Back to results

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

Primary Purpose

HIV, Stigma, Social, Self Efficacy

Status

Recruiting

Phase

Not Applicable

Locations

Tanzania

Study Type

Interventional

Intervention

Labda Siku Moja stigma reduction intervention

About this trial

This is an interventional supportive care trial for HIV focused on measuring HIV, women living with HIV, clinical trial, Tanzania, efficacy, feasibility

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Muhimbili University of Health and Allied SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Treatment as Usual Group

Stigma Intervention Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of participants recruited as measured by enrollment logs

Number of study participants retained in study as measured by enrollment logs

Percent of questions left blank on study instruments

Number of women who completed all 5 sessions

Secondary Outcome Measures

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

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.

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

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

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

Full Information

NCT ID

NCT05033002

First Posted

August 31, 2021

Last Updated

October 26, 2022

Sponsor

Duke University

Collaborators

Muhimbili University of Health and Allied Sciences, RTI International

1. Study Identification

Unique Protocol Identification Number

NCT05033002

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 24, 2022 (Actual)

Primary Completion Date

November 2023 (Anticipated)

Study Completion Date

November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

Collaborators

Muhimbili University of Health and Allied Sciences, RTI International

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment as Usual Group

Arm Type

No Intervention

Arm Description

Arm Title

Stigma Intervention Group

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Labda Siku Moja stigma reduction intervention

Intervention Description

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 Outcome Measure Information:

Title

Number of participants recruited as measured by enrollment logs

Time Frame

up to 6 months

Title

Number of study participants retained in study as measured by enrollment logs

Time Frame

up to 180 days

Title

Percent of questions left blank on study instruments

Time Frame

up to 180 days

Title

Number of women who completed all 5 sessions

Time Frame

up to 10 weeks after enrollment

Secondary Outcome Measure Information:

Title

change in internalized stigma, as measured by the Swahili version of the Multidimensional Measure of Internalized Stigma Scale

Description

Scores range from 0 to 100 with lower scores indicating less stigma and higher scores indicating more stigma

Time Frame