A Randomized Study to Compare Three Counseling Strategies and Evaluate the Efficacy of Reminders for Regular HIV, Hepatitis B and C, and Syphilis Testing
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 1,961
- Locations
- 3
- Primary Endpoint
- Percentage of participants from at-risk populations coming for a HIV re-test
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Residing or working in Thailand
- •Able to communicate with the counselor
- •Adults (>= 18 years old)
Exclusion Criteria
- •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)
Arms & Interventions
Computer-assisted counseling
Computer-assisted informational/educational interactive session followed by an interactive face-to-face session to discuss personal issues with a counselor as needed
Intervention: Appointment + reminder (Behavioral)
Computer-assisted counseling
Computer-assisted informational/educational interactive session followed by an interactive face-to-face session to discuss personal issues with a counselor as needed
Intervention: Computer-assisted counseling (Behavioral)
Computer-assisted counseling
Computer-assisted informational/educational interactive session followed by an interactive face-to-face session to discuss personal issues with a counselor as needed
Intervention: Reminder (Behavioral)
Computer-assisted counseling
Computer-assisted informational/educational interactive session followed by an interactive face-to-face session to discuss personal issues with a counselor as needed
Intervention: No appointment and no reminder (Behavioral)
On-demand counseling
The counselor asks whether the participant has any questions
Intervention: On-demand counseling (Behavioral)
On-demand counseling
The counselor asks whether the participant has any questions
Intervention: Appointment + reminder (Behavioral)
On-demand counseling
The counselor asks whether the participant has any questions
Intervention: Reminder (Behavioral)
On-demand counseling
The counselor asks whether the participant has any questions
Intervention: No appointment and no reminder (Behavioral)
Standard counseling
Interactive face-to-face counseling session
Intervention: Standard counseling (Behavioral)
Standard counseling
Interactive face-to-face counseling session
Intervention: Appointment + reminder (Behavioral)
Standard counseling
Interactive face-to-face counseling session
Intervention: Reminder (Behavioral)
Standard counseling
Interactive face-to-face counseling session
Intervention: No appointment and no reminder (Behavioral)
Appointment + reminder
Make appointment and send SMS reminder
Intervention: Computer-assisted counseling (Behavioral)
Appointment + reminder
Make appointment and send SMS reminder
Intervention: On-demand counseling (Behavioral)
Appointment + reminder
Make appointment and send SMS reminder
Intervention: Standard counseling (Behavioral)
Appointment + reminder
Make appointment and send SMS reminder
Intervention: Appointment + reminder (Behavioral)
Reminder only
Send SMS reminder only
Intervention: Computer-assisted counseling (Behavioral)
Reminder only
Send SMS reminder only
Intervention: On-demand counseling (Behavioral)
Reminder only
Send SMS reminder only
Intervention: Standard counseling (Behavioral)
Reminder only
Send SMS reminder only
Intervention: Reminder (Behavioral)
No appointment and no reminder
No appointment and no SMS reminder sent
Intervention: Computer-assisted counseling (Behavioral)
No appointment and no reminder
No appointment and no SMS reminder sent
Intervention: On-demand counseling (Behavioral)
No appointment and no reminder
No appointment and no SMS reminder sent
Intervention: Standard counseling (Behavioral)
No appointment and no reminder
No appointment and no SMS reminder sent
Intervention: No appointment and no reminder (Behavioral)
Outcomes
Primary Outcomes
Percentage of participants from at-risk populations coming for a HIV re-test
Time Frame: Within 7 months following the first visit
Number of participants having a re-test divided by number of at-risk participants
Secondary Outcomes
No secondary outcomes reported
Investigators
GONZAGUE JOURDAIN
PHPT research Team
Institut de Recherche pour le Developpement
