NCT04585165

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

April 27, 2020

Completed
6 months until next milestone

First Posted

Study publicly available on registry

October 14, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

October 19, 2020

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

October 31, 2023

Status Verified

October 1, 2023

Enrollment Period

3.9 years

First QC Date

April 27, 2020

Last Update Submit

October 29, 2023

Conditions

Keywords

HIVTestingSelf-testingRetestingEarly diagnosisCounselingComputerReminderShort message servicePre-exposure prophylaxis

Outcome Measures

Primary Outcomes (1)

  • HIV incidence

    HIV incidence

    Through study completion, an average of 3 years

Secondary Outcomes (3)

  • Participants initiating pre-exposure prophylaxis

    Through study completion, an average of 3 years

  • Retention

    Through study completion, an average of 3 years

  • HIV knowledge

    Through study completion, an average of 3 years

Study Arms (1)

Risk of HIV acquisition

Individuals reporting behavioral risk of HIV acquisition.

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals requesting a test for HIV and sexually transmitted infections

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

STIs Clinic of the Office of Disease Prevention and Control Region 1

Chiang Mai, 50100, Thailand

RECRUITING

Clinical Service Center, Faculty of Associated Medical Sciences, Chiang Mai University

Chiang Mai, 50200, Thailand

RECRUITING

MAP Foundation

Chiang Mai, Thailand

RECRUITING

Chiang Rai Obstetrics Clinic

Chiang Rai, 57000, Thailand

RECRUITING

Phayao Hospital

Phayao, 56000, Thailand

NOT YET RECRUITING

University of Phayao Medical Center and Hospital

Phayao, 56000, Thailand

RECRUITING

Related Publications (2)

  • 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: 31605294BACKGROUND
  • Salvadori N, Adam P, Mary JY, Decker L, Sabin L, Chevret S, Arunothong S, Khamduang W, Luangsook P, Suksa-Ardphasu V, Achalapong J, Rouzioux C, Sirirungsi W, Ngo-Giang-Huong N, Jourdain G. Appointment reminders to increase uptake of HIV retesting by at-risk individuals: a randomized controlled study in Thailand. J Int AIDS Soc. 2020 Apr;23(4):e25478. doi: 10.1002/jia2.25478.

    PMID: 32294318BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Plasma from remaining blood sample

MeSH Terms

Conditions

HIV InfectionsSexually Transmitted DiseasesHepatitis B, ChronicHepatitis CDisease

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHepatitis BHepadnaviridae InfectionsDNA Virus InfectionsHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseFlaviviridae Infections

Study Officials

  • Gonzague Jourdain, MD, PhD

    Chiang Mai University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gonzague Jourdain, MD, PhD

CONTACT

Nicolas Salvadori, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

April 27, 2020

First Posted

October 14, 2020

Study Start

October 19, 2020

Primary Completion

September 1, 2024

Study Completion

December 1, 2024

Last Updated

October 31, 2023

Record last verified: 2023-10

Locations