Counseling for HIV and STIs Screening (Lightning)
|HIV, Hepatitis B, Hepatitis C and Syphilis Infections||Behavioral: Computer-assisted counseling Behavioral: On-demand counseling Behavioral: Standard counseling|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Randomized Study to Compare Three Counseling Strategies for HIV, Hepatitis B and C, and Syphilis Testing|
- Proportion of participants in at-risk populations coming for a HIV re-test [ Time Frame: Within 7 months following the first visit ]
|Study Start Date:||December 2015|
|Estimated Study Completion Date:||February 2019|
|Estimated Primary Completion Date:||January 2019 (Final data collection date for primary outcome measure)|
Experimental: Computer-assisted counseling
Computer-assisted informational/educational interactive session followed by an interactive face-to-face session to discuss personal issues with a counselor
Behavioral: Computer-assisted counseling
The counselor opens the computer-assisted information/educational interactive counseling program on the tablet computer and invites the participant to use the program.
Experimental: On-demand counseling
The counselor asks whether the participant has any questions
Behavioral: On-demand counseling
The counselor only invites the participants to ask questions about HIV and other STIs.
Active Comparator: Standard counseling
Interactive face-to-face counseling session
Behavioral: Standard counseling
The counselor gives face-to-face general information/education
The study will be presented to clients, who will be asked to formally consent to participate. Clients residing or working in northern 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 followed by a face-to-face counseling, or minimal counseling (the counselor invites the participant to ask questions).
At each visit, blood sample will be collected to test for HIV, hepatitis B and C, and syphilis. at the Faculty of Associated Medical Sciences. 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02752152
|Contact: Gonzague Jourdain, MD. PhD||+66 5381 email@example.com|
|Contact: Wasna Sirirungsi, PhD||+66 5394 firstname.lastname@example.org|
|Faculty of Associated Medical Sciences, Chiang Mai University||Recruiting|
|Chiang Mai, Thailand, 50100|
|Contact: Wasna Sirirungsi, PhD +6653945063 email@example.com|
|Principal Investigator:||Gonzague Jourdain, MD. PhD||IRD|