External oversight
An External Advisory Panel (EAP) met at study initiation and mid‐way through follow‐up to evaluate safety and endpoints. At the mid‐way evaluation, baseline differences were noted between trial arms. The EAP advised that analyses be adjusted for key differences at baseline (marital status and HIV risk). Two Community Advisory Boards, one in Homa Bay and one in Siaya, met at least annually to review study progress and to make recommendations.