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

NCT ID: NCT05033002

Last Updated: 2025-05-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

167 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-24

Study Completion Date

2024-05-28

Brief Summary

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

Detailed Description

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

Conditions

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HIV Stigma, Social Self Efficacy Self Esteem Hope Depressive Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Treatment as Usual Group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Stigma Intervention Group

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.

Group Type EXPERIMENTAL

Labda Siku Moja stigma reduction intervention

Intervention Type 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.

Interventions

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Labda Siku Moja stigma reduction intervention

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* (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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Muhimbili University of Health and Allied Sciences

OTHER

Sponsor Role collaborator

RTI International

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael V. Relf, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University School of Nursing

Locations

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Muhimbili University of Health and Allied Sciences

Dar es Salaam, , Tanzania

Site Status

Countries

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Tanzania

References

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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.

Reference Type DERIVED
PMID: 40138392 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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Pro00109278

Identifier Type: -

Identifier Source: org_study_id

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