NeoplasmsNCT02752061
Potlako: A Programmatic Intervention to Improve Access to Timely Oncology Care
A study testing Potlako intervention in people with Neoplasms and HIV, run by Harvard School of Public Health (HSPH) at 1 site in Botswana.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neoplasms, HIV, Healthcare Disparity
- What is being tested?
- Potlako intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 979 participants
- Where
- 1 siteBotswana
- Study dates
- 13 May 2016to 21 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Citizen of Botswana
- Suspected or diagnosed cancer
Who cannot join
- Involuntary incarceration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Potlako: A Programmatic Multi-facility Level Intervention to Improve Access to Timely Oncology Care in Botswana
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.
- Conditions
- Neoplasms, HIV, Healthcare Disparity
- Being tested
- Potlako intervention
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Potlako interventionOther
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
| Study group | Role | What they receive |
|---|---|---|
| Kweneng East District | Experimental | Patient presenting with possible cancer symptoms/sign to a clinic or hospital in Kweneng East District during study period. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer stage
Measured: 1 day visit
Time from initial clinic visit with cancer symptom/sign to entry into oncology care
Measured: 1 day visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study start13 May 2016
- Primary completion21 Jul 2020
- Study completion21 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 979 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Botswana Harvard AIDS Institute Partnership, Botswana Ministry of Health, Dana-Farber Cancer Institute
- Responsible party
- Principal investigator, Scott Dryden-Peterson, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02752061
- Sponsor's protocol ID
- BHP078
- Status last verified
- Jul 2020
- First submitted
- 22 Apr 2016
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29896450
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potlako: A Programmatic Multi-facility Level Intervention to Improve Access to Timely Oncology Care in Botswana
- ClinicalTrials.gov ID
- NCT02752061
- Acronym / sponsor ID
- BHP078
- Conditions
- Neoplasms, HIV, Healthcare Disparity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 979 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Botswana Harvard AIDS Institute Partnership, Botswana Ministry of Health, Dana-Farber Cancer Institute
- Study start
- 13 May 2016 (actual)
- Primary completion
- 21 Jul 2020 (actual)
- Study completion
- 21 Jul 2020 (actual)
- First posted
- 26 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kweneng East District | Experimental | Other: Potlako interventionPatient presenting with possible cancer symptoms/sign to a clinic or hospital in Kweneng East District during study period. |
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Citizen of Botswana
- Suspected or diagnosed cancer
Key exclusion criteria (1 listed)
- Involuntary incarceration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Potlako interventionMulticomponent 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 | Other | Kweneng East District |
Primary outcome
Cancer stage
Time frame: 1 day visit
Time from initial clinic visit with cancer symptom/sign to entry into oncology care
Time frame: 1 day visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
- Derived from this study: PubMed 29896450Tapela 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Potlako intervention in people with Neoplasms and HIV, run by Harvard School of Public Health (HSPH) at 1 site in Botswana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Botswana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer stage (time frame: 1 day visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02752061, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2020; AzTrials last refreshed its copy on 1 Nov 2026.