Oral Abstract Session 01 - Global HIV Vaccine Enterprise

POSTERS
Posters
Topic 10: Social/Ethical/Access/Regulatory Issues
P10.05
Willingness to Participate in Vaccine Trials Among
MSM in São Paulo, Brazil
G. Calazans 1 , R. Gamboa 1 , A. Kalichman 1 , M. Ribeiro 2 ,
M. Veras 2
1 Sao Paulo HVTU - CRT-DST/AIDS, São Paulo, Brazil; 2 School of
Medical Sciences, Santa Casa de São Paulo, Brazil
Background: An effective HIV vaccine still poses a great challenge
to research scientists. Among the most vulnerable populations
to HIV infection in Europe, United States and Latin America are
men who have sex with men (MSM), potential volunteers for HIV
vaccine research. We have asked MSM from a large LA city about
their willingness to participate (WTP) in HIV vaccine trials.
Methods: A survey of men who attend MSM-identified venues in
downtown São Paulo was carried out between November 2011
and January 2012. Time-location sampling approach was used.
During sampling events, interviewers approached and asked
men to respond a brief eligibility interview and consecutively
applied a questionnaire to men who referred having ever anal
or oral sex with men or transvestite. Here we analyze WTP in
hypothetical HIV preventative vaccine trials.
Results: 1217 MSM were interviewed (missing data=3), 54,6%
would accept participating, 35,3% would deny, and 9,9% stated
they were unsure/maybe/depending on more information or
assurances before deciding whether to participate in vaccine trials.
WTP in HIV vaccine trial was similar across age groups (p=.450) and
race/ethnicity (p=.534). There was no patterned difference among
those who self-identified as homosexual, bisexual or transgender
(p=.542) as well as among those who would have sex with an HIVinfected
person, the size of their HIV-infected network (p=.251).
Although not significant (p=0.06) a trend was suggested with WTP
and the level of education of the head of the household, as years
of education increased greater WTP.
Conclusion: Findings indicate that, despite the lack of success in
recent phase II/III trials, there is substantial WTP in HIV vaccine
studies, expressing the hope for an effective vaccine retain a pool
of potential volunteers among the most vulnerable population.
Subsequent analysis should focus on association with behavioral
aspects, as risk behaviors, experience of discrimination due to
sexuality and WTP.
212
AIDS Vaccine 2012
P10.06
A Case Study of a National Ethics Committee:-
Challenges in Regulating HIV Prevention Research in
Zimbabwe
M.E. Phiri-Shana 1 , R. Musesengwa 1 , S. Ruzario 1 , R.B. Gutsire-
Zinyama 1 , R. Gunda 1
1 Medical Research Council of Zimbabwe, Harare, Zimbabwe
Background: As efforts in search of effective HIV prevention
strategies intensify, studies have become exceedingly complex,
posing several regulatory challenges to most African Ethics
Committees, the MRCZ included. Challenges faced include:
Researchers not being clear on how to operate in compliance to
local and sponsor country regulations; i.e. when a host country
ethics committee has issued a decision on an issue concerning
rights, safety and well being of participants while an overseas
ethics committee has not. Prevention studies require frequent
assessment, at MRCZ this has been hampered by limited
resources. Ascertaining comprehension of these complex studies
by participants and ensuring they receive new information
promptly has also been a challenge. MRCZ has taken several
measures to address regulatory challenges faced.
Methods: Routine, for- cause and passive inspections of ongoing
approved research studies have been done. During these,
participant comprehension checklists used at enrollment were
audited and interviews with participants held to assess study
knowledge levels. MRCZ has also set up a database to record
types of inspections, number of Serious Adverse Events and
protocol deviations
Results: From year 2000, MRCZ has actively and passively
inspected about 1000 studies of these 5 were for- cause. MRCZ
has also trained 340 research staff and 15 members of Council in
Research Ethics, GCP and National Research Guidelines to build
capacity. Due to this there has been: - Adoption of a harmonized
review process; A decrease in for- cause inspections and an
improvement in study documentation. All initial and continuing
review submissions now include GCP certificates of study staff as
well as participant comprehension checklists. 90% of interviewed
participants show understanding of research studies they are
involved in.
Conclusion: Regulatory bodies should consolidate efforts in
understanding the complex and dynamic HIV research arena and
in ensuring that research is carried out in a well regulated arena.