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临床试验/NCT02752152
NCT02752152已完成不适用

A Randomized Study to Compare Three Counseling Strategies and Evaluate the Efficacy of Reminders for Regular HIV, Hepatitis B and C, and Syphilis Testing

Institut de Recherche pour le Developpement3 个研究点 分布在 1 个国家目标入组 1,961 人开始时间: 2015年12月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,961
试验地点
3
主要终点
Percentage of participants from at-risk populations coming for a HIV re-test

研究概览

简要总结

Counseling intervention:

Primary objective: to evaluate and compare, in at-risk populations, the efficacy of three different counseling methods in terms of propensity to come back for a HIV re-test. Secondary objectives: to evaluate and compare the efficacy of the counseling methods in terms of reported risk behavior and HIV knowledge as well as their acceptability and cost-effectiveness; describe the distribution of duration from HIV primary infection to detection; and estimate the prevalence of chronic hepatitis B and C, and syphilis in HIV-uninfected participants of targeted populations.

Reminder intervention Primary objective: to evaluate and compare, in at-risk individuals who require frequent testing, the efficacy of reminders in terms of propensity to come back for a HIV re-test within 7 months.

Secondary objective: to assess the cost-effectiveness of reminders.

The interim analyses have shown that that some strategies are better than the others and the Advisory Committee recommended to use only the most efficient strategies (Computer assisted counseling and Scheduling an appointment and sending reminder to clients).

In addition, CD4 cell count normal ranges in 30 HIV uninfected individuals in Thailand will be assessed. Transient elastometry (FibroScan) will be used to assess liver fibrosis in participants with and without viral hepatitis.

详细描述

The study will be presented to clients, who will be asked to formally consent to participate. Clients residing or working in Thailand and able to communicate with the counselor will be eligible. Foreigners staying in Thailand for vacation or retirement will be excluded, except if presenting together with their partner who is otherwise eligible for the study. At each visit, participants will be proposed an appointment for a re-test. If they wish, the study team will send them reminders.

At the first visit, participants will be randomly assigned to one of three different methods for counseling on HIV, hepatitis B and C, and syphilis: standard face-to-face counseling, computer-assisted informational/educational counseling, or on-demand counseling (the counselor invites the participant to ask questions). Participants will then be randomly assigned to one of three reminder strategies: Appointment+reminder, Reminder only, or No appointment and no reminder.

At each visit, blood sample will be collected to test for HIV, hepatitis B and C, and syphilis. Laboratory examinations will be free of charge for all participants. After the blood draw, participants will be invited to complete a questionnaire to assess their knowledge, attitudes and practices with regard to HIV and other infections. Test results will then be provided. In case of confirmed HIV infection, participants will be provided with further counseling, CD4 cell count measurement and referral options for immediate treatment. Blood samples collected during the study for the diagnosis will be stored for determination of the Fiebig stage (duration since HIV primary infection), evaluation of transmitted HIV drug resistance (sequencing) and investigation of viral transmission networks.

In a substudy, we will compare liver fibrosis assessed by transient elastometry and serum biomarkers (i.e. APRI and FIB-4) in Napneung participants with HBsAg and those with anti-HCV antibodies, and compare the measures with that obtained in participants negative for these tests.

The interim analyses have shown that that some strategies are better than the others and the Advisory Committee recommended to use only the most efficient strategies (Computer assisted counseling and Scheduling an appointment and sending reminder to clients). Thus the accrual to the arms "No appointment, no reminder" and "Reminder only" has been discontinued on 12 January 2019.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Residing or working in Thailand
  • •Able to communicate with the counselor
  • •Adults (>= 18 years old)

排除标准

  • •Foreigners staying in Thailand for vacation or retirement, except if they are presenting together with their partner staying permanently in Thailand or working in Thailand
  • •Couples requesting a couple counseling session
  • •HIV-positive participants (based on the client declaration)

研究组 & 干预措施

Computer-assisted counseling

Experimental

Computer-assisted informational/educational interactive session followed by an interactive face-to-face session to discuss personal issues with a counselor as needed

干预措施: Appointment + reminder (Behavioral)

Computer-assisted counseling

Experimental

Computer-assisted informational/educational interactive session followed by an interactive face-to-face session to discuss personal issues with a counselor as needed

干预措施: Computer-assisted counseling (Behavioral)

Computer-assisted counseling

Experimental

Computer-assisted informational/educational interactive session followed by an interactive face-to-face session to discuss personal issues with a counselor as needed

干预措施: Reminder (Behavioral)

Computer-assisted counseling

Experimental

Computer-assisted informational/educational interactive session followed by an interactive face-to-face session to discuss personal issues with a counselor as needed

干预措施: No appointment and no reminder (Behavioral)

On-demand counseling

Experimental

The counselor asks whether the participant has any questions

干预措施: On-demand counseling (Behavioral)

On-demand counseling

Experimental

The counselor asks whether the participant has any questions

干预措施: Appointment + reminder (Behavioral)

On-demand counseling

Experimental

The counselor asks whether the participant has any questions

干预措施: Reminder (Behavioral)

On-demand counseling

Experimental

The counselor asks whether the participant has any questions

干预措施: No appointment and no reminder (Behavioral)

Standard counseling

Active Comparator

Interactive face-to-face counseling session

干预措施: Standard counseling (Behavioral)

Standard counseling

Active Comparator

Interactive face-to-face counseling session

干预措施: Appointment + reminder (Behavioral)

Standard counseling

Active Comparator

Interactive face-to-face counseling session

干预措施: Reminder (Behavioral)

Standard counseling

Active Comparator

Interactive face-to-face counseling session

干预措施: No appointment and no reminder (Behavioral)

Appointment + reminder

Experimental

Make appointment and send SMS reminder

干预措施: Computer-assisted counseling (Behavioral)

Appointment + reminder

Experimental

Make appointment and send SMS reminder

干预措施: On-demand counseling (Behavioral)

Appointment + reminder

Experimental

Make appointment and send SMS reminder

干预措施: Standard counseling (Behavioral)

Appointment + reminder

Experimental

Make appointment and send SMS reminder

干预措施: Appointment + reminder (Behavioral)

Reminder only

Experimental

Send SMS reminder only

干预措施: Computer-assisted counseling (Behavioral)

Reminder only

Experimental

Send SMS reminder only

干预措施: On-demand counseling (Behavioral)

Reminder only

Experimental

Send SMS reminder only

干预措施: Standard counseling (Behavioral)

Reminder only

Experimental

Send SMS reminder only

干预措施: Reminder (Behavioral)

No appointment and no reminder

Active Comparator

No appointment and no SMS reminder sent

干预措施: Computer-assisted counseling (Behavioral)

No appointment and no reminder

Active Comparator

No appointment and no SMS reminder sent

干预措施: On-demand counseling (Behavioral)

No appointment and no reminder

Active Comparator

No appointment and no SMS reminder sent

干预措施: Standard counseling (Behavioral)

No appointment and no reminder

Active Comparator

No appointment and no SMS reminder sent

干预措施: No appointment and no reminder (Behavioral)

结局指标

主要结局

Percentage of participants from at-risk populations coming for a HIV re-test

时间窗: Within 7 months following the first visit

Number of participants having a re-test divided by number of at-risk participants

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

GONZAGUE JOURDAIN

PHPT research Team

Institut de Recherche pour le Developpement

研究点 (3)

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