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| ID | Type | Description | Link |
|---|---|---|---|
| 1U01CA294756 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| University of California, Los Angeles | OTHER |
| Partners in Hope, Inc. | INDUSTRY |
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The goal of this clinical trial is identify an effective and implementable set of implementation strategies to increase cervical cancer prevention in Malawi. The main questions it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Condition 1: In-person training | Active Comparator |
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| Condition 2: In-person training + Prompt | Experimental |
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| Condition 3: In-person training + Coaching | Experimental |
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| Condition 4: In-person training + Prompt + Coaching | Experimental |
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| Condition 5: Virtual training | Experimental |
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| Condition 6: Virtual training + Prompt | Experimental |
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| Condition 7: Virtual training + Coaching | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| In-person training | Behavioral | An in-person educational session. |
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| Measure | Description | Time Frame |
|---|---|---|
| Difference in prevalence of discussions surrounding methods of cervical cancer prevention | Discussions about methods of cervical cancer prevention will be reported by clients following each routine HIV care visit. This rate is defined as the percentage of visits during which there is a discussion about methods of cervical cancer prevention. This rate will be compared between the groups with and without each intervention component. | Months 7-18 |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in prevalence of completing a cervical cancer prevention program | Completing a cervical cancer prevention program will be reported by clients following each routine HIV care visit. This prevalence is defined as the percentage of clients who complete a cervical cancer prevention program. This prevalence will be compared between the groups with and without each intervention component. | Months 7-18 |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of the implementation strategies | Health workers will be asked a set of questions to assess their perceived acceptability of the implementation strategies, based on the Theoretical Framework of Acceptability questionnaire, and these will be combined into an acceptability score (ranging from 0-27 with a higher score indicating greater acceptability). We will compare the average acceptability score between groups with and without each intervention component. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Corrina Moucheraud | Contact | 212-992-6129 | c.moucheraud@nyu.edu | |
| Risa M Hoffman | Contact | RHoffman@mednet.ucla.edu |
| Name | Affiliation | Role |
|---|---|---|
| Corrina Moucheraud | New York University | Principal Investigator |
| Risa M Hoffman | University of California, Los Angeles | Principal Investigator |
| Sam Phiri |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Partners in Hope | Recruiting | Lilongwe | Malawi |
Fully deidentified survey data and focus group discussion transcripts
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Survey data will be deposited into a data repository after it has been fully de-identified. De-identified focus group discussion data will be available on a by-request basis via a data repository.
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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: Provider Baseline Consent English | Jul 2, 2025 | Jan 8, 2026 | ICF_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Parent Consent Baseline English | Jul 2, 2025 | Jan 8, 2026 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Client Consent Baseline English | Jul 2, 2025 | Jan 8, 2026 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: Client Consent FollowUp English | Jul 30, 2025 | Jan 8, 2026 | ICF_003.pdf |
| ICF | No | No | Yes | Informed Consent Form: Parent Consent FollowUp English | Jul 30, 2025 | Jan 8, 2026 | ICF_004.pdf |
| ICF | No | No | Yes | Informed Consent Form: Provider FGD Consent English | Jun 13, 2025 | Jan 8, 2026 | ICF_005.pdf |
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| Condition 8: Virtual training + Prompt + Coaching | Experimental |
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| Virtual training | Behavioral | A virtual educational session. |
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| Coaching | Behavioral | Short video vignettes plus reinforcing messages |
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| Prompts | Behavioral | Visual aide to remind providers to discuss cervical cancer prevention methods. |
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| Difference in prevalence of initiating a cervical cancer prevention program among those uninitiated | This prevalence is defined among those who have not begun a cervical cancer prevention program at study entry. This prevalence will be compared between the groups with and without each intervention component. | Months 7-18 |
| Months 1-9 |
| Partners in Hope, Inc. |
| Principal Investigator |