Trial Outcomes & Findings for Addressing the Continuum of Care Among High-risk Thai Men (NCT NCT05161689)
NCT ID: NCT05161689
Last Updated: 2025-12-26
Results Overview
Number of Participants who answered "yes" to the question if they have tested in the past 6 months
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
636 participants
Primary outcome timeframe
Assessed at baseline
Results posted on
2025-12-26
Participant Flow
Participant milestones
| Measure |
Mpowerment-based Intervention
Young men who have sex with men (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.
HUG-M+: A multicomponent, multi-level, community mobilization, combination intervention (HUG-M+) to address the entire HIV Continuum of Prevention and Care.
|
Standard of Care
YMSM in this arm will not be exposed to the intervention.
|
|---|---|---|
|
Overall Study
STARTED
|
318
|
318
|
|
Overall Study
Completed 6 Months Follow-up
|
259
|
236
|
|
Overall Study
Completed 12 Months Follow-up
|
234
|
231
|
|
Overall Study
Completed 18 Months Follow-up
|
218
|
223
|
|
Overall Study
Completed 24 Months Follow-up
|
187
|
205
|
|
Overall Study
COMPLETED
|
187
|
205
|
|
Overall Study
NOT COMPLETED
|
131
|
113
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Addressing the Continuum of Care Among High-risk Thai Men
Baseline characteristics by cohort
| Measure |
Mpowerment-based Intervention
n=318 Participants
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.
HUG-M+: A multicomponent, multi-level, community mobilization, combination intervention (HUG-M+) to address the entire HIV Continuum of Prevention and Care.
|
Standard of Care
n=318 Participants
YMSM in this arm will not be exposed to the intervention.
|
Total
n=636 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
56 Participants
n=9 Participants
|
80 Participants
n=6 Participants
|
136 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
262 Participants
n=9 Participants
|
238 Participants
n=6 Participants
|
500 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Age, Continuous
|
21.1 years
STANDARD_DEVIATION 3.1 • n=9 Participants
|
20.1 years
STANDARD_DEVIATION 2.6 • n=6 Participants
|
20.6 years
STANDARD_DEVIATION 2.9 • n=9 Participants
|
|
Sex/Gender, Customized
Self-Identified Sexual/Gender Identity · Transwomen who are Biologically Male
|
3 Participants
n=9 Participants
|
11 Participants
n=6 Participants
|
14 Participants
n=9 Participants
|
|
Sex/Gender, Customized
Self-Identified Sexual/Gender Identity · Males who have sex with Men
|
285 Participants
n=9 Participants
|
292 Participants
n=6 Participants
|
577 Participants
n=9 Participants
|
|
Sex/Gender, Customized
Self-Identified Sexual/Gender Identity · Bisexual Males
|
30 Participants
n=9 Participants
|
15 Participants
n=6 Participants
|
45 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Thai
|
318 Participants
n=9 Participants
|
318 Participants
n=6 Participants
|
636 Participants
n=9 Participants
|
|
Region of Enrollment
Thailand
|
318 participants
n=9 Participants
|
318 participants
n=6 Participants
|
636 participants
n=9 Participants
|
|
Self-Reported Last HIV Testing Date
Never tested
|
141 Participants
n=9 Participants
|
178 Participants
n=6 Participants
|
319 Participants
n=9 Participants
|
|
Self-Reported Last HIV Testing Date
More than 12 months ago
|
52 Participants
n=9 Participants
|
63 Participants
n=6 Participants
|
115 Participants
n=9 Participants
|
|
Self-Reported Last HIV Testing Date
7-12 months ago
|
33 Participants
n=9 Participants
|
29 Participants
n=6 Participants
|
62 Participants
n=9 Participants
|
|
Self-Reported Last HIV Testing Date
≤ 6 months ago
|
92 Participants
n=9 Participants
|
48 Participants
n=6 Participants
|
140 Participants
n=9 Participants
|
|
HIV status data from Ministry of Public Health national database
HIV-positive
|
76 Participants
n=9 Participants
|
26 Participants
n=6 Participants
|
102 Participants
n=9 Participants
|
|
HIV status data from Ministry of Public Health national database
HIV-negative
|
126 Participants
n=9 Participants
|
169 Participants
n=6 Participants
|
295 Participants
n=9 Participants
|
|
HIV status data from Ministry of Public Health national database
Not Found in System
|
116 Participants
n=9 Participants
|
123 Participants
n=6 Participants
|
239 Participants
n=9 Participants
|
|
Condom use consistency during anal sex with men over the past 6 months
Never
|
3 Participants
n=9 Participants
|
9 Participants
n=6 Participants
|
12 Participants
n=9 Participants
|
|
