Depressive Symptoms, HIV, Hope, Self Efficacy, Self Esteem, Stigma, Social
Conditions
Keywords
HIV, women living with HIV, clinical trial, Tanzania, efficacy, feasibility
Brief summary
This study will test a stigma reduction intervention with women living with HIV in Tanzania.
Detailed description
This study will test a culturally and linguistically relevant stigma reduction intervention, Labda Siku Moja, among women living with HIV in Tanzania.
Interventions
BEHAVIORALLabda 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.
Sponsors
Muhimbili University of Health and Allied Sciences
RTI International
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The inclusion criteria for this study are: * (1) women who are living with HIV; * (2) age 18 (age of adulthood as defined by the Tanzanian government); * (3) able and willing to voluntarily consent to participate in the study; * (4) able to travel to a data collection in their local community (as described above); * (5) demonstrate mental competence at time of informed consent; * (6) verbally indicate that they plan to reside in their current community for at least 6 months after enrollment (necessary to prevent attrition); * (7) score at the median or higher level on the Swahili Version of the Multidimensional Measure of Internalized HIV Stigma Scale.
Exclusion criteria
* (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. * (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. * (3) Participants may be enrolled in other HIV-related studies except cognitive-behavioral intervention studies addressing stigma, self-efficacy, self-esteem, and/or disclosure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Women Who Completed All 5 Sessions | up to 5 weeks |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Internalized Stigma, as Measured by the Swahili Version of the Multidimensional Measure of Internalized Stigma Scale | baseline and 30, 90, and 180 days after intervention | Scores range from 0 to 100 with lower scores indicating less stigma and higher scores indicating more stigma |
| Change in Coping Self-efficacy, as Measured by the Swahili Version of the Coping Self-Efficacy Scale | baseline and 30, 90, and 180 days after intervention | Scores range from 0 to 26, with lower scores indicating lower coping self-efficacy and higher scores indicating greater coping self-efficacy. |
| Change in Self-esteem, as Measured by the Swahili Version of the Rosenberg Self-Esteem Scale | baseline and 30, 90, and 180 days after intervention | Scores range from 10 to 40, with lower scores indicating lower self-esteem and higher scores indicating higher self-esteem |
| Hope, as Measured by the Swahili Version of the State of Hope Scale | Baseline | Scores range from 6 to 24, with lower scores indicating less hope and higher scores indicating more hope |
| Change in Depressive Symptoms, as Measured by the Swahili Version of the Patient Health Questionnaire 9 | baseline and 30, 90, and 180 days after intervention | Scores range from 0 to 27, with lower scores indicating less depressive symptoms and higher scores indicating more depressive symptoms |
Countries
Tanzania
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 80 |
| 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. | 87 |
| Total | 167 |
Baseline characteristics
| Characteristic | Treatment as Usual Group | Total | Stigma Intervention Group |
|---|---|---|---|
| Age, Continuous | 32.69 years STANDARD_DEVIATION 14.1 | 32.54 years STANDARD_DEVIATION 13.36 | 32.40 years STANDARD_DEVIATION 12.73 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 80 Participants | 167 Participants | 87 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 80 Participants | 167 Participants | 87 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Tanzania | 80 participants | 167 participants | 87 participants |
| Sex: Female, Male Female | 80 Participants | 167 Participants | 87 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 80 | 0 / 87 |
| other Total, other adverse events | 0 / 80 | 0 / 87 |
| serious Total, serious adverse events | 0 / 80 | 0 / 87 |
Outcome results
Primary
Number of Participants Recruited as Measured by Enrollment Logs
Time frame: up to 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment as Usual Group | Number of Participants Recruited as Measured by Enrollment Logs | 80 Participants |
| Stigma Intervention Group | Number of Participants Recruited as Measured by Enrollment Logs | 87 Participants |
