Skip to main content
Top
Published in: Journal of the International AIDS Society 2/2011

Open Access 01-12-2011 | Research

Critically engaging: integrating the social and the biomedical in international microbicides research

Authors: Catherine M Montgomery, Robert Pool

Published in: Journal of the International AIDS Society | Special Issue 2/2011

Login to get access

Abstract

Randomized controlled trials and critical social theory are known not to be happy bedfellows. Such trials are embedded in a positivist view of the world, seeking definitive answers to testable questions; critical social theory questions the methods by which we deem the world knowable and may consider experiments in the biomedical sciences as social artifacts. Yet both of these epistemologically and methodologically divergent fields offer potentially important advances in HIV research. In this paper, we describe collaboration between social and biomedical researchers on a large, publicly funded programme to develop vaginal microbicides for HIV prevention. In terms of critical engagement, having integrated and qualitative social science components in the protocol meant potentially nesting alternative epistemologies at the heart of the randomized controlled trial. The social science research highlighted the fallibility and fragility of trial data by demonstrating inconsistencies in key behavioural measurements. It also foregrounded the disjuncture between biomedical conceptions of microbicides and the meanings and uses of the study gel in the context of users’ everyday lives. These findings were communicated to the clinical and epidemiological members of the team on an ongoing basis via a feedback loop, through which new issues of concern could also be debated and, in theory, data collection adjusted to the changing needs of the programme. Although critical findings were taken on board by the trialists, a hierarchy of evidence nonetheless remained that limited the utility of some social science findings. This was in spite of mutual respect between clinical epidemiologists and social scientists, equal representation in management and coordination bodies, and equity in funding for the different disciplines. We discuss the positive role that social science integrated into an HIV prevention trial can play, but nonetheless highlight tensions that remain where a hierarchy of epistemologies exists alongside competing paradigms and priorities.
Literature
1.
go back to reference May C: Mobilising modern facts: health technology assessment and the politics of evidence. Sociology of Health & Illness. 2006, 28: 513-532. 10.1111/j.1467-9566.2006.00505.x.CrossRef May C: Mobilising modern facts: health technology assessment and the politics of evidence. Sociology of Health & Illness. 2006, 28: 513-532. 10.1111/j.1467-9566.2006.00505.x.CrossRef
2.
go back to reference Bell J: Foreword. Clinical Trials. Edited by: Duley L, Farrell B. 2002, London: BMJ Books Bell J: Foreword. Clinical Trials. Edited by: Duley L, Farrell B. 2002, London: BMJ Books
3.
go back to reference Halperin DT: Combination HIV prevention must be based on evidence. The Lancet. 2009, 373: 544-545.CrossRef Halperin DT: Combination HIV prevention must be based on evidence. The Lancet. 2009, 373: 544-545.CrossRef
4.
go back to reference Goldenberg MJ: Iconoclast or creed? Objectivism, pragmatism, and the hierarchy of evidence. Perspectives in Biology and Medicine. 2009, 52: 168-187. 10.1353/pbm.0.0080.CrossRefPubMed Goldenberg MJ: Iconoclast or creed? Objectivism, pragmatism, and the hierarchy of evidence. Perspectives in Biology and Medicine. 2009, 52: 168-187. 10.1353/pbm.0.0080.CrossRefPubMed
5.
go back to reference Wahlberg A, McGoey L: An elusive evidence base: the construction and governance of randomized controlled trials. BioSocieties. 2007, 2: 1-10. 10.1017/S1745855207005017.CrossRef Wahlberg A, McGoey L: An elusive evidence base: the construction and governance of randomized controlled trials. BioSocieties. 2007, 2: 1-10. 10.1017/S1745855207005017.CrossRef
6.
go back to reference Mykhalovskiy E, Weir L: The problem of evidence-based medicine: directions for social science. Social Science & Medicine. 2004, 59: 1059-1069. 10.1016/j.socscimed.2003.12.002.CrossRef Mykhalovskiy E, Weir L: The problem of evidence-based medicine: directions for social science. Social Science & Medicine. 2004, 59: 1059-1069. 10.1016/j.socscimed.2003.12.002.CrossRef
7.
