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

Not Applicable

Completed

• Conditions: Self Esteem; Hope; Self Efficacy; Depressive Symptoms; HIV; Stigma, Social
• Interventions: Behavioral: Labda Siku Moja stigma reduction intervention

• Registration Number: NCT05033002
• Lead Sponsor: Duke University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-08-31
• Study First Submitted QC: 2021-08-31
• Study First Posted: 2021-09-02
• Study Start: 2022-10-24
• Primary Completion: 2024-05-16
• Study Completion: 2024-05-28
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-21
• Last Update Posted: 2024-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 167

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stigma Intervention Group	Labda Siku Moja stigma reduction intervention	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.

Primary Outcome Measures

Name	Time	Method
Percent of questions left blank on study instruments	up to 180 days
Number of study participants retained in study as measured by enrollment logs	up to 180 days
Number of participants recruited as measured by enrollment logs	up to 6 months
Number of women who completed all 5 sessions	up to 10 weeks after enrollment

Secondary Outcome Measures

Name	Time	Method
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
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 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
change in hope, as measured by the Swahili version of the State of Hope Scale	baseline and 30, 90, and 180 days after intervention	Scores range from 6 to 24, with lower scores indicating less hope and higher scores indicating more hope

Trial Locations

Locations (1)

Muhimbili University of Health and Allied Sciences; 🇹🇿 Dar Es Salaam, Tanzania