Background:  We describe some of the challenges in recruiting subjects for a large HIV clinical trial in resource-limited countries. In implementing the Breastfeeding, Antiretroviral and Nutritional (BAN) study in Lilongwe, Malawi, lessons were learned concerning recruitment in this setting.

Methods:  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 breastfeeding. We plan to enroll 2688 HIV⁺ women with CD4 counts > 200 cells/µL and hepatitis B (HBV) > 7g/dL. HIV-infected pregnant women are told about the study as part of the antenatal prevention of mother-to-child- transmission (MTCT) testing and prophylaxis 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 due to the following reasons: > 30 weeks gestation (n = 43), exposure to ART (n = 14), unwilling to breast feed (n = 9), active tuberculosis (TB) (n = 11), work conflict (n = 11), likely to relocate (n = 8), or other (e.g., poor obstetric history and hypertension) (n = 3). Of the 441 eligible, 176 (40%) declined to schedule an enrollment visit; 2 of the main reasons cited were need to consult the husband (n = 34) or not interested (n = 38). 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. 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.

Keywords: clinical trials; recruitment; africa