Primary
Number of Study Participants Retained in Study as Measured by Enrollment Logs
Time frame: 30, 90, and 180 days after intervention
Population: Analysis includes participants who completed the visit at the applicable time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment as Usual Group | Number of Study Participants Retained in Study as Measured by Enrollment Logs | 30 days after intervention | 77 Participants |
| Treatment as Usual Group | Number of Study Participants Retained in Study as Measured by Enrollment Logs | 90 days after intervention | 79 Participants |
| Treatment as Usual Group | Number of Study Participants Retained in Study as Measured by Enrollment Logs | 180 days after intervention | 76 Participants |
| Stigma Intervention Group | Number of Study Participants Retained in Study as Measured by Enrollment Logs | 30 days after intervention | 77 Participants |
| Stigma Intervention Group | Number of Study Participants Retained in Study as Measured by Enrollment Logs | 90 days after intervention | 76 Participants |
| Stigma Intervention Group | Number of Study Participants Retained in Study as Measured by Enrollment Logs | 180 days after intervention | 76 Participants |
Primary
Number of Women Who Completed All 5 Sessions
Time frame: up to 5 weeks
Population: This outcome measure only applies to the intervention group
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment as Usual Group | Number of Women Who Completed All 5 Sessions | 76 Participants |
Primary
Percent of Questions Left Blank on Study Instruments
Time frame: baseline and 30, 90, and 180 days after intervention
Population: Analysis includes participants who completed surveys at the time point indicated.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment as Usual Group | Percent of Questions Left Blank on Study Instruments | baseline | 0 percent of questions left blank |
| Treatment as Usual Group | Percent of Questions Left Blank on Study Instruments | 30 days after intervention | 0 percent of questions left blank |
| Treatment as Usual Group | Percent of Questions Left Blank on Study Instruments | 90 days after intervention | 0 percent of questions left blank |
| Treatment as Usual Group | Percent of Questions Left Blank on Study Instruments | 180 days after intervention | 0 percent of questions left blank |
| Stigma Intervention Group | Percent of Questions Left Blank on Study Instruments | 180 days after intervention | 0 percent of questions left blank |
| Stigma Intervention Group | Percent of Questions Left Blank on Study Instruments | baseline | 0 percent of questions left blank |
| Stigma Intervention Group | Percent of Questions Left Blank on Study Instruments | 90 days after intervention | 0 percent of questions left blank |
| Stigma Intervention Group | Percent of Questions Left Blank on Study Instruments | 30 days after intervention | 0 percent of questions left blank |
Primary
Time it Takes in Minutes for Participants to Complete the Questionnaires
Time frame: baseline and 30, 90, and 180 days after intervention
Population: Analysis includes participants who completed surveys at the time point indicated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment as Usual Group | Time it Takes in Minutes for Participants to Complete the Questionnaires | 180 days | 43 minutes | Standard Deviation 5 |
| Treatment as Usual Group | Time it Takes in Minutes for Participants to Complete the Questionnaires | 30 days | 42 minutes | Standard Deviation 11 |
| Treatment as Usual Group | Time it Takes in Minutes for Participants to Complete the Questionnaires | 90 days | 44 minutes | Standard Deviation 9 |
| Treatment as Usual Group | Time it Takes in Minutes for Participants to Complete the Questionnaires | Baseline | 48 minutes | Standard Deviation 8 |
| Stigma Intervention Group | Time it Takes in Minutes for Participants to Complete the Questionnaires | 180 days | 43 minutes | Standard Deviation 7 |
| Stigma Intervention Group | Time it Takes in Minutes for Participants to Complete the Questionnaires | Baseline | 49 minutes | Standard Deviation 8 |
| Stigma Intervention Group | Time it Takes in Minutes for Participants to Complete the Questionnaires | 90 days | 42 minutes | Standard Deviation 8 |
| Stigma Intervention Group | Time it Takes in Minutes for Participants to Complete the Questionnaires | 30 days | 41 minutes | Standard Deviation 9 |
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.