Condom use consistency during anal sex with men over the past 6 months
Less than half the time
|
9 Participants
n=9 Participants
|
7 Participants
n=6 Participants
|
16 Participants
n=9 Participants
|
|
Condom use consistency during anal sex with men over the past 6 months
About half the time
|
14 Participants
n=9 Participants
|
8 Participants
n=6 Participants
|
22 Participants
n=9 Participants
|
|
Condom use consistency during anal sex with men over the past 6 months
More than half the time
|
30 Participants
n=9 Participants
|
39 Participants
n=6 Participants
|
69 Participants
n=9 Participants
|
|
Condom use consistency during anal sex with men over the past 6 months
Every time
|
76 Participants
n=9 Participants
|
59 Participants
n=6 Participants
|
135 Participants
n=9 Participants
|
|
Condom use consistency during anal sex with men over the past 6 months
Did not have anal sex with men in the past 6 months
|
186 Participants
n=9 Participants
|
196 Participants
n=6 Participants
|
382 Participants
n=9 Participants
|
|
STI Prevalence (Chlamydia and Gonorrhea)
|
58 Participants
n=9 Participants
|
53 Participants
n=6 Participants
|
111 Participants
n=9 Participants
|
|
Participation in group sex activities (ever)
|
46 Participants
n=9 Participants
|
61 Participants
n=6 Participants
|
107 Participants
n=9 Participants
|
|
Participant has given or received items or opportunities in exchange for sex
Yes, I was the one receiving money, things, or opportunities
|
36 Participants
n=9 Participants
|
41 Participants
n=6 Participants
|
77 Participants
n=9 Participants
|
|
Participant has given or received items or opportunities in exchange for sex
Yes, I was the one giving money, things, or opportunities
|
7 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
9 Participants
n=9 Participants
|
|
Participant has given or received items or opportunities in exchange for sex
Yes, I have both given and received money, things, or opportunities
|
10 Participants
n=9 Participants
|
6 Participants
n=6 Participants
|
16 Participants
n=9 Participants
|
|
Participant has given or received items or opportunities in exchange for sex
No
|
265 Participants
n=9 Participants
|
269 Participants
n=6 Participants
|
534 Participants
n=9 Participants
|
|
Participant has agreed to meet someone contacted online (via app or website) for sex
|
183 Participants
n=9 Participants
|
191 Participants
n=6 Participants
|
374 Participants
n=9 Participants
|
|
Participant has had anal sex with a man while under the influence of drugs or alcohol
|
77 Participants
n=9 Participants
|
94 Participants
n=6 Participants
|
171 Participants
n=9 Participants
|
|
Number of Participants with Depression (CES-D-10)
|
110 Participants
n=9 Participants
|
114 Participants
n=6 Participants
|
224 Participants
n=9 Participants
|
|
Number of Participants at Risk of Suicide (SBQ-R)
|
65 Participants
n=9 Participants
|
79 Participants
n=6 Participants
|
144 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Assessed at baselineNumber of Participants who answered "yes" to the question if they have tested in the past 6 months
Outcome measures
| Measure |
Mpowerment-based Intervention
n=318 Participants
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.
HUG-M+: A multicomponent, multi-level, community mobilization, combination intervention (HUG-M+) to address the entire HIV Continuum of Prevention and Care.
|
Standard of Care
n=318 Participants
YMSM in this arm will not be exposed to the intervention.
|
|---|---|---|
|
Prevalence of HIV Testing in the Past 6 Months Among YMSM at Baseline
|
92 Participants
|
48 Participants
|
PRIMARY outcome
Timeframe: Assessed at 6 monthsNumber of Participants who answered "yes" to the question if they have tested in the past 6 months
Outcome measures
| Measure |
Mpowerment-based Intervention
n=259 Participants
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.
HUG-M+: A multicomponent, multi-level, community mobilization, combination intervention (HUG-M+) to address the entire HIV Continuum of Prevention and Care.
|
Standard of Care
n=236 Participants
YMSM in this arm will not be exposed to the intervention.
|
|---|---|---|
|
Prevalence of HIV Testing in the Past 6 Months Among YMSM at 6 Months
|
114 Participants
|
80 Participants
|
PRIMARY outcome
Timeframe: Assessed at 12 monthsNumber of Participants who answered "yes" to the question if they have tested in the past 6 months
Outcome measures
| Measure |
Mpowerment-based Intervention
n=234 Participants
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.