go back to reference Bryman A: Quality and Quantity in Social Research. 1988, London: Unwin HymanCrossRef Bryman A: Quality and Quantity in Social Research. 1988, London: Unwin HymanCrossRef
8.
go back to reference Pareja Béhague D, Gonçalves H, Gomes C: Anthropology and epidemiology: learning epistemological lessons through a collaborative venture. Cien Saude Colet. 2008, 13: 1701-1710. 10.1590/S1413-81232008000600002.CrossRef Pareja Béhague D, Gonçalves H, Gomes C: Anthropology and epidemiology: learning epistemological lessons through a collaborative venture. Cien Saude Colet. 2008, 13: 1701-1710. 10.1590/S1413-81232008000600002.CrossRef
9.
go back to reference Napolitano DA, Jones COH: Who needs ‘pukka anthropologists’? A study of the perceptions of the use of anthropology in tropical public health research. Tropical Medicine & International Health. 2006, 11: 1264-1275. 10.1111/j.1365-3156.2006.01669.x.CrossRef Napolitano DA, Jones COH: Who needs ‘pukka anthropologists’? A study of the perceptions of the use of anthropology in tropical public health research. Tropical Medicine & International Health. 2006, 11: 1264-1275. 10.1111/j.1365-3156.2006.01669.x.CrossRef
10.
go back to reference Denzin NK, Lincoln YS: The SAGE handbook of qualitative research. 2005, Thousand Oaks, CA: Sage, 3rd Denzin NK, Lincoln YS: The SAGE handbook of qualitative research. 2005, Thousand Oaks, CA: Sage, 3rd
11.
go back to reference Green J, Thorogood N: Qualitative Methods for Health Research. 2009, London: Sage Green J, Thorogood N: Qualitative Methods for Health Research. 2009, London: Sage
12.
go back to reference Friedman SR, Rossi D: Dialectical theory and the study of HIV/AIDS and other epidemics. Dialectical Anthropology. 2011, 1-25. 28 February 2011 Friedman SR, Rossi D: Dialectical theory and the study of HIV/AIDS and other epidemics. Dialectical Anthropology. 2011, 1-25. 28 February 2011
13.
go back to reference Holstein JA, Gubrium JF: Handbook of Constructionist Research. 2008, New York & London: The Guildford Press Holstein JA, Gubrium JF: Handbook of Constructionist Research. 2008, New York & London: The Guildford Press
14.
go back to reference McCormack S, Ramjee G, Kamali A, Rees H, Crook AM, Gafos M, Jentsch U, Pool R, Chisembele M, Kapiga S, et al: PRO2000 vaginal gel for prevention of HIV-1 infection (Microbicides Development Programme 301): a phase 3, randomised, double-blind, parallel-group trial. Lancet. 2010, 376: 1329-1337. 10.1016/S0140-6736(10)61086-0.PubMedCentralCrossRefPubMed McCormack S, Ramjee G, Kamali A, Rees H, Crook AM, Gafos M, Jentsch U, Pool R, Chisembele M, Kapiga S, et al: PRO2000 vaginal gel for prevention of HIV-1 infection (Microbicides Development Programme 301): a phase 3, randomised, double-blind, parallel-group trial. Lancet. 2010, 376: 1329-1337. 10.1016/S0140-6736(10)61086-0.PubMedCentralCrossRefPubMed
15.
go back to reference Nunn A, McCormack S, Crook AM, Pool R, Rutterford C, Hayes R: Microbicides Development Programme: design of a phase III trial to measure the efficacy of the vaginal microbicide PRO 2000/5 for HIV prevention. Trials. 2009, 10- Nunn A, McCormack S, Crook AM, Pool R, Rutterford C, Hayes R: Microbicides Development Programme: design of a phase III trial to measure the efficacy of the vaginal microbicide PRO 2000/5 for HIV prevention. Trials. 2009, 10-
16.
go back to reference Pool R, Montgomery CM, Morar NS, Mweemba O, Ssali A, Gafos M, Lees S, Stadler J, Nunn A, Crook A, et al: Assessing the accuracy of adherence and sexual behaviour data in the MDP301 Vaginal Microbicides Trial using a mixed methods and triangulation model. PLoS ONE. 2010, 5: e11632-10.1371/journal.pone.0011632.PubMedCentralCrossRefPubMed Pool R, Montgomery CM, Morar NS, Mweemba O, Ssali A, Gafos M, Lees S, Stadler J, Nunn A, Crook A, et al: Assessing the accuracy of adherence and sexual behaviour data in the MDP301 Vaginal Microbicides Trial using a mixed methods and triangulation model. PLoS ONE. 2010, 5: e11632-10.1371/journal.pone.0011632.PubMedCentralCrossRefPubMed
17.
go back to reference Pool R, Montgomery CM, Morar NS, Mweemba O, Ssali A, Gafos M, Lees S, Stadler J, Nunn A, Crook A, et al: A mixed methods and triangulation model for increasing the accuracy of adherence and sexual behaviour data: The Microbicides Development Programme. PLoS ONE. 2010, 5: e11600-10.1371/journal.pone.0011600.PubMedCentralCrossRefPubMed Pool R, Montgomery CM, Morar NS, Mweemba O, Ssali A, Gafos M, Lees S, Stadler J, Nunn A, Crook A, et al: A mixed methods and triangulation model for increasing the accuracy of adherence and sexual behaviour data: The Microbicides Development Programme. PLoS ONE. 2010, 5: e11600-10.1371/journal.pone.0011600.PubMedCentralCrossRefPubMed
