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

Duke University

Status: Active, not recruiting

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

Treatments: Behavioral: Labda Siku Moja stigma reduction intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05033002

Pro00109278

Details and patient eligibility

About

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

Full description

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

Enrollment: 167 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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167 participants in 2 patient groups

Treatment as Usual Group

No Intervention group

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.

Stigma Intervention Group

Experimental group

Description:

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.

Treatment:

Behavioral: Labda Siku Moja stigma reduction intervention