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

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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

160 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)

160 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

Trial documents
1

Trial contacts and locations

0

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Central trial contact

Michael V. Relf, PhD

Data sourced from clinicaltrials.gov

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