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

NCT05033002 | Completed Results

• 1 other identifier: Pro00109278
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

HIV; women living with HIV; clinical trial; Tanzania; efficacy; feasibility

Outcome Measures

Primary Outcomes (5)

• 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

• Number of Women Who Completed All 5 Sessions

  up to 5 weeks

Secondary Outcomes (5)

• 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

• 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

• 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

• Hope, as Measured by the Swahili Version of the State of Hope Scale

  Baseline

• 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

Study Arms (2)

Treatment as Usual Group

NO INTERVENTION

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.

Stigma Intervention Group

EXPERIMENTAL

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

Interventions

Labda Siku Moja stigma reduction intervention BEHAVIORAL

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.

Stigma Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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

Sponsors & Collaborators

• Duke University: lead
• Muhimbili University of Health and Allied Sciences: collaborator
• RTI International: collaborator

Study Sites (1)

Muhimbili University of Health and Allied Sciences

Dar es Salaam, Tanzania

Location

Related Publications (1)

• Nyblade L, Kilonzo MN, Kisamo DH, Mtei RJ, Pan W, Relf MV. Efficacy Testing of a Culturally Relevant Stigma Reduction Intervention for Women Living With HIV in Tanzania: Protocol for a Randomized Controlled Trial. J Assoc Nurses AIDS Care. 2025 Mar 26;36(5):470-481. doi: 10.1097/JNC.0000000000000538.

  PMID: 40138392 DERIVED

MeSH Terms

Conditions

Social Stigma; Depression

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Behavioral Symptoms

Results Point of Contact

• Title: Michael Relf, Ph.D.
• Organization: Duke University School of Nursing

michael.relf@duke.edu

919-684-9219

Study Officials

• Michael V. Relf, PhD

  Duke University School of Nursing

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 2, 2021
• Study Start: October 24, 2022
• Primary Completion: May 16, 2024
• Study Completion: May 28, 2024
• Last Updated: May 29, 2025
• Results First Posted: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TA (1)