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Addressing the Continuum of Care Among High-risk Thai Men

Primary Purpose

HIV/AIDS, STD

Status
Recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
HUG-M+
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV/AIDS

Eligibility Criteria

15 Years - 29 Years (Child, Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 15-29 years at cohort baseline
  • Self-reported male gender
  • Self-reported having had anal sex with another man in the past 12 months
  • Speak, read and write Thai
  • Thai citizenship
  • Resident of the assessment city for the next 2 years (live, work or go to school)

Exclusion Criteria:

  • Do not consent to urine testing or anal swab
  • Not willing to give contact information for follow-up assessments

Sites / Locations

  • M-Health Office Maha SarakhamRecruiting
  • M-Health Office UbonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mpowerment-based intervention

Standard of care

Arm Description

YMSM in this arm may be exposed to a multicomponent, multi-level, community mobilization, combination intervention to address the entire HIV Continuum of Prevention and Care.

YMSM in this arm will not be exposed to the intervention.

Outcomes

Primary Outcome Measures

Number of participants who have tested for HIV the past 6 months
Participants will answer a yes/no question if they have tested in the past 6 months
Number of participants who have engaged in condomless anal intercourse in the past 6 months
Participants will answer a yes/no question if they engage in condomless anal intercourse (CAI) with non-primary or primary partners who are serodiscordant or of unknown serostatus, nonmonogamous, or who have been primary partners less than 6 months.

Secondary Outcome Measures

Number of participants who report using PrEP daily or on demand
Participants will answer a series of questions related to PrEP use and patterns of use (either daily or on demand)
Undetectable viral load
Self-reported undetectable viral load
HIV prevalence
HIV prevalence at baseline
HIV incidence/seroconversion
HIV incidence/seroconversion
STI incidence
Chlamydia and gonorrhoea by urine and anal swab

Full Information

First Posted
November 3, 2021
Last Updated
June 1, 2023
Sponsor
Mahidol University
Collaborators
University of California, San Francisco, University of Malaya, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05161689
Brief Title
Addressing the Continuum of Care Among High-risk Thai Men
Official Title
Addressing the Continuum of Care Among High-risk Thai Men
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 27, 2021 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University
Collaborators
University of California, San Francisco, University of Malaya, National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Young Thai men who have sex with men (YMSM) are at high risk for HIV. However, the Thailand National HIV Strategy does not adequately cover HIV prevention for YMSM using specific methods relevant to them, and instead uses a one-size-fits all approach. Partnering with the Thailand Ministry of Public Health (MOPH), the proposed study seeks to finalize, implement and evaluate a multicomponent, multi-level, community mobilization, combination intervention (HUG-M+) to address the entire Continuum of Prevention and Care. The investigators propose to test the efficacy of this approach by conducting research in two Northeastern Thai cities, one randomized to the intervention condition, which will receive HUG-M+ and the other to the control condition, where standard of care will be provided. If HUG-M+ is found to be efficacious, it might be scaled up, with the support of the MOPH, to other regions in Thailand, elsewhere in Asia and the US.
Detailed Description
The HIV epidemic in Thailand is escalating among young men who have sex with men (YMSM). Particularly, HIV prevalence among YMSM is estimated to be 10-15% in Northeastern Thailand. Obviously high risk sexual behavior is occurring, and the uptake of HIV testing remains low even though free testing services are offered by public clinics. Despite provision of free antiretroviral treatment (ART) by the government, less than 25% of HIV-positive YMSM (HIV+YMSM) are retained in care, suggesting very few have achieved viral suppression. The suboptimal access to HIV testing and treatment services among YMSM pose tremendous challenge in much needed prevention efforts to improve linkage to care and achieve individual and community viral suppression to prevent onward HIV transmission. Community mobilization and an empowerment approach that targets barriers at individual, social/community, and health systems levels are needed to improve access to prevention and treatment services, including sexual risk reduction, HIV testing, and linkage and engagement in the care continuum (CC). Based on a cultural adaptation of the evidence-based Mpowerment intervention, we developed and piloted HUG-M, a multilevel, theory-based intervention that diffuses social support and empowers the YMSM community in order to establish social norms supportive of risk reduction and biannual HIV testing. HUG-M was acceptable to YMSM in a prior pilot study, feasible to implement, and has the potential to increase HIV testing and decrease sexual risk behavior. The proposed study will test a community mobilization, multi-level intervention in two well-matched cities in Northeastern Thailand. The project's aims are: (1) to finalize and manualize HUG-M+, a community mobilization, multicomponent, multi-level, combination intervention that focuses on the entire Continuum of Prevention and Care, (2) to implement HUG-M+ for 2 years in collaboration with the Thailand Ministry of Public Health (MOPH) clinics that provide HIV testing and treatment, and (3) to evaluate the pilot efficacy of HUG-M+ in decreasing sexual risk behavior; increasing HIV testing to at least biannually; and increasing prompt, sustained engagement in care among men living with HIV by (a) longitudinal cohorts of YMSM in two cities in Northeastern Thailand; oversampling HIV+YMSM, which will provide data on the CC including sexual risk behavior; anal bacterial STIs; HIV testing frequency; and engagement in care among HIV+YMSM; and (b) longitudinal public health data, already collected by the MOPH, which include CD4 and viral load data for HIV patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS, STD