Time frame: baseline and 30, 90, and 180 days after intervention
Population: Analysis includes participants who completed surveys at the time point indicated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment as Usual Group | 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 |
| Treatment as Usual Group | 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 |
| Treatment as Usual Group | 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 |
| Treatment as Usual Group | 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 |
| Stigma Intervention Group | Change in Coping Self-efficacy, as Measured by the Swahili Version of the Coping Self-Efficacy Scale | 180 days after intervention | 17.34 score on a scale | Standard Deviation 5.3 |
| Stigma Intervention Group | Change in Coping Self-efficacy, as Measured by the Swahili Version of the Coping Self-Efficacy Scale | Baseline | 13.17 score on a scale | Standard Deviation 5.41 |
| Stigma Intervention Group | Change in Coping Self-efficacy, as Measured by the Swahili Version of the Coping Self-Efficacy Scale | 90 days after intervention | 18.00 score on a scale | Standard Deviation 5.02 |
| Stigma Intervention Group | Change in Coping Self-efficacy, as Measured by the Swahili Version of the Coping Self-Efficacy Scale | 30 days after intervention | 17.86 score on a scale | Standard Deviation 5.06 |
p-value: 0.002Mixed Models Analysis
p-value: 0.01Mixed Models Analysis
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
Time frame: baseline and 30, 90, and 180 days after intervention
Population: Analysis includes participants who completed surveys at the time point indicated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment as Usual Group | 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 |
| Treatment as Usual Group | 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 |
| Treatment as Usual Group | 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 |
| Treatment as Usual Group | 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 |
| Stigma Intervention Group | Change in Depressive Symptoms, as Measured by the Swahili Version of the Patient Health Questionnaire 9 | 90 days after intervention | 1.77 score on a scale | Standard Deviation 2.63 |
| Stigma Intervention Group | Change in Depressive Symptoms, as Measured by the Swahili Version of the Patient Health Questionnaire 9 | 30 days after intervention | 2.09 score on a scale | Standard Deviation 2.84 |
| Stigma Intervention Group | Change in Depressive Symptoms, as Measured by the Swahili Version of the Patient Health Questionnaire 9 | Baseline | 4.63 score on a scale | Standard Deviation 3.91 |
| Stigma Intervention Group | Change in Depressive Symptoms, as Measured by the Swahili Version of the Patient Health Questionnaire 9 | 180 days after intervention | 1.84 score on a scale | Standard Deviation 2.76 |
p-value: 0.441Mixed Models Analysis
p-value: 0.734Mixed Models Analysis
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
Time frame: baseline and 30, 90, and 180 days after intervention
Population: Analysis includes participants who completed surveys at the time point indicated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment as Usual Group | 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 |
| Treatment as Usual Group | 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 |
| Treatment as Usual Group | 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 |
| Treatment as Usual Group | 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 |
| Stigma Intervention Group | Change in Internalized Stigma, as Measured by the Swahili Version of the Multidimensional Measure of Internalized Stigma Scale | 180 days after intervention | 4.61 score on a scale | Standard Deviation 11.46 |
| Stigma Intervention Group | Change in Internalized Stigma, as Measured by the Swahili Version of the Multidimensional Measure of Internalized Stigma Scale | 90 days after intervention | 5.21 score on a scale | Standard Deviation 11.27 |
| Stigma Intervention Group | Change in Internalized Stigma, as Measured by the Swahili Version of the Multidimensional Measure of Internalized Stigma Scale | 30 days after intervention | 6.01 score on a scale | Standard Deviation 11.24 |
| Stigma Intervention Group | Change in Internalized Stigma, as Measured by the Swahili Version of the Multidimensional Measure of Internalized Stigma Scale | Baseline | 40.18 score on a scale | Standard Deviation 23.85 |
p-value: <0.0001Mixed Models Analysis
p-value: <0.0001Mixed Models Analysis
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
Time frame: baseline and 30, 90, and 180 days after intervention
Population: Analysis includes participants who completed surveys at the time point indicated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment as Usual Group | 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 |
| Treatment as Usual Group | 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 |
| Treatment as Usual Group | 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 |
| Treatment as Usual Group | 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 |
| Stigma Intervention Group | Change in Self-esteem, as Measured by the Swahili Version of the Rosenberg Self-Esteem Scale | 180 days after intervention | 32.38 score on a scale | Standard Deviation 3.72 |
| Stigma Intervention Group | Change in Self-esteem, as Measured by the Swahili Version of the Rosenberg Self-Esteem Scale | Baseline | 28.17 score on a scale | Standard Deviation 4.31 |
| Stigma Intervention Group | Change in Self-esteem, as Measured by the Swahili Version of the Rosenberg Self-Esteem Scale | 90 days after intervention | 32.26 score on a scale | Standard Deviation 3.19 |
| Stigma Intervention Group | Change in Self-esteem, as Measured by the Swahili Version of the Rosenberg Self-Esteem Scale | 30 days after intervention | 32.66 score on a scale | Standard Deviation 3.86 |
p-value: 0.001Mixed Models Analysis
p-value: 0.032Mixed Models Analysis
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
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment as Usual Group | Hope, as Measured by the Swahili Version of the State of Hope Scale | 15.48 score on a scale | Standard Deviation 3.24 |
| Stigma Intervention Group | Hope, as Measured by the Swahili Version of the State of Hope Scale | 15.82 score on a scale | Standard Deviation 3.36 |
p-value: 0.506t-test, 2 sided