Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-31 @ 2:12 PM
Study NCT ID:
NCT05033002
Status:
COMPLETED
Last Update Posted:
2025-05-29
First Post:
2021-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy Testing of a Culturally Relevant Stigma Intervention With WLWH in Tanzania
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057545', 'term': 'Social Stigma'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'michael.relf@duke.edu', 'phone': '919-684-9219', 'title': 'Michael Relf, Ph.D.', 'organization': 'Duke University School of Nursing'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'baseline and 30, 90, and 180 days after intervention', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment as Usual Group', 'description': '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.', 'otherNumAtRisk': 80, 'deathsNumAtRisk': 80, 'otherNumAffected': 0, 'seriousNumAtRisk': 80, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Stigma Intervention Group', 'description': '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.\n\nLabda 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.', 'otherNumAtRisk': 87, 'deathsNumAtRisk': 87, 'otherNumAffected': 0, 'seriousNumAtRisk': 87, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Recruited as Measured by Enrollment Logs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment as Usual Group', 'description': '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.'}, {'id': 'OG001', 'title': 'Stigma Intervention Group', 'description': '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.\n\nLabda 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 6 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Study Participants Retained in Study as Measured by Enrollment Logs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment as Usual Group', 'description': '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.'}, {'id': 'OG001', 'title': 'Stigma Intervention Group', 'description': '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.\n\nLabda 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.'}], 'classes': [{'title': '30 days after intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}]}, {'title': '90 days after intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}]}, {'title': '180 days after intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30, 90, and 180 days after intervention', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis includes participants who completed the visit at the applicable time point.'}, {'type': 'PRIMARY', 'title': 'Percent of Questions Left Blank on Study Instruments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment as Usual Group', 'description': '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.'}, {'id': 'OG001', 'title': 'Stigma Intervention Group', 'description': '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.\n\nLabda 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.'}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '30 days after intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '90 days after intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '180 days after intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline and 30, 90, and 180 days after intervention', 'unitOfMeasure': 'percent of questions left blank', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis includes participants who completed surveys at the time point indicated.'}, {'type': 'PRIMARY', 'title': 'Time it Takes in Minutes for Participants to Complete the Questionnaires', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment as Usual Group', 'description': '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.'}, {'id': 'OG001', 'title': 'Stigma Intervention Group', 'description': '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.\n\nLabda 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.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48', 'spread': '8', 'groupId': 'OG000'}, {'value': '49', 'spread': '8', 'groupId': 'OG001'}]}]}, {'title': '30 days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42', 'spread': '11', 'groupId': 'OG000'}, {'value': '41', 'spread': '9', 'groupId': 'OG001'}]}]}, {'title': '90 days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44', 'spread': '9', 'groupId': 'OG000'}, {'value': '42', 'spread': '8', 'groupId': 'OG001'}]}]}, {'title': '180 days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43', 'spread': '5', 'groupId': 'OG000'}, {'value': '43', 'spread': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 30, 90, and 180 days after intervention', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis includes participants who completed surveys at the time point indicated.'}, {'type': 'PRIMARY', 'title': 'Number of Women Who Completed All 5 Sessions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stigma Intervention Group', 'description': '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.\n\nLabda 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 5 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure only applies to the intervention group'}, {'type': 'SECONDARY', 'title': 'Change in Internalized Stigma, as Measured by the Swahili Version of the Multidimensional Measure of Internalized Stigma Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment as Usual Group', 'description': '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.'}, {'id': 'OG001', 'title': 'Stigma Intervention Group', 'description': '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.