Clinical trial NCT05033002: 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
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Stigma, Social
Self Efficacy
Self Esteem
Hope
Depressive Symptoms
Keywords: HIV
women living with HIV
clinical trial
Tanzania
efficacy
feasibility
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Muhimbili University of Health and Allied Sciences
name: RTI International
First posted: 2021-09-02
Enrollment: 167
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Recruited as Measured by Enrollment Logs
timeFrame: up to 6 months
measure: Number of Study Participants Retained in Study as Measured by Enrollment Logs
timeFrame: 30, 90, and 180 days after intervention
measure: Percent of Questions Left Blank on Study Instruments
timeFrame: baseline and 30, 90, and 180 days after intervention
measure: Time it Takes in Minutes for Participants to Complete the Questionnaires
timeFrame: baseline and 30, 90, and 180 days after intervention
measure: Number of Women Who Completed All 5 Sessions
timeFrame: up to 5 weeks
Secondary outcomes:
measure: Change in Internalized Stigma, as Measured by the Swahili Version of the Multidimensional Measure of Internalized Stigma Scale
timeFrame: baseline and 30, 90, and 180 days after intervention
measure: Change in Coping Self-efficacy, as Measured by the Swahili Version of the Coping Self-Efficacy Scale
timeFrame: baseline and 30, 90, and 180 days after intervention
measure: Change in Self-esteem, as Measured by the Swahili Version of the Rosenberg Self-Esteem Scale
timeFrame: baseline and 30, 90, and 180 days after intervention
measure: Hope, as Measured by the Swahili Version of the State of Hope Scale
timeFrame: Baseline
measure: Change in Depressive Symptoms, as Measured by the Swahili Version of the Patient Health Questionnaire 9
timeFrame: baseline and 30, 90, and 180 days after intervention
Other outcomes:
Locations:
city: Dar Es Salaam
country: Tanzania
facility: Muhimbili University of Health and Allied Sciences
Study officials:
affiliation: Duke University School of Nursing
name: Michael V. Relf, PhD
role: PRINCIPAL_INVESTIGATOR
References: