Trial Outcomes & Findings for Efficacy Testing of a Culturally Relevant Stigma Intervention With WLWH in Tanzania (NCT NCT05033002)
NCT ID: NCT05033002
Last Updated: 2025-05-29
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
167 participants
Primary outcome timeframe
up to 6 months
Results posted on
2025-05-29
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
80
|
87
|
|
Overall Study
COMPLETED
|
80
|
78
|
|
Overall Study
NOT COMPLETED
|
0
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy Testing of a Culturally Relevant Stigma Intervention With WLWH in Tanzania
Baseline characteristics by cohort
| Measure |
Treatment as Usual Group
n=80 Participants
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
n=87 Participants
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.
|
Total
n=167 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.69 years
STANDARD_DEVIATION 14.10 • n=99 Participants
|
32.40 years
STANDARD_DEVIATION 12.73 • n=107 Participants
|
32.54 years
STANDARD_DEVIATION 13.36 • n=206 Participants
|
|
Sex: Female, Male
Female
|
80 Participants
n=99 Participants
|
87 Participants
n=107 Participants
|
167 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
80 Participants
n=99 Participants
|
87 Participants
n=107 Participants
|
167 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
80 Participants
n=99 Participants
|
87 Participants
n=107 Participants
|
167 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Tanzania
|
80 participants
n=99 Participants
|
87 participants
n=107 Participants
|
167 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: up to 6 monthsOutcome measures
| Measure |
Treatment as Usual Group
n=80 Participants
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
n=87 Participants
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.
|
|---|---|---|
|
Number of Participants Recruited as Measured by Enrollment Logs
|
80 Participants
|
87 Participants
|
PRIMARY outcome
Timeframe: 30, 90, and 180 days after interventionPopulation: Analysis includes participants who completed the visit at the applicable time point.
Outcome measures
| Measure |
Treatment as Usual Group
n=80 Participants
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
n=87 Participants
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.
|
|---|---|---|
|
Number of Study Participants Retained in Study as Measured by Enrollment Logs
30 days after intervention
|
77 Participants
|
77 Participants
|
|
Number of Study Participants Retained in Study as Measured by Enrollment Logs
90 days after intervention
|
79 Participants
|
76 Participants
|
|
Number of Study Participants Retained in Study as Measured by Enrollment Logs
180 days after intervention
|
76 Participants
|
76 Participants
|
PRIMARY outcome
Timeframe: baseline and 30, 90, and 180 days after interventionPopulation: Analysis includes participants who completed surveys at the time point indicated.
Outcome measures
| Measure |
Treatment as Usual Group
n=80 Participants
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
n=87 Participants
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.
|
|---|---|---|
|
Percent of Questions Left Blank on Study Instruments
baseline
|
0 percent of questions left blank
|
0 percent of questions left blank
|
|
Percent of Questions Left Blank on Study Instruments
30 days after intervention
|
0 percent of questions left blank
|
0 percent of questions left blank
|
|
Percent of Questions Left Blank on Study Instruments
90 days after intervention
|
0 percent of questions left blank
|
0 percent of questions left blank
|
|
Percent of Questions Left Blank on Study Instruments
180 days after intervention
|
0 percent of questions left blank
|
0 percent of questions left blank
|
PRIMARY outcome
Timeframe: baseline and 30, 90, and 180 days after interventionPopulation: Analysis includes participants who completed surveys at the time point indicated.
Outcome measures
| Measure |
Treatment as Usual Group
n=80 Participants
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
n=87 Participants
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.
|
|---|---|---|
|
Time it Takes in Minutes for Participants to Complete the Questionnaires
Baseline
|
48 minutes
Standard Deviation 8
|
49 minutes
Standard Deviation 8
|
|
Time it Takes in Minutes for Participants to Complete the Questionnaires
30 days
|
42 minutes
Standard Deviation 11
|
41 minutes
Standard Deviation 9
|
|
Time it Takes in Minutes for Participants to Complete the Questionnaires
90 days
|
44 minutes
Standard Deviation 9
|
42 minutes
Standard Deviation 8
|
|
Time it Takes in Minutes for Participants to Complete the Questionnaires
180 days
|
43 minutes
Standard Deviation 5
|
43 minutes
Standard Deviation 7
|
PRIMARY outcome
Timeframe: up to 5 weeksPopulation: This outcome measure only applies to the intervention group
Outcome measures
| Measure |
Treatment as Usual Group
n=87 Participants
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
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.
|
|---|---|---|
|
Number of Women Who Completed All 5 Sessions
|
76 Participants
|
—
|
SECONDARY outcome
Timeframe: baseline and 30, 90, and 180 days after interventionPopulation: Analysis includes participants who completed surveys at the time point indicated.
