Benenson, MW

Kaewkungwal, J

Khamboonruang, C

Kim, JH

Kunasol, P

Nitayaphan, S

Pitisuttithum, P

Rerks-Ngarm, S

Suntharasamai, P

English

PubMed

P Pitisuttithum

S Rerks-Ngarm

J Kaewkungwal

S Nitayaphan

C Khamboonruang

P Kunasol

P Suntharasamai

MW Benenson

JH Kim

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P14-05. Recruitment, retention and participation impact events among women participating in phase III community trial in Thailand

Benenson MW

Suntharasamai P

Kunasol P

Khamboonruang C

Nitayaphan S

Kaewkungwal J

Rerks-Ngarm S

Pitisuttithum P

Kim JH

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Retrovirology

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Retrovirology
Open AccessPoster presentation
P14-05. Recruitment, retention and participation impact events 
among women participating in phase III community trial in 
Thailand
P Pitisuttithum*1, S Rerks-Ngarm2, J Kaewkungwal1, S Nitayaphan3, 
C Khamboonruang4, P Kunasol4, P Suntharasamai1, MW Benenson5 and 
JH Kim5
Address: 1Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand, 2Department of Diseases Control, 
Ministry of Public Health, Bangkok, Thailand, 3Armed Forces Research Institute of Medical Sciences Thai component, Bangkok, Thailand, 
4Department of Disease Control, Ministry of Public Health, Bangkok, Thailand and 5Armed Forces Research Institute of Medical Sciences U.S. 
component, Bangkok, Thailand
* Corresponding author    
Background
Participation of women is considered necessary in HIV
vaccine trials. However, recruitment, decision process,
retention and participation impact events may differ from
men. The trials also require that pregnancy and breast-
feeding be avoided, and this may put pressure on partici-
pants, especially when the study is conducted in sexually
active women aged 18–30 years.
Methods
Randomized, double-blind placebo controlled trial
involving eligible volunteers 18–30 years old of a prime-
boost HIV vaccine. The study has completed enrollment
and vaccination and is now in the follow up phase. Gen-
eral demographic characteristics, reasons for enrolment,
follow up rate and participant impact events (PIE) in
women were analyzed.
Results
6334 out of 16402 (38.6%) participants were female.
66% were married. 20% were single, and the rest were
divorced, widowed or separated. 33% had primary educa-
tion, and 65% had junior secondary or higher education.
Only 2% reported of no education. 76% were employed;
12% were unemployed; and 12% were housewives.
4.34% became pregnant during the initial 7 months
period after first vaccination. The retention rate among
women was high. There was no significant difference in
withdrawal rate between males and females (p = 0.17).
4.6% (297) of women reported PIE which is significantly
different from men (p < 0.01). Marital status was signifi-
cantly associated with PIE among woman with PIE (p <
0.01). 85.2% of PIE were related to personal relationship
problems, and almost all PIE (92.4%) were resolved satis-
factorily. 17.4% of women reporting a PIE withdrew from
participation in spite of satisfactory resolution of the PIE.
Conclusion
The phase III trial successfully enrolled women (38.6%).
They were well educated and typically employed. The
pregnancy rate is reasonable when compared to other vac-
cine trials. Married women reported higher rates of PIE
than other groups. Resolution of PIEs was satisfactory in
most cases.
from AIDS Vaccine 2009
Paris, France. 19–22 October 2009
Published: 22 October 2009
Retrovirology 2009, 6(Suppl 3):P193 doi:10.1186/1742-4690-6-S3-P193
<supplement> <title> <p>AIDS Vaccine 2009</p> </title> <editor>Anna Laura Ross</editor> <note>Meeting abstracts – A single PDF containing all abstracts in this Supplement is available <a href="http://www.biomedcentral.com/content/files/pdf/1742-4690-6-S3-full.pdf">here</a>.</note> <url>http://www.biomedcentral.com/content/pdf/1471-2105-10-S12-info.pdf</url> </supplement>
This abstract is available from: http://www.retrovirology.com/content/6/S3/P193
© 2009 Pitisuttithum et al; licensee BioMed Central Ltd. 


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P14-05. Recruitment, retention and participation impact events among women participating in phase III community trial in Thailand

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