Feasibility and acceptability of early infant male circumcision as an HIV prevention intervention in Zimbabwe Thesis submitted in fulfilment of the requirements of the University College London degree of Doctor of Philosophy (PhD) in Social Science Webster Mavhu 2014 Author’s Declaration I, Webster Mavhu, confirm that the work presented in this thesis is my own. Where information has been derived from other sources, I confirm that this has been indicated in the thesis. i Abstract The overall aim of the research outlined in this PhD thesis is to assess the feasibility and acceptability of early infant male circumcision (EIMC) as an HIV prevention intervention in Zimbabwe in order to inform roll out. Mathematical modelling estimates that circumcising 1.9 million Zimbabwean men aged 15-49 by 2015 could avert 42% of new HIV infections that would have otherwise occurred by 2025. Since 2009, Zimbabwe has provided voluntary medical male circumcision (VMMC) to over 300,000 adult and adolescent men. In order to ensure that the protective effect of male circumcision is sustained in the longer-term, Zimbabwe intends to roll out EIMC alongside adult MC, starting 2015. Although EIMC’s effects on HIV will take longer to realise, infant circumcision is easier, safer and cheaper than adult MC. Further, EIMC may more effectively prevent HIV acquisition as the procedure is carried out before the individual becomes sexually active, negating the risk associated with acquisition or transmission of HIV during the healing period. Since large-scale EIMC for HIV prevention, or indeed for other reasons, has never been practised in Zimbabwe or more widely in Southern Africa, there are concerns around its feasibility and acceptability. Clearly, acceptability of infant MC will have a bearing on uptake, roll out and subsequent effectiveness in preventing HIV. In Zimbabwe, there are also concerns about the feasibility of rolling out EIMC for HIV prevention within the context of existing health services, many of which are already overburdened and understaffed. The PhD research is in two phases. The first phase describes a systematic review and thematic synthesis I conducted to explore parental reasons for non-adoption of infant MC for HIV prevention in sub-Saharan Africa. Additionally, this phase qualitatively explored hypothetical acceptability of EIMC among parents and wider family as well as hypothetical feasibility and acceptability of EIMC among health-care workers. Findings from the first phase informed the design of a study to pilot EIMC roll out. The second phase was nested within a trial that assessed the feasibility, safety, acceptability and cost of rolling out EIMC using devices in Zimbabwe. It explored actual acceptability of EIMC among parents and wider family as well as actual feasibility and acceptability of EIMC among health-care workers. Findings from both phases informed recommendations for a demand generation intervention for EIMC which is currently being developed and will subsequently be tested for impact. Given that EIMC has been identified as a key HIV prevention intervention for sustaining the prevention gains anticipated through VMMC across sub-Saharan Africa, the findings of this research are likely to have broad implications for HIV prevention across the region. ii Table of Contents Abstract ........................................................................................................................................... ii List of Tables ................................................................................................................................ vii List of Figures .............................................................................................................................. viii List of Abbreviations ..................................................................................................................... ix Acknowledgements ...................................................................................................................... xi CHAPTER 1: INTRODUCTION ................................................................................................... 1 1.1 Overview ............................................................................................................................... 1 1.2 Background: Zimbabwe HIV/AIDS epidemic .................................................................. 1 1.3 National response to the HIV/AIDS epidemic ................................................................. 3 1.4 Background to the PhD Project......................................................................................... 3 1.5 Aim and objectives .............................................................................................................. 5 1.5.1 The aim of the PhD research ........................................................................................... 5 1.5.2 The specific objectives of the PhD research .................................................................... 5 1.6 Organisation of the thesis .................................................................................................. 5 1.7 Role of the candidate .......................................................................................................... 6 CHAPTER 2: MALE CIRCUMCISION – HISTORY AND POTENTIAL HIV BENEFITS .... 7 2.1 Overview ............................................................................................................................... 7 2.2 Male circumcision: historical perspective ........................................................................ 7 2.3 Estimated global prevalence of male circumcision ........................................................ 