Study Setting

1
Recruitment of Pregnant Women into Clinical
Research in Developing Countries Challenges and
Experiences on an Operational Level in
Malawi. Charles Chasela1, Yusuf Ahmed2, Stacey
Hurst2, Wezi Msungama1, Margaret Chigwenembe1,
Misheck Luhanga1, Gerald Mwapasa1, Isabel
Mayuni1, David Jones1, Francis Martinson1, Gerald
Tegha1, Charity Chavula1, Denise Jamieson1, Peter
Kazembe3, and Charles van der Horst4 1Univ of
North Carolina Project, Lilongwe, Malawi 2CDC,
Atlanta, GA, USA 3Kamuzu Central Hosp, Lilongwe,
Malawi and 4Univ of North Carolina at Chapel
Hill, NC, USA
12th Conference on Retroviruses and
Opportunistic Infections
631
Methods
Abstract
Target population
Study Setting UNC project is a research and care
centre located at Kamuzu Central Hospital (KCH),
a government tertiary care hospital, in Lilongwe
Malawi. We are recruiting from two clinics,
Bottom Hospital and Kawale Health Center.
Background  We describe some of the challenges
in recruiting subjects for a large HIV clinical
trial in Lilongwe, Malawi. In implementing the
study lessons were learned concerning recruitment
in this setting. Methods HIV-infected pregnant
women are told about the study as part of the
prevention mother-to-child- transmission (PMTCT)
program and asked if they are interested in
participating in the research study. Reasons for
declining participation are recorded by the MTCT
nurse. Results  Among 3004 women tested for HIV
antenatally from March to October, 2004, 540
(18) were HIV infected. Of those testing
positive, 99 (18.3) were ineligible. Of the 441
eligible, 176 (40) declined to schedule an
enrollment visit due to consult the husband or
not interested. Other barriers included
indecision, inability to obtain time off work,
and temporary residence. Of the 265 who scheduled
enrollment for the coming week, 204 (77)
reported. Thus, of the 441 eligible HIV-infected
women, 54 (n 237) chose not to enroll despite
being eligible. Conclusions  The low enrollment
rate among eligible women in this study prompted
new strategies to address barriers to enrollment.
The target population are HIV infected women, who
plan to breast feed, of CD4 200,7g/dl
hemoglobin. Every morning women are told about
the study as part of PMTCT and asked if there are
interested to join. ( see Schema for the process)
Study Design
HIV positive women (CD4 200, Hb 7g/dl who
intend to exclusively breast feed( n2,226)
Maternal Supplements( n 1,113)
No Maternal Supplements
Mom ART (371)
Baby NVP (n 371)
HIV net 012 (n371)
Mom ART (n 371)
HIV net 012 (n371)
Baby NVP (n371)
Results
Design Schema for Screening and enrollment
Introduction
General VCT sensitization talk
Over 31 of Mother to Child transmission of HIV
world wide is estimated to occur through
breastfeeding (BF) in settings where safe feeding
alternatives and antiretroviral therapy (ART) are
not available. A recent Ministry of Health
(MOH) survey projects that 4.2 of births are
HIVve, or 20,000 a year ( MOHP Global Fund
Application 2002) BAN is an open-label
interventional trial that includes both a 2-arm
maternal nutrition intervention to promote
maternal health and a 3-arm ART intervention with
drugs given to the mother, the infant, or neither
to prevent HIV transmission during breast
feeding.
Opts for VCT
Does not Opt for VCT.
ANC
HIV positive
HIV negative
Conclusions and Discussion
Assessed for Eligibility CD4 count 200 Hb
7g/dl
The low enrollment rate among eligible women in
this study prompted new strategies to address
barriers to enrollment. These included  meetings
with influential community leaders drama group
presentations and pre-visit clinic talks on study
misconceptions education for husbands support
for concerns about blood drawing and study
benefits opening of satellite clinics and
reduction of waiting time. With these activities,
average weekly recruitment increased 5-fold, from
3 to 15 per week.
Eligible and Opts for BAN.
Acknowledgements
Eligible but not opt for BAN
Ineligible
Funding/Support This research was funded by the
U.S. Centers for Disease Control and Prevention
Special Interest Project 26-01 U48/CCU409660-9
DHHS/NIH/FIC 2-D43 Tw01039-06 AIDS International
Training and Research Program NIAID P30-AI50410
UNC Center for AIDS Research and the Elizabeth
Glaser Pediatric AIDS Foundation Call to Action
Award and International Leadership Awards,
UNICEF, World Food Programme, Malawi Ministry of
Health and Population, GlaxoSmithKline,
Boehringer-Ingelheim, Roche Pharmaceuticals and
Bristol-Myers Squibb. BAN Study Team both at
University of North Carolina Chapel Hill, Centers
For Disease Control, Atlanta, and UNC Project
team in Lilongwe. Finally all the partcipants
that have accepted VCT and accepted to
participate in the study.
CTA -PMTCT programme
BAN study