Addressing Health Disparities in Engagement, Retention, and Utilization of PrEP Among South Florida Women of Color
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 6
- 主要终点
- Percentage of women
研究概览
简要总结
Women of color (WOC) in South Florida, the region with the highest HIV rates in the U.S., experience significant barriers to accessibility, uptake, and utilization of Pre-exposure prophylaxis (PrEP) for HIV prevention, despite FDA approval since 2012. The purpose of this study is to use a Community-Based Participatory Research (CBPR) approach to finalize, and pilot-test a multi-component evidence-based intervention to reduce health disparities in engagement, utilization, and retention in PrEP care, with the goal of improving HIV prevention outcomes for the target population of WOC in S. Florida, primarily African American, Latina, and Haitian women in 3 designated Ending the HIV Epidemic (EHE) counties: Miami-Dade, Broward, and Palm Beach counties.
详细描述
The purpose of this study is to use a Community-Based Participatory Research (CBPR) approach to finalize, and pilot-test a multi-component evidence-based intervention to reduce health disparities in engagement, utilization, and retention in PrEP care, with the goal of improving HIV prevention outcomes for the target population of WOC in S. Florida. We will conduct an exploratory pilot of the PrEP intervention, using a quasi-experimental design, among 80 multi-ethnic WOC in Miami-Dade, Broward, and Palm Beach counties to evaluate feasibility, acceptability, and fidelity. PrEP uptake, adherence, and retention in care will be measured over a 4-month period, including biomarkers of adherence. Adult women initiating or returning to PrEP services at our collaborating sites will be recruited, consented, enrolled and complete baseline assessments. They will participate in an adapted Integrating ENGagement and Adherence Upon Entry (iENGAGE) intervention to address social determinants of health barriers to maintaining PrEP care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- 是
入选标准
- •>=18 years of age;
- •female and identifying as female gender;
- •able to provide informed consent;
- •willing to document a negative HIV antibody test before starting PrEP;
- •reporting recent sexual risk (e.g., sex without condoms in last 3 months, sexually transmitted infection (STI) diagnosis in the last 6 months, post-exposure prophylaxis (PEP) use in the last 12 months, transactional sex, partners who are HIV+);
- •report history of alcohol and other drug (AOD) use in last 3 months;
- •willing to screen for medical contraindications to PrEP according to Florida Health Department guidelines;
- •currently not cognitively impaired;
- •reporting no history of bipolar disorder, psychosis, or current need for inpatient psychiatric hospitalization.
排除标准
- •Less than 18 years of age;
- •not female at birth
- •unable to provide informed consent;
- •unwilling to document a negative HIV antibody test before starting PrEP;
- •unwilling to screen for medical contraindications to PrEP according to Florida Health Department guidelines;
- •currently cognitively impaired;
- •reporting recent history of bipolar disorder, psychosis, or inpatient psychiatric hospitalization
结局指标
主要结局
Percentage of women
时间窗: Baseline
We will measure the percentage of women who, having been invited for screening, complete the screening and enroll in the study.
Monthly Change in concentration of Tenofovir measured by urine biomarker
时间窗: Monthly through study completion, an average of 4 months
In measuring adherence, we will also use point of care urine testing to evaluate short-term Tenofovir concentration (for those prescribed Tenofovir) at each monthly visit to compare with self-report data.
Monthly Change in self-reported PrEP Adherence from Baseline to 4 month follow up
时间窗: Monthly through study completion, an average of 4 months
In measuring adherence, we will use a self-report questionnaire to assess the of number of missed doses in the last 7 days assessed at baseline, at each monthly intervention session and at the 4 month follow-up.
Concentration of Tenofovir measured by dried blood spot test
时间窗: 4 month follow up
In measuring adherence, we will also use dried blood spot testing for longer-term Tenofovir levels (for those prescribed Tenofovir) at the 4-month follow up assessment.
Percentage of participants retained in PrEP Care
时间窗: 4 month follow up from those enrolled in the study.
Retention in PrEP Care will be considered the percentage of women who complete the 4-month follow up assessment from those who enrolled in the study.
次要结局
未报告次要终点