Experiences in recruiting volunteers through community based initiatives in phase-1 vaccine trials in India

Abstract

Success of HIV vaccine trials is dependent on infrastructural preparedness of the site, technical expertise of the trial team and strong Socio-political support of the local community. The processes followed and experiences gained while implementing various community based initiatives for recruitment of healthy volunteers during the three HIV vaccine trials in India are described. Major initiatives in community engagement implemented for the first time in India included establishment and involvement of Community Advisory Board and capacity building and engagement of lay community based volunteers called "peers" using "lay health promotion" model. Community education program designed for trial participants' education, identification and enrollment was a three-tiered approach, moving from large community awareness meetings (first step) to facility-based small group meeting to provide trial specific information (second step); ending with one-to-one vaccine center based meeting with the volunteers to clear doubts, myths, and misconceptions about HIV/AIDS, the experimental vaccine and HIV vaccine trials as well as to explain trial specific procedures (third step). It is important to focus on gender issues, locally relevant socio-cultural factors, informed consent, and post-trial care related matters during the conduct of sensitive clinical trials in socio-culturally diverse and resource limited setting like India.

Keywords: Community Advisory Board; Phase 1 HIV vaccine trial; autonomy; community engagement; gender issues; peer; recruitment; trial participation; volunteers.

Figure 1. A conceptual framework of community involvement using lay health promotion model and using participatory approach to facilitate community based recruitment of healthy volunteers for phase 1 HIV vaccine trial in India. The structural components of recruitment plan were: (1) Community Advisory Board; (2) Community volunteers designated as peers. Peers and CAB were involved in evolving strategies of recruitment based on lessons learnt during interim assessments. Media was informed periodically.

Figure 2. Proportion of volunteers enrolled from each referral source in 3 phase 1 vaccine trials conducted at Pune and Chennai in India.