HUG-M+: A multicomponent, multi-level, community mobilization, combination intervention (HUG-M+) to address the entire HIV Continuum of Prevention and Care.
|
Standard of Care
n=231 Participants
YMSM in this arm will not be exposed to the intervention.
|
|---|---|---|
|
Prevalence of HIV Testing in the Past 6 Months Among YMSM at 12 Months
|
104 Participants
|
98 Participants
|
PRIMARY outcome
Timeframe: Assessed at 18 monthsNumber of Participants who answered "yes" to the question if they have tested in the past 6 months
Outcome measures
| Measure |
Mpowerment-based Intervention
n=218 Participants
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.
HUG-M+: A multicomponent, multi-level, community mobilization, combination intervention (HUG-M+) to address the entire HIV Continuum of Prevention and Care.
|
Standard of Care
n=223 Participants
YMSM in this arm will not be exposed to the intervention.
|
|---|---|---|
|
Prevalence of HIV Testing in the Past 6 Months Among YMSM at 18 Months
|
96 Participants
|
96 Participants
|
PRIMARY outcome
Timeframe: Assessed at 24 monthsNumber of Participants who answered "yes" to the question if they have tested in the past 6 months
Outcome measures
| Measure |
Mpowerment-based Intervention
n=187 Participants
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.
HUG-M+: A multicomponent, multi-level, community mobilization, combination intervention (HUG-M+) to address the entire HIV Continuum of Prevention and Care.
|
Standard of Care
n=205 Participants
YMSM in this arm will not be exposed to the intervention.
|
|---|---|---|
|
Prevalence of HIV Testing in the Past 6 Months Among YMSM at 24 Months
|
61 Participants
|
77 Participants
|
PRIMARY outcome
Timeframe: Assessed at baselineParticipants 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.
Outcome measures
| Measure |
Mpowerment-based Intervention
n=318 Participants
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.
HUG-M+: A multicomponent, multi-level, community mobilization, combination intervention (HUG-M+) to address the entire HIV Continuum of Prevention and Care.
|
Standard of Care
n=318 Participants
YMSM in this arm will not be exposed to the intervention.
|
|---|---|---|
|
Prevalence of Condomless Anal Sex in the Past 6 Months Among YMSM at Baseline
|
56 Participants
Interval 10.5 to 17.0
|
63 Participants
Interval 16.9 to 19.3
|
PRIMARY outcome
Timeframe: Assessed at 6 monthsParticipants 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.
Outcome measures
| Measure |
Mpowerment-based Intervention
n=259 Participants
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.
HUG-M+: A multicomponent, multi-level, community mobilization, combination intervention (HUG-M+) to address the entire HIV Continuum of Prevention and Care.
|
Standard of Care
n=236 Participants
YMSM in this arm will not be exposed to the intervention.
|
|---|---|---|
|
Prevalence of Condomless Anal Sex in the Past 6 Months Among YMSM at 6 Months
|
37 Participants
|
42 Participants
|
PRIMARY outcome
Timeframe: Assessed at 12 monthsParticipants 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.
Outcome measures
| Measure |
Mpowerment-based Intervention
n=234 Participants
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.
HUG-M+: A multicomponent, multi-level, community mobilization, combination intervention (HUG-M+) to address the entire HIV Continuum of Prevention and Care.
|
Standard of Care
n=231 Participants
YMSM in this arm will not be exposed to the intervention.
|
|---|---|---|
|
Prevalence of Condomless Anal Sex in the Past 6 Months Among YMSM at 12 Months
|
24 Participants
|
40 Participants
|
PRIMARY outcome
Timeframe: Assessed at 18 monthsParticipants 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.
Outcome measures
| Measure |
Mpowerment-based Intervention
n=218 Participants
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.
HUG-M+: A multicomponent, multi-level, community mobilization, combination intervention (HUG-M+) to address the entire HIV Continuum of Prevention and Care.
|
Standard of Care
n=223 Participants
YMSM in this arm will not be exposed to the intervention.
|
|---|---|---|
|
Prevalence of Condomless Anal Sex in the Past 6 Months Among YMSM at 18 Months
|
29 Participants
|
39 Participants
|
PRIMARY outcome
Timeframe: Assessed at 24 monthsParticipants 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.
Outcome measures
| Measure |
Mpowerment-based Intervention
n=187 Participants
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.
HUG-M+: A multicomponent, multi-level, community mobilization, combination intervention (HUG-M+) to address the entire HIV Continuum of Prevention and Care.
|
Standard of Care
n=205 Participants
YMSM in this arm will not be exposed to the intervention.
|
|---|---|---|
|
Prevalence of Condomless Anal Sex in the Past 6 Months Among YMSM at 24 Months
|
25 Participants
|
37 Participants
|
Adverse Events
Mpowerment-based Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Chair of the Institutional Review Board
Mahidol University Faculty of Social Sciences and Humanities
Phone: +662-441-9180
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place