Trial Outcomes & Findings for A Cognitive Behavioral Therapy Group Intervention to Increase HIV Testing and PrEP Use Among Latinx Sexual Minority Men (NCT NCT04225832)
NCT ID: NCT04225832
Last Updated: 2025-08-13
Results Overview
Participants report being tested for HIV at least once in the 12 months after baseline
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
289 participants
Primary outcome timeframe
from baseline to 12-months
Results posted on
2025-08-13
Participant Flow
Participants were recruited across Southern California using: in-person in-reach at the partner organization; in-person outreach at relevant events and businesses; passive recruitment via hard copy fliers left at the partner community-based organization and other relevant local organizations; social media recruitment via paid advertisements, video posts, and direct messaging. Participants also were offered $10 per referral, for up to three referrals.
Of 607 screened, 455 met inclusion criteria, of whom 289 were randomized.
Participant milestones
| Measure |
CBT Coping Intervention
The intervention is an 8-session cognitive behavior therapy (CBT) group intervention that aims to improve HIV outcomes by increasing adaptive, effective coping responses to stigma from intersectional identities related to ethnicity, immigration status, sexual minority identity, HIV status, and PrEP among Latinx sexual minority men (SMM). The intervention sessions will address topics such as: understanding and coping with intersectional stigma, multiple identities (e.g., race/ethnicity, sexual orientation), medical mistrust, social support, and structural stigma. Intervention groups will be led by a trained facilitator (with expertise in group therapy with Latinx SMM) and a trained peer co-facilitator matched in identities with participants (Latinx SMM).
CBT Coping Intervention: A cognitive behavior therapy group intervention for HIV-negative Latinx sexual minority men aimed at increasing HIV testing and prevention strategies.
|
Control
Participants who are randomized to the control condition will receive standard of care
|
|---|---|---|
|
Overall Study
STARTED
|
145
|
144
|
|
Overall Study
COMPLETED
|
103
|
136
|
|
Overall Study
NOT COMPLETED
|
42
|
8
|
Reasons for withdrawal
| Measure |
CBT Coping Intervention
The intervention is an 8-session cognitive behavior therapy (CBT) group intervention that aims to improve HIV outcomes by increasing adaptive, effective coping responses to stigma from intersectional identities related to ethnicity, immigration status, sexual minority identity, HIV status, and PrEP among Latinx sexual minority men (SMM). The intervention sessions will address topics such as: understanding and coping with intersectional stigma, multiple identities (e.g., race/ethnicity, sexual orientation), medical mistrust, social support, and structural stigma. Intervention groups will be led by a trained facilitator (with expertise in group therapy with Latinx SMM) and a trained peer co-facilitator matched in identities with participants (Latinx SMM).
CBT Coping Intervention: A cognitive behavior therapy group intervention for HIV-negative Latinx sexual minority men aimed at increasing HIV testing and prevention strategies.
|
Control
Participants who are randomized to the control condition will receive standard of care
|
|---|---|---|
|
Overall Study
No longer eligible (e.g., seroconversion)
|
6
|
3
|
|
Overall Study
Unable to recontact or too busy/not recontacted or unknown reason
|
36
|
5
|
Baseline Characteristics
Data missing for n=7 participants who did not answer whether they had ever had an HIV test or who did not provide the date of their last test
Baseline characteristics by cohort
| Measure |
CBT Coping Intervention
n=145 Participants
The intervention is an 8-session cognitive behavior therapy (CBT) group intervention that aims to improve HIV outcomes by increasing adaptive, effective coping responses to stigma from intersectional identities related to ethnicity, immigration status, sexual minority identity, HIV status, and PrEP among Latinx sexual minority men (SMM). The intervention sessions will address topics such as: understanding and coping with intersectional stigma, multiple identities (e.g., race/ethnicity, sexual orientation), medical mistrust, social support, and structural stigma. Intervention groups will be led by a trained facilitator (with expertise in group therapy with Latinx SMM) and a trained peer co-facilitator matched in identities with participants (Latinx SMM).
