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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: HIV; Depressive Symptoms; Self Efficacy; Stigma, Social; Self Esteem; Hope
• Intervention / Treatment: Behavioral: Labda Siku Moja stigma reduction intervention

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Tanzania
  • Dar Es Salaam, Tanzania
    • Muhimbili University of Health and Allied Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: RTI International; Muhimbili University of Health and Allied Sciences
• Investigators: Principal Investigator: Michael V. Relf, PhD, Duke University School of Nursing

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2022
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: August 31, 2021
• First Submitted That Met QC Criteria: August 31, 2021
• First Posted (Actual): September 2, 2021

Study Record Updates

• Last Update Posted (Actual): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: HIV; clinical trial; Tanzania; efficacy; feasibility; women living with HIV
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: Pro00109278

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No