\n\nLabda 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.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.72', 'spread': '21.59', 'groupId': 'OG000'}, {'value': '40.18', 'spread': '23.85', 'groupId': 'OG001'}]}]}, {'title': '30 days after intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.89', 'spread': '19.59', 'groupId': 'OG000'}, {'value': '6.01', 'spread': '11.24', 'groupId': 'OG001'}]}]}, {'title': '90 days after intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.58', 'spread': '14.92', 'groupId': 'OG000'}, {'value': '5.21', 'spread': '11.27', 'groupId': 'OG001'}]}]}, {'title': '180 days after intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.93', 'spread': '13.82', 'groupId': 'OG000'}, {'value': '4.61', 'spread': '11.46', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.41', 'pValueComment': 'The p-value is for the t-test of the coefficient of linear (TimeXGroup) trends.', 'estimateComment': 'The estimated value is for the slope of linear (TimeXGroup) trends. Controlled for significant covariates.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.002', 'pValueComment': 'The p-value is for the t-test of the coefficient of quadratic (TimeXTimeXGroup) trends.', 'estimateComment': 'The estimated value is for the slope of quadratic (TimeXTimeXGroup) trends. Controlled for significant covariates.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 30, 90, and 180 days after intervention', 'description': 'Scores range from 0 to 100 with lower scores indicating less stigma and higher scores indicating more stigma', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis includes participants who completed surveys at the time point indicated.'}, {'type': 'SECONDARY', 'title': 'Change in Coping Self-efficacy, as Measured by the Swahili Version of the Coping Self-Efficacy Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment as Usual Group', 'description': '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.'}, {'id': 'OG001', 'title': 'Stigma Intervention Group', 'description': '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.\n\nLabda 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.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.28', 'spread': '4.76', 'groupId': 'OG000'}, {'value': '13.17', 'spread': '5.41', 'groupId': 'OG001'}]}]}, {'title': '30 days after intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.4', 'spread': '5.63', 'groupId': 'OG000'}, {'value': '17.86', 'spread': '5.06', 'groupId': 'OG001'}]}]}, {'title': '90 days after intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.9', 'spread': '5.28', 'groupId': 'OG000'}, {'value': '18.00', 'spread': '5.02', 'groupId': 'OG001'}]}]}, {'title': '180 days after intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.26', 'spread': '4.49', 'groupId': 'OG000'}, {'value': '17.34', 'spread': '5.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.06', 'pValueComment': 'The p-value is for the t-test of the coefficient of linear (TimeXGroup) trends.', 'estimateComment': 'The estimated value is for the slope of linear (TimeXGroup) trends. Controlled for significant covariates.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.010', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.0003', 'pValueComment': 'The p-value is for the t-test of the coefficient of quadratic (TimeXTimeXGroup) trends.', 'estimateComment': 'The estimated value is for the slope of quadratic (TimeXTimeXGroup) trends. Controlled for significant covariates.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 30, 90, and 180 days after intervention', 'description': 'Scores range from 0 to 26, with lower scores indicating lower coping self-efficacy and higher scores indicating greater coping self-efficacy.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis includes participants who completed surveys at the time point indicated.'}, {'type': 'SECONDARY', 'title': 'Change in Self-esteem, as Measured by the Swahili Version of the Rosenberg Self-Esteem Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment as Usual Group', 'description': '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.'}, {'id': 'OG001', 'title': 'Stigma Intervention Group', 'description': '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.\n\nLabda 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.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.30', 'spread': '4.32', 'groupId': 'OG000'}, {'value': '28.17', 'spread': '4.31', 'groupId': 'OG001'}]}]}, {'title': '30 days after intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.97', 'spread': '3.69', 'groupId': 'OG000'}, {'value': '32.66', 'spread': '3.86', 'groupId': 'OG001'}]}]}, {'title': '90 days after intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.57', 'spread': '4.51', 'groupId': 'OG000'}, {'value': '32.26', 'spread': '3.19', 'groupId': 'OG001'}]}]}, {'title': '180 days after intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.76', 'spread': '3.31', 'groupId': 'OG000'}, {'value': '32.38', 'spread': '3.72', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.05', 'pValueComment': 'The p-value is for the t-test of the coefficient of linear (TimeXGroup) trends.', 'estimateComment': 'The estimated value is for the slope of linear (TimeXGroup) trends. Controlled for significant covariates.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.032', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.0002', 'pValueComment': 'The p-value is for the t-test of the coefficient of quadratic (TimeXTimeXGroup) trends.', 'estimateComment': 'The estimated value is for the slope of quadratic (TimeXTimeXGroup) trends. Controlled for significant covariates.