Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04141449

A Multilevel Intervention to Improve Timely Cancer Detection and Treatment Initiation

This study evaluates whether the Potlako+ intervention of community education, clinical provider support, and patient navigation can improve access to cancer case for patients presenting with symptoms of cancer. Half of communities will receive the Potlako+ intervention, while the other communities will continue to receive standard programs.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Neoplasms Acquired Immunodeficiency Syndrome Anal Cancer Anus Diseases Anus Neoplasms Blood-Borne Infections Breast Cancer Breast Diseases Breast Neoplasms Cancer Suspect Carcinoma Carcinoma, Squamous Cell Cervical Cancer Colorectal Neoplasms Communicable Diseases Digestive System Diseases Digestive System Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female HIV HIV Infections HNSCC Head and Neck Neoplasms Immune System Diseases Immunologic Deficiency Syndromes Infections Intestinal Diseases Intestinal Neoplasms Lentivirus Infections Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial RNA Virus Infections Rectal Diseases Rectal Neoplasms Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Skin Diseases Skin and Connective Tissue Diseases Slow Virus Diseases Squamous Cell Carcinoma of Head and Neck Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Virus Diseases Vulvar Cancer Vulvar Diseases Vulvar Neoplasms

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Botswana Harvard AIDS Institute

Gaborone, Botswana

About this study

The Potlako+ trial is a pair-matched, community-randomized study involving 20 rural and peri-urban communities in Botswana (population ~190,100 with ~100,000 30 years or older). Communities will be randomized 1:1 to the Potlako+ intervention versus standard care. The goal of the intervention is to identify individuals with symptoms/signs suggestive of cancer and expedite diagnosis (and treatment).

The trial includes a community education component focused on cancer awareness and importance of early diagnosis and a patient navigation component that aims to expedite the diagnostic evaluation. Community education will be directed at approximately 50,000 community residents (30 years and older). We anticipate approximately 1500 cancer suspects will be identified by their clinic providers.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • Community members
  • Inclusion Criteria:
  • Botswana citizen
  • Age 30 years or older
  • engaged in longitudinal care for chronic health problem
  • resident of study community
  • Exclusion Criteria:
  • Involuntary incarceration
  • Educational messaging could interfere with clinical management or increase distress in the opinion or clinic or research staff
  • Cancer suspects
  • Inclusion Criteria:
  • Botswana citizen
  • Age 30 years or older
  • resident of study community
  • Recorded as a cancer suspect by clinic staff
  • Exclusion Criteria
  • Involuntary incarceration
  • Unable or unwilling to provide confirmation of informed consent
  • Already engaged in oncology care

Treatment and study plan

Potlako intervention

Other

Combined provider, patient, and health system intervention to expedite cancer diagnosis and care.

Enhanced Care

Other

Provider education and limited patient counseling.

Primary outcomes

  1. Duration of combined Appraisal and Help-seeking intervals

    Time frame: Baseline

    Number of days from patient symptom awareness to first clinic visit, among patients with moderate or high probability of cancer

  2. Duration of Diagnostic interval

    Time frame: From date of first clinic visit to date of cancer diagnosis or diagnosis excluding cancer, up to 365 days

    Number of days from first clinic visit to cancer diagnosis or diagnosis excluding cancer, among patients with moderate or high probability of cancer

  3. Duration of Pre-Treatment interval

    Time frame: From date of cancer diagnosis to date of cancer treatment up to 365 days

    Number of days from cancer diagnosis to cancer treatment

  4. Proportion of patients treated with limited stage cancer

    Time frame: From date of cancer diagnosis to date of cancer treatment up to 365 days

    Among patients with confirmed cancer, proportion treated with stage I/II disease

  5. Incidence of curative-intent treatment

    Time frame: From intervention start up to trial end at 1825 days

    Cumulative incidence (cases per standardized population) of initiation of curative-intent cancer treatment

Secondary outcomes

  1. Cancer presenting as emergency

    Time frame: From date of cancer diagnosis to date of cancer treatment up to 7 days

    Among patients with confirmed cancer, proportion of cancer cases presenting as emergency (inpatient admission or death within 1 week of presentation with symptom).

  2. Incident low probability cancer syndromes

    Time frame: Baseline

    Cumulative incidence (cases per standardized population) of presentation with low probability cancer syndromes

  3. Final diagnosis within 8 weeks

    Time frame: From date of first clinic visit to date of cancer diagnosis or diagnosis excluding cancer, up to 56 days

    Among patients with moderate to high probability cancer symptoms, proportion with cancer diagnosis or exclusion of cancer diagnosis within 8 weeks of initial clinic visit

  4. Incident invasive procedures in cancer suspects

    Time frame: From intervention start up to trial end at 1825 days

    Cumulative incidence (cases per standardized population) of presentation with low, moderate, or high probability cancer syndromes

  5. Patients treated for cancer

    Time frame: From date of cancer diagnosis to date of cancer treatment up to 365 days

    Among patients with confirmed cancer, proportion of cancer cases receiving any cancer-specific therapy

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Botswana Harvard AIDS Institute Partnership
  • Dana-Farber Cancer Institute
  • National Cancer Institute (NCI)
  • Rutgers Cancer Institute of New Jersey

Registry information

Official study title

A Multilevel Intervention (Potlako+) to Improve Timely Cancer Detection and Treatment

Acronym: Potlako+

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Oct 28, 2019
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.