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

• Sponsor: Harvard School of Public Health (HSPH) (Other)
• Overall Status: Completed
• CT.gov ID: NCT02752061
• Collaborator: Brigham and Women's Hospital (Other), Botswana Harvard AIDS Institute Partnership (Other), Botswana Ministry of Health (Other), Dana-Farber Cancer Institute (Other)
• Enrollment: 979
• Location: 1
• Arms: 2
• Actual Duration (Months): 50.3
• Patients Per Site Per Month: 19.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Neoplasms; HIV; Healthcare Disparity	Other: Potlako intervention	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 979 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Potlako: A Programmatic Multi-facility Level Intervention to Improve Access to Timely Oncology Care in Botswana
• Actual Study Start Date: May 13, 2016
• Actual Primary Completion Date: Jul 21, 2020
• Actual Study Completion Date: Jul 21, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Kweneng East District Patient presenting with possible cancer symptoms/sign to a clinic or hospital in Kweneng East District during study period.	Other: Potlako 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
No Intervention: All other districts 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).

Outcome Measures

Primary Outcome Measures

1. Cancer stage [1 day visit]

2. Time from initial clinic visit with cancer symptom/sign to entry into oncology care [1 day visit]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Citizen of Botswana

• Suspected or diagnosed cancer

Exclusion Criteria:

• Involuntary incarceration

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Botswana Harvard AIDS Institute	Gaborone		Botswana

Sponsors and Collaborators

• Harvard School of Public Health (HSPH)
• Brigham and Women's Hospital
• Botswana Harvard AIDS Institute Partnership
• Botswana Ministry of Health
• Dana-Farber Cancer Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Scott Dryden-Peterson, Assistant Professor, Research Affiliate, Harvard School of Public Health (HSPH)
• ClinicalTrials.gov Identifier: NCT02752061
• Other Study ID Numbers: BHP078
• First Posted: Apr 26, 2016
• Last Update Posted: Jul 23, 2020
• Last Verified: Jul 1, 2020

Study Results

No Results Posted as of Jul 23, 2020