Abstract
BackgroundDeveloping an effective HIV vaccine is the overriding priority for HIV prevention research. Enrolling and maintaining cohorts of men into HIV vaccine efficacy trials is a necessary prerequisite for the development and licensure of a safe and efficacious vaccine.MethodsOne hundred-fifty consenting HIV-negative men were enrolled into a pilot 1:1 randomised controlled trial of immediate vaccination with a three-dose hepatitis B vaccine compared to deferred vaccination (at 12 months) to investigate feasibility and acceptability of a future HIV vaccine trial in this population. Adverse events, changes in risk behaviour, acceptability of trial procedures and motivations for participation in future trials were assessed.ResultsMen were a median 25 years old (inter-quartile range = 23–29), 53% were employed, 90% secondary school educated and 67% uncircumcised. Of the 900 scheduled study visits, 90% were completed in the immediate vaccination arm (405/450) and 88% (396/450) in the delayed arm (P = 0.338). Acceptability of trial procedures and services was very high overall. However, only 65% of the deferred group strongly liked being randomised compared to 90% in the immediate group (P = 0.001). Informed consent processes were viewed favourably by 92% of the delayed and 82% of the immediate group (P = 0.080). Good quality health services, especially if provided by a male nurse, were rated highly. Even though almost all participants had some concern about the safety of a future HIV vaccine (98%), the majority were willing to participate in a future trial. Future trial participation would be motivated mainly by the potential for accessing an effective vaccine (81%) and altruism (75%), rather than by reimbursement incentives (2%).ConclusionsRecruitment and retention of men into vaccine trials is feasible and acceptable in our setting. Findings from this surrogate vaccine trial show a high willingness to participate in future HIV vaccine trials. While access to potentially effective vaccines is important, quality health services are an equally compelling incentive for enrolment.
Highlights
Developing an effective Human immuno-deficiency virus (HIV) vaccine is the overriding priority for HIV prevention research
We evaluated the recruitment rate, retention, adverse events, behaviour changes and willingness to participate in future HIV vaccine trials, and explored whether participation in a trial would be motivated by access to the vaccine, or to the clinical care and the trial as a whole
Despite its limitations, the study was able to demonstrate a high degree of willingness to participate (WTP) in future trials, as shown by the actual retention rates and views expressed on the issue
Summary
Developing an effective HIV vaccine is the overriding priority for HIV prevention research. The RV144 Thai phase III HIV vaccine trial using two booster injections in addition to a recombinant canarypox vector vaccine showed a modest reduction in HIV infections [9]. Most HIV prevention interventions investigated so far have been targeted at women, who have a higher risk for infection and a compelling need for female-controlled methods of HIV prevention [11,12,13] In this context, research is usually focussed only indirectly on men in their role as sexual partners of women, rather than as actual participants in a trial [14]. Evaluation and licensure of an HIV vaccine will, require the enrolment of large cohorts of men at risk for HIV infection, given, among other reasons, that immune responses to vaccines vary by gender [15]
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