Lessons learnt from implementing an empirically informed recruitment approach for FEM-PrEP, a large HIV prevention clinical trial

Caleb Parker, Amy Corneli, Kawango Agot, Jacob Odhiambo, Jesse Asewe, Khatija Ahmed, Joseph Skhosana, Malebo Ratlhagana, Michele Lanham, Christina Wong, Jennifer Deese, Rachel Manongi, Lut Van Damme
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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.