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Trial record 137 of 348 for:    hepatitis b | Open Studies

Counseling for HIV and STIs Screening (Lightning)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by Institut de Recherche pour le Developpement
Sponsor:
Collaborators:
Chiang Mai University
Expertise France
Information provided by (Responsible Party):
Gonzague Jourdain, Institut de Recherche pour le Developpement
ClinicalTrials.gov Identifier:
NCT02752152
First received: April 22, 2016
Last updated: November 1, 2016
Last verified: November 2016
  Purpose
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.

Condition Intervention
HIV, Hepatitis B, Hepatitis C and Syphilis Infections
Behavioral: Computer-assisted counseling
Behavioral: On-demand counseling
Behavioral: Standard counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Randomized Study to Compare Three Counseling Strategies for HIV, Hepatitis B and C, and Syphilis Testing

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1600
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)
Arms Assigned Interventions
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
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.
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.
Active Comparator: Standard counseling
Interactive face-to-face counseling session
Behavioral: Standard counseling
The counselor gives face-to-face general information/education

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02752152

Contacts
Contact: Gonzague Jourdain, MD. PhD +66 5381 9125 gonzague.jourdain@ird.fr
Contact: Wasna Sirirungsi, PhD +66 5394 5063 wasna.s@cmu.ac.th

Locations
Thailand
Faculty of Associated Medical Sciences, Chiang Mai University Recruiting
Chiang Mai, Thailand, 50100
Contact: Wasna Sirirungsi, PhD    +6653945063    wasna.s@cmu.ac.th   
Sponsors and Collaborators
Institut de Recherche pour le Developpement
Chiang Mai University
Expertise France
Investigators
Principal Investigator: Gonzague Jourdain, MD. PhD IRD
  More Information

Additional Information:
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
Health Authority: Thailand: Chiang Mai University
Individual Participant Data  
Plan to Share IPD: Undecided
Plan Description: To be discussed with the steering committee

Keywords provided by Institut de Recherche pour le Developpement:
Counseling

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis B
Hepatitis, Viral, Human
Syphilis
Liver Diseases
Digestive System Diseases
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

ClinicalTrials.gov processed this record on December 09, 2016