HIV/AIDSNCT03203265

Innovative Strategy to Offer Online Test and Treat for Thai MSM/TG

A study testing Group A: Offline HTC, Group B1: Offline HIV testing and post-test counseling and Group B2: Online HIV testing and post-test counseling in people with HIV/AIDS, run by Thai Red Cross AIDS Research Centre at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for: HIV/AIDS
What is being tested?: Group A: Offline HTC, Group B1: Offline HIV testing and post-test counseling and Group B2: Online HIV testing and post-test counseling
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 600 participants
Where: 1 siteThailand
Study dates: 6 Apr 2015to 1 Jul 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

1. Known HIV-positive serostatus

Trial locations and contacts

1 site in 1 country.

Thailand1 site

The Thai Red Cross AIDS Research Centre
Pathum Wan, Bangkok, 10330

Other trials in Thailand

About this study

Official title: Thai Red Cross AIDS Research Centre (TRCARC)

This study will ask Thai MSM and transgender women (TG) participants to self-select to participate in one of the 3 different study groups which provide various degrees of integrated online interventions and offline interventions for the Recruit-Test-Treat-Retain for HIV prevention and care among 3 groups (A, B1 and B2). All participants will be followed up either offline or online for 12 months. HIV-negative participants will be scheduled for repeat HTC at months 6 and 12. HIV-positive participants will be scheduled either offline or online to review their treatment history at months 6 and 12. HIV-negative participants in Group B1 and B2 can choose again at months 6 and 12 to switch from the online to offline, and vice versa, at the HIV testing/post-test counseling step and the referral to HIV treatment step

Conditions: HIV/AIDS
Being tested: Group A: Offline HTC, Group B1: Offline HIV testing and post-test counseling, Group B2: Online HIV testing and post-test counseling
Keywords: HIV home testing
Medical subject headings: Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Group A: Offline HTCOther
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.
Group B1: Offline HIV testing and post-test counselingOther
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.
Group B2: Online HIV testing and post-test counselingOther
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.

Study groups in NCT03203265
Study group	Role	What they receive
A:Offline HIV testing and counseling	Other	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. Receives: Other: Group A: Offline HTC
B1:Offline	Other	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. Receives: Other: Group B1: Offline HIV testing and post-test counseling
B2: Online	Other	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. Receives: Other: Group B2: Online HIV testing and post-test counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

The proportion of first-time HIV testers, proportion of successful HIV tests completed, proportion of successful referral to HIV treatment, and retention rate.
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:
- The first-time HIV testers: this outcome variable is collected from the questionnaire; the probability of the outcome is likely to be "yes" or "no".
- Successful HIV tests completed: this outcome variable is collected form the result of the laboratory; the probability of the outcome is likely to be "complete" or "incomplete".
- Successful referral to HIV treatment: this outcome variable is collected form the confirmation of antiretroviral treatment; the probability of the outcome is likely to be "successful" or "failure".
Therefore frequency and proportions of participants who have the possible outcome that we are interested (who are the first HIV testers, who
Measured: 1 Years

Secondary outcomes (3)

The proportion of HIV-positive participants who have virological suppression at each study visit after initiating ART.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 1 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Apr 20151 Jul 2021

First posted29 Jun 2017
Study start6 Apr 2015
Primary completion1 Jun 2021
Study completion1 Jul 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HIV/AIDSStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Screening
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: Prospective study to evaluate the first-time HIV testing, successful referral to HIV treatment, retention HIV testing among 3 different study groups. A participants will receive offline HIV testing,counseling and conventional retention strategies. HIV-positive result in A can choose to have either online or offline to HIV treatment. B1 participants will be guided to access services at the 'Adam's Love Clinic, that set up specifically to provide private, fast HIV testing and post-test counseling. B2 participants will be mailed a rapid HIV test kit. Counselor will guide the participant through an online HIV testing process. Post-test counseling will provided HIV test result online. Participants can choose one of two HIV testing and post-test counseling options. HIV-positive participants in B1 and B2 can choose again to refer to HIV treatment either online or offline. All participants in B1 and B2 will receive an online retention strategy.
Masking: Single blind
Who is masked: Participant
Enrolment: 600 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03203265
Sponsor's protocol ID: amfAR Test and Treat
Status last verified: Oct 2019
First submitted: 25 May 2017
Last updated: 25 Nov 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

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.
PubMed 31960589
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.
PubMed 30033644

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Thai Red Cross AIDS Research Centre (TRCARC)
ClinicalTrials.gov ID: NCT03203265
Acronym / sponsor ID: amfAR Test and Treat
Conditions: HIV/AIDS
Keywords: HIV home testing
Study type: Interventional
Recruitment status: Completed
Enrolment: 600 participants (actual)
Lead sponsor: Thai Red Cross AIDS Research CentreUniversity, hospital or other
Collaborators: amfAR GMT Implementation Research Grant
Study start: 6 Apr 2015 (actual)
Primary completion: 1 Jun 2021 (actual)
Study completion: 1 Jul 2021 (actual)
First posted: 29 Jun 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Screening
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3
Model description: Prospective study to evaluate the first-time HIV testing, successful referral to HIV treatment, retention HIV testing among 3 different study groups. A participants will receive offline HIV testing,counseling and conventional retention strategies. HIV-positive result in A can choose to have either online or offline to HIV treatment. B1 participants will be guided to access services at the 'Adam's Love Clinic, that set up specifically to provide private, fast HIV testing and post-test counseling. B2 participants will be mailed a rapid HIV test kit. Counselor will guide the participant through an online HIV testing process. Post-test counseling will provided HIV test result online. Participants can choose one of two HIV testing and post-test counseling options. HIV-positive participants in B1 and B2 can choose again to refer to HIV treatment either online or offline. All participants in B1 and B2 will receive an online retention strategy.

Arm	Type	Receives
A:Offline HIV testing and counseling	Other	Other: Group A: Offline HTCParticipants 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.
B1:Offline	Other	Other: Group B1: Offline HIV testing and post-test counselingparticipants 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.
B2: Online	Other	Other: Group B2: Online HIV testing and post-test counselingparticipants 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.

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (1 listed)

1. Known HIV-positive serostatus

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Group A: Offline HTCOffline 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	A:Offline HIV testing and counseling
Group B1: Offline HIV testing and post-test counselingparticipants 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	B1:Offline
Group B2: Online HIV testing and post-test counselingA 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.	Other	B2: Online

Primary outcome

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: * The first-time HIV testers: this outcome variable is collected from the questionnaire; the probability of the outcome is likely to be "yes" or "no". * Successful HIV tests completed: this outcome variable is collected form the result of the laboratory; the probability of the outcome is likely to be "complete" or "incomplete". * Successful referral to HIV treatment: this outcome variable is collected form the confirmation of antiretroviral treatment; the probability of the outcome is likely to be "successful" or "failure". Therefore frequency and proportions of participants who have the possible outcome that we are interested (who are the first HIV testers, who

3 secondary outcomes

The proportion of HIV-positive participants who have virological suppression at each study visit after initiating ART.
Time frame: 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 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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
Derived from this study: PubMed 31960589Phanuphak 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.
Derived from this study: PubMed 30033644Phanuphak 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nittaya Phanuphak, MD, PhD principal investigator

Thai Red Cross AIDS Research Centre (TRCARC)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03203265, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.