Access to Pre-exposure Prophylaxis for Men Who Have Sex With Men: Acceptability and Feasibility in Community-based Clinics in West Africa (CohMSM-PrEP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 649
- 试验地点
- 5
- 主要终点
- Clinical and biological adverse events related to TDF and FTC
研究概览
简要总结
This demonstration project will assess the acceptability and feasibility of pre-exposure prophylaxis (PrEP) for men who have sex with men (MSM) as part of a comprehensive HIV prevention package in community-based clinics in West Africa.
An interventional, open label, multidisciplinary and multicentre cohort study will be performed in Burkina Faso, Côte d'Ivoire, Mali, and Togo.
All MSM enrolled will benefit from a comprehensive HIV prevention package including quarterly clinical examinations, screening and treatment of STIs, screening of HIV, PrEP (daily or on-demand, according the participant's choice), immunisation against hepatitis B, individualised peer-led support (for adherence and prevention), group discussions, condoms, and lubricants.
详细描述
This demonstration project will assess the acceptability and feasibility of pre-exposure prophylaxis (PrEP) for men who have sex with men (MSM) as part of a comprehensive HIV prevention package in community-based clinics in West Africa.
The specific objectives are to assess the acceptability of PrEP, the adherence to PrEP and to quarterly HIV testing, the safety of daily and on-demand use of TDF/FTC, the impact of PrEP on the other prevention strategies, the incidence of sexually transmitted infections (STIs) on PrEP, the "real life" effectiveness of PrEP use and treatment-related resistance, and the cost and cost-effectiveness of PrEP.
This interventional, open label, multidisciplinary and multicentre cohort study will be performed in Burkina Faso, Côte d'Ivoire, Mali, and Togo.
All MSM enrolled will benefit from a comprehensive HIV prevention package including quarterly clinical examinations, screening and treatment of STIs, screening of HIV, PrEP (daily or on-demand, according the participant's choice), immunisation against hepatitis B, individualised peer-led support (for adherence and prevention), group discussions, condoms, and lubricants.
These activities will be performed by community-based organisations which are pioneer in the fight against HIV, especially in MSM. The study will have a total duration of 3 years.
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
- Male
- 接受健康志愿者
- 是
入选标准
- •Male (or transgender male person at birth)
- •At least 18 years old
- •HIV-seronegative
- •Having had at least one anal sex episode with another man within the previous 6 months
- •Having at least one of the following criteria:
- •Have a sexual partner (male or female) infected with HIV without evidence of virological suppression
- •Have had anal or vaginal sex episodes without condoms with more than one partner within the previous 6 months
- •Have had a sexually-transmitted infection (STI) within the previous 6 months (syndromic or biological approach, or mentioned by the participant)
- •Have received post-exposure prophylaxis for HIV within the previous 6 months
- •Wishing to reinforce its means of prevention through the use of PrEP
- •Accepting to participate in the study and signing the informed consent form
排除标准
- •Clinical manifestations suggesting a primary HIV infection
- •Recent probable HIV exposure
- •Creatinine clearance <60 mL/min calculated according to the Cockroft & Gault formula
- •Positive or undetermined HBsAg
- •Allergy or contraindication to any of the components of PrEP
- •Participation in another biomedical and/or behavioral study on HIV or STIs (excluding CohMSM)
- •Disability of the person making it difficult, if not impossible, to participate in the study or understanding of the information given to him
- •Predictable non-compliance with the protocol (geographical distance, non-compliance with monitoring or other reasons)
研究组 & 干预措施
HIV prevention package including PrEP
干预措施: HIV prevention package including PrEP (Drug)
结局指标
主要结局
Clinical and biological adverse events related to TDF and FTC
时间窗: 3 years
To assess the safety of daily and on-demand use of TDF/FTC
Number of MSM followed after 3 years compared to the number of MSM included (retention in the program)
时间窗: 3 years
To assess the acceptability of PrEP
Percentage of adherence reported by MSM
时间窗: 3 years
To assess the adherence to PrEP
Counting of TDF/FTC tablets
时间窗: 3 years
To assess the adherence to PrEP
Percentage of HIV tests performed
时间窗: 3 years
To assess the adherence to quarterly HIV testing
Plasma concentrations of TDF and FTC
时间窗: 3 years
To assess the adherence to PrEP
Total cost of the intervention over the study period and in the long term
时间窗: 3 years
To assess the cost and cost-effectiveness of PrEP
Frequency of condomless anal intercourse
时间窗: 3 years
To assess the evolution of the other prevention strategies on PrEP
Percentage of MSM under PrEP among eligible HIV-seronegative participants
时间窗: 3 years
To assess the acceptability of PrEP
Incidence rate of HIV infection
时间窗: 3 years
To assess the "real life" effectiveness of PrEP use and the emergence of treatment-related resistance
Percentage of MSM using daily and/ord on-demand PrEP
时间窗: 3 years
To assess the acceptability of PrEP
Frequency of sexual intercourse associated with alcohol and/or drug use
时间窗: 3 years
To assess the evolution of the other prevention strategies on PrEP
Percentage of TDF/FTC resistance among MSM newly infected by HIV
时间窗: 3 years
To assess the "real life" effectiveness of PrEP use and the emergence of treatment-related resistance
Conditions of TDF/FTC price and of effectiveness for the intervention to be cost-effective in the study countries
时间窗: 3 years
To assess the cost and cost-effectiveness of PrEP
Incidence rate of STIs
时间窗: 3 years
To assess the incidence of STIs on PrEP
Incremental cost-effectiveness ratio of the intervention (versus no intervention) over the study period and in the long term
时间窗: 3 years
To assess the cost and cost-effectiveness of PrEP
次要结局
未报告次要终点