8 2.4 Social and cultural significance of male circumcision in Southern Africa ................... 9 2.5 Male circumcision and prevention of HIV acquisition .................................................. 10 2.6 Comparison of male circumcision with other biomedical interventions .................... 12 2.7 WHO/UNAIDS recommendations for male circumcision scale-up ............................ 12 2.8 Adult voluntary medical male circumcision for HIV prevention .................................. 14 2.9 Zimbabwe: history and prevalence of male circumcision ........................................... 16 2.10 Potential impact of rolling out male circumcision in Zimbabwe ............................... 18 2.11 Reasons for non-adoption of VMMC for HIV prevention in Zimbabwe ................... 18 2.12 General and HIV-related advantages of infant male circumcision .......................... 19 2.13 Disadvantages of infant male circumcision for HIV prevention ............................... 20 2.14 Concerns around acceptability and feasibility of EIMC in Zimbabwe ..................... 22 CHAPTER 3: SYSTEMATIC REVIEW AND THEMATIC SYNTHESIS .............................. 23 3.1 Overview ............................................................................................................................. 23 3.2 Background to the systematic review and thematic synthesis ................................... 23 3.3 Debate surrounding qualitative synthesis ..................................................................... 24 3.4 A brief description of qualitative synthesis approaches .............................................. 24 3.5 Methods for the systematic review ................................................................................. 25 3.5.1 Inclusion criteria for publications .................................................................................. 25 iii 3.5.2 Exclusion criteria............................................................................................................ 25 3.5.3 Search strategy .............................................................................................................. 25 3.5.4 Selection of eligible papers ........................................................................................... 26 3.5.5 Assessment of quality of included studies .................................................................... 26 3.6 Results of systematic review ........................................................................................... 27 3.6.1 Identified and selected papers ...................................................................................... 27 3.6.2 Characteristics of included studies ................................................................................ 28 3.7 Methods for the thematic synthesis ................................................................................ 34 3.7.1 Stage one: line-by-line coding of study findings............................................................ 34 3.7.2 Stage two: developing descriptive themes ................................................................... 35 3.7.3 Stage three: generating analytical themes .................................................................... 38 3.8 Results and discussion of the thematic synthesis........................................................ 38 3.9 Strengths and limitations of the study ............................................................................ 39 3.10 Conclusion ....................................................................................................................... 40 CHAPTER 4: METHODS ........................................................................................................... 41 4.1 Overview ............................................................................................................................. 41 4.2 Design of the studies ........................................................................................................ 41 4.3 Data collection methods ................................................................................................... 42 4.3.1 Phase I data collection ................................................................................................... 42 4.3.2 Phase 2 data collection .................................................................................................. 43 4.4 Data analysis ..................................................................................................................... 52 4.4.1 Theoretical approaches to qualitative data analysis ..................................................... 52 4.4.2 Qualitative data analysis for the PhD research ............................................................. 53 CHAPTER 5: RESULTS - HYPOTHETICAL ACCEPTABILITY OF EARLY INFANT MALE CIRCUMCISION FOR HIV PREVENTION - PARENTS AND WIDER FAMILY ........... 55 5.1 Chapter overview .............................................................................................................. 55 5.2. Description of focus group discussion participants ..................................................... 55 5.3 Overview of focus group discussion findings ................................................................ 56 5.3.1 Early infant male circumcision knowledge .................................................................... 56 5.3.2 General acceptability of early infant male circumcision ............................................... 57 5.3.3 Decision-making around early infant male circumcision .............................................. 59 5.3.4 Acceptability of EIMC among traditionally circumcising groups ................................... 