Participant views and experiences of participating in HIV research in sub-saharan Africa: a qualitative systematic review protocol Sylvia Nalubega, RN, BSc, MSc 1 Catrin Evans, RN, BSc, MA, PhD 1 1. The University of Nottingham Centre of Evidence Based Health Care: a Collaborating Centre of the Joanna Briggs Institute, United Kingdom Corresponding author: Catrin Evans catrin.evans@nottingham.ac.uk Review question/objective The review objective is to synthesize and present the best available evidence in relation to HIV research participation in sub-saharan Africa, considering the views and experiences of research participants. The specific objectives include: 1. To identify the views, attitudes and understandings of research participants in sub-saharan Africa towards HIV research. 2. To describe how research participants experience the processes associated with HIV research such as recruitment, informed consent, research participation, and study termination in sub-saharan Africa. 3. From the research participants perspective, to identify factors that influence recruitment, retention or withdrawal of research participants in HIV research in sub-saharan Africa. Background Human Immunodeficiency Virus (HIV) remains a global challenge despite the efforts directed towards its control and prevention (the Joint United Nations Programme on HIV/AIDS [UNAIDS]). 1 In the last decade, there has been a steady decrease in the incidence, morbidity and mortality due to HIV/AIDS, which is attributed to new initiatives, including behavioural prevention strategies such as condom use and male circumcision, provision of Anti-retro Viral Drugs (ARVs), and research. 2 However, despite the efforts to address HIV globally, there are still important obstacles and unmet priorities. 3 There are calls for health systems strengthening through an integrated approach, with an increased focus on prevention, expanded Anti-retro Viral Treatment (ART), and continued scientific research. UNAIDS 1 recommends that an extra effort is required to combat the HIV infection, which includes well-conducted biomedical HIV trials to discover additional technologies to reduce new HIV infections. An affordable doi: 10.11124/jbisrir-2014-1797 Page 102
and effective HIV vaccine remains a key strategy in the prevention of population level spread of the HIV infection 4,5, in addition to other preventive measures. The extent of the HIV epidemic in sub-saharan Africa has led to a large number of HIV clinical trials being conducted in this region. 1 Like most health-related research, HIV research exposes participants to potential risk of harm, 6 and this has raised ethical concerns. Furthermore, HIV trials conducted in low income settings have generated ethical debates in HIV research, associated with the socio-economic, educational, and cultural contexts in these settings which may hamper understanding of the research and/or compromise voluntary consent to research participation. 7,8 Moreover, HIV research presents particular challenges due to the stigma and discrimination associated with the disease, and to the fact that the most affected people in society are likely to be from vulnerable and marginalized groups. 9 Researchers therefore need to be aware of the particular ethical issues that affect HIV research conduct in low income settings in order to ensure ethical HIV research practice. In HIV research, a key issue is how to encourage research participation and protect the rights of research participants in a context where social stigma is high. 10 This requires researchers to have a good understanding of the issues that affect HIV research participation among individuals. Considerable research has been done regarding stakeholder views and experiences of HIV research participation, and a number of key issues have been identified that are likely to influence recruitment or retention of research participants. However, much of this research has considered the views of non-research-participant stakeholders (e.g. community members, family members, health personnel and sometimes researchers). There is surprisingly limited research that has focused on the views and experiences of the research participants themselves. In order to develop best practice in research conduct, it is important to hear the voices of those who have agreed to participate in research and have experienced the process first hand. It is this latter group that comprise the focus of this review. A preliminary search for previous systematic reviews on the topic was conducted on four databases including JBI Library, Cochrane Library, CINAHL and Medline. Two reviews were found, however, none focused on the views and experiences of HIV research participants. The reviews included: A quantitative review by Dhalla and Poole, 10 which examined published literature on the barriers of enrolment in HIV vaccine trials among developed and developing countries. This review was limited to vaccine trials and did not assess for positive views and/or experiences of HIV research participation. Another review by Smit, Middelkoop Myer et al. 11 assessed the socio-behaviour challenges to participation in phase III HIV vaccine trials in Sub-Saharan Africa. This review included quantitative literature, only focused on vaccine trials, and assessed only the socio-behavioural challenges. Thus it appeared very relevant to conduct a qualitative systematic review that was not restricted to vaccine trials but focused generally on the views and experiences of HIV research participants in sub-saharan Africa, to provide a broader and deeper understanding of the issues which are related to HIV research in this region. Keywords views and experiences; research participants; HIV; AIDS; sub-saharan Africa doi: 10.11124/jbisrir-2014-1797 Page 103
