Self-Sampling for Human Papillomavirus (HPV) Testing in African American Women - Mississippi Delta
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to examine the efficacy and costs of this patient-centered
      approach ("Choice" between two cervical cancer screening modalities) in adherence to cervical
      cancer screening as compared to the current standard of care within the public health system
      in Mississippi (Pap test at the local department -"Pap") among un/under-screened African
      American women in the Mississippi Delta using a theory-based, culturally relevant
      intervention implemented by Peer Health Educators (PHEs).
    

Detailed description: 
      OBJECTIVE: Our objective is to examine the efficacy and costs of a patient-centered approach
      ("Choice" between self-sampling and Pap test) in adherence to cervical cancer screening as
      compared to Pap test at the local health department ("Pap") among un/under-screened African
      American women in the Mississippi Delta.

      HYPOTHESES: Women in the "Choice" arm will have a higher cervical cancer screening adherence
      as well as higher satisfaction than women assigned to the "Pap" arm; (2) Within the "Choice"
      arm, more women will choose and complete self-sampling than Pap test; and (3) The "Choice"
      intervention will be on average less costly and more cost-effective than the "Pap"
      intervention.

      SPECIFIC AIMS: (1) To compare the impact of these two intervention approaches, "Choice"
      versus "Pap", on cervical cancer screening adherence through a group randomized controlled
      trial; (2) To compare patient satisfaction between the two intervention approaches; and (3)
      To compare the costs and cost-effectiveness of these two intervention approaches, "Choice"
      versus "Pap".

      STUDY DESIGN: 12 towns will be randomized to either "Choice" or "Pap" (180 women/arm). Peer
      Health Educators (PHEs) will identify African American women who report not having undergone
      cervical cancer screening in the past three years and deliver a brief theory-based, cultural
      relevant educational session on cervical cancer and screening using a door-to-door approach.
      Women randomized to the "Pap" arm will be provided with information on how to schedule an
      appointment at the local health department. Women randomized to the "Choice" arm will be
      given the choice of attending the health department for a Pap test or self-collecting their
      own sample at home to be sent for HPV testing. PHEs will follow-up with women in either arm
      who have a positive test in order to assure diagnostic evaluation and care.
    

Intervention name(s): Pap testing; Choice
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Women will be approached in the community by a Peer Health Educator and scheduled an appointment for a Pap testing at the local health department; Women will be approached in the community by a Peer Health Educator and they will be given a choice between scheduling an appointment for a Pap testing at the local health department or engage in self-sampling for HPV testing at home
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: self-sampling for HPV testing