18.
go back to reference Adam B: Timewatch: The Social Analysis of Time. 1995, Cambridge: Polity Press Adam B: Timewatch: The Social Analysis of Time. 1995, Cambridge: Polity Press
19.
go back to reference Law J, Mol A: On metrics and fluids. Notes on otherness. Organised Worlds: Explorations in Technology, Organisations & Modernity. Edited by: Chia R. 1998, London: Routledge, 20-38. Law J, Mol A: On metrics and fluids. Notes on otherness. Organised Worlds: Explorations in Technology, Organisations & Modernity. Edited by: Chia R. 1998, London: Routledge, 20-38.
20.
go back to reference Heaven B, Murtagh M, Rapley T, May C, Graham R, Kaner E, Thomson R: Patients or research subjects? A qualitative study of participation in a randomised controlled trial of a complex intervention. Patient Education and Counseling. 2006, 62: 260-270. 10.1016/j.pec.2005.07.013.CrossRefPubMed Heaven B, Murtagh M, Rapley T, May C, Graham R, Kaner E, Thomson R: Patients or research subjects? A qualitative study of participation in a randomised controlled trial of a complex intervention. Patient Education and Counseling. 2006, 62: 260-270. 10.1016/j.pec.2005.07.013.CrossRefPubMed
21.
go back to reference Helgesson C-F: From dirty data to credible scientific evidence: some practices used to clean data in large randomised clinical trials. Medical Proofs, Social Experiments: Clinical Trials in Shifting Contexts. Edited by: Will C, Moreira T. 2010, Farnham: Ashgate, 49-63. Helgesson C-F: From dirty data to credible scientific evidence: some practices used to clean data in large randomised clinical trials. Medical Proofs, Social Experiments: Clinical Trials in Shifting Contexts. Edited by: Will C, Moreira T. 2010, Farnham: Ashgate, 49-63.
22.
go back to reference Headland TN, Pike KL, Harris M: Emics and Etics. The Insider/Outsider Debate. 1990, Newbury Park, CA: Sage Publications Headland TN, Pike KL, Harris M: Emics and Etics. The Insider/Outsider Debate. 1990, Newbury Park, CA: Sage Publications
23.
go back to reference Severy LJ, Tolley E, Woodsong C, Guest G: A framework for examining the sustained acceptability of microbicides. AIDS and Behavior. 2005, 9: 121-131. 10.1007/s10461-005-1687-y.CrossRefPubMed Severy LJ, Tolley E, Woodsong C, Guest G: A framework for examining the sustained acceptability of microbicides. AIDS and Behavior. 2005, 9: 121-131. 10.1007/s10461-005-1687-y.CrossRefPubMed
24.
go back to reference Montgomery CM, Gafos M, Lees S, Morar NS, Mweemba O, Ssali A, Stadler J, Pool R: Re-framing microbicide acceptability: findings from the MDP301 trial. Culture, Health & Sexuality. 2010, 12: 649-662. 10.1080/13691051003736261.CrossRef Montgomery CM, Gafos M, Lees S, Morar NS, Mweemba O, Ssali A, Stadler J, Pool R: Re-framing microbicide acceptability: findings from the MDP301 trial. Culture, Health & Sexuality. 2010, 12: 649-662. 10.1080/13691051003736261.CrossRef
25.
go back to reference Stadler J, Saethre E: Blockage and flow: intimate experiences of condoms and microbicides in a South African clinical trial. Culture, Health & Sexuality. 2010, 13: 31-44.CrossRef Stadler J, Saethre E: Blockage and flow: intimate experiences of condoms and microbicides in a South African clinical trial. Culture, Health & Sexuality. 2010, 13: 31-44.CrossRef
26.
go back to reference Stadler J, Saethre E: Rumours about blood and reimbursements in a microbicide gel trial. African Journal of AIDS Research. 2010, 9: 345-353. 10.2989/16085906.2010.545636.CrossRefPubMed Stadler J, Saethre E: Rumours about blood and reimbursements in a microbicide gel trial. African Journal of AIDS Research. 2010, 9: 345-353. 10.2989/16085906.2010.545636.CrossRefPubMed
27.
go back to reference Kippax S, Van de Vena P: An epidemic of orthodoxy? Design and methodology in the evaluation of the effectiveness of HIV health promotion. Critical Public Health. 1998, 8: 371-386. 10.1080/09581599808402921.CrossRef Kippax S, Van de Vena P: An epidemic of orthodoxy? Design and methodology in the evaluation of the effectiveness of HIV health promotion. Critical Public Health. 1998, 8: 371-386. 10.1080/09581599808402921.CrossRef
Metadata
Title
Critically engaging: integrating the social and the biomedical in international microbicides research
Authors
Catherine M Montgomery
Robert Pool
Publication date
01-12-2011
Publisher
BioMed Central
DOI
https://doi.org/10.1186/1758-2652-14-S2-S4