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The community-based, multilevel and theory-based intervention diffuses social support and empowers the YMSM community in order to establish social norms supportive of risk reduction and biannual HIV testing.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mpowerment-based intervention
Arm Type
Experimental
Arm Description
YMSM in this arm may be exposed to a multicomponent, multi-level, community mobilization, combination intervention to address the entire HIV Continuum of Prevention and Care.
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
YMSM in this arm will not be exposed to the intervention.
Intervention Type
Behavioral
Intervention Name(s)
HUG-M+
Intervention Description
A multicomponent, multi-level, community mobilization, combination intervention (HUG-M+) to address the entire HIV Continuum of Prevention and Care.
Primary Outcome Measure Information:
Title
Number of participants who have tested for HIV the past 6 months
Description
Participants will answer a yes/no question if they have tested in the past 6 months
Time Frame
6 months
Title
Number of participants who have engaged in condomless anal intercourse in the past 6 months
Description
Participants will answer a yes/no question if they engage in condomless anal intercourse (CAI) with non-primary or primary partners who are serodiscordant or of unknown serostatus, nonmonogamous, or who have been primary partners less than 6 months.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of participants who report using PrEP daily or on demand
Description
Participants will answer a series of questions related to PrEP use and patterns of use (either daily or on demand)
Time Frame
6 months
Title
Undetectable viral load
Description
Self-reported undetectable viral load
Time Frame
6 months
Title
HIV prevalence
Description
HIV prevalence at baseline
Time Frame
baseline
Title
HIV incidence/seroconversion
Description
HIV incidence/seroconversion
Time Frame
6 months
Title
STI incidence
Description
Chlamydia and gonorrhoea by urine and anal swab
Time Frame
6 months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Since this study is focusing on an HIV key population, namely men who have sex men, participants need to be biological males and identify as males.
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 15-29 years at cohort baseline Self-reported male gender Self-reported having had anal sex with another man in the past 12 months Speak, read and write Thai Thai citizenship Resident of the assessment city for the next 2 years (live, work or go to school) Exclusion Criteria: Do not consent to urine testing or anal swab Not willing to give contact information for follow-up assessments
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Guadamuz, PhD
Phone
+662-441-9184
Email
tguadamu@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nattharat Samoh, MA
Phone
+6686-969-0850
Email
ice.hssp@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas E Guadamuz, PhD
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
M-Health Office Maha Sarakham
City
Maha Sarakham
ZIP/Postal Code
44000
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kanthaya Lampai, BA
Phone
+6689-448-6391
Email
Manassanan930@gmail.com
Facility Name
M-Health Office Ubon
City
Ubon Ratchathani
ZIP/Postal Code
34000
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mudjalin Chonratana, MEd
Phone
+6663-218-9383
Email
mudjalin@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32842048
Citation
Samoh N, Peerawaranun P, Jonas KJ, Lim SH, Wickersham JA, Guadamuz TE. Willingness to Use HIV Self-Testing With Online Supervision Among App-Using Young Men Who Have Sex With Men in Bangkok. Sex Transm Dis. 2021 Mar 1;48(3):e41-e44. doi: 10.1097/OLQ.0000000000001271.
Results Reference
background
PubMed Identifier
25750498
Citation
Guadamuz TE, Goldsamt LA, Boonmongkon P. Consent Challenges for Participation of Young Men Who Have Sex With Men (YMSM) in HIV Prevention Research in Thailand. Ethics Behav. 2015 Mar;25(2):180-195. doi: 10.1080/10508422.2014.949721.
Results Reference
background
PubMed Identifier
29691128
Citation
Guadamuz TE, Boonmongkon P. Ice parties among young men who have sex with men in Thailand: Pleasures, secrecy and risks. Int J Drug Policy. 2018 May;55:249-255. doi: 10.1016/j.drugpo.2018.04.005. Epub 2018 Apr 23.
Results Reference
background
PubMed Identifier
24989128
Citation
Guadamuz TE, McCarthy K, Wimonsate W, Thienkrua W, Varangrat A, Chaikummao S, Sangiamkittikul A, Stall RD, van Griensven F. Psychosocial health conditions and HIV prevalence and incidence in a cohort of men who have sex with men in Bangkok, Thailand: evidence of a syndemic effect. AIDS Behav. 2014 Nov;18(11):2089-96. doi: 10.1007/s10461-014-0826-8.
Results Reference
background
PubMed Identifier
32160793
Citation
Kongjareon Y, Samoh N, Lim SH, Peerawaranun P, Jonas KJ, Guadamuz TE. Group sex, suicidality and online partners: implications for HIV and suicide prevention: a short report. AIDS Care. 2020 Aug;32(8):954-958. doi: 10.1080/09540121.2020.1734174. Epub 2020 Mar 12.
Results Reference
background

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Addressing the Continuum of Care Among High-risk Thai Men

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