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 30, 90, and 180 days after intervention', 'description': 'Scores range from 10 to 40, with lower scores indicating lower self-esteem and higher scores indicating higher self-esteem', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis includes participants who completed surveys at the time point indicated.'}, {'type': 'SECONDARY', 'title': 'Hope, as Measured by the Swahili Version of the State of Hope Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment as Usual Group', 'description': '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.'}, {'id': 'OG001', 'title': 'Stigma Intervention Group', 'description': '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.\n\nLabda 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.48', 'spread': '3.24', 'groupId': 'OG000'}, {'value': '15.82', 'spread': '3.36', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.506', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.34', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Scores range from 6 to 24, with lower scores indicating less hope and higher scores indicating more hope', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Depressive Symptoms, as Measured by the Swahili Version of the Patient Health Questionnaire 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment as Usual Group', 'description': '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.'}, {'id': 'OG001', 'title': 'Stigma Intervention Group', 'description': '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.\n\nLabda 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.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.20', 'spread': '3.69', 'groupId': 'OG000'}, {'value': '4.63', 'spread': '3.91', 'groupId': 'OG001'}]}]}, {'title': '30 days after intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.05', 'spread': '3.69', 'groupId': 'OG000'}, {'value': '2.09', 'spread': '2.84', 'groupId': 'OG001'}]}]}, {'title': '90 days after intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.00', 'spread': '2.72', 'groupId': 'OG000'}, {'value': '1.77', 'spread': '2.63', 'groupId': 'OG001'}]}]}, {'title': '180 days after intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.84', 'spread': '3.51', 'groupId': 'OG000'}, {'value': '1.84', 'spread': '2.76', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.441', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The p-value is for the t-test of the coefficient of linear (TimeXGroup) trends.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The estimated value is for the slope of linear (TimeXGroup) trends. Controlled for significant covariates.'}, {'pValue': '.734', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.0002', 'pValueComment': 'The p-value is for the t-test of the coefficient of quadratic (TimeXTimeXGroup) trends.', 'estimateComment': 'The estimated value is for the slope of quadratic (TimeXTimeXGroup) trends. Controlled for significant covariates.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 30, 90, and 180 days after intervention', 'description': 'Scores range from 0 to 27, with lower scores indicating less depressive symptoms and higher scores indicating more depressive symptoms', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis includes participants who completed surveys at the time point indicated.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment as Usual Group', 'description': '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.'}, {'id': 'FG001', 'title': 'Stigma Intervention Group', 'description': '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.\n\nLabda 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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '87'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '78'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '167', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment as Usual Group', 'description': '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.'}, {'id': 'BG001', 'title': 'Stigma Intervention Group', 'description': '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.\n\nLabda 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.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.69', 'spread': '14.10', 'groupId': 'BG000'}, {'value': '32.40', 'spread': '12.73', 'groupId': 'BG001'}, {'value': '32.54', 'spread': '13.36', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '167', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '167', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '167', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Tanzania', 'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '167', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-04-23', 'size': 220123, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-05-06T16:31', 'hasProtocol': True}, {'date': '2023-09-13', 'size': 219259, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-11-28T09:56', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 167}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-27', 'studyFirstSubmitDate': '2021-08-31', 'resultsFirstSubmitDate': '2025-05-07', 'studyFirstSubmitQcDate': '2021-08-31', 'lastUpdatePostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-27', 'studyFirstPostDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Recruited as Measured by Enrollment Logs', 'timeFrame': 'up to 6 months'}, {'measure': 'Number of Study Participants Retained in Study as Measured by Enrollment Logs', 