (adjusted odds ratio 0.70 [95% CI 0.53-0.94]). Stillbirth rates were similar in both groups. The maternal mortality ratio was 69 per 100000 (two deaths per 2899 livebirths) in intervention clusters compared with 341 per 100000 (11 deaths per 3226 livebirths) in control clusters (0.22 [0.05-0.90]). Women in intervention clusters were more likely to have antenatal care, institutional delivery, trained birth attendance, and hygienic care than were controls. Birth outcomes in a poor rural population improved greatly through a low cost, potentially sustainable and scalable, participatory intervention with women's groups.
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              Effect of a participatory intervention with women's groups on birth outcomes and maternal depression in Jharkhand and Orissa, India: a cluster-randomised controlled trial.

              Community mobilisation through participatory women's groups might improve birth outcomes in poor rural communities. We therefore assessed this approach in a largely tribal and rural population in three districts in eastern India. From 36 clusters in Jharkhand and Orissa, with an estimated population of 228 186, we assigned 18 clusters to intervention or control using stratified randomisation. Women were eligible to participate if they were aged 15-49 years, residing in the project area, and had given birth during the study. In intervention clusters, a facilitator convened 13 groups every month to support participatory action and learning for women, and facilitated the development and implementation of strategies to address maternal and newborn health problems. The primary outcomes were reductions in neonatal mortality rate (NMR) and maternal depression scores. Analysis was by intention to treat. This trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN21817853. After baseline surveillance of 4692 births, we monitored outcomes for 19 030 births during 3 years (2005-08). NMRs per 1000 were 55.6, 37.1, and 36.3 during the first, second, and third years, respectively, in intervention clusters, and 53.4, 59.6, and 64.3, respectively, in control clusters. NMR was 32% lower in intervention clusters adjusted for clustering, stratification, and baseline differences (odds ratio 0.68, 95% CI 0.59-0.78) during the 3 years, and 45% lower in years 2 and 3 (0.55, 0.46-0.66). Although we did not note a significant effect on maternal depression overall, reduction in moderate depression was 57% in year 3 (0.43, 0.23-0.80). This intervention could be used with or as a potential alternative to health-worker-led interventions, and presents new opportunities for policy makers to improve maternal and newborn health outcomes in poor populations. Health Foundation, UK Department for International Development, Wellcome Trust, and the Big Lottery Fund (UK). Copyright 2010 Elsevier Ltd. All rights reserved.
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                Author and article information

                Contributors
                peach.indravudh@gmail.com
                katherine.fielding@lshtm.ac.uk
                mkumwenda@mlw.mw
                rnzawa@mlw.mw
                rchilongosi@psimalawi.org
                nicola.desmond@lstmed.ac.uk
                nyirendarose@gmail.com
                johnsonc@who.int
                baggaleyr@who.int
                khatzold@psi.org
                fern.terris-prestholt@lshtm.ac.uk
                liz.corbett@lshtm.ac.uk
                Journal
                BMC Infect Dis
                BMC Infect. Dis
                BMC Infectious Diseases
                BioMed Central (London )
                1471-2334
                18 September 2019
                18 September 2019
                2019
                : 19
                Affiliations
                [1 ]ISNI 0000 0004 0425 469X, GRID grid.8991.9, Department of Global Health and Development, Faculty of Public Health and Policy, , London School of Hygiene & Tropical Medicine, ; London, UK
                [2 ]GRID grid.419393.5, Malawi-Liverpool-Wellcome Trust Clinical Research Programme, ; Blantyre, Malawi
                [3 ]ISNI 0000 0004 0425 469X, GRID grid.8991.9, Department of Infectious Disease Epidemiology, , London School of Hygiene & Tropical Medicine, ; London, UK
                [4 ]Population Services International, Lilongwe, Malawi
                [5 ]ISNI 0000 0004 1936 9764, GRID grid.48004.38, Clinical Sciences Department, , Liverpool School of Tropical Medicine, ; Liverpool, UK
                [6 ]GRID grid.415722.7, Department of HIV and AIDS, , Ministry of Health, ; Lilongwe, Malawi
                [7 ]ISNI 0000000121633745, GRID grid.3575.4, Department of HIV/AIDS, , World Health Organisation, ; Geneva, Switzerland
                [8 ]Population Services International, Johannesburg, South Africa
                [9 ]ISNI 0000 0004 0425 469X, GRID grid.8991.9, Department of Clinical Research, , London School of Hygiene & Tropical Medicine, ; London, UK
                4430
                10.1186/s12879-019-4430-4
                6751650
                31533646
                © The Author(s). 2019

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100004440, Wellcome Trust;
                Award ID: WT091769
                Award Recipient :
                Funded by: Unitaid
                Award ID: PO#8477-0-600
                Award Recipient :
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2019

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