- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03203265
Innovative Strategy to Offer Online Test and Treat for Thai MSM/TG
Thai Red Cross AIDS Research Centre (TRCARC)
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bangkok
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Pathum Wan, Bangkok, Thailand, 10330
- The Thai Red Cross AIDS Research Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Thai national
- Age >18 years
- Men or transgender women who have at least 1 unprotected anal sex with men within the past 6 months
- Live in the Bangkok Metropolitan Region (Bangkok, Pathumthani, Samutprakarn, Samutsakorn, Nakornpathom and Nonthaburi) or Pattaya
- Not known to be HIV-positive, i.e., never tested for HIV or previous HIV test(s) negative
- Willing to participate in the study for 12 months.
- Provide verbal informed consent
Exclusion Criteria:
1. Known HIV-positive serostatus
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: A:Offline HIV testing and counseling
Participants in Group A will be invited to come to the Thai Red Cross Anonymous Clinic, RSAT or SWING drop-in centers in Bangkok, or SWING or Sisters drop-in centers in Pattaya.
After registration, they will receive standard HIV Testing and Counseling (HTC) services.
|
Offline or online referral to HIV treatment facility HIV-positive participants can choose to receive either an offline or online referral to HIV treatment facilities.
An offline referral method usually includes a referral letter and/or a telephone call, followed by a series of calls to participants to ensure successful referral.
Those who choose an online referral will be able to register online with an HIV treatment facility which provides ART without cost under the national programs.
Participants will receive a registration code which will allow them to access HIV treatment clinics directly without the need to go through the regular registration and appointment system at that facility.
|
Other: B1:Offline
participants will be guided to access services at the 'Adam's Love Offline Clinic,' a clinic set up specifically to provide private and fast HIV testing and post-test counseling only.
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participants will be guided to access services at the 'Adam's Love Offline Clinic,' a clinic set up specifically to provide private and fast HIV testing and post-test counseling only referred from the Adam's Love Online Clinic.
|
Other: B2: Online
participants will be mailed a rapid HIV test kit.
A trained online counselor will guide the participant through an online HIV testing process which includes quality checking of the test kit, obtaining blood through finger prick, performing the testing steps, and reading the test result.
|
A trained online counselor will guide the participant through an online HIV testing process which includes quality checking of the test kit,obtaining blood through finger prick,performing the testing steps,reading the test result.
A positive result from the first test will trigger the need for referral to confirmatory tests.
The provisional nature of the positive result from the single rapid HIV test will be emphasized but the urgency to get immediate confirmatory tests and linkage to HIV treatment facilities will encouraged and supported.
HIV positive test result will be confirmed only with three positive tests.
Any online testing session with uncertain qualities at any step will be repeated at a later time or the participant will be offered offline HIV testing.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The proportion of first-time HIV testers, proportion of successful HIV tests completed, proportion of successful referral to HIV treatment, and retention rate.
Time Frame: 1 Years
|
The first-time HIV testers, successful HIV tests completed and successful referral to HIV treatment are the categorical data which don't have the units to measure. These variables are the binary outcome in which there are only two possible status e.g. yes or no, therapeutic successes or failure. The details are as follows:
Therefore frequency and proportions of participants who have the possible outcome that we are interested (who are the first HIV testers, who |
1 Years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The proportion of HIV-positive participants who have virological suppression at each study visit after initiating ART.
Time Frame: 1 Years
|
The proportion of HIV-positive participants who have virological suppression at each study visit after initiating ART among MSM and TG who access online vs. offline services will be reported together with 95% confidence intervals.
Formal comparisons between groups will be made using a Chi-squared test.
|
1 Years
|
The retention rates of HIV-negative MSM and TG for repeated HIV testing and HIV-positive MSM and TG for antiretroviral treatment when online vs. offline retention methods are used
Time Frame: 1 Years
|
The retention rate (or event-free survival functions) is the probability value that participant will remain in the study in any time point.
The probability value is between 0 to 100% and will be estimated using Kaplan-Meier method for overall and separately by HIV-status and arms.
Formal comparisons between HIV-status, online and offline retention arms will be made by a log-rank test.
|
1 Years
|
The factors associated with the preferences for the online option of HIV pre-test counseling, HIV testing and post-test counseling, referral for HIV treatment, and retention services among MSM and TG
Time Frame: 1 Years
|
The association of covariates with a preference for online vs. offline services at first visit will be modeled using logistic regression.
Predictor covariates will include socio-demographic data, sexual and drug use behaviors, social network characteristics, perceived barriers and facilitators for HIV testing, beliefs and experiences around stigma and discrimination related to HIV and/or being MSM or TG, strengths and supports for stigma/discrimination, and HIV testing history.
|
1 Years
|
Collaborators and Investigators
Collaborators
Publications and helpful links
General Publications
- Phanuphak N, Jantarapakde J, Himmad L, Sungsing T, Meksena R, Phomthong S, Phoseeta P, Tongmuang S, Mingkwanrungruang P, Meekrua D, Sukthongsa S, Hongwiangchan S, Upanun N, Jirajariyavej S, Jadwattanakul T, Barisri S, Pankam T, Phanuphak P. Linkages to HIV confirmatory testing and antiretroviral therapy after online, supervised, HIV self-testing among Thai men who have sex with men and transgender women. J Int AIDS Soc. 2020 Jan;23(1):e25448. doi: 10.1002/jia2.25448.
- Phanuphak N, Anand T, Jantarapakde J, Nitpolprasert C, Himmad K, Sungsing T, Trachunthong D, Phomthong S, Phoseeta P, Tongmuang S, Mingkwanrungruang P, Meekrua D, Sukthongsa S, Hongwiangchan S, Upanun N, Barisri J, Pankam T, Phanuphak P. What would you choose: Online or Offline or Mixed services? Feasibility of online HIV counselling and testing among Thai men who have sex with men and transgender women and factors associated with service uptake. J Int AIDS Soc. 2018 Jul;21 Suppl 5(Suppl Suppl 5):e25118. doi: 10.1002/jia2.25118.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- amfAR Test and Treat
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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