Study Objectives

  1. Aim 1: Assess the effectiveness of cancer symptom awareness intervention delivered in communities and clinics in decreasing time to presentation with cancer syndromes. Our qualitative research has identified that gaps in knowledge and self-efficacy contribute to appraisal delay and the gaps are potentially amenable to intervention with information and family support. We will test the effectiveness of theory-informed group and individualized counselling and printed media. 
  2. Aim 2: Assess impact of a comprehensive, real-time, closed-loop, patient navigation and advocacy platform in reducing time to initiation of cancer treatment. Our current pilot of this platform has increased the number of patients presenting for oncology treatment. We will now assess the impact of the platform in geographically diverse communities with use of randomized controls.
  3. Aim 3: Evaluate whether the combined multilevel intervention decreases cancer stage and increases number treated with curative intent. All patients identified as presenting with a moderate and high probability cancer syndrome will be followed to assess diagnosis, treatment initiation, and vital status. Responses will be validated through pathology records and Thabatse Cancer Cohort. 

Study Design: The Potlako+ trial will be a pair-matched, community-randomized study involving 20 rural and peri-urban communities (population ~190,100 with ~100,000 30 years or older, average growth 5% annually) participating in the BCPP HIV prevention trial. Communities will be randomized 1:1 to the Potlako+ intervention versus control. 

Study Population: 1500 cancer suspects and 400 diagnosed cancers. Human subjects will be enrolled to complete the analyses described in the research approach. The each of the study aims involve human subjects residing in one of the 20 rural and peri-urban communities in Botswana.  Community resident including patients engaged in longitudinal clinical care (HIV, hypertension, diabetes, etc) will receive the patient educational components (Aim 1) delivered by routine clinic staff, study staff, and community leaders.  Cancer suspects from these communities (identified by routine provider of having symptoms/sign suggestive of possible cancer) and those confirmed to have cancer will be involved in navigation and delay mitigation intervention (Aims 2 and 3).

Study Duration: 5 years 

Sponsor: National Institutes of Health (NIH).