Demonstration Project on the Feasibility to Implement a Pre-Exposure Oral Prophylaxis Program in Men Who Have Sex With Other Men and Transgender Women at Risk of Acquiring HIV
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 5
- 主要终点
- Acceptability, use and adherence of a pre-exposure prophylaxis (PrEP) program using the co-formulation tenofovir disoproxil fumarate 300 mg/emtricitabine 200 mg (TDF/FTC) administered daily by mouth,
研究概览
简要总结
The purpose of the study is to evaluating the acceptability, use and adherence of a pre-exposure prophylaxis (PrEP) program using the co-formulation tenofovir disoproxil fumarate 300 mg/emtricitabine 200 mg (TDF/FTC) administered daily by mouth, at four health facilities and one community-based organization providing health care services for MSM and transgender women.
This is an Observational, longitudinal, multicenter, open-label study to evaluate the acceptability, use and adherence to TDF/FTC-based PrEP in volunteer men who have sex with men and transgender women at substantial high risk of acquiring HIV, who were prescribed for PrEP , following the clinical guidelines to prevent HIV infection of the U.S. Centers for Disease Control and Prevention (2014) and the World Health Organization (2015).
Follow-up: Participants will be followed for 96 weeks (approximately two years) after the start of prophylactic treatment.
Implementation Target Population: Adults (≥18 years of age), without HIV infection diagnosis, and who were prescribed with PrEP and have a substantial risk of acquiring HIV infection according to the international guidelines for HIV prevention.
Sample Size: 1,000 participants
Implementation Sites:
- Asociación Civil Impacta Salud y Educación, Barranco study site
- Asociación Civil Impacta Salud y Educación, San Miguel study site
- Asociación Civil Selva Amazónica, ACSA study site
- Asociación Vía Libre, Vía Libre study site
- Espacio Común, Epicentro study site
Primary Objectives:
- Describing the acceptability and its socio-demographic and sexual behavior correlates for the use of PrEP.
- Evaluate the persistence of the use of PrEP and its correlates with risk behaviors
- Evaluating the adherence to the PrEP using self-reporting and pill counts
Secondary Objectives:
- Describing the changes over time in risky sexual behavior among study participants.
- Describing the number of participants who acquire HIV infection.
- Evaluate the deviation of the indication of use of PrEP through self- reporting of its sale or sharing with third parties.
详细描述
HYPOTHESIS
- Hypothesis 1. The use of PrEP based on daily intake of TDF/FTC is acceptable for MSM and transgender women and their acceptance correlates with knowledge of PrEP and sexual risk behavior.
- Hypothesis 2. Adherence and duration of use of PrEP based on daily intake of TDF/FTC correlates with the level of education, socioeconomic level, knowledge of PrEP and risk behavior.
OBJECTIVES AND DESIGN OF THE STUDY
Primary Objectives:
- Describing the acceptability and its socio-demographic and sexual behavior correlates for the use of PrEP.
- Evaluate the persistence of the use of PrEP and its correlates with risk behaviors
- Evaluating the adherence to the PrEP using self-reporting and pill counts
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Be prescribed with PrEP
- •Male biological sex;
- •Age ≥18 years;
- •Willing and able to provide written informed consent;
排除标准
- •Signs or symptoms of acute retroviral syndrome;
- •Upon enrollment, having a condition that, based on the opinion of the investigator or designee, prevents the participant from providing informed consent; makes participation in the project unsafe; complicates the interpretation of results; or somehow interferes with the achievement of project objectives
结局指标
主要结局
Acceptability, use and adherence of a pre-exposure prophylaxis (PrEP) program using the co-formulation tenofovir disoproxil fumarate 300 mg/emtricitabine 200 mg (TDF/FTC) administered daily by mouth,
时间窗: through study completion, an average of 4 years
At all study visits, a Computer Assisted Self Interview will be performed and get information about acceptability, self reported adherence. Pharmacist at each site will get information counting pills to measure adherence.
次要结局
- Describing the changes over time in risky sexual behavior among study participants.(through study completion, an average of 4 years)
- Evaluating the deviation of the indication of use of PrEP through self-reporting of its sale or sharing with third parties.(through study completion, an average of 4 years)