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      Evaluating the impact of the DREAMS partnership to reduce HIV incidence among adolescent girls and young women in four settings: a study protocol

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          Abstract

          Background

          HIV risk remains unacceptably high among adolescent girls and young women (AGYW) in southern and eastern Africa, reflecting structural and social inequities that drive new infections. In 2015, PEPFAR (the United States President’s Emergency Plan for AIDS Relief) with private-sector partners launched the DREAMS Partnership, an ambitious package of interventions in 10 sub-Saharan African countries. DREAMS aims to reduce HIV incidence by 40% among AGYW over two years by addressing multiple causes of AGYW vulnerability. This protocol outlines an impact evaluation of DREAMS in four settings.

          Methods

          To achieve an impact evaluation that is credible and timely, we describe a mix of methods that build on longitudinal data available in existing surveillance sites prior to DREAMS roll-out. In three long-running surveillance sites (in rural and urban Kenya and rural South Africa), the evaluation will measure: (1) population-level changes over time in HIV incidence and socio-economic, behavioural and health outcomes among AGYW and young men (before, during, after DREAMS); and (2) causal pathways linking uptake of DREAMS interventions to ‘mediators’ of change such as empowerment, through to behavioural and health outcomes, using nested cohort studies with samples of ~ 1000–1500 AGYW selected randomly from the general population and followed for two years. In Zimbabwe, where DREAMS includes an offer of pre-exposure HIV prophylaxis (PrEP), cohorts of young women who sell sex will be followed for two years to measure the impact of ‘DREAMS+PrEP’ on HIV incidence among young women at highest risk of HIV. In all four settings, process evaluation and qualitative studies will monitor the delivery and context of DREAMS implementation. The primary evaluation outcome is HIV incidence, and secondary outcomes include indicators of sexual behavior change, and social and biological protection.

          Discussion

          DREAMS is, to date, the most ambitious effort to scale-up combinations or ‘packages’ of multi-sectoral interventions for HIV prevention. Evidence of its effectiveness in reducing HIV incidence among AGYW, and demonstrating which aspects of the lives of AGYW were changed, will offer valuable lessons for replication.

          Electronic supplementary material

          The online version of this article (10.1186/s12889-018-5789-7) contains supplementary material, which is available to authorized users.

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          Most cited references19

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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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            Theory of Change: a theory-driven approach to enhance the Medical Research Council's framework for complex interventions

            Background The Medical Research Councils’ framework for complex interventions has been criticized for not including theory-driven approaches to evaluation. Although the framework does include broad guidance on the use of theory, it contains little practical guidance for implementers and there have been calls to develop a more comprehensive approach. A prospective, theory-driven process of intervention design and evaluation is required to develop complex healthcare interventions which are more likely to be effective, sustainable and scalable. Methods We propose a theory-driven approach to the design and evaluation of complex interventions by adapting and integrating a programmatic design and evaluation tool, Theory of Change (ToC), into the MRC framework for complex interventions. We provide a guide to what ToC is, how to construct one, and how to integrate its use into research projects seeking to design, implement and evaluate complex interventions using the MRC framework. We test this approach by using ToC within two randomized controlled trials and one non-randomized evaluation of complex interventions. Results Our application of ToC in three research projects has shown that ToC can strengthen key stages of the MRC framework. It can aid the development of interventions by providing a framework for enhanced stakeholder engagement and by explicitly designing an intervention that is embedded in the local context. For the feasibility and piloting stage, ToC enables the systematic identification of knowledge gaps to generate research questions that strengthen intervention design. ToC may improve the evaluation of interventions by providing a comprehensive set of indicators to evaluate all stages of the causal pathway through which an intervention achieves impact, combining evaluations of intervention effectiveness with detailed process evaluations into one theoretical framework. Conclusions Incorporating a ToC approach into the MRC framework holds promise for improving the design and evaluation of complex interventions, thereby increasing the likelihood that the intervention will be ultimately effective, sustainable and scalable. We urge researchers developing and evaluating complex interventions to consider using this approach, to evaluate its usefulness and to build an evidence base to further refine the methodology. Trial registration Clinical trials.gov: NCT02160249
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              Profile: the KEMRI/CDC Health and Demographic Surveillance System--Western Kenya.