Inclusion criteria Types of participants This review will consider qualitative studies that include current or former HIV research participants. Studies which included male and/or female adult (18 years and above) participants will be considered. Phenomena of interest Views and experiences of HIV research participants (views, attitudes, understandings, perceptions, and perspectives) regarding participation in HIV research. Types of studies This review will consider qualitative studies that include but are not limited to, designs such as phenomenology, grounded theory, ethnography, action research and feminist research. In the absence of research studies, other text such as opinion papers and reports will be considered. Methods of data collection such as interviews, focus group discussions and observations will be considered. Qualitative elements of a mixed method study will be included if they are presented separately within the publication. Context The review will consider studies conducted in Sub-Saharan Africa, the area in the African continent that lies south of the Sahara Desert, and consists of all African countries that are fully or partially located south of the Sahara (except Sudan). 2 The region accounts for nearly 75% of all the global HIV/AIDS deaths, hence most HIV research is conducted in this region. 2 Search strategy The search strategy aims to find both published and unpublished studies. A three-step search strategy will be utilised in this review. An initial limited search of MEDLINE and CINAHL will be undertaken followed by analysis of the text words contained in the tittle and abstract, and of the index terms used to describe the articles. A second search using all identified keywords and index terms will then be undertaken across all included databases. Thirdly, the reference list of all identified reports and articles will be searched for additional studies. Studies published in the English language will be considered for inclusion in this review. All studies regardless of dates of publication will be considered for inclusion in this review. The databases to be searched include: CINAHL, MEDLINE, ASSIA, PsychInfo, Web of Science, EMBASE, and African Index Medicus. The search for unpublished studies will include reports from World Health Organization (WHO) United Nations (UN) and Joint United Nations Programme on HIV/AIDS (UNAIDS), while hand searching will be carried out from Google web and Google scholar databases. Initial keywords to be used will be: views and experiences, research participants, HIV, AIDS, and sub-saharan Africa. Initial keywords to be used will be: views and experiences, research participants, HIV, AIDS, sub-saharan Africa. doi: 10.11124/jbisrir-2014-1797 Page 104
Assessment of methodological quality Qualitative papers selected for retrieval will be assessed by two independent reviewers for methodological validity prior to inclusion in the review using standardized critical appraisal instruments from the Joanna Briggs Institute Qualitative Assessment and Review Instrument (JBI-QARI) (Appendix I). Any disagreements that arise between the reviewers will be resolved through discussion, or with a third reviewer. Data collection Qualitative data will be extracted from papers included in the review using the standardized data extraction tool from JBI-QARI (Appendix II). 27 The data extracted will include specific details about the phenomena of interest, populations, study methods and outcomes of significance to the review questions and specific objectives. One reviewer (the primary reviewer) will extract the data and thereafter will discuss with the second reviewer. Data synthesis Qualitative research findings, where possible, will be pooled using JBI-QARI. This will involve the aggregation or synthesis of findings to generate a set of statements that represent that aggregation, through assembling the findings rated according to their quality, and categorizing these findings on the basis of similarity in meaning. These categories are then subjected to a meta-synthesis in order to produce a single comprehensive set of synthesized findings that can be used as a basis for evidence-based practice. Where textual pooling is not possible the findings will be presented in narrative form. Conflicts of interest The reviewers declare no conflict of interest Acknowledgements The reviewers wish to thank the Centre for Evidence Based Healthcare at the University of Nottingham for support with this review. doi: 10.11124/jbisrir-2014-1797 Page 105
References 1. The Joint United Nations Programme on HIV/AIDS. Global Report: UNAIDS report on the global AIDS epidemic. 2013. 2. World Health Organization. World Health Organization Global report: UNAIDS report on the global AIDS epidemic. 2012. 3. Vitoria M, Granich R, Gilks CF, Gunneberg C, Hosseini M, Were W, Raviglione M, De Cock K.M. The global fight against HIV/AIDS, tuberculosis, and malaria: current status and future perspectives. Am J Clin Pathol. 2009; 131(6): 844-8. 4.Benatar SR, Gill S and Bakker I. Global health and the global economic crisis. American Journal of Public Health. 2011; 101: 646-53. 5. Smit J, Middelkoop K, Myer L, Lindegger G, Swartz L, Seedat S, Tucker T, Wood R, Bekker L, Stein DJ. Socio-behaviour challenges to phase III HIV vaccine trials in Sub-Saharan Africa. African health sciences. 2005; 5(3): 198-206. 6. Grady C and Edgerly M. Science, Technology, and Innovation: Nursing Responsibilities in Clinical Research. Nursing Clinics of North America. 2009; 44(4): 471-481. 7. Mbuagbaw L, Thabane L, Ongolo-Zogo P, Lang T. The challenges and opportunities of conducting a clinical trial in a low resource setting: The case of the Cameroon mobile phone SMS (CAMPS) trial, an investigator initiated trial. Trials. 2011; 12: 7. 8. Fitchett JR. Ethical considerations of clinical trials in the developing world. Transactions of the Royal Society of Tropical Medicine and Hygiene. 2009; 103(8): 756-760. 9. Canadian Association for HIV Research. Ethics Issues for Canadian HIV/AIDS Researchers in International Settings. Toronto, Ontario: Canadian Association for HIV Research, 2008. 10. Dhalla S and Poole G. Barriers of enrolment in HIV vaccine trials: a review of HIV vaccine preparedness studies. Vaccine. 2011; 29(35): 5850-9. 11. Smit J, Middelkoop K, Myer L, Lindegger G, Swartz L, Seedat S, Tucker T, Wood R, Bekker L, Stein DJ. Socio-behaviour challenges to phase III HIV vaccine trials in Sub-Saharan Africa. African health sciences. 2005; 5(3): 198-206. 12.Joanna Briggs Institute. Joanna Briggs Institute Reviewers Manual: 2011 edition. The Joanna Briggs Institute. 2011. doi: 10.11124/jbisrir-2014-1797 Page 106
Appendix I: Appraisal instruments QARI appraisal instrument Insert page break doi: 10.11124/jbisrir-2014-1797 Page 107
Appendix II: Data extraction instruments QARI data extraction instrument Insert page break doi: 10.11124/jbisrir-2014-1797 Page 108
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