Counseling and Reminders for Regular HIV and STIs Screening
NCT ID: NCT02752152
Last Updated: 2021-02-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1961 participants
INTERVENTIONAL
2015-12-09
2020-10-18
Brief Summary
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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.
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Detailed Description
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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.
Following the published of CD4 cell count normal ranges in HIV uninfected individuals in Thailand since 1997 (Vithayasai, Sirisanthana, Sakonwasun, \& Suvanpiyasiri, 1997), It is unknown whether these norms have changed in relation to changes in nutritional status and lifestyle in young adults. We will assess the number of CD4 cells/mL in the blood of the first 30 HIV-uninfected female and the first 30 HIV-uninfected male clients aged less than 26 years to determine whether there is a trend for an increase in young people due to the changes in nutrition and lifestyle during the last decades. This sub-study will be conducted from 1 February 2019 to 31 January 2021.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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
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.
Appointment + reminder
Has an appointment and receive reminders for further testing
Reminder
Only receive reminders for further testing
No appointment and no reminder
No appointment and no reminders for further testing
On-demand counseling
The counselor asks whether the participant has any questions
On-demand counseling
The counselor only invites the participants to ask questions about HIV and other STIs.
Appointment + reminder
Has an appointment and receive reminders for further testing
Reminder
Only receive reminders for further testing
No appointment and no reminder
No appointment and no reminders for further testing
Standard counseling
Interactive face-to-face counseling session
Standard counseling
The counselor gives face-to-face general information/education
Appointment + reminder
Has an appointment and receive reminders for further testing
Reminder
Only receive reminders for further testing
No appointment and no reminder
No appointment and no reminders for further testing
Appointment + reminder
Make appointment and send SMS reminder
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.
On-demand counseling
The counselor only invites the participants to ask questions about HIV and other STIs.
Standard counseling
The counselor gives face-to-face general information/education
Appointment + reminder
Has an appointment and receive reminders for further testing
Reminder only
Send SMS reminder only
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.
On-demand counseling
The counselor only invites the participants to ask questions about HIV and other STIs.
Standard counseling
The counselor gives face-to-face general information/education
Reminder
Only receive reminders for further testing
No appointment and no reminder
No appointment and no SMS reminder sent
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.
On-demand counseling
The counselor only invites the participants to ask questions about HIV and other STIs.
Standard counseling
The counselor gives face-to-face general information/education
No appointment and no reminder
No appointment and no reminders for further testing
Interventions
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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.
On-demand counseling
The counselor only invites the participants to ask questions about HIV and other STIs.
Standard counseling
The counselor gives face-to-face general information/education
Appointment + reminder
Has an appointment and receive reminders for further testing
Reminder
Only receive reminders for further testing
No appointment and no reminder
No appointment and no reminders for further testing
Eligibility Criteria
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Inclusion Criteria
* Able to communicate with the counselor
* Adults (\>= 18 years old)
Exclusion Criteria
* Couples requesting a couple counseling session
* HIV-positive participants (based on the client declaration)
18 Years
ALL
Yes
Sponsors
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Chiang Mai University
OTHER
Expertise France
OTHER
Institut de Recherche pour le Developpement
OTHER_GOV
Responsible Party
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GONZAGUE JOURDAIN
PHPT research Team
Principal Investigators
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Gonzague Jourdain, MD. PhD
Role: PRINCIPAL_INVESTIGATOR
IRD
Locations
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Faculty of Associated Medical Sciences, Chiang Mai University
Chiang Mai, , Thailand
MAP Foundation testing facility
Chiang Mai, , Thailand
Special clinic of Chiangrai Prachanukroh Hospital
Chiang Rai, , Thailand
Countries
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References
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Salvadori N, Decker L, Ngo-Giang-Huong N, Mary JY, Chevret S, Arunothong S, Adam P, Khamduang W, Samleerat T, Luangsook P, Suksa-Ardphasu V, Achalapong J, Rouzioux C, Sirirungsi W, Jourdain G. Impact of Counseling Methods on HIV Retesting Uptake in At-Risk Individuals: A Randomized Controlled Study. AIDS Behav. 2020 May;24(5):1505-1516. doi: 10.1007/s10461-019-02695-2.
Related Links
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Official study site for the recruitment
Official facebook page for the recruitment
Other Identifiers
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Napneung-1
Identifier Type: -
Identifier Source: org_study_id
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