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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05033002
• Other study ID #: Pro00109278
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 24, 2022
• Est. completion date: April 2024

Study information

• Verified date: November 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will test a stigma reduction intervention with women living with HIV in Tanzania.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms
• HIV
• Hope
• Self Efficacy
• Self Esteem
• Stigma, Social

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Tanzania	Muhimbili University of Health and Allied Sciences	Dar Es Salaam

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	Muhimbili University of Health and Allied Sciences, RTI International

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants recruited as measured by enrollment logs		up to 6 months
Primary	Number of study participants retained in study as measured by enrollment logs		up to 180 days
Primary	Percent of questions left blank on study instruments		up to 180 days
Primary	Number of women who completed all 5 sessions		up to 10 weeks after enrollment
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	baseline and 30, 90, and 180 days after intervention
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.	baseline and 30, 90, and 180 days after intervention
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	baseline and 30, 90, and 180 days after intervention
Secondary	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
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	baseline and 30, 90, and 180 days after intervention