CBT Coping Intervention: A cognitive behavior therapy group intervention for HIV-negative Latinx sexual minority men aimed at increasing HIV testing and prevention strategies.
|
Control
n=144 Participants
Participants who are randomized to the control condition will be referred to the standard of care program at Bienestar, which includes an ongoing weekly open wellness-oriented support group available to all clients.
|
Total
n=289 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.3 years
STANDARD_DEVIATION 9.8 • n=145 Participants
|
37.5 years
STANDARD_DEVIATION 10.0 • n=144 Participants
|
37.9 years
STANDARD_DEVIATION 9.9 • n=289 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=145 Participants
|
0 Participants
n=144 Participants
|
0 Participants
n=289 Participants
|
|
Sex: Female, Male
Male
|
145 Participants
n=145 Participants
|
144 Participants
n=144 Participants
|
289 Participants
n=289 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
145 Participants
n=145 Participants
|
144 Participants
n=144 Participants
|
289 Participants
n=289 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=145 Participants
|
0 Participants
n=144 Participants
|
0 Participants
n=289 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=145 Participants
|
0 Participants
n=144 Participants
|
0 Participants
n=289 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=145 Participants
|
2 Participants
n=144 Participants
|
2 Participants
n=289 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=145 Participants
|
0 Participants
n=144 Participants
|
0 Participants
n=289 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=145 Participants
|
0 Participants
n=144 Participants
|
0 Participants
n=289 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=145 Participants
|
0 Participants
n=144 Participants
|
0 Participants
n=289 Participants
|
|
Race (NIH/OMB)
White
|
145 Participants
n=145 Participants
|
142 Participants
n=144 Participants
|
287 Participants
n=289 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=145 Participants
|
0 Participants
n=144 Participants
|
0 Participants
n=289 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=145 Participants
|
0 Participants
n=144 Participants
|
0 Participants
n=289 Participants
|
|
Region of Enrollment
United States
|
145 participants
n=145 Participants
|
144 participants
n=144 Participants
|
289 participants
n=289 Participants
|
|
HIV testing in past 12 months
|
86 Participants
n=141 Participants • Data missing for n=7 participants who did not answer whether they had ever had an HIV test or who did not provide the date of their last test
|
81 Participants
n=141 Participants • Data missing for n=7 participants who did not answer whether they had ever had an HIV test or who did not provide the date of their last test
|
167 Participants
n=282 Participants • Data missing for n=7 participants who did not answer whether they had ever had an HIV test or who did not provide the date of their last test
|
|
Current PrEP use
|
40 Participants
n=145 Participants
|
43 Participants
n=144 Participants
|
83 Participants
n=289 Participants
|
|
Brief COPE: Social support-seeking
|
2.12 scores on a scale
STANDARD_DEVIATION .86 • n=145 Participants • Coping missing for n=2 who did not respond to any of the 4 survey items in the scale
|
2.28 scores on a scale
STANDARD_DEVIATION .90 • n=142 Participants • Coping missing for n=2 who did not respond to any of the 4 survey items in the scale
|
2.20 scores on a scale
STANDARD_DEVIATION 0.88 • n=287 Participants • Coping missing for n=2 who did not respond to any of the 4 survey items in the scale
|
PRIMARY outcome
Timeframe: from baseline to 12-monthsParticipants report being tested for HIV at least once in the 12 months after baseline
Outcome measures
| Measure |
CBT Coping Intervention
n=103 Participants
The intervention is an 8-session cognitive behavior therapy (CBT) group intervention that aims to improve HIV outcomes by increasing adaptive, effective coping responses to stigma from intersectional identities related to ethnicity, immigration status, sexual minority identity, HIV status, and PrEP among Latinx sexual minority men (SMM). The intervention sessions will address topics such as: understanding and coping with intersectional stigma, multiple identities (e.g., race/ethnicity, sexual orientation), medical mistrust, social support, and structural stigma. Intervention groups will be led by a trained facilitator (with expertise in group therapy with Latinx SMM) and a trained peer co-facilitator matched in identities with participants (Latinx SMM).
CBT Coping Intervention: A cognitive behavior therapy group intervention for HIV-negative Latinx sexual minority men aimed at increasing HIV testing and prevention strategies.
|
Control
n=136 Participants
Participants who are randomized to the control condition will receive standard of care
|
|---|---|---|
|
HIV Test at Least Annually
|
96 Participants
|
114 Participants
|
PRIMARY outcome
Timeframe: from baseline to 12-monthsPopulation: Of the N=289 described in Baseline Characteristics, N=50 did not complete any follow up assessments. Outcome measures are assessed for the remaining N=239
Participants report taking PrEP at any follow-up time-point (within the 12-month follow-up time period)
Outcome measures
| Measure |
CBT Coping Intervention
n=103 Participants
The intervention is an 8-session cognitive behavior therapy (CBT) group intervention that aims to improve HIV outcomes by increasing adaptive, effective coping responses to stigma from intersectional identities related to ethnicity, immigration status, sexual minority identity, HIV status, and PrEP among Latinx sexual minority men (SMM). The intervention sessions will address topics such as: understanding and coping with intersectional stigma, multiple identities (e.g., race/ethnicity, sexual orientation), medical mistrust, social support, and structural stigma. Intervention groups will be led by a trained facilitator (with expertise in group therapy with Latinx SMM) and a trained peer co-facilitator matched in identities with participants (Latinx SMM).