59 5.3.5 Participants’ concerns ................................................................................................... 60 5.4 Conclusion .......................................................................................................................... 64 CHAPTER 6: RESULTS – HYPOTHETICAL FEASIBILITY AND ACCEPTABILITY OF EIMC FOR HIV PEVENTION – HEALTH-CARE WORKERS ..................................................... 65 6.1 Chapter overview .............................................................................................................. 65 6.2. Description of in-depth interview participants .............................................................. 65 iv 6.3 Overview of in-depth interview findings ......................................................................... 66 6.3.1 EIMC knowledge among health-care workers .............................................................. 66 6.3.2 Hypothetical acceptability of EIMC among health-care workers .................................. 68 6.3.3 Health-care workers’ perceptions around feasibility of EIMC ...................................... 70 6.3.4 Health-care workers’ concerns ...................................................................................... 71 6.4 Conclusion .......................................................................................................................... 76 6.5 Brief discussion of phase 1 findings ............................................................................... 77 6.6 How phase 1 findings informed the EIMC pilot study .................................................. 78 CHAPTER 7: RESULTS – ACTUAL ACCEPTABILITY OF EARLY INFANT MALE CIRCUMCISION FOR HIV PREVENTION AMONG PARENTS AND WIDER FAMILY ......... 79 7.1 Chapter overview .............................................................................................................. 79 7.2. A brief discussion of EIMC uptake during the comparative trial ............................... 80 7.3 A brief description of qualitative study participants ...................................................... 80 7.4 An overview of qualitative findings ................................................................................. 80 7.5 Parental motivators for adopting early infant male circumcision ............................... 81 7.5.1 Desire to protect son from sexually acquired HIV infection ......................................... 81 7.5.2 Appreciating advantages of EIMC over MC later in life................................................. 81 7.6 Parental initial anxieties ................................................................................................... 82 7.7 Perceptions of procedure, outcome and providers ...................................................... 83 7.8 Early infant male circumcision decision-making ........................................................... 85 7.9 Parental reasons for non-adoption of EIMC ................................................................. 87 7.9.1 Fear of harm .................................................................................................................. 88 7.9.2 Cultural/traditional considerations ............................................................................... 89 7.9.3 Myths and misconceptions ............................................................................................ 89 7.9.4 Other reasons ................................................................................................................ 90 7.10 Parental views on possible strategies to increase EIMC uptake ............................. 93 7.11 A brief discussion of findings......................................................................................... 94 7.12 Conclusion ....................................................................................................................... 95 CHAPTER 8: RESULTS – ACTUAL FEASIBILITY AND ACCEPTABILITY OF EARLY INFANT MALE CIRCUMCISION FOR HIV PEVENTION – HEALTH-CARE WORKERS ...... 97 8.1 Chapter overview .............................................................................................................. 97 8.2 An overview of findings .................................................................................................... 97 8. 3 Actual EIMC acceptability among health-care workers .............................................. 97 8.3.1 EIMC acceptability among study clinicians .................................................................... 97 8.3.2 EIMC acceptability among non-EIMC clinic staff ........................................................... 99 8.4 Clinicians’ perceptions: EIMC procedure, devices and outcome............................. 101 8.5 Clinicians’ perceptions: feasibility of wide-scale EIMC .............................................. 103 8.6 Possible strategies to increase EIMC uptake: clinicians’ views ............................... 105 v 8.7 Clinicians’ concerns ........................................................................................................ 106 8.7.1 EIMC study clinicians’ concern: dealing with parental anxieties................................. 106 8.7.2 EIMC study clinicians’ concern: wound care management ......................................... 106 8.7.3 Non-EIMC study clinicians’ concerns: staff and space shortages ................................ 107 8.8 A brief discussion of findings ......................................................................................... 107 8.9 Conclusion ........................................................................................................................ 108 CHAPTER 9: DISCUSSION..................................................................................................... 110 9.1 Overview ........................................................................................................................... 110 9.2 Summary of findings ....................................................................................................... 110 9.2.1 Systematic review and thematic synthesis findings .................................................... 110 9.2.2 Hypothetical acceptability and feasibility findings ...................................................... 110 9.2.3 Actual acceptability and feasibility findings ................................................................ 111 9.3 Discussion of research findings: EIMC acceptability ................................................. 112 9.3.1 Knowledge of EIMC ..................................................................................................... 113 9.3.2 Decision-making around EIMC .................................................................................... 115 9.4 Implications of research findings .................................................................................. 120 9.4.1 Possible EIMC providers for scale-up .......................................................................... 120 9.4.2 Possible device for EIMC scale-up ............................................................................... 120 9.4.3 Possible strategies to increase demand during EIMC scale-up ................................... 121 9.4.4 Possible strategies to ensure demand for EIMC is sustained during EIMC scale-up... 123 9.5 Strengths of the research............................................................................................... 125 9.6 Limitations of the research............................................................................................. 126 9.7 Conclusion ........................................................................................................................ 127 REFERENCES ........................................................................................................................... 128 APPENDICES ............................................................................................................................ 137 Appendix A: Systematic review search terms (Medline) ................................................. 138 Appendix B: FGD and in-depth interview topic guides .................................................... 139 Appendix C: Example of interview summary – EIMC actual acceptability .................... 149 Appendix D: Example of analytic memo – EIMC actual acceptability ........................... 152 Appendix E: Conference abstracts, prizes and publications ........................................... 154 vi List of Tables Table 3.1: Criteria used to assess quality of studies……………………………….. 27 Table 3.2: Characteristics of included studies.……………………………………… 29 Table 3.3: Results – Quality assessment of included studies.…………………….. 30 Table 3.4: Codes identified from the studies………………….……………………... 34 Table 3.5: Themes - Parental reasons for not adopting IMC for HIV prevention... 36 Table 5.1: Characteristics of focus group discussion participants.………………... 55 Table 6.1: Characteristics of interviewed participants……….……………………... 66 Table 7.1: Telephone interview responses – reasons for defaulting on EIMC…... 91 vii List of Figures Fig 1.1: Map of Zimbabwe showing country's 10 provinces……………………….. 1 Fig 1.2: Trends in Zimbabwe’s HIV incidence, prevalence and AIDS deaths…… 2 Fig 2.1: Uncircumcised penis, foreskin removal and circumcised penis ………… 7 Fig 2.2: One of earliest MC records …………………………………………………. 8 Fig 2.3: The penis and possible HIV entry points.………………………………….. 12 Fig 2.4: VMMC priority countries: adult HIV plus MC prevalence.………………… 13 Fig 2.5: Male circumcision using forceps-guided method.…………………………. 15 Fig 2.6: Traditional adolescent male circumcision.…………………………………. 17 Fig 3.1: Selection of eligible papers.…………………………………………………. 27 Fig 4.1: Diagrammatic illustration of overall study design.………………………… 41 Fig 4.2: Mogen clamp and AccuCirc………………………….……………………… 45 Fig 4.3: Infant MC using Mogen clamp……………………….……………………… 48 Fig 4.4: Infant MC using AccuCirc…………………………….……………………… 48 Fig 4.5: Trial participants recruitment and qualitative sampling.…………………... 50 Fig 9.1: VMMCs performed in Zimbabwe, 2010-2013………...…………………… 113 Fig 9.2: Adverse publicity & late MMR uptake in Scotland, 1988–2000…..……… 114 Fig 9.3: Zimbabwe EIMC decision tree (model)………...…………………………... 119 Fig 9.4: Possible strategies to sustain acceptability during EIMC scale-up.……... 123 viii List of Abbreviations AAP American Academy of Pediatrics AccuCirc Atraumatic Circumcision device AE Adverse Event AIDS Acquired Immunodeficiency Syndrome ANC Antenatal Care ART Antiretroviral Therapy BCF Behaviour Change Facilitator BCG Bacillus Calmette-Guérin CFA Circumcision Foundation of Australia CINAHL Cumulative Index to Nursing and Allied Health Literature DAAC District AIDS Action Committee DMO District Medical Officer DNO District Nursing Officer DRC Democratic Republic of Congo EIMC Early Infant Male Circumcision Embase Excerpta Medica Database EMLA Eutectic Mixture of Local Anaesthetics cream ENTREQ Enhancing Transparency in Reporting the Synthesis of Qualitative Research FGD Focus Group Discussion HCT HIV Counselling and Testing HCW Health-care Worker HIV Human Immunodeficiency Virus HP Health Promoter HPO Health Promoting Officer IDI In-depth Interview IMC Infant Male Circumcision MC Male Circumcision MeSH Medline Medical Subject Headings mHealth Mobile Health MMR Measles, Mumps and Rubella vaccine PMD Provincial Medical Director PO Participant Observation PPTCT Prevention of Parent to Child Transmission of HIV ix