NeoplasmsPhase 2Potlako+NCT04141449
A Multilevel Intervention to Improve Timely Cancer Detection and Treatment Initiation
A Phase 2 study testing Potlako intervention and Enhanced care in people with Neoplasms and Hiv, run by Brigham and Women's Hospital at 1 site in Botswana.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neoplasms, Hiv, Cervical Cancer
- What is being tested?
- Potlako intervention and Enhanced care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 874 participants
- Where
- 1 siteBotswana
- Study dates
- 18 Nov 2020to 30 Sep 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multilevel Intervention (Potlako+) to Improve Timely Cancer Detection and Treatment
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.
Read the detailed description
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.
- Conditions
- Neoplasms, Hiv, Cervical Cancer, Breast Cancer, HNSCC, Vulvar Cancer
- Being tested
- Potlako intervention, Enhanced care
- Medical subject headings
- Neoplasms, Acquired Immunodeficiency Syndrome, Uterine Cervical Neoplasms, Breast Neoplasms, Squamous Cell Carcinoma of Head and Neck, Vulvar Neoplasms, Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Potlako interventionOther
Combined provider, patient, and health system intervention to expedite cancer diagnosis and care.
Enhanced careOther
Provider education and limited patient counseling.
| Study group | Role | What they receive |
|---|---|---|
| Potlako intervention | Experimental | * 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. Receives: Other: Potlako intervention |
| Enhanced Care | Active comparator | * 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. Receives: Other: Enhanced care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of combined Appraisal and Help-seeking intervals
Number of days from patient symptom awareness to first clinic visit, among patients with moderate or high probability of cancer
Measured: Baseline
Duration of Diagnostic interval
Number of days from first clinic visit to cancer diagnosis or diagnosis excluding cancer, among patients with moderate or high probability of cancer
Measured: From date of first clinic visit to date of cancer diagnosis or diagnosis excluding cancer, up to 365 days
Duration of Pre-Treatment interval
Number of days from cancer diagnosis to cancer treatment
Measured: From date of cancer diagnosis to date of cancer treatment up to 365 days
Proportion of patients treated with limited stage cancer
Among patients with confirmed cancer, proportion treated with stage I/II disease
Measured: From date of cancer diagnosis to date of cancer treatment up to 365 days
Incidence of curative-intent treatment
Cumulative incidence (cases per standardized population) of initiation of curative-intent cancer treatment
Measured: From intervention start up to trial end at 1825 days
Secondary outcomes (5)
Cancer presenting as emergency
Among patients with confirmed cancer, proportion of cancer cases presenting as emergency (inpatient admission or death within 1 week of presentation with symptom).
Measured: From date of cancer diagnosis to date of cancer treatment up to 7 days
Incident low probability cancer syndromes
Cumulative incidence (cases per standardized population) of presentation with low probability cancer syndromes
Measured: Baseline
Final diagnosis within 8 weeks
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
Measured: From date of first clinic visit to date of cancer diagnosis or diagnosis excluding cancer, up to 56 days
Incident invasive procedures in cancer suspects
Cumulative incidence (cases per standardized population) of presentation with low, moderate, or high probability cancer syndromes
Measured: From intervention start up to trial end at 1825 days
Patients treated for cancer
Among patients with confirmed cancer, proportion of cancer cases receiving any cancer-specific therapy
Measured: From date of cancer diagnosis to date of cancer treatment up to 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start18 Nov 2020
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Paired, community-randomized trial
- Masking
- None (open label)
- Enrolment
- 874 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Botswana Harvard AIDS Institute Partnership, Dana-Farber Cancer Institute, National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey
- Responsible party
- Principal investigator, Scott Lee Dryden-Peterson, Brigham and Women's Hospital
- Investigators
- Scott Dryden-Peterson, MD, MSc, Principal investigator, Brigham and Women's Hospital, Botswana Harvard AIDS Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04141449
- Sponsor's protocol ID
- BHP0120
- Other IDs
- R01CA236546
- Acronym
- Potlako+
- Status last verified
- Dec 2025
- First submitted
- 24 Oct 2019
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multilevel Intervention (Potlako+) to Improve Timely Cancer Detection and Treatment
- ClinicalTrials.gov ID
- NCT04141449
- Acronym / sponsor ID
- Potlako+ / BHP0120
- Conditions
- Neoplasms, Hiv, Cervical Cancer, Breast Cancer, HNSCC, Vulvar Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 874 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Botswana Harvard AIDS Institute Partnership, Dana-Farber Cancer Institute, National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey
- Study start
- 18 Nov 2020 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 28 Oct 2019 (actual)
- 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Paired, community-randomized trial
| Arm | Type | Receives |
|---|---|---|
| Potlako intervention | Experimental | Other: Potlako intervention* 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. |
| Enhanced Care | Active comparator | Other: Enhanced care* 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. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 interventionCombined provider, patient, and health system intervention to expedite cancer diagnosis and care. | Other | Potlako intervention |
| Enhanced careProvider education and limited patient counseling. | Other | Enhanced Care |
Primary outcome
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
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
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
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
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
5 secondary outcomes
Cancer presenting as emergency
Time frame: From date of cancer diagnosis to date of cancer treatment up to 7 days
Incident low probability cancer syndromes
Time frame: Baseline
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
Incident invasive procedures in cancer suspects
Time frame: From intervention start up to trial end at 1825 days
Patients treated for cancer
Time frame: From date of cancer diagnosis to date of cancer treatment up to 365 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: Yes. 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.
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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.
Scott Dryden-Peterson, MD, MSc principal investigator
Brigham and Women's Hospital, Botswana Harvard AIDS Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Potlako intervention and Enhanced care in people with Neoplasms and Hiv, run by Brigham and Women's Hospital 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?
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: under way, not looking for participants, as of the sponsor's last update on 31 Dec 2025. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Duration of combined Appraisal and Help-seeking intervals (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Dec 2025.