Motivation, recruitment, and screening of volunteers for a phase I/II HIV preventive vaccine trial in Thailand

J Acquir Immune Defic Syndr Hum Retrovirol. 1998 Jun 1;18(2):171-7. doi: 10.1097/00042560-199806010-00009.

Abstract

Data from recruitment and screening for a phase I/II preventive HIV-1 vaccine trial in Thailand were evaluated with respect to correlates of participation at each phase. Correlates included demographic variables, motivation for interest in the trial, and factors related to communication and contact. Participants were recruited at two sites through varied methods. The majority of prescreenees reported altruistic motives for interest in the trial and blood donors emerged as a group that may have been particularly altruistic. Findings indicated site differences in attrition during recruitment and screening, but not in enrollment into the vaccine trial. Blood donation and willingness to be contacted by phone at home were significantly related to making and keeping screening appointments.

PIP: The issue of recruitment of volunteers for trials of an HIV preventive vaccine has raised concerns, especially in developing countries, about motivation, the potential for coercion, informed consent, unblinding, and the social consequences of vaccine-induced seropositivity. The present study evaluated factors related to the recruitment and retention of volunteers for a double-blind, placebo-controlled phase I/II preventive HIV vaccine trial conducted at two medical centers in Thailand (Bangkok and Chiang Mai). 217 men and women responded to calls for volunteers, 124 scheduled a screening appointment, and 104 appeared for the appointment; 54 actually enrolled. 56.2% of prescreenees expressed altruistic motives (desire to benefit Thai society or contribute to stopping the AIDS epidemic) for their interest in the study. Multivariate analysis indicated that willingness to schedule an appointment was significantly associated with a history of blood donation and a willingness to be contacted by the project at home by phone. Actual attendance at the appointment was significantly associated only with blood donation history. None of the factors examined--motives, willingness to be contacted by phone or mail, site, demographics, and blood donation history--was related to whether screened volunteers were deemed eligible and enrolled. Only 2 volunteers dropped out of the study, both at an early point. The presence of multiple stages of recruitment allows potential volunteers an opportunity to reevaluate their willingness to participate and seems to ensure a high level of commitment.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I
  • Clinical Trial, Phase II
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • AIDS Vaccines / administration & dosage*
  • Adult
  • Clinical Trials as Topic / methods*
  • Developing Countries
  • Double-Blind Method
  • Female
  • HIV Infections / prevention & control*
  • HIV Infections / psychology
  • HIV-1*
  • Humans
  • Male
  • Motivation*
  • Patient Compliance
  • Patient Participation / psychology
  • Patient Selection*
  • Research
  • Risk-Taking
  • Thailand

Substances

  • AIDS Vaccines