Scores range from 0 to 100 with lower scores indicating less stigma and higher scores indicating more stigma
Outcome measures
| Measure |
Treatment as Usual Group
n=80 Participants
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
n=87 Participants
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.
|
|---|---|---|
|
Change in Internalized Stigma, as Measured by the Swahili Version of the Multidimensional Measure of Internalized Stigma Scale
Baseline
|
36.72 score on a scale
Standard Deviation 21.59
|
40.18 score on a scale
Standard Deviation 23.85
|
|
Change in Internalized Stigma, as Measured by the Swahili Version of the Multidimensional Measure of Internalized Stigma Scale
30 days after intervention
|
24.89 score on a scale
Standard Deviation 19.59
|
6.01 score on a scale
Standard Deviation 11.24
|
|
Change in Internalized Stigma, as Measured by the Swahili Version of the Multidimensional Measure of Internalized Stigma Scale
90 days after intervention
|
23.58 score on a scale
Standard Deviation 14.92
|
5.21 score on a scale
Standard Deviation 11.27
|
|
Change in Internalized Stigma, as Measured by the Swahili Version of the Multidimensional Measure of Internalized Stigma Scale
180 days after intervention
|
21.93 score on a scale
Standard Deviation 13.82
|
4.61 score on a scale
Standard Deviation 11.46
|
SECONDARY outcome
Timeframe: baseline and 30, 90, and 180 days after interventionPopulation: Analysis includes participants who completed surveys at the time point indicated.
Scores range from 0 to 26, with lower scores indicating lower coping self-efficacy and higher scores indicating greater coping self-efficacy.
Outcome measures
| Measure |
Treatment as Usual Group
n=80 Participants
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
n=87 Participants
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.
|
|---|---|---|
|
Change in Coping Self-efficacy, as Measured by the Swahili Version of the Coping Self-Efficacy Scale
Baseline
|
13.28 score on a scale
Standard Deviation 4.76
|
13.17 score on a scale
Standard Deviation 5.41
|
|
Change in Coping Self-efficacy, as Measured by the Swahili Version of the Coping Self-Efficacy Scale
30 days after intervention
|
14.4 score on a scale
Standard Deviation 5.63
|
17.86 score on a scale
Standard Deviation 5.06
|
|
Change in Coping Self-efficacy, as Measured by the Swahili Version of the Coping Self-Efficacy Scale
90 days after intervention
|
14.9 score on a scale
Standard Deviation 5.28
|
18.00 score on a scale
Standard Deviation 5.02
|
|
Change in Coping Self-efficacy, as Measured by the Swahili Version of the Coping Self-Efficacy Scale
180 days after intervention
|
14.26 score on a scale
Standard Deviation 4.49
|
17.34 score on a scale
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: baseline and 30, 90, and 180 days after interventionPopulation: Analysis includes participants who completed surveys at the time point indicated.
Scores range from 10 to 40, with lower scores indicating lower self-esteem and higher scores indicating higher self-esteem
Outcome measures
| Measure |
Treatment as Usual Group
n=80 Participants
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
n=87 Participants
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.
|
|---|---|---|
|
Change in Self-esteem, as Measured by the Swahili Version of the Rosenberg Self-Esteem Scale
Baseline
|
28.30 score on a scale
Standard Deviation 4.32
|
28.17 score on a scale
Standard Deviation 4.31
|
|
Change in Self-esteem, as Measured by the Swahili Version of the Rosenberg Self-Esteem Scale
30 days after intervention
|
29.97 score on a scale
Standard Deviation 3.69
|
32.66 score on a scale
Standard Deviation 3.86
|
|
Change in Self-esteem, as Measured by the Swahili Version of the Rosenberg Self-Esteem Scale
90 days after intervention
|
29.57 score on a scale
Standard Deviation 4.51
|
32.26 score on a scale
Standard Deviation 3.19
|
|
Change in Self-esteem, as Measured by the Swahili Version of the Rosenberg Self-Esteem Scale
180 days after intervention
|
28.76 score on a scale
Standard Deviation 3.31
|
32.38 score on a scale
Standard Deviation 3.72
|
SECONDARY outcome
Timeframe: BaselineScores range from 6 to 24, with lower scores indicating less hope and higher scores indicating more hope
Outcome measures
| Measure |
Treatment as Usual Group
n=80 Participants
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
n=87 Participants
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.
|
|---|---|---|
|
Hope, as Measured by the Swahili Version of the State of Hope Scale
|
15.48 score on a scale
Standard Deviation 3.24
|
15.82 score on a scale
Standard Deviation 3.36
|
SECONDARY outcome
Timeframe: baseline and 30, 90, and 180 days after interventionPopulation: Analysis includes participants who completed surveys at the time point indicated.
Scores range from 0 to 27, with lower scores indicating less depressive symptoms and higher scores indicating more depressive symptoms
Outcome measures
| Measure |
Treatment as Usual Group
n=80 Participants
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
n=87 Participants
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.
|
|---|---|---|
|
Change in Depressive Symptoms, as Measured by the Swahili Version of the Patient Health Questionnaire 9
Baseline
|
4.20 score on a scale
Standard Deviation 3.69
|
4.63 score on a scale
Standard Deviation 3.91
|
|
Change in Depressive Symptoms, as Measured by the Swahili Version of the Patient Health Questionnaire 9
30 days after intervention
|
3.05 score on a scale
Standard Deviation 3.69
|
2.09 score on a scale
Standard Deviation 2.84
|
|
Change in Depressive Symptoms, as Measured by the Swahili Version of the Patient Health Questionnaire 9
90 days after intervention
|
2.00 score on a scale
Standard Deviation 2.72
|
1.77 score on a scale
Standard Deviation 2.63
|
|
Change in Depressive Symptoms, as Measured by the Swahili Version of the Patient Health Questionnaire 9
180 days after intervention
|
2.84 score on a scale
Standard Deviation 3.51
|
1.84 score on a scale
Standard Deviation 2.76
|
Adverse Events
Treatment as Usual Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stigma Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place