HIV
Conditions
Keywords
Latino/Hispanic/Latinx, men who have sex with men
Brief summary
This study consists of a randomized controlled trial (RCT) of a multi-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 use among Latinx sexual minority men (SMM).
Detailed description
This study consists of a randomized controlled trial (RCT) of a multi-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 use among Latinx sexual minority men (SMM). We will test intervention effects on regular HIV testing and use of prevention strategies. The intervention was developed in partnership with community stakeholders at Bienestar Human Services, Inc., a Latinx-focused organization in Los Angeles County (LAC), CA. The intervention is flexible for use in community-based organizations, such as in ongoing support groups. The Specific Aims are: Aim 1. To conduct a randomized controlled trial of a culturally congruent cognitive behavior therapy group intervention for immigrant Latinx sexual minority men, to test intervention effects on regular HIV testing and PrEP uptake. Aim 2. To examine mechanisms of intervention effects on regular HIV testing and PrEP uptake, including more effective coping (e.g., reduced internalized stigma). Aim 3. To conduct a cost-effectiveness analysis of the intervention.
Interventions
BEHAVIORALCBT Coping Intervention
A cognitive behavior therapy group intervention for HIV-negative Latinx sexual minority men aimed at increasing HIV testing and prevention strategies.
Sponsors
Bienestar Human Services, Inc.
RAND
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes assessor does not randomize participant until after the baseline assessment
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* at least 18 years-old * biologically male at birth * identify as male * identify as Latino * is an immigrant * report having sex with men in the past 12 months * report HIV-negative or unknown serostatus * anticipate being available for the next 12 months to attend study visits * able to interact and communicate in spoken Spanish or English.
Exclusion criteria
* HIV-positive * cisgender women * transgender women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HIV Test at Least Annually | from baseline to 12-months | Participants report being tested for HIV at least once in the 12 months after baseline |
| Took PrEP in the Past 12 Months | from baseline to 12-months | Participants report taking PrEP at any follow-up time-point (within the 12-month follow-up time period) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of Adaptive Coping | measured at 4-months, 8-months, and 12-months post baseline | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Of 607 screened, 455 met inclusion criteria, of whom 289 were randomized.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 145 |
| Control 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. | 144 |
| Total | 289 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 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
| Characteristic | CBT Coping Intervention | Control | Total |
|---|---|---|---|
| Age, Continuous | 38.3 years STANDARD_DEVIATION 9.8 | 37.5 years STANDARD_DEVIATION 10 | 37.9 years STANDARD_DEVIATION 9.9 |
| Brief COPE: Social support-seeking | 2.12 scores on a scale STANDARD_DEVIATION 0.86 | 2.28 scores on a scale STANDARD_DEVIATION 0.9 | 2.20 scores on a scale STANDARD_DEVIATION 0.88 |
| Current PrEP use | 40 Participants | 43 Participants | 83 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 145 Participants | 144 Participants | 289 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| HIV testing in past 12 months | 86 Participants | 81 Participants | 167 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 145 Participants | 142 Participants | 287 Participants |
| Region of Enrollment United States | 145 participants | 144 participants | 289 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 145 Participants | 144 Participants | 289 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 145 | 0 / 144 |
| other Total, other adverse events | 0 / 145 | 0 / 144 |
| serious Total, serious adverse events | 21 / 145 | 3 / 144 |
Outcome results
Primary
HIV Test at Least Annually
Participants report being tested for HIV at least once in the 12 months after baseline
Time frame: from baseline to 12-months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CBT Coping Intervention | HIV Test at Least Annually | 96 Participants |
| Control | HIV Test at Least Annually | 114 Participants |
p-value: 0.04995% CI: [1.01, 6.26]Regression, Logistic
Primary
Took PrEP in the Past 12 Months
Participants report taking PrEP at any follow-up time-point (within the 12-month follow-up time period)
Time frame: from baseline to 12-months
Population: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CBT Coping Intervention | Took PrEP in the Past 12 Months | 56 Participants |
| Control | Took PrEP in the Past 12 Months | 71 Participants |
p-value: 0.8395% CI: [0.62, 1.81]Regression, Logistic
Secondary
Level of Adaptive Coping
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.
Time frame: measured at 4-months, 8-months, and 12-months post baseline
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBT Coping Intervention | Level of Adaptive Coping | 4-month assessment | 2.14 scores on a scale | Standard Deviation 0.96 |
| CBT Coping Intervention | Level of Adaptive Coping | 8-month assessment | 2.04 scores on a scale | Standard Deviation 0.84 |
| CBT Coping Intervention | Level of Adaptive Coping | 12-month assessment | 2.02 scores on a scale | Standard Deviation 0.92 |
| Control | Level of Adaptive Coping | 4-month assessment | 2.05 scores on a scale | Standard Deviation 0.89 |
| Control | Level of Adaptive Coping | 8-month assessment | 2.02 scores on a scale | Standard Deviation 0.91 |
| Control | Level of Adaptive Coping | 12-month assessment | 1.96 scores on a scale | Standard Deviation 0.92 |
Comparison: Unlike the observed at any FU primary outcomes which have a single value for each participant, for this outcome we employed a repeated measures style structure with one record for each of up to 3 FU observations. A sandwich estimator (SAS Proc Surveyreg) was employed to account for clustering of observations within participant.p-value: 0.14Regression, Linear