NCT05033002已完成不适用
Efficacy Testing of a Culturally Relevant Stigma Intervention With Women Living With HIV in Tanzania
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 167
- 试验地点
- 2
- 主要终点
- Number of Participants Recruited as Measured by Enrollment Logs
研究概览
简要总结
This study will test a stigma reduction intervention with women living with HIV in Tanzania.
详细描述
This study will test a culturally and linguistically relevant stigma reduction intervention, Labda Siku Moja, among women living with HIV in Tanzania.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •(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
结局指标
主要结局
Number of Participants Recruited as Measured by Enrollment Logs
时间窗: up to 6 months
Number of Study Participants Retained in Study as Measured by Enrollment Logs
时间窗: 30, 90, and 180 days after intervention
Percent of Questions Left Blank on Study Instruments
时间窗: baseline and 30, 90, and 180 days after intervention
Time it Takes in Minutes for Participants to Complete the Questionnaires
时间窗: baseline and 30, 90, and 180 days after intervention
Number of Women Who Completed All 5 Sessions
时间窗: up to 5 weeks
次要结局
- Change in Internalized Stigma, as Measured by the Swahili Version of the Multidimensional Measure of Internalized Stigma Scale(baseline and 30, 90, and 180 days after intervention)
- Change in Coping Self-efficacy, as Measured by the Swahili Version of the Coping Self-Efficacy Scale(baseline and 30, 90, and 180 days after intervention)
- Change in Self-esteem, as Measured by the Swahili Version of the Rosenberg Self-Esteem Scale(baseline and 30, 90, and 180 days after intervention)
- Hope, as Measured by the Swahili Version of the State of Hope Scale(Baseline)
- Change in Depressive Symptoms, as Measured by the Swahili Version of the Patient Health Questionnaire 9(baseline and 30, 90, and 180 days after intervention)
研究者
研究点 (2)
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