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