A Phase 2 interventional study of Potlako intervention and Enhanced care in Neoplasms, Hiv and Cervical Cancer, sponsored by Brigham and Women's Hospital. Active, not recruiting at 1 site in Botswana. Open to participants aged 30 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-31.
Sponsored by Brigham and Women's Hospital · Phase 2, Interventional, and Health services research
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.
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's enrollment of 874 is above the median of 60 across 7,703 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Brigham and Women's Hospital is the lead sponsor of 1,267 studies on the registry; 228 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Community members
Inclusion Criteria:
Exclusion Criteria:
Cancer suspects
Inclusion Criteria:
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* 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.
Other: Potlako intervention
* 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.
Other: Enhanced care
Combined provider, patient, and health system intervention to expedite cancer diagnosis and care.
Provider education and limited patient counseling.
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From intervention start up to trial end at 1825 days
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).
Time frame: 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
Time frame: 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
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
Cumulative incidence (cases per standardized population) of presentation with low, moderate, or high probability cancer syndromes
Time frame: 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
Time frame: From date of cancer diagnosis to date of cancer treatment up to 365 days
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: Following publication of primary study endpoints and for up to 5 years.
Access criteria: IRB-approved (approval by Botswana Ministry of Health and Wellness required), cancer-related analyses consistent with informed consent document.
This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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