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

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ClinicalTrials.gov Identifier: NCT03203265
Recruitment Status : Active, not recruiting
First Posted : June 29, 2017
Last Update Posted : October 4, 2019
Sponsor:
Collaborator:
amfAR GMT Implementation Research Grant
Information provided by (Responsible Party):
Thai Red Cross AIDS Research Centre

Brief Summary:
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

Condition or disease Intervention/treatment Phase
HIV/AIDS Other: Group A: Offline HTC Other: Group B1: Offline HIV testing and post-test counseling Other: Group B2: Online HIV testing and post-test counseling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant)
Primary Purpose: Screening
Official Title: Thai Red Cross AIDS Research Centre (TRCARC)
Actual Study Start Date : April 6, 2015
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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.
Other: Group A: Offline HTC
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.

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.
Other: Group B1: Offline HIV testing and post-test counseling
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.

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.
Other: Group B2: Online HIV testing and post-test counseling
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.




Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Thai national
  2. Age >18 years
  3. Men or transgender women who have at least 1 unprotected anal sex with men within the past 6 months
  4. Live in the Bangkok Metropolitan Region (Bangkok, Pathumthani, Samutprakarn, Samutsakorn, Nakornpathom and Nonthaburi) or Pattaya
  5. Not known to be HIV-positive, i.e., never tested for HIV or previous HIV test(s) negative
  6. Willing to participate in the study for 12 months.
  7. Provide verbal informed consent

Exclusion Criteria:

1. Known HIV-positive serostatus


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03203265


Locations
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Thailand
The Thai Red Cross AIDS Research Centre
Pathum Wan, Bangkok, Thailand, 10330
Sponsors and Collaborators
Thai Red Cross AIDS Research Centre
amfAR GMT Implementation Research Grant
Investigators
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Principal Investigator: Nittaya Phanuphak, MD, PhD Thai Red Cross AIDS Research Centre (TRCARC)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Thai Red Cross AIDS Research Centre
ClinicalTrials.gov Identifier: NCT03203265     History of Changes
Other Study ID Numbers: amfAR Test and Treat
First Posted: June 29, 2017    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Thai Red Cross AIDS Research Centre:
HIV home testing