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| Name | Class |
|---|---|
| Muhimbili University of Health and Allied Sciences | OTHER |
| RTI International | OTHER |
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This study will test a stigma reduction intervention with women living with HIV in Tanzania.
This study will test a culturally and linguistically relevant stigma reduction intervention, Labda Siku Moja, among women living with HIV in Tanzania.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment as Usual Group | No Intervention | This group will receive treatment as usual which means that no formal stigma reduction intervention will be provided. At the end of the follow-up period, this group will be invited to view the Labda Siku Moja stigma reduction intervention without follow-up. | |
| Stigma Intervention Group | Experimental | This group will participate in a 5 week intervention. Each week, intervention group participants will watch one ethnodrama segment of the Labda Siku Moja stigma reduction intervention followed by a guided debrief using motivational interviewing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Labda Siku Moja stigma reduction intervention | Behavioral | The Labda Siku Moja stigma reduction intervention is a tailored stigma reduction intervention for women living with HIV in Tanzania. It is comprised of five ethnodramas (video stories) culturally and linguistically relevant to the Tanzanian women living with HIV. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Recruited as Measured by Enrollment Logs | up to 6 months | |
| Number of Study Participants Retained in Study as Measured by Enrollment Logs | 30, 90, and 180 days after intervention | |
| Percent of Questions Left Blank on Study Instruments | baseline and 30, 90, and 180 days after intervention | |
| Time it Takes in Minutes for Participants to Complete the Questionnaires | baseline and 30, 90, and 180 days after intervention | |
| Number of Women Who Completed All 5 Sessions | up to 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Internalized Stigma, as Measured by the Swahili Version of the Multidimensional Measure of Internalized Stigma Scale | Scores range from 0 to 100 with lower scores indicating less stigma and higher scores indicating more stigma | baseline and 30, 90, and 180 days after intervention |
| Change in Coping Self-efficacy, as Measured by the Swahili Version of the Coping Self-Efficacy Scale |
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Inclusion Criteria:
The inclusion criteria for this study are:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael V. Relf, PhD | Duke University School of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Muhimbili University of Health and Allied Sciences | Dar es Salaam | Tanzania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40138392 | Derived | Nyblade L, Kilonzo MN, Kisamo DH, Mtei RJ, Pan W, Relf MV. Efficacy Testing of a Culturally Relevant Stigma Reduction Intervention for Women Living With HIV in Tanzania: Protocol for a Randomized Controlled Trial. J Assoc Nurses AIDS Care. 2025 Mar 26;36(5):470-481. doi: 10.1097/JNC.0000000000000538. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment as Usual Group | This group will receive treatment as usual which means that no formal stigma reduction intervention will be provided. At the end of the follow-up period, this group will be invited to view the Labda Siku Moja stigma reduction intervention without follow-up. |
| FG001 | Stigma Intervention Group | This group will participate in a 5 week intervention. Each week, intervention group participants will watch one ethnodrama segment of the Labda Siku Moja stigma reduction intervention followed by a guided debrief using motivational interviewing. Labda Siku Moja stigma reduction intervention: The Labda Siku Moja stigma reduction intervention is a tailored stigma reduction intervention for women living with HIV in Tanzania. It is comprised of five ethnodramas (video stories) culturally and linguistically relevant to the Tanzanian women living with HIV. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment as Usual Group | This group will receive treatment as usual which means that no formal stigma reduction intervention will be provided. At the end of the follow-up period, this group will be invited to view the Labda Siku Moja stigma reduction intervention without follow-up. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Recruited as Measured by Enrollment Logs | Posted | Count of Participants | Participants | up to 6 months |
|
baseline and 30, 90, and 180 days after intervention
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment as Usual Group | This group will receive treatment as usual which means that no formal stigma reduction intervention will be provided. At the end of the follow-up period, this group will be invited to view the Labda Siku Moja stigma reduction intervention without follow-up. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Relf, Ph.D. | Duke University School of Nursing | 919-684-9219 | michael.relf@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 23, 2024 | May 6, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 13, 2023 | Nov 28, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D057545 | Social Stigma |
| D003863 | Depression |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
| D001526 | Behavioral Symptoms |
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|
Scores range from 0 to 26, with lower scores indicating lower coping self-efficacy and higher scores indicating greater coping self-efficacy. |
| baseline and 30, 90, and 180 days after intervention |
| Change in Self-esteem, as Measured by the Swahili Version of the Rosenberg Self-Esteem Scale | Scores range from 10 to 40, with lower scores indicating lower self-esteem and higher scores indicating higher self-esteem | baseline and 30, 90, and 180 days after intervention |
| Hope, as Measured by the Swahili Version of the State of Hope Scale | Scores range from 6 to 24, with lower scores indicating less hope and higher scores indicating more hope | Baseline |
| Change in Depressive Symptoms, as Measured by the Swahili Version of the Patient Health Questionnaire 9 | Scores range from 0 to 27, with lower scores indicating less depressive symptoms and higher scores indicating more depressive symptoms | baseline and 30, 90, and 180 days after intervention |