Other articles of this Special Issue 2/2011

Journal of the International AIDS Society 2/2011 Go to the issue
Live Webinar | 27-06-2024 | 18:00 (CEST)

Keynote webinar | Spotlight on medication adherence

Live: Thursday 27th June 2024, 18:00-19:30 (CEST)

WHO estimates that half of all patients worldwide are non-adherent to their prescribed medication. The consequences of poor adherence can be catastrophic, on both the individual and population level.

Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.

Prof. Kevin Dolgin
Prof. Florian Limbourg
Prof. Anoop Chauhan
Developed by: Springer Medicine
Obesity Clinical Trial Summary

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.

Developed by: Springer Medicine

Highlights from the ACC 2024 Congress

Year in Review: Pediatric cardiology

Watch Dr. Anne Marie Valente present the last year's highlights in pediatric and congenital heart disease in the official ACC.24 Year in Review session.

Year in Review: Pulmonary vascular disease

The last year's highlights in pulmonary vascular disease are presented by Dr. Jane Leopold in this official video from ACC.24.

Year in Review: Valvular heart disease

Watch Prof. William Zoghbi present the last year's highlights in valvular heart disease from the official ACC.24 Year in Review session.

Year in Review: Heart failure and cardiomyopathies

Watch this official video from ACC.24. Dr. Biykem Bozkurt discusses last year's major advances in heart failure and cardiomyopathies.