NCT02752061

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
979

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 26, 2016

Completed
17 days until next milestone

Study Start

First participant enrolled

May 13, 2016

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2020

Completed
Last Updated

July 23, 2020

Status Verified

July 1, 2020

Enrollment Period

4.2 years

First QC Date

April 22, 2016

Last Update Submit

July 21, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Cancer stage

    1 day visit

  • Time from initial clinic visit with cancer symptom/sign to entry into oncology care

    1 day visit

Study Arms (2)

Kweneng East District

EXPERIMENTAL

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

Other: Potlako intervention

All other districts

NO INTERVENTION

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).

Interventions

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

Kweneng East District

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Citizen of Botswana
  • Suspected or diagnosed cancer

You may not qualify if:

  • Involuntary incarceration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Botswana Harvard AIDS Institute

Gaborone, Botswana

Location

Related Publications (1)

  • Tapela NM, Peluso MJ, Kohler RE, Setlhako II, Botebele K, Gabegwe K, Nkele I, Narasimhamurthy M, Mmalane M, Grover S, Barak T, Shulman LN, Lockman S, Dryden-Peterson S. A Step Toward Timely Referral and Early Diagnosis of Cancer: Implementation and Impact on Knowledge of a Primary Care-Based Training Program in Botswana. Front Oncol. 2018 May 29;8:187. doi: 10.3389/fonc.2018.00187. eCollection 2018.

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Research Affiliate

Study Record Dates

First Submitted

April 22, 2016

First Posted

April 26, 2016

Study Start

May 13, 2016

Primary Completion

July 21, 2020

Study Completion

July 21, 2020

Last Updated

July 23, 2020

Record last verified: 2020-07

Locations