'Who is Helsinki?' Sex workers advise improving communication for good participatory practice in clinical trials

Abstract

After premature closures in 2004 of biomedical human immunodeficiency virus (HIV) prevention trials involving sex workers in Africa and Asia, the Joint United Nations Programme on HIV/AIDS (UNAIDS) and Global Advocacy for HIV Prevention (AVAC) undertook consultations to establish better participatory guidelines for such trials in order to address ethical concerns. This study investigated sex workers’ knowledge and beliefs about research ethics and good participatory practices (GPP) and the perspectives of sex workers on research participation. A 33-question survey based on criteria identified by UNAIDS and AVAC was translated into three other languages. Participants were recruited through mailing lists and contacts with existing sex work networks. In total, 74 responses from Europe, the Americas and Asia were received. Thirty percent of respondents reported first-hand involvement in biomedical HIV prevention trials. Seventy percent indicated a lack of familiarity with codes of ethics for research. This paper focuses exclusively on communication issues described in survey responses. Communication was an important theme: the absence of clear communication between trial participants and investigators contributed to premature trial closures in at least two sites. Sex workers had recommendations for how researchers might implement GPP through improved communication, including consultation at the outset of planning, explaining procedures in non-technical terms and establishing clear channels for feedback from participants.

Stakeholder engagement to informHIVclinical trials: a systematic review of the evidence

“…In contrast, fewer studies conducted stakeholder engagement in middle‐ (30 studies; 27.8%) 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100 and low‐income (nine studies; 8.3%) 101, 102, 103, 104, 105, 106, 107, 108, 109 countries. The location of stakeholder engagement could not be discerned in six studies (5.6%) 110, 111, 112, 113, 114, 115, and fifteen studies (13.9%) 16, 24, 116, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128 conducted stakeholder engagement in multiple countries at different income levels.…”

Confidentiality, Privacy, and Respect: Experiences of Female Sex Workers Participating in HIV Research in Andhra Pradesh, India

“…In contrast to this work among drug using populations, to date, there has been less empirical attention to research ethics relevant experiences among FSW. The existing, but limited, work on the topic of research ethics among FSW has identified the issues of confidentiality, privacy, and respect as pertinent to this population; findings have indicated high levels of stigma and victimization as security challenges when conducting research among FSW (Shaver, 2005; Ditmore & Allman, 2011). However, the majority of these studies have not been specific to research ethics pertaining to HIV research among FSW.…”

“…Furthermore, very few studies have occurred within high HIV prevalence Indian states, where a multitude of FSW directed HIV social and behavioral research studies have been conducted. Additionally, the existing work among FSW within this context, and elsewhere, has often been limited to studies focused on research ethics issues within vaccine or other HIV prevention trials (Suhadev et al, 2006; Ditmore & Allman, 2011; Berkley, 2008; Jayaraman, 2008; NIMH Collaborative HIV/STD Prevention Trial Group, 2007; Sahay & Mehendale, 2004; Thomas, 2004). In conclusion, less investigation on HIV research ethics issues (in India and elsewhere) has focused on the conduct of social and behavioral epidemiological studies, and this is particularly limited among FSW.…”

Social and Structural Constraints on Disclosure and Informed Consent for HIV Survey Research Involving Female Sex Workers and Their Bar Managers in the Philippines

“…Female sex workers are often subject to police raids, rape, violence, emotional abuse and marginalization (Platt et al, 2013; Shannon & Csete, 2010; Silverman, et al, 2011). As a result, recruitment, disclosure and participation of female sex workers in research are often compromised (Uusküla et al, 2010; Ditmore & Allman, 2011). Respect and relationality, the reciprocal ‘give and take’ relationship in which the researcher maintains the participant's trust (Fisher, 2011), are especially critical when conducting research with female sex workers.…”

“…Care also needs to be taken to avoid “therapeutic misconception,” – the expectation from participants to personally gain over and above what they normally would receive from participating in the research (Fisher et al, 2008). To address these concerns, investigators have cited the need to be transparent about research aims and to provide participants with education, training, and familiarity with ethical research standards (Jeffreys, 2010; Ditmore & Allman, 2011). …”