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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA236546 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Botswana Harvard AIDS Institute Partnership | OTHER |
| Dana-Farber Cancer Institute | OTHER |
| National Cancer Institute (NCI) | NIH |
| Rutgers Cancer Institute of New Jersey |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Potlako intervention | Experimental |
|
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| Enhanced Care | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Potlako intervention | Other | Combined provider, patient, and health system intervention to expedite cancer diagnosis and care. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 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 | 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 | From intervention start up to trial end at 1825 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From date of cancer diagnosis to date of cancer treatment up to 7 days |
| Incident low probability cancer syndromes |
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Community members
Inclusion Criteria:
Exclusion Criteria:
Cancer suspects
Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Scott Dryden-Peterson, MD, MSc | Brigham and Women's Hospital, Botswana Harvard AIDS Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Botswana Harvard AIDS Institute | Gaborone | Botswana |
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.
Following publication of primary study endpoints and for up to 5 years.
IRB-approved (approval by Botswana Ministry of Health and Wellness required), cancer-related analyses consistent with informed consent document.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 5, 2019 | Jul 23, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D000163 | Acquired Immunodeficiency Syndrome |
| D002583 | Uterine Cervical Neoplasms |
| D001943 | Breast Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D014846 | Vulvar Neoplasms |
| D001005 | Anus Neoplasms |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| OTHER |
Paired, community-randomized trial
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| Enhanced care | Other | Provider education and limited patient counseling. |
|
Cumulative incidence (cases per standardized population) of presentation with low probability cancer syndromes |
| 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 | 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 | 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 | From date of cancer diagnosis to date of cancer treatment up to 365 days |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D006258 | Head and Neck Neoplasms |
| D014845 | Vulvar Diseases |
| D012004 | Rectal Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |