Cross-sectional study to assess some psychosocial factors related to volunteering in a clinical HIV/AIDS vaccine trial
Abstract
Of particular concern to those conducting clinical HIV vaccines research is the impact
psychosocial factors could have on trial participation as either a deterrent to
participation or supporting the participation of others. Discrimination and non disclosure
have been known to affect volunteers in HIV Vaccine trials who face an unacceptable
high risk of social harm from their families, friends and society. (Fuchs J et al 2007).
This was a descriptive cross-sectional study executed over a period of 6 months from
the month of September 2007 and March 2008. The study assessed some of the
psychosocialfactors related to participation in HIV vaccine clinical trial in persons who
had previously participated in the clinical trials at Kenya Aids Vaccine Initiative (KAVI),
Nairobi, Kenya.
Objectives
The study sought to asses some psychosocial factors related to volunteering in a
HIVjAIDs vaccine clinical trial by determining the socio demographics characteristics of
participants, assessing negative psychosocial factors, and determining other
psychosocial factors related to participation and make recommendation to the HIV
vaccine clinical trials researchers on how to minimize psychosocial harm experienced by
participants
Methodology
A total of 96 persons who had previously participated in a HIV vaccine clinical trial
between 2001 and 2007 were contacted and recruited into the study. Their Sociodemographic
data was collected; data on psychosocial factors related to participation
was collected using semi structured questionnaire. The data was entered using
statistical package for social science (SPSS), and analysis of variance (ANOVA) and ttest
was used. The results were presented in tables and figures
Results:
The results show that most participants were young (mean age 24 year), majority were
students(39%) as compared to other occupations, majority were Males (77.1 %), all
participants subscribed to one form of religion, majority lived in Nairobi (83.3%),
majority had had an education above secondary level, and most earned less that 5.000
Kshs,Majority were single (83.3%).
Reasons for participation included; For HIV information (9.4%), to help find a vaccine
(84.4%), medical care (1.0%), Reimbursement (3.1 %) , wanting to know their HIV
status(1.0%) and lost a friend/relative (1.0%). When asked if participation had
changed their life in any way, 38 out of 96 participants said that they had gained HIV
knowledge(47.4%), had sexual behavior changes (39.5%), wanted to find cure
(10.5%) and wanted to know their health status by having a medical examination
(2.6%).
The findings indicate that participants did not experience any negative Psychosocial
factors which were depicted as experiencing discrimination (mean score 1.89) as a
result of participation. However, although the findings of the study showed that
participants did not feel discriminated for participating in the clinical trials, Student
were Significantly more likely than professional to feel discriminated with a (p value
=0.015), unskilled employees were significantly more likely than professional to feel
discriminated with a (p value=0.048), males were Significantly more likely than females
to feel discriminated with a (p value =0.039),and participants who had an income of
to 5,000 were Significantly more likely than those earning 10,001 to 20,000 to feel
discriminated with a (p value =0.03).
The findings indicate that participants were able to disclose their participation to others
(mean score 2.82). However, although the findings of the study showed that
participants were able to disclose their participation, those with primary level of
education were Significantly more unlikely than those of college level and graduate level
to disclose their participation with a (p value =0.031 and 0.011 respectively) and
participants with secondary level of education were significantly more unlikely than
those with graduate level of education to disclose with a (p value =0.020).
The study observed that majority of the participants were comfortable with their
participation in the HIV clinical trials by reporting positive effects (mean score 3.88)
with being married associated with more significant positive effects with a (p
value=0.014)
Conclusion:
The study concludes that persons of all social demographic characteristics were not
represented in the clinical trials.
Despite concerns that participants in HIV Vaccine trials face an unacceptable high risk
of psychosocial harm; it was not been borne in this study. While the study is the first in
a Kenyan setting and results are reassuring, they should be interpreted with caution. It
is unclear whether these results can be generalized to a phase III clinical trial enrolling
persons at higher risk of HIV infection and in the general public.
Recommendations:
The researcher recommends that HIV vaccine clinical trial researchers recruit and enroll
participants of all socio-demographic characteristics into the trials in order to ensure
that the vaccine developed is fit for everyone. There is need for HIV vaccine
researchers put in measures to asses the Negative Psychosocial Factors (NPFs) in order
to assess and decreases negative psychosocial that may be experienced by participants
during the course of their participation. It is also recommended that the study be
repeated in people who at higher risk of acquiring HIV who may be targeted for phase
III vaccine studies and determine whether similar results will be found
Citation
Masters Of Science In Clinical Psychology, The University of Nairobi, 2008Publisher
University of Nairobi Department of Psychiatry