Overall, we found that the majority of pregnant women in this Nairobi-based study were willing to participate in research (>90%) and were receptive to having their child immunized with a safe and effective HIV-1 vaccine (>95%). A lower proportion of women was willing to have their child participate in studies requiring frequent blood draws for HIV-1 testing or in an HIV-1 vaccine trial (80% and 64%, respectively). The most frequently cited reason for not wanting to participate in a vaccine trial was fear of side effects, mentioned by approximately 80% of women. Other barriers included concerns about their male partner’s response, stigmatization, and fear of HIV-1 acquisition. Prior to initiating recruitment for pediatric vaccine studies, it will be important to address these specific concerns within the community through education and outreach efforts.
Our findings also suggest that special recruitment strategies may be required for pediatric HIV-1 vaccine studies. Thirty-four percent of women refusing to participate in a pediatric vaccine trial believed that their male partner would object and reported this as a primary reason. In addition, 76% of 750 women responding that they would participate in a research study believed they would need the prior approval of their spouse or partner. Approximately two-thirds of these women believed that their spouse would be in favor and the remaining one-third was uncertain of his response. As male partners were not interviewed in this study we were unable to assess their perspective. Additional studies exploring male attitudes toward participation in vaccine trials will be important to help clarify this. It will also be necessary to target men when launching community out-reach and educational programs directed at potential pediatric research participants. Using couple counseling to identify parents who are willing to participate in vaccine trials is another strategy that may work well. Couple counseling in the antenatal setting has been associated with increased uptake of interventions to prevent vertical as well as heterosexual transmission and may enhance recruitment and retention in clinical trials for HIV-1 vaccines.24
The most significant correlate for participation in pediatric studies was the woman’s willingness to be enrolled in research herself. This suggests that discussing pediatric study participation from the perspective of the parents may contribute to successful mobilization. In addition, identifying those parents willing to participate in research may be a useful strategy for recruitment into pediatric vaccine studies. Other correlates of participation in HIV-1 and vaccine studies were younger age and fewer years of education. One explanation for this is that younger, less educated individuals believe themselves to be at higher risk for HIV-1 acquisition and therefore their perception of the risk–benefit ratio is more favorable.
This cross-sectional study of pediatric vaccine acceptability and willingness to participate in vaccine research has its limitations. As noted earlier, men were not interviewed as part of this study and attitudes of male partners are likely to be important determinants of a woman’s willingness and ability to enroll her child in a vaccine study. In addition, participants were interviewed before learning their HIV-1 status, making it difficult to know whether women who knew they were HIV-1 seropositive and at risk for vertical HIV-1 transmission would have responded differently. It is possible they would have been more receptive toward participation in HIV-1 vaccine trials and infant vaccination against HIV-1. Finally, our study could not address whether behavior will change for women participating in pediatric HIV-1 vaccine trials. Specifically, will women choose to breastfeed over formula feed if their child participates in an HIV-1 vaccine trial, thus increasing risky behavior because they perceive a protective benefit from having their child vaccinated with a candidate vaccine? This concern has come up in HIV-1 vaccine studies among adults and will need to be further examined in mother–infant prevention studies.
In conclusion, as vaccine research continues, feasibility studies such as this one will help prepare for future pediatric vaccine studies in sub-Saharan Africa. Pediatric HIV-1 vaccine trials pose
unique scientific, ethical, and logistical challenges,2
making it important to educate communities most affected by HIV-1 and to address specific concerns well before introducing an HIV-1 vaccine. Evaluating parental attitudes toward participation in research and particularly in vaccine trials may help to shape these educational efforts and may guide trial design and community preparation. Furthermore, while immunization campaigns against childhood illnesses have been successful in Kenya and other developing countries, there is no guarantee that availability of an HIV-1 vaccine will lead to widespread public acceptance. Many factors are likely to contribute and effectiveness of HIV vaccine programs will ultimately depend on the availability and willingness of individuals to accept vaccination.