Counseling for HIV and STIs Screening (Lightning)
Verified November 2016 by Gonzague Jourdain, Institut de Recherche pour le Developpement
Institut de Recherche pour le Developpement
Chiang Mai University
Information provided by (Responsible Party)
Gonzague Jourdain, Institut de Recherche pour le Developpement
First received: April 22, 2016
Last updated: November 1, 2016
Last Verified: November 2016
History of Changes
The primary objective of the study is 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 are 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.
HIV, Hepatitis B, Hepatitis C and Syphilis Infections
Behavioral : Computer-assisted counseling
Behavioral : On-demand counseling
Behavioral : Standard counseling
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
|Official Title:||A Randomized Study to Compare Three Counseling Strategies for HIV, Hepatitis B and C, and Syphilis Testing|
Further study details as provided by Gonzague Jourdain, Institut de Recherche pour le Developpement:
Primary Outcome Measures
- Proportion of participants in at-risk populations coming for a HIV re-test [ Time Frame: Within 7 months following the first visit ]
|Study Start Date:||December 2015|
|Estimated Study Completion Date:||February 2019|
|Estimated Primary Completion Date:||January 2019 (Final data collection date for primary outcome measure)|
Computer-assisted informational/educational interactive session followed by an interactive face-to-face session to discuss personal issues with a counselor
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 asks whether the participant has any questions
The counselor only invites the participants to ask questions about HIV and other STIs.
Interactive face-to-face counseling session
The counselor gives face-to-face general information/education
The study will be presented to clients, who will be asked to formally consent to participate.
Clients residing or working in northern 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 followed by a face-to-face counseling, or minimal counseling (the counselor invites the participant to ask questions).
At each visit, blood sample will be collected to test for HIV, hepatitis B and C, and syphilis. at the Faculty of Associated Medical Sciences. 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.
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Residing or working in Thailand
- Able to communicate with the counselor
- Adults (>= 18 years old)
- 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)
Contacts and LocationsChoosing 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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02752152
|Contact: Gonzague Jourdain, MD. PhD||+66 5381 firstname.lastname@example.org|
|Contact: Wasna Sirirungsi, PhD||+66 5394 email@example.com|
Locations Show More
|Faculty of Associated Medical Sciences, Chiang Mai University||Recruiting|
|Chiang Mai, Thailand, 50100|
Contact: Wasna Sirirungsi, PhD  +6653945063  firstname.lastname@example.org
Sponsors and CollaboratorsInstitut de Recherche pour le Developpement
Chiang Mai University
|Principal Investigator:||Gonzague Jourdain, MD. PhD||IRD|
Additional Information:Official study site for the recruitment
Additional Information:Official facebook page for the recruitment
|Responsible Party:||Gonzague Jourdain, Director, International Research Unit 174 (PHPT), Institut de Recherche pour le Developpement|
|ClinicalTrials.gov Identifier:||NCT02752152 History of Changes|
|Other Study ID Numbers:||Lightning|
|Study First Received:||April 22, 2016|
|Last Updated:||November 1, 2016|
|Individual Participant Data|
|Plan to Share IPD:||Undecided|
Keywords provided by Gonzague Jourdain, Institut de Recherche pour le Developpement:Counseling
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on October 20, 2017
This information is provided by ClinicalTrials.gov.