| Stigma Intervention Group |
This group will participate in a 5 week intervention. Each week, intervention group participants will watch one ethnodrama segment of the Labda Siku Moja stigma reduction intervention followed by a guided debrief using motivational interviewing. Labda Siku Moja stigma reduction intervention: The Labda Siku Moja stigma reduction intervention is a tailored stigma reduction intervention for women living with HIV in Tanzania. It is comprised of five ethnodramas (video stories) culturally and linguistically relevant to the Tanzanian women living with HIV. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Number of Study Participants Retained in Study as Measured by Enrollment Logs | Analysis includes participants who completed the visit at the applicable time point. | Posted | Count of Participants | Participants | 30, 90, and 180 days after intervention |
|
|
|
| Primary | Percent of Questions Left Blank on Study Instruments | Analysis includes participants who completed surveys at the time point indicated. | Posted | Number | percent of questions left blank | baseline and 30, 90, and 180 days after intervention |
|
|
|
| Primary | Time it Takes in Minutes for Participants to Complete the Questionnaires | Analysis includes participants who completed surveys at the time point indicated. | Posted | Mean | Standard Deviation | minutes | baseline and 30, 90, and 180 days after intervention |
|
|
|
| Primary | Number of Women Who Completed All 5 Sessions | This outcome measure only applies to the intervention group | Posted | Count of Participants | Participants | up to 5 weeks |
|
|
|
| Secondary | Change in Internalized Stigma, as Measured by the Swahili Version of the Multidimensional Measure of Internalized Stigma Scale | Scores range from 0 to 100 with lower scores indicating less stigma and higher scores indicating more stigma | Analysis includes participants who completed surveys at the time point indicated. | Posted | Mean | Standard Deviation | score on a scale | baseline and 30, 90, and 180 days after intervention |
|
|
|
|
| Secondary | Change in Coping Self-efficacy, as Measured by the Swahili Version of the Coping Self-Efficacy Scale | Scores range from 0 to 26, with lower scores indicating lower coping self-efficacy and higher scores indicating greater coping self-efficacy. | Analysis includes participants who completed surveys at the time point indicated. | Posted | Mean | Standard Deviation | score on a scale | baseline and 30, 90, and 180 days after intervention |
|
|
|
|
| Secondary | Change in Self-esteem, as Measured by the Swahili Version of the Rosenberg Self-Esteem Scale | Scores range from 10 to 40, with lower scores indicating lower self-esteem and higher scores indicating higher self-esteem | Analysis includes participants who completed surveys at the time point indicated. | Posted | Mean | Standard Deviation | score on a scale | baseline and 30, 90, and 180 days after intervention |
|
|
|
|
| Secondary | Hope, as Measured by the Swahili Version of the State of Hope Scale | Scores range from 6 to 24, with lower scores indicating less hope and higher scores indicating more hope | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
|
| Secondary | Change in Depressive Symptoms, as Measured by the Swahili Version of the Patient Health Questionnaire 9 | Scores range from 0 to 27, with lower scores indicating less depressive symptoms and higher scores indicating more depressive symptoms | Analysis includes participants who completed surveys at the time point indicated. | Posted | Mean | Standard Deviation | score on a scale | baseline and 30, 90, and 180 days after intervention |
|
|
|
|
| 0 |
| 80 |
| 0 |
| 80 |
| 0 |
| 80 |
| EG001 | Stigma Intervention Group | This group will participate in a 5 week intervention. Each week, intervention group participants will watch one ethnodrama segment of the Labda Siku Moja stigma reduction intervention followed by a guided debrief using motivational interviewing. Labda Siku Moja stigma reduction intervention: The Labda Siku Moja stigma reduction intervention is a tailored stigma reduction intervention for women living with HIV in Tanzania. It is comprised of five ethnodramas (video stories) culturally and linguistically relevant to the Tanzanian women living with HIV. | 0 | 87 | 0 | 87 | 0 | 87 |
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| 90 days after intervention |
|
|
| 180 days after intervention |
|
|
| 30 days after intervention |
|
|
| 90 days after intervention |
|
|
| 180 days after intervention |
|
|
| 30 days |
|
|
| 90 days |
|
|
| 180 days |
|
|
| 30 days after intervention |
|
|
| 90 days after intervention |
|
|
| 180 days after intervention |
|
|
| Mixed Models Analysis |
| <.0001 |
The p-value is for the t-test of the coefficient of quadratic (TimeXTimeXGroup) trends. |
| Slope |
| 0.002 |
| 2-Sided |
The estimated value is for the slope of quadratic (TimeXTimeXGroup) trends. Controlled for significant covariates. |
| Superiority |
| 30 days after intervention |
|
|
| 90 days after intervention |
|
|
| 180 days after intervention |
|
|
| Mixed Models Analysis |
| .010 |
The p-value is for the t-test of the coefficient of quadratic (TimeXTimeXGroup) trends. |
| Slope |
| -0.0003 |
| 2-Sided |
The estimated value is for the slope of quadratic (TimeXTimeXGroup) trends. Controlled for significant covariates. |
| Superiority |
| 30 days after intervention |
|
|
| 90 days after intervention |
|
|
| 180 days after intervention |
|
|
| Mixed Models Analysis |
| .032 |
The p-value is for the t-test of the coefficient of quadratic (TimeXTimeXGroup) trends. |
| Slope |
| -0.0002 |
| 2-Sided |
The estimated value is for the slope of quadratic (TimeXTimeXGroup) trends. Controlled for significant covariates. |
| Superiority |
| 30 days after intervention |
|
|
| 90 days after intervention |
|
|
| 180 days after intervention |
|
|
| Mixed Models Analysis |
| .734 |
The p-value is for the t-test of the coefficient of quadratic (TimeXTimeXGroup) trends. |
| Slope |
| 0.0002 |
| 2-Sided |
The estimated value is for the slope of quadratic (TimeXTimeXGroup) trends. Controlled for significant covariates. |
| Superiority |