'timeFrame': '30, 90, and 180 days after intervention'}, {'measure': 'Percent of Questions Left Blank on Study Instruments', 'timeFrame': 'baseline and 30, 90, and 180 days after intervention'}, {'measure': 'Time it Takes in Minutes for Participants to Complete the Questionnaires', 'timeFrame': 'baseline and 30, 90, and 180 days after intervention'}, {'measure': 'Number of Women Who Completed All 5 Sessions', 'timeFrame': 'up to 5 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in Internalized Stigma, as Measured by the Swahili Version of the Multidimensional Measure of Internalized Stigma Scale', 'timeFrame': 'baseline and 30, 90, and 180 days after intervention', 'description': 'Scores range from 0 to 100 with lower scores indicating less stigma and higher scores indicating more stigma'}, {'measure': 'Change in Coping Self-efficacy, as Measured by the Swahili Version of the Coping Self-Efficacy Scale', 'timeFrame': 'baseline and 30, 90, and 180 days after intervention', 'description': 'Scores range from 0 to 26, with lower scores indicating lower coping self-efficacy and higher scores indicating greater coping self-efficacy.'}, {'measure': 'Change in Self-esteem, as Measured by the Swahili Version of the Rosenberg Self-Esteem Scale', 'timeFrame': 'baseline and 30, 90, and 180 days after intervention', 'description': 'Scores range from 10 to 40, with lower scores indicating lower self-esteem and higher scores indicating higher self-esteem'}, {'measure': 'Hope, as Measured by the Swahili Version of the State of Hope Scale', 'timeFrame': 'Baseline', 'description': 'Scores range from 6 to 24, with lower scores indicating less hope and higher scores indicating more hope'}, {'measure': 'Change in Depressive Symptoms, as Measured by the Swahili Version of the Patient Health Questionnaire 9', 'timeFrame': 'baseline and 30, 90, and 180 days after intervention', 'description': 'Scores range from 0 to 27, with lower scores indicating less depressive symptoms and higher scores indicating more depressive symptoms'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV', 'women living with HIV', 'clinical trial', 'Tanzania', 'efficacy', 'feasibility'], 'conditions': ['HIV', 'Stigma, Social', 'Self Efficacy', 'Self Esteem', 'Hope', 'Depressive Symptoms']}, 'referencesModule': {'references': [{'pmid': '40138392', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'This study will test a stigma reduction intervention with women living with HIV in Tanzania.', 'detailedDescription': 'This study will test a culturally and linguistically relevant stigma reduction intervention, Labda Siku Moja, among women living with HIV in Tanzania.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe inclusion criteria for this study are:\n\n* (1) women who are living with HIV;\n* (2) age 18 (age of adulthood as defined by the Tanzanian government);\n* (3) able and willing to voluntarily consent to participate in the study;\n* (4) able to travel to a data collection in their local community (as described above);\n* (5) demonstrate mental competence at time of informed consent;\n* (6) verbally indicate that they plan to reside in their current community for at least 6 months after enrollment (necessary to prevent attrition);\n* (7) score at the median or higher level on the Swahili Version of the Multidimensional Measure of Internalized HIV Stigma Scale.\n\nExclusion Criteria:\n\n* (1) any acute psychological or physiological distress; if there is evidence of acute psychologic and/or physiologic, they will be excluded from this study and referred to an appropriate site for evaluation and treatment.\n* (2) Transgender women living with HIV will not be eligible to participate in this study to reduce the potential for confounding sources of stigma recognizing that a transgender identity is highly stigmatized and culturally sensitive in Tanzania. Further, it would be exceedingly difficult to recruit a sufficient sample of transgender women living with HIV to conduct an appropriate analysis.\n* (3) Participants may be enrolled in other HIV-related studies except cognitive-behavioral intervention studies addressing stigma, self-efficacy, self-esteem, and/or disclosure'}, 'identificationModule': {'nctId': 'NCT05033002', 'briefTitle': 'Efficacy Testing of a Culturally Relevant Stigma Intervention With WLWH in Tanzania', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Efficacy Testing of a Culturally Relevant Stigma Intervention With Women Living With HIV in Tanzania', 'orgStudyIdInfo': {'id': 'Pro00109278'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Treatment as Usual Group', 'description': '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.'}, {'type': 'EXPERIMENTAL', 'label': 'Stigma Intervention Group', 'description': '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.', 'interventionNames': ['Behavioral: Labda Siku Moja stigma reduction intervention']}], 'interventions': [{'name': 'Labda Siku Moja stigma reduction intervention', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Stigma Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dar es Salaam', 'country': 'Tanzania', 'facility': 'Muhimbili University of Health and Allied Sciences', 'geoPoint': {'lat': -6.82349, 'lon': 39.26951}}], 'overallOfficials': [{'name': 'Michael V. Relf, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University School of Nursing'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Muhimbili University of Health and Allied Sciences', 'class': 'OTHER'}, {'name': 'RTI International', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}