TY - JOUR
T1 - Issues in women's participation in a phase III community HIV vaccine trial in Thailand
AU - Kaewkungwal, Jaranit
AU - Pitisuttithum, Punnee
AU - Rerks-Ngarm, Supachai
AU - Nitayaphan, Sorachai
AU - Khamboonruang, Chirasak
AU - Kunasol, Prayura
AU - Suntharasamai, Pravan
AU - Pungpak, Swangjai
AU - Vanijanonta, Sirivan
AU - Bussaratid, Valai
AU - Maek-A-Nantawat, Wirach
AU - Dhitavat, Jittima
AU - Thongcharoen, Prasert
AU - Pawarana, Rungrawee
AU - Sabmee, Yupa
AU - Benenson, Mike W.
AU - Morgan, Patricia
AU - O'Connell, Robert J.
AU - Kim, Jerome
PY - 2013
Y1 - 2013
N2 - To assess qualities and outcomes of women participating in a large, community-based HIV vaccine trial, the present study was conducted among female participants of the RV 144 prime-boost trial in Thailand from 2003 to 2009. Qualities of participation refer to complete vaccination, retention, and status change. Outcomes of participation refer to incident rate, adverse event, and participation impact event. A total of 6,334 (38.6%) women participated in the trial, of whom about 50% were classified as low risk and 11% as high risk. About 85% of participants completed four vaccinations and 76% were included in the per-protocol analysis of the on-time vaccination schedule. More women (88%) completed 42 months follow-up compared with men (85%). Women aged 21 and above had more adverse events compared to younger age groups. More women (5%) compared with men (3%) reported participation impact events (PIEs). High-risk women had more PIEs and a higher infection rate compared to the low-risk group. Complete vaccination and retention on last follow-up were more common in married women aged above 21, and being a housewife. Female volunteers showed the same qualities and outcomes of participation as males in the HIV vaccine trial. There was no statistically significant difference in vaccine efficacy between men and women, especially among the high-risk and married women. The study highlighted the important behavioral, social, and cultural issues that could be considered for future HIV vaccine trial designs.
AB - To assess qualities and outcomes of women participating in a large, community-based HIV vaccine trial, the present study was conducted among female participants of the RV 144 prime-boost trial in Thailand from 2003 to 2009. Qualities of participation refer to complete vaccination, retention, and status change. Outcomes of participation refer to incident rate, adverse event, and participation impact event. A total of 6,334 (38.6%) women participated in the trial, of whom about 50% were classified as low risk and 11% as high risk. About 85% of participants completed four vaccinations and 76% were included in the per-protocol analysis of the on-time vaccination schedule. More women (88%) completed 42 months follow-up compared with men (85%). Women aged 21 and above had more adverse events compared to younger age groups. More women (5%) compared with men (3%) reported participation impact events (PIEs). High-risk women had more PIEs and a higher infection rate compared to the low-risk group. Complete vaccination and retention on last follow-up were more common in married women aged above 21, and being a housewife. Female volunteers showed the same qualities and outcomes of participation as males in the HIV vaccine trial. There was no statistically significant difference in vaccine efficacy between men and women, especially among the high-risk and married women. The study highlighted the important behavioral, social, and cultural issues that could be considered for future HIV vaccine trial designs.
UR - http://www.scopus.com/inward/record.url?scp=84886689572&partnerID=8YFLogxK
U2 - 10.1089/aid.2012.0265
DO - 10.1089/aid.2012.0265
M3 - Article
C2 - 23343395
AN - SCOPUS:84886689572
SN - 0889-2229
VL - 29
SP - 1524
EP - 1534
JO - AIDS Research and Human Retroviruses
JF - AIDS Research and Human Retroviruses
IS - 11
ER -