HIV, Hepatitis B, Hepatitis C and Syphilis InfectionsNapneung-1NCT02752152
Counseling and Reminders for Regular HIV and STIs Screening
A study testing Computer-assisted counseling, On-demand counseling and Standard counseling in people with HIV, Hepatitis B, Hepatitis C and Syphilis Infections, run by Institut de Recherche pour le Developpement at 3 sites in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV, Hepatitis B, Hepatitis C and Syphilis Infections
- What is being tested?
- Computer-assisted counseling, On-demand counseling and Standard counseling
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,961 participants
- Where
- 3 sitesThailand
- Study dates
- 9 Dec 2015to 18 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Residing or working in Thailand
- Able to communicate with the counselor
- Adults (>= 18 years old)
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country.
Thailand3 sites
Faculty of Associated Medical Sciences, Chiang Mai University
Chiang Mai, 50100
MAP Foundation testing facility
Chiang Mai
Special clinic of Chiangrai Prachanukroh Hospital
Chiang Rai
About this study
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
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.
Read more
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.
Read the 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.
- Being tested
- Computer-assisted counseling, On-demand counseling, Standard counseling, Appointment + reminder, Reminder
- Keywords
- Counseling, Reminder, Early diagnosis
- Medical subject headings
- Hepatitis B, Hepatitis C, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-assisted counselingBehavioural
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 counselingBehavioural
The counselor only invites the participants to ask questions about HIV and other STIs.
Standard counselingBehavioural
The counselor gives face-to-face general information/education
Appointment + reminderBehavioural
Has an appointment and receive reminders for further testing
ReminderBehavioural
Only receive reminders for further testing
No appointment and no reminderBehavioural
No appointment and no reminders for further testing
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Computer-assisted counseling; Behavioral: Appointment + reminder; Behavioral: Reminder; Behavioral: No appointment and no reminder |
| On-demand counseling | Experimental | The counselor asks whether the participant has any questions Receives: Behavioral: On-demand counseling; Behavioral: Appointment + reminder; Behavioral: Reminder; Behavioral: No appointment and no reminder |
| Standard counseling | Active comparator | Interactive face-to-face counseling session Receives: Behavioral: Standard counseling; Behavioral: Appointment + reminder; Behavioral: Reminder; Behavioral: No appointment and no reminder |
| Appointment + reminder | Experimental | Make appointment and send SMS reminder Receives: Behavioral: Computer-assisted counseling; Behavioral: On-demand counseling; Behavioral: Standard counseling; Behavioral: Appointment + reminder |
| Reminder only | Experimental | Send SMS reminder only Receives: Behavioral: Computer-assisted counseling; Behavioral: On-demand counseling; Behavioral: Standard counseling; Behavioral: Reminder |
| No appointment and no reminder | Active comparator | No appointment and no SMS reminder sent Receives: Behavioral: Computer-assisted counseling; Behavioral: On-demand counseling; Behavioral: Standard counseling; Behavioral: No appointment and no reminder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants from at-risk populations coming for a HIV re-test
Number of participants having a re-test divided by number of at-risk participants
Measured: Within 7 months following the first visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study start9 Dec 2015
- Primary completion1 Jul 2018
- Study completion18 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV, Hepatitis B, Hepatitis C and Syphilis InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,961 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherche pour le Developpement
- Sponsor type
- Other government
- Collaborators
- Chiang Mai University, Expertise France
- Responsible party
- Principal investigator, GONZAGUE JOURDAIN, Institut de Recherche pour le Developpement
- Investigators
- Gonzague Jourdain, MD. PhD, Principal investigator, IRD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02752152
- Sponsor's protocol ID
- Napneung-1
- Acronym
- Napneung-1
- Status last verified
- Feb 2021
- First submitted
- 22 Apr 2016
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: To be discussed with the steering committee
Publications
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.
PubMed 31605294
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02752152
- Acronym / sponsor ID
- Napneung-1 / Napneung-1
- Keywords
- Counseling, Reminder, Early diagnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,961 participants (actual)
- Lead sponsor
- Institut de Recherche pour le DeveloppementOther government
- Collaborators
- Chiang Mai University, Expertise France
- Study start
- 9 Dec 2015 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 18 Oct 2020 (actual)
- First posted
- 26 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Computer-assisted counseling | Experimental | Behavioral: Computer-assisted counseling, Behavioral: Appointment + reminder, Behavioral: Reminder, Behavioral: No appointment and no reminderComputer-assisted informational/educational interactive session followed by an interactive face-to-face session to discuss personal issues with a counselor as needed |
| On-demand counseling | Experimental | Behavioral: On-demand counseling, Behavioral: Appointment + reminder, Behavioral: Reminder, Behavioral: No appointment and no reminderThe counselor asks whether the participant has any questions |
| Standard counseling | Active comparator | Behavioral: Standard counseling, Behavioral: Appointment + reminder, Behavioral: Reminder, Behavioral: No appointment and no reminderInteractive face-to-face counseling session |
| Appointment + reminder | Experimental | Behavioral: Computer-assisted counseling, Behavioral: On-demand counseling, Behavioral: Standard counseling, Behavioral: Appointment + reminderMake appointment and send SMS reminder |
| Reminder only | Experimental | Behavioral: Computer-assisted counseling, Behavioral: On-demand counseling, Behavioral: Standard counseling, Behavioral: ReminderSend SMS reminder only |
| No appointment and no reminder | Active comparator | Behavioral: Computer-assisted counseling, Behavioral: On-demand counseling, Behavioral: Standard counseling, Behavioral: No appointment and no reminderNo appointment and no SMS reminder sent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Residing or working in Thailand
- Able to communicate with the counselor
- Adults (>= 18 years old)
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer-assisted counselingThe counselor opens the computer-assisted information/educational interactive counseling program on the tablet computer and invites the participant to use the program. | Behavioural | Appointment + reminder, Computer-assisted counseling, No appointment and no reminder, Reminder only |
| On-demand counselingThe counselor only invites the participants to ask questions about HIV and other STIs. | Behavioural | Appointment + reminder, No appointment and no reminder, On-demand counseling, Reminder only |
| Standard counselingThe counselor gives face-to-face general information/education | Behavioural | Appointment + reminder, No appointment and no reminder, Reminder only, Standard counseling |
| Appointment + reminderHas an appointment and receive reminders for further testing | Behavioural | Appointment + reminder, Computer-assisted counseling, On-demand counseling, Standard counseling |
| ReminderOnly receive reminders for further testing | Behavioural | Computer-assisted counseling, On-demand counseling, Reminder only, Standard counseling |
| No appointment and no reminderNo appointment and no reminders for further testing | Behavioural | Computer-assisted counseling, No appointment and no reminder, On-demand counseling, Standard counseling |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- Derived from this study: PubMed 31605294Salvadori 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.
- Official study site for the recruitmentLink provided by the sponsor.
- Official facebook page for the recruitmentLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. To be discussed with the steering committee
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gonzague Jourdain, MD. PhD principal investigator
IRD
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-assisted counseling, On-demand counseling and Standard counseling in people with HIV, Hepatitis B, Hepatitis C and Syphilis Infections, run by Institut de Recherche pour le Developpement at 3 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants from at-risk populations coming for a HIV re-test (time frame: Within 7 months following the first visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02752152, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2021.