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Completed

NCT Number: NCT05033002

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

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

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Key information

Conditions

HIV Behavior Behavioral Symptoms Depression Depressive Symptoms Hope Self Efficacy Self Esteem Social Behavior Social Stigma Stigma, Social

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Muhimbili University of Health and Allied Sciences

Dar es Salaam, Tanzania

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Number of Participants Recruited as Measured by Enrollment Logs

    Time frame: up to 6 months

  2. Number of Study Participants Retained in Study as Measured by Enrollment Logs

    Time frame: 30, 90, and 180 days after intervention

  3. Percent of Questions Left Blank on Study Instruments

    Time frame: baseline and 30, 90, and 180 days after intervention

  4. Time it Takes in Minutes for Participants to Complete the Questionnaires

    Time frame: baseline and 30, 90, and 180 days after intervention

  5. Number of Women Who Completed All 5 Sessions

    Time frame: up to 5 weeks

Secondary outcomes

  1. Change in Internalized Stigma, as Measured by the Swahili Version of the Multidimensional Measure of Internalized Stigma Scale

    Time frame: 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

  2. Change in Coping Self-efficacy, as Measured by the Swahili Version of the Coping Self-Efficacy Scale

    Time frame: 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.

  3. Change in Self-esteem, as Measured by the Swahili Version of the Rosenberg Self-Esteem Scale

    Time frame: 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

  4. Hope, as Measured by the Swahili Version of the State of Hope Scale

    Time frame: Baseline

    Scores range from 6 to 24, with lower scores indicating less hope and higher scores indicating more hope

  5. Change in Depressive Symptoms, as Measured by the Swahili Version of the Patient Health Questionnaire 9

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Muhimbili University of Health and Allied Sciences
  • RTI International

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 2, 2021
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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