HIV Prevention Among Latina Transgender Women Who Have Sex With Men: Evaluation of a Locally Developed Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Uptake of medically supervised hormone therapy
研究概览
简要总结
Wake Forest University and its partners, Triad Health Project, and the University of North Carolina, Greensboro, will be evaluating the effectiveness of ChiCAS (Chicas Creando Acceso a la Salud or Girls Creating Access to Health), a locally developed, Spanish language small group behavioral intervention that promotes access to and participation by Hispanic/Latina transgender women who are HIV negative and who have sex with men in pre-exposure prophylaxis (PrEP), medically supervised hormone therapy, and consistent condom use.
详细描述
ChiCAS will be delivered as two 4-hour group sessions over a period of two weeks to groups of about 10 participants at seven community-based organizations (CBOs) in five metropolitan locations in North Carolina (Asheville, Charlotte, Greensboro/Winston-Salem, Raleigh/Durham and Wilmington).
The intervention will be evaluated by comparing women randomized to the ChiCAS intervention group to those randomized to the delayed-intervention (waitlist) comparison group. As many as 140 participants (as many 70 participants per arm) in total will be recruited to the study. All participants will complete identical quantitative assessments at baseline and 6-month follow up. Baseline and 6-month follow-up data collection will include the following measures:
Outcome variables:
Use of PrEP and medically supervised hormone therapy and consistent condom use.
Demographics:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Study participants will be randomly assigned to the intervention or the wait list comparison arm
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Self-identify as male-to-female transgender or report having been born male and identifying as female;
- •Self-identify as Hispanic or Latina;
- •Are ≥ 18 years of age;
- •Report sex with at least 1 man in the past 6 months;
- •Are HIV negative (based on self-report and verification by HIV testing);
- •Are fluent in Spanish; and
- •Provide informed consent.
排除标准
- •(a) Having participated in any HIV prevention intervention within the past 12 months, including Chicas or other interventions co-developed by Wake Gorest University (HOLA en Grupos or HOLA).
- •Are ≥ 18 years of age;
研究组 & 干预措施
Intervention arm
Persons randomized to this arm will have completed the study consent process (including being tested with the INSTI rapid HIV test to verify their self-reported HIV negative status and their eligibility to participate in the study) and the baseline survey, and will receive the Spanish language ChiCAS intervention shortly after being randomized and will complete a follow-up assessment 6 months after completing the intervention.
.
干预措施: ChiCAS (Behavioral)
Wait list comparison (control) arm
Persons randomized to this arm will have completed the study consent process (including being tested with the INSTI rapid HIV test to verify their self-reported HIV negative status and their eligibility to participate in the study) and the baseline survey, but will not receive the Spanish language ChiCAS intervention until they complete a follow-up assessment 6 months after completing the baseline assessment.
干预措施: ChiCAS (Behavioral)
结局指标
主要结局
Uptake of medically supervised hormone therapy
时间窗: Uptake compared to baseline assessed 6 months after completion of the intervention.
Increased uptake of medically supervised hormone therapy relative to baseline use measures
Uptake of PrEP
时间窗: Uptake compared to baseline assessed 6 months after completion of the intervention.
Increased uptake of PrEP relative to baseline measures of use
Consistent condom use
时间窗: Uptake compared to baseline assessed 6 months after completion of the intervention.
Increased consistent condom relative to baseline use measures
次要结局
未报告次要终点