Efficacy Testing of a Culturally Relevant Stigma Intervention With WLWH in Tanzania

Study Overview
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Brief Summary
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This study will test a stigma reduction intervention with women living with HIV in Tanzania.

Detailed Description
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This study will test a culturally and linguistically relevant stigma reduction intervention, Labda Siku Moja, among women living with HIV in Tanzania.

Official Title
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Efficacy Testing of a Culturally Relevant Stigma Intervention With Women Living With HIV in Tanzania

Conditions
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HIV, Stigma, Social, Self Efficacy, Self Esteem, Hope, Depressive Symptoms

Intervention / Treatment
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* Behavioral: Labda Siku Moja stigma reduction intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Treatment as Usual Group<br>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. | |
| Experimental: Stigma Intervention Group<br>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. | Behavioral: Labda Siku Moja stigma reduction intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |  | up to 180 days | 
| Percent of questions left blank on study instruments |  | up to 180 days | 
| Number of women who completed all 5 sessions |  | up to 10 weeks after enrollment | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 
| change in 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 and 30, 90, and 180 days after intervention | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, women living with HIV, clinical trial, Tanzania, efficacy, feasibility