Lessons learnt from implementing an empirically informed recruitment approach for FEM-PrEP, a large HIV prevention clinical trial
We implemented an empirically informed, geographically based recruitment
approach for FEM-PrEP, a human immunodeficiency virus (HIV) prevention clinical trial of
daily oral emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) for HIV prevention.
During the formative research phase, we conducted a modification of the Priorities for Local
AIDS Control Efforts (PLACE) method and used those data and staff experiences to identify
and prioritize for recruitment geographic areas where HIV incidence might be high. During
the clinical trial, we implemented a routinely monitored and flexible recruitment plan in the
geographical areas identified in the formative research. We describe three lessons learnt from
implementing this approach: 1) the PLACE data were critical in identifying places presumed
to be high risk; 2) staff experiences, in combination with PLACE data, were needed to inform
a practical recruitment strategy; and 3) recruiting in establishments in priority areas identified
by the PLACE data led to screening many HIV-positive women at the Bondo site (Kenya), placing
additional burden on clinic staff. These lessons learnt highlight the critical importance of
having a flexible and monitored recruitment strategy. Although we successfully recruited a
study population at higher risk for HIV, FEM-PrEP was unable to determine the effectiveness of
FTC/TDF for HIV prevention, due to low adherence to the study product among participants.
We must shift the paradigm of recruitment for clinical trials of new products from focusing
on identifying populations with high incidence to identifying populations at risk who are
motivated and able to adhere to the study product regimen.