              The KEMRI/Centers for Disease Control and Prevention (CDC) Health and Demographic Surveillance System (HDSS) is located in Rarieda, Siaya and Gem Districts (Siaya County), lying northeast of Lake Victoria in Nyanza Province, western Kenya. The KEMRI/CDC HDSS, with approximately 220 000 inhabitants, has been the foundation for a variety of studies, including evaluations of insecticide-treated bed nets, burden of diarrhoeal disease and tuberculosis, malaria parasitaemia and anaemia, treatment strategies and immunological correlates of malaria infection, and numerous HIV, tuberculosis, malaria and diarrhoeal disease treatment and vaccine efficacy and effectiveness trials for more than a decade. Current studies include operations research to measure the uptake and effectiveness of the programmatic implementation of integrated malaria control strategies, HIV services, newly introduced vaccines and clinical trials. The HDSS provides general demographic and health information (such as population age structure and density, fertility rates, birth and death rates, in- and out-migrations, patterns of health care access and utilization and the local economics of health care) as well as disease- or intervention-specific information. The HDSS also collects verbal autopsy information on all deaths. Studies take advantage of the sampling frame inherent in the HDSS, whether at individual, household/compound or neighbourhood level.
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                Author and article information

                Contributors
                Isolde.Birdthistle@lshtm.ac.uk
                schaffnit@ucsb.edu
                kdan2008@gmail.com
                m.shahmanesh@ucl.ac.uk
                aziraba@aphrc.org
                carolinekabiru@gmail.com
                Penelope.Phillips-Howard@lstmed.ac.uk
                NChimbindi@ahri.org
                KOndenge@kemricdc.org
                Annabelle.Gourlay@lshtm.ac.uk
                Frances.Cowan@lstmed.ac.uk
                James.Hargreaves@lshtm.ac.uk
                Bernadette.Hensen@lshtm.ac.uk
                tarisai@ceshhar.co.zw
                Judith.Glynn@lshtm.ac.uk
                Sian.Floyd@lshtm.ac.uk
                Journal
                BMC Public Health
                BMC Public Health
                BMC Public Health
                BioMed Central (London )
                1471-2458
                25 July 2018
                25 July 2018
                2018
                : 18
                : 912
                Affiliations
                [1 ]ISNI 0000 0004 0425 469X, GRID grid.8991.9, Faculty of Epidemiology and Population Health, , London School of Hygiene & Tropical Medicine, ; Keppel Street, London, WC1E 7HT UK
                [2 ]ISNI 0000 0004 1936 9676, GRID grid.133342.4, University of California at Santa Barbara, ; Santa Barbara, USA
                [3 ]Centre for Global Health Research, Kenyan Medical Research Institute, Kisumu, 40100 Kenya
                [4 ]ISNI 0000000121901201, GRID grid.83440.3b, Institute for Global Health, , University College of London, ; Capper St, London, WC1E 6JB UK
                [5 ]GRID grid.488675.0, Africa Health Research Institute, ; 719 Umbilo Road, Durban, KwaZulu-Natal 4001 South Africa
                [6 ]ISNI 0000 0001 2221 4219, GRID grid.413355.5, African Population and Health Research Center, ; Manga Close off Kirawa Road, Nairobi, Kenya
                [7 ]ISNI 0000 0004 1936 9764, GRID grid.48004.38, Department of Clinical Sciences, , Liverpool School of Tropical Medicine, ; Pembroke Place, Liverpool, L3 5QA UK
                [8 ]Department of International Public Health, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool, L3 5QA Zimbabwe
                [9 ]Centre for Sexual Health and HIV/AIDS Research (CeSHHAR), 9 Monmouth Road, Avondale West Harare, Zimbabwe
                [10 ]ISNI 0000 0004 0425 469X, GRID grid.8991.9, Faculty of Public Health & Policy, , London School of Hygiene & Tropical Medicine, ; 15-17 Tavistock Place, London, WC1H 9SH UK
                [11 ]ISNI 0000 0004 0425 469X, GRID grid.8991.9, Faculty of Infectious and Tropical Diseases, , London School of Hygiene & Tropical Medicine, ; Keppel Street, London, WC1E 7HT UK
                Author information
                http://orcid.org/0000-0001-5742-6588
                Article
                5789
                10.1186/s12889-018-5789-7
                6060450
                30045711
                455b0d16-4367-4804-94ae-3b8dcfc22dff
                © The Author(s). 2018

                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.

                History
                : 23 May 2018
                : 3 July 2018
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100000865, Bill and Melinda Gates Foundation;
                Award ID: OPP1136774
                Award Recipient :
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2018

                Public health
                hiv prevention,adolescent health,complex intervention,impact evaluation,gender equity,kenya,south africa,zimbabwe

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