Infections

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Immune System Diseases

All Conditions

Acquired Immunodeficiency Syndrome

HIV Infections

Patient presenting with possible cancer symptoms/sign to a clinic or hospital in Kweneng East District during study period.

Patient presenting with possible cancer symptoms/sign to a clinic or hospital in all other districts of Botswana (or Kweneng East prior to implementation of intervention).

Multicomponent intervention including:

* provider training on early detection and diagnostic approaches to cancer
* patient education on importance of obtaining timely cancer diagnosis
* provision of a patient navigator to facilitate diagnosis and entry into care
* provision of transportation support to vulnerable patients

Potlako intervention

Diagnostic and treatment delays contribute substantially to disparities in cancer morbidity and mortality between low- and middle- income countries (LMICs) and high-income countries. Individuals present with advanced stage disease resulting in minimal chance for cure or long-term survival.

The Potlako project will implement and evaluate a multifaceted intervention to test the hypothesis that a package of enhanced coordination of care including an electronic messaging, transportation support, and training targeted at generalist clinicians at primary and secondary level facilities, can reduce time to diagnosis and stage at diagnosis for HIV-infected individuals with cancer.

Potlako: A Programmatic Intervention to Improve Access to Timely Oncology Care

Potlako: A Programmatic Multi-facility Level Intervention to Improve Access to Timely Oncology Care in Botswana

Brigham and Women's Hospital

Botswana Harvard AIDS Institute Partnership

Botswana Ministry of Health

Dana-Farber Cancer Institute

Harvard School of Public Health (HSPH)

Assistant Professor, Research Affiliate

Neoplasms

Skin and Connective Tissue Diseases

Digestive System Diseases

Rare Diseases

Breast Neoplasms

Uterine Cervical Neoplasms

Vulvar Neoplasms

Anus Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Anus Diseases

Rectal Diseases

Vulvar Diseases

Anal Cancer

Vulvar Cancer

* Provider oncology training focused on detection of cancer symptoms/signs and performance of appropriate diagnostic evaluation
* Community-led cancer symptom awareness campaign to educate residents on methods and importance of early detection of cancer
* Support/counselling call after initial clinician recognition that patient requires evaluation for possible cancer.
* Cross-sectional community-facing activities partnered with longitudinal clinic-based targeted educational program
* Remote phone/SMS-based cancer suspect navigation program to support and expedite evaluation for symptoms/signs of possible cancer.

* Provider oncology training focused on detection of cancer symptoms/signs and performance of appropriate diagnostic evaluation.
* Support/counselling call after initial clinician recognition that patient requires evaluation for possible cancer.

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

Provider education and limited patient counseling.

Enhanced care

Kutlo Manyake, Dip Nursing

Mompati Mmalane, MD

Scott Dryden-Peterson, MD, MSc

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.

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.

A Multilevel Intervention to Improve Timely Cancer Detection and Treatment Initiation

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

Data documentation and any de-identified information arising from this project will be deposited for sharing within the collaboration at a central secure, password protected electronic database managed initially by Botswana Harvard AIDS Institute with longer-term plans to move the database and responsibility for managing it to University of Botswana.

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

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

Number of days from cancer diagnosis to cancer treatment

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

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

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

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

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

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Potlako: A Programmatic Intervention to Improve Access to Timely Oncology Care	NCT02752061	Neoplasms HIV Healthcare Disp...	Potlako interve...	18 Years -	Harvard School of Public Health (HSPH)
A Multilevel Intervention to Improve Timely Cancer Detection and Treatment Initiation	NCT04141449	Neoplasms Hiv Cervical Cancer Breast Cancer HNSCC Vulvar Cancer Anal Cancer Cancer Suspect	Potlako interve... Enhanced care	30 Years -	Brigham and Women's Hospital
Potlako: A Programmatic Intervention to Improve Access to Timely Oncology Care	NCT02752061	Neoplasms HIV Healthcare Disp...	Potlako interve...	18 Years -	Harvard School of Public Health (HSPH)
A Multilevel Intervention to Improve Timely Cancer Detection and Treatment Initiation	NCT04141449	Neoplasms Hiv Cervical Cancer Breast Cancer HNSCC Vulvar Cancer Anal Cancer Cancer Suspect	Potlako interve... Enhanced care	30 Years -	Brigham and Women's Hospital

Spots Global Cancer Trial Database for potlako intervention