Counseling and Reminders for Regular HIV and STIs Screening
Napneung-1
A Randomized Study to Compare Three Counseling Strategies and Evaluate the Efficacy of Reminders for Regular HIV, Hepatitis B and C, and Syphilis Testing
1 other identifier
interventional
1,961
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2015
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 9, 2015
CompletedFirst Submitted
Initial submission to the registry
April 22, 2016
CompletedFirst Posted
Study publicly available on registry
April 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 18, 2020
CompletedFebruary 16, 2021
February 1, 2021
2.6 years
April 22, 2016
February 14, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Within 7 months following the first visit
Study Arms (6)
Computer-assisted counseling
EXPERIMENTALComputer-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
EXPERIMENTALThe counselor asks whether the participant has any questions
Standard counseling
ACTIVE COMPARATORInteractive face-to-face counseling session
Appointment + reminder
EXPERIMENTALMake appointment and send SMS reminder
Reminder only
EXPERIMENTALSend SMS reminder only
No appointment and no reminder
ACTIVE COMPARATORNo appointment and no SMS reminder sent
Interventions
The counselor opens the computer-assisted information/educational interactive counseling program on the tablet computer and invites the participant to use the program.
The counselor only invites the participants to ask questions about HIV and other STIs.
The counselor gives face-to-face general information/education
Has an appointment and receive reminders for further testing
Only receive reminders for further testing
No appointment and no reminders for further testing
Eligibility Criteria
You may qualify if:
- Residing or working in Thailand
- Able to communicate with the counselor
- Adults (\>= 18 years old)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institut de Recherche pour le Developpementlead
- Chiang Mai Universitycollaborator
- Expertise Francecollaborator
Study Sites (3)
Faculty of Associated Medical Sciences, Chiang Mai University
Chiang Mai, 50100, Thailand
MAP Foundation testing facility
Chiang Mai, Thailand
Special clinic of Chiangrai Prachanukroh Hospital
Chiang Rai, Thailand
Related Publications (1)
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.
PMID: 31605294DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gonzague Jourdain, MD. PhD
IRD
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PHPT research Team
Study Record Dates
First Submitted
April 22, 2016
First Posted
April 26, 2016
Study Start
December 9, 2015
Primary Completion
July 1, 2018
Study Completion
October 18, 2020
Last Updated
February 16, 2021
Record last verified: 2021-02