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

NCT03203265 | Completed DMC

• 1 other identifier: amfAR Test and Treat
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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

Conditions

HIV/AIDS

Keywords

HIV home testing

Outcome Measures

Primary Outcomes (1)

• 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

  1 Years

Secondary Outcomes (3)

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

  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

  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

  1 Years

Study Arms (3)

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.

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.

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.

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

Interventions

Group A: Offline HTC OTHER

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.

A:Offline HIV testing and counseling

Group B1: Offline HIV testing and post-test counseling 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 referred from the Adam's Love Online Clinic.

B1:Offline

Group B2: Online HIV testing and post-test counseling OTHER

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.

B2: Online

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \. Known HIV-positive serostatus

Sponsors & Collaborators

• Thai Red Cross AIDS Research Centre: lead
• amfAR GMT Implementation Research Grant: collaborator

Study Sites (1)

The Thai Red Cross AIDS Research Centre

Pathum Wan, Bangkok, 10330, Thailand

Location

Related Publications (2)

• 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.

  PMID: 31960589 DERIVED

• 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.

  PMID: 30033644 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Nittaya Phanuphak, MD, PhD

  Thai Red Cross AIDS Research Centre (TRCARC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 25, 2017
• First Posted: June 29, 2017
• Study Start: April 6, 2015
• Primary Completion: June 1, 2021
• Study Completion: July 1, 2021
• Last Updated: November 25, 2024

Record last verified: 2019-10

Locations

TH (1)