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Counseling and Reminders for Regular HIV and STIs Screening (Napneung-1)

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ClinicalTrials.gov Identifier: NCT02752152
Recruitment Status : Recruiting
First Posted : April 26, 2016
Last Update Posted : October 3, 2019
Sponsor:
Collaborators:
Chiang Mai University
Expertise France
Information provided by (Responsible Party):
GONZAGUE JOURDAIN, Institut de Recherche pour le Developpement

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.


Condition or disease Intervention/treatment Phase
HIV, Hepatitis B, Hepatitis C and Syphilis Infections Behavioral: Computer-assisted counseling Behavioral: On-demand counseling Behavioral: Standard counseling Behavioral: Appointment + reminder Behavioral: Reminder Behavioral: No appointment and no reminder Not Applicable

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.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized Study to Compare Three Counseling Strategies and Evaluate the Efficacy of Reminders for Regular HIV, Hepatitis B and C, and Syphilis Testing
Study Start Date : December 2015
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 as needed
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.

Behavioral: Appointment + reminder
Has an appointment and receive reminders for further testing

Behavioral: Reminder
Only receive reminders for further testing

Behavioral: No appointment and no reminder
No appointment and no reminders for further testing

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.

Behavioral: Appointment + reminder
Has an appointment and receive reminders for further testing

Behavioral: Reminder
Only receive reminders for further testing

Behavioral: No appointment and no reminder
No appointment and no reminders for further testing

Active Comparator: Standard counseling
Interactive face-to-face counseling session
Behavioral: Standard counseling
The counselor gives face-to-face general information/education

Behavioral: Appointment + reminder
Has an appointment and receive reminders for further testing

Behavioral: Reminder
Only receive reminders for further testing

Behavioral: No appointment and no reminder
No appointment and no reminders for further testing

Experimental: Appointment + reminder
Make appointment and send SMS reminder
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.

Behavioral: On-demand counseling
The counselor only invites the participants to ask questions about HIV and other STIs.

Behavioral: Standard counseling
The counselor gives face-to-face general information/education

Behavioral: Appointment + reminder
Has an appointment and receive reminders for further testing

Experimental: Reminder only
Send SMS reminder only
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.

Behavioral: On-demand counseling
The counselor only invites the participants to ask questions about HIV and other STIs.

Behavioral: Standard counseling
The counselor gives face-to-face general information/education

Behavioral: Reminder
Only receive reminders for further testing

Active Comparator: No appointment and no reminder
No appointment and no SMS reminder sent
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.

Behavioral: On-demand counseling
The counselor only invites the participants to ask questions about HIV and other STIs.

Behavioral: Standard counseling
The counselor gives face-to-face general information/education

Behavioral: No appointment and no reminder
No appointment and no reminders for further testing




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02752152


Contacts
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Contact: Gonzague Jourdain, MD. PhD +66 5324 0910 gonzague.jourdain@ird.fr
Contact: Nicolas Salvadori, MSc +66 5324 0910 nicolas.salvadori@phpt.org

Locations
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Thailand
Faculty of Associated Medical Sciences, Chiang Mai University Recruiting
Chiang Mai, Thailand, 50100
Contact: Sakorn Sakorn Pornprasert, PhD    +6653945063    dean.ams@cmu.ac.th   
MAP Foundation testing facility Recruiting
Chiang Mai, Thailand
Contact: Brahm Press       brahm.press@gmail.com   
Special clinic of Chiangrai Prachanukroh Hospital Recruiting
Chiang Rai, Thailand
Contact: Jullapong Achalapong, MD       jullapongachalapong@gmail.com   
Sponsors and Collaborators
Institut de Recherche pour le Developpement
Chiang Mai University
Expertise France
Investigators
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Principal Investigator: Gonzague Jourdain, MD. PhD IRD
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: GONZAGUE JOURDAIN, PHPT research Team, Institut de Recherche pour le Developpement
ClinicalTrials.gov Identifier: NCT02752152    
Other Study ID Numbers: Napneung-1
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: To be discussed with the steering committee
Keywords provided by GONZAGUE JOURDAIN, Institut de Recherche pour le Developpement:
Counseling
Reminder
Early diagnosis
Additional relevant MeSH terms:
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Syphilis
Hepatitis A
Hepatitis C
Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepadnaviridae Infections
DNA Virus Infections
Treponemal Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Spirochaetales Infections
Sexually Transmitted Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female