CBT Coping Intervention: A cognitive behavior therapy group intervention for HIV-negative Latinx sexual minority men aimed at increasing HIV testing and prevention strategies.
|
Control
n=136 Participants
Participants who are randomized to the control condition will receive standard of care
|
|---|---|---|
|
Took PrEP in the Past 12 Months
|
56 Participants
|
71 Participants
|
SECONDARY outcome
Timeframe: measured at 4-months, 8-months, and 12-months post baselinePopulation: Of the N=289 described in Baseline Characteristics, N=50 did not complete any follow up assessments. An additional N=2 control participants did not respond to any of the 4 items in the scale, leaving N=237 for analysis
Participants completed the Brief COPE, a general measure of coping strategies. Items have the instruction "indicate the extent you do what the item says when you are faced with discrimination," and response options 1 = "I haven't been doing this at all," 2 = "I've been doing this a little bit," 3 = "I've been doing this a medium amount" and 4 = "I've been doing this a lot." This scale (identified by EFA) is the mean of 4 items such as "I get emotional support from others". Higher values indicate more use of these coping strategies.
Outcome measures
| Measure |
CBT Coping Intervention
n=103 Participants
The intervention is an 8-session cognitive behavior therapy (CBT) group intervention that aims to improve HIV outcomes by increasing adaptive, effective coping responses to stigma from intersectional identities related to ethnicity, immigration status, sexual minority identity, HIV status, and PrEP among Latinx sexual minority men (SMM). The intervention sessions will address topics such as: understanding and coping with intersectional stigma, multiple identities (e.g., race/ethnicity, sexual orientation), medical mistrust, social support, and structural stigma. Intervention groups will be led by a trained facilitator (with expertise in group therapy with Latinx SMM) and a trained peer co-facilitator matched in identities with participants (Latinx SMM).
CBT Coping Intervention: A cognitive behavior therapy group intervention for HIV-negative Latinx sexual minority men aimed at increasing HIV testing and prevention strategies.
|
Control
n=134 Participants
Participants who are randomized to the control condition will receive standard of care
|
|---|---|---|
|
Level of Adaptive Coping
4-month assessment
|
2.14 scores on a scale
Standard Deviation 0.96
|
2.05 scores on a scale
Standard Deviation 0.89
|
|
Level of Adaptive Coping
8-month assessment
|
2.04 scores on a scale
Standard Deviation 0.84
|
2.02 scores on a scale
Standard Deviation 0.91
|
|
Level of Adaptive Coping
12-month assessment
|
2.02 scores on a scale
Standard Deviation 0.92
|
1.96 scores on a scale
Standard Deviation 0.92
|
Adverse Events
CBT Coping Intervention
Serious events: 21 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CBT Coping Intervention
n=145 participants at risk
The intervention is an 8-session cognitive behavior therapy (CBT) group intervention that aims to improve HIV outcomes by increasing adaptive, effective coping responses to stigma from intersectional identities related to ethnicity, immigration status, sexual minority identity, HIV status, and PrEP among Latinx sexual minority men (SMM). The intervention sessions will address topics such as: understanding and coping with intersectional stigma, multiple identities (e.g., race/ethnicity, sexual orientation), medical mistrust, social support, and structural stigma. Intervention groups will be led by a trained facilitator (with expertise in group therapy with Latinx SMM) and a trained peer co-facilitator matched in identities with participants (Latinx SMM).
CBT Coping Intervention: A cognitive behavior therapy group intervention for HIV-negative Latinx sexual minority men aimed at increasing HIV testing and prevention strategies.
|
Control
n=144 participants at risk
Participants who are randomized to the control condition will receive standard of care
|
|---|---|---|
|
Social circumstances
Potential confidentiality breach
|
9.7%
14/145 • Number of events 14 • 3 years, 9 months
|
0.00%
0/144 • 3 years, 9 months
|
|
Psychiatric disorders
Suicidal ideation
|
3.4%
5/145 • Number of events 5 • 3 years, 9 months
|
0.69%
1/144 • Number of events 1 • 3 years, 9 months
|
|
Social circumstances
social threat/violence
|
0.69%
1/145 • Number of events 1 • 3 years, 9 months
|
0.69%
1/144 • Number of events 1 • 3 years, 9 months
|
|
Surgical and medical procedures
Surgery due to pre-existing condition
|
0.69%
1/145 • Number of events 1 • 3 years, 9 months
|
0.69%
1/144 • Number of events 1 • 3 years, 9 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place