User-friendly HIV Testing and Counseling Services | NCT04585165

Studies
User-friendly HIV Testing and Counseling Services

NCT04585165

Sponsor

Institut de Recherche pour le Developpement

Status

Unknown status

Last Update Posted

Oct 31, 2023Actual

Enrollment

3,000Estimated

Phase

Not provided

Conditions

HIV Infections
Sexually Transmitted Infection
Hepatitis B, Chronic
Hepatitis C

Interventions

Not provided

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 19, 2020Actual

Primary Completion Date

Sep 2024Estimated

Completion Date

Dec 2024Estimated

First Submitted Date

Apr 27, 2020

First Submission Date that Met QC Criteria

Oct 12, 2020

First Posted Date

Oct 14, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 29, 2023

Last Update Posted Date

Oct 31, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

GONZAGUE JOURDAIN, Researcher, Chiang Mai UniversityPrincipal Investigator

Lead Sponsor

Institut de Recherche pour le DeveloppementOTHER_GOV

Collaborators

Name	Class
Expertise France	OTHER
French National Research Institute for Sustainable Development (IRD)	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Multicenter cohort study of individuals reporting behavioral risks of HIV acquisition, recruited among those presenting for testing for HIV and other sexually transmitted infections.

Overarching goal: to study factors associated with uptake of HIV prevention and (re)testing services in medium-sized cities in Thailand.

Primary objective: To estimate the incidence of HIV and other sexually transmitted infections (syphilis, chronic hepatitis B and C) among individuals presenting for retesting.

Secondary objectives:

To evaluate the uptake of pre-exposure prophylaxis
To assess retention in the study
To evaluate client HIV knowledge
To describe HIV prevalence and characteristics of individuals newly diagnosed with HIV
To describe characteristics of individuals at risk of HIV infection
To assess the quality of the testing and referral services.

Detailed Description

Testing and counseling for HIV, syphilis and other sexually transmitted infections is provided to consenting individuals.

Components: interactive counseling program, self sampling (finger prick) under supervision, questionnaire (on a tablet computer) to assess risks of HIV acquisition, understanding of HIV transmission routes and pre-exposure prophylaxis, willingness to take pre-exposure prophylaxis if at risk of HIV, and satisfaction with regard to services provided.

Referral to appropriate care facility of participants diagnosed with infection. HIV negative participants with significant risk of HIV are advised to come back for HIV retesting within 3 to 6 months and informed about pre-exposure prophylaxis.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

3,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Risk of HIV acquisition		Individuals reporting behavioral risk of HIV acquisition.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HIV incidence	HIV incidence	Through study completion, an average of 3 years

Secondary Outcomes

Measure	Description	Time Frame
Participants initiating pre-exposure prophylaxis	Proportion of participants initiating pre-exposure prophylaxis among those at significant risk of HIV	Through study completion, an average of 3 years
Retention

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged 15 years or more
Willing to be tested for HIV and other sexually transmitted infections
Able to understand the study and its procedures

Exclusion Criteria: None

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Individuals requesting a test for HIV and sexually transmitted infections

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Gonzague Jourdain, MD, PhD	Contact	+66 5324 0910		Gonzague.Jourdain@phpt.org
Nicolas Salvadori, PhD	Contact	+66 5324 0910		Nicolas.Salvadori@phpt.org

Overall Officials

Name	Affiliation	Role
Gonzague Jourdain, MD, PhD	Chiang Mai University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
STIs Clinic of the Office of Disease Prevention and Control Region 1	Recruiting	Chiang Mai		50100	Thailand

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31605294	Background	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.
32294318

ID	Term
D015658	HIV Infections
D012749	Sexually Transmitted Diseases
D019694	Hepatitis B, Chronic
D006526	Hepatitis C
D004194	Disease

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral