A Cognitive Behavioral Therapy Group Intervention to Increase HIV Testing and PrEP Use Among Latinx Sexual Minority Men
Phase: NA
Conditions: HIV
Sponsor: RAND

A Cognitive Behavioral Therapy Group Intervention to Increase HIV Testing and PrEP Use Among 
Latinx Sexual Minority Men 
January 6, 2020 
PROTOCOL SUMMARY  
1. Background and Rationale  
HIV-related disparities persist among Latinx communities, especially those who are immigrants and 
sexual minority men (SMM). In 2017, Latinx adults showed HIV rates 3.2 times higher than White adults, 
and Latinx SMM (LSMM) accounted for 75% of all HIV diagnoses among Latinx adults; 67% of newly 
diagnosed HIV infections among LSMM were immigrants. Latinx adults, especially those who are 
immigrants, are diagnosed with HIV (i.e., tested) at a later disease stage, leading to delays in treatment. 
In addition, only 13.1% of Latinx adults reported pre-exposure prophylaxis (PrEP) use in 2016, compared 
to 68.7% of White adults. However, of the HIV prevention interventions listed in the CDC’s Compendium 
of Evidence-Based Interventions, only one was developed for LSMM, and none have yet been developed 
or assessed for PrEP use. 
In this study we will integrate HIV prevention strategies into a coping intervention that includes 8-
sessions of group cognitive behavioral therapy (CBT) for HIV-negative LSMM that aims to improve 
adaptive coping responses to discrimination and increase preventive strategies. We hypothesize that the 
intervention will improve coping responses to discrimination and HIV testing and PrEP use. 
2. Objectives  
This objectives of this study are to: 1) conduct a randomized controlled trial of a coping intervention that 
is a culturally congruent CBT group intervention for immigrant LSMM, to test intervention effects on 
regular HIV testing and PrEP use; 2) examine mechanisms of intervention effects on regular HIV testing 
and PrEP use, including more effective coping; and 3) conduct a cost-effectiveness analysis of the 
intervention. 
3. Study Design  
We will conduct 10 intervention groups and 10 standard of care control groups of about 15 participants 
each (n=300). After participants complete the baseline assessment, we will randomize them into the 
intervention or standard of care control groups. Participants will complete audio computer-assisted 
interviews at baseline, and 4, 8, and 12-month follow-ups. The intervention will last 8 weeks (7 sessions 
of content plus a "graduation").  
The proposed study is a partnership among academic researchers and stakeholders of Los Angeles 
County (LAC) Latinx and HIV-affected communities. Bienestar will be a full and equal partner throughout 
the research. Bienestar, LAC’s largest Latinx-serving HIV service organization, provides services (e.g., 
case management, substance use, mental health) in 7 offices in LAC to people living with HIV and HIV 
prevention to those at risk.  
Participants in the standard of care control group will be provided with information about an ongoing 
weekly two-hour open wellness-oriented support group available to all clients at Bienestar. The program 
includes an open support group; psychoeducation on wellness topics (e.g., HIV prevention, sexuality, 
spirituality, self-esteem, other health promotion topics); and social and cultural activities with food, art, 
and music. 
 

4. Methods  
Screening/Recruitment  
As in our prior pilot test, we will recruit participants via fliers left at the clinic at which the intervention 
will be conducted (Bienestar) and other community-based organizations and clinic (in waiting areas, on 
bulletin boards), fliers disseminated by Bienestar staff (e.g., HIV testing counselors, substance use 
counselors) to clients, and online advertisements. We will hold brief information sessions at client and 
staff gatherings. We will hire a research assistant from the local community for recruitment and tracking 
who is well-connected with the local HIV population and familiar with local HIV services for Latinx adults. 
Members of the Community Advisory Committee will also be asked to assist with recruitment.   
Participants will be eligible if they are ≥18 years-old, biologically male at birth; identify as male; identify 
as a Latino 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; and able to 
interact and communicate in spoken Spanish or English. The latter two criteria will be important to 
ensure that individuals will be able to actively participate in the intervention sessions.  
Women, including transgender women, will not be eligible because they face discrimination regarding 
gender/gender identity that would necessitate a differently tailored intervention with additional content 
and components that the present intervention lacks. 
Procedures  
The coping intervention will be conducted in groups and situated in a trusted community venue. The 
intervention was developed with, and will be delivered by, credible community stakeholders 
knowledgeable about SMM culture—individuals not viewed as authority figures or part of the medical 
system. The intervention will be led by an expert facilitator (with experience leading groups) and a peer 
co-facilitator (with experience working with SMM). Both facilitators are matched on client ethnicity to 
increase credibility and trust.  
The intervention will utilize several counseling techniques: 
Psychoeducation: All participants will receive basic HIV and prevention education. We will raise 
awareness about disparities and discrimination (e.g., links between discrimination and lack of 
engagement in medical care) and address medical mistrust. Facilitators will acknowledge historical and 
current challenges, including discrimination, which lead to mistrust, and mental health, substance use, 
and poverty (and, if necessary, provide referrals for services). The intervention will also address HIV and 
sexual orientation stigma in Latinx communities, and how stigma can be a barrier to seeking support, 
accessing healthcare, and adherence to prevention strategies such as PrEP. 
Cognitive Behavioral Therapy: CBT aims to empower clients to be their own agents of change, building 
on existing strengths and skills. CBT involves educating clients about the relations among their thoughts, 
behaviors, and emotions. Counselors help clients to understand a given problem behavior (e.g., 
rumination after discrimination) in terms of the chain of events that led to the behavior (a functional 
analysis/chain analysis) as well as the behavior’s consequences. Clients can be guided through a step-by-
step, micro-level recounting of thoughts, feelings, and emotions related to a specific event/behavior 
chain (distal vulnerability factors, proximal prompting events, immediate and longer-term consequences 
of coping strategies), and they work with the counselor collaboratively to identify problematic ‘links’ in 
the chain. Counselors teach clients cognitive and behavioral skills (mindfulness, cognitive restructuring, 
relaxation) for better coping. Skills are practiced in session, and behavioral self-monitoring and further 
practice are assigned between sessions to facilitate skills generalization. The counselor teaches clients 
the utility of having a ‘toolbox’ of potential strategies to use for different situations, and how to 

strategically select a skill that best matches a given problem. Skills are understood and evaluated in the 
context of clients’ values (“It’s important to stay healthy”) and goals (“I want to get tested regularly for 
HIV”). CBT is useful in groups because antecedents or consequences of many problem behaviors are 
interpersonal (e.g., disrupted relationships) and because clients can 'test out' new skills vicariously 
through the experiences of other group members.  
We will administer 4 survey waves: baseline, 4-months post-baseline (shortly after intervention 
completion), 8-months post-baseline, and 12-months post-baseline. Surveys will be administered at 
Bienestar using audio computer-assisted self-interviews. Participants will complete the baseline survey 
before randomization. Participants who drop out of the program will be encouraged to complete all 
surveys.  
To validate self-reports, we will obtain HIPAA consent to obtain medical and administrative records, 
which we will use to verify HIV status, HIV testing practices, service use, and PrEP use.  
For process evaluation purposes, we will assess feasibility and acceptability to inform future 
dissemination efforts. Following implementation science recommendations, we will assess feasibility in 
terms of: recruitment rate (number recruited per month, of number expected); refusal rates, and 
intervention session retention. We will assess feasibility of eligibility criteria (sufficient vs. too 
restrictive) by examining proportion of potential participants screened as ineligible and reasons why. 
Feasibility will also be assessed with post-session evaluation forms completed by facilitators and the site 
Co-Investigator (who will listen to all recorded sessions), to assess session flow, areas for improvement 
(whether some activities need to be changed, shortened, or eliminated), and whether key elements 
were covered adequately (which will also be used for fidelity). Acceptability, the extent to which people 
delivering or receiving an intervention consider it to be appropriate, based on anticipated or 
experienced responses, will be assessed via facilitator and participant post-session evaluation forms, 
which will ask how much the facilitator and participant liked or did not like the session on Likert scales, 
and why, in open-ended responses.  
5. Statistical Analysis  
Main Analyses. We hypothesize that the coping intervention will result in higher likelihoods of regular 
HIV testing and PrEP use, and improved coping with stigma (e.g., reduced internalized stigma). We will 
perform descriptive statistics and transform outcomes with skewed distributions (log or other as 
appropriate) to stabilize error variances and reduce outlier influence in regressions. We will select 
covariates from variables hypothesized on the basis of theory and previous research to predict 
outcomes, and for which we find support in bivariate baseline analyses (at p<.10). We will use intention-
to-treat analysis, i.e., analyze participants according to the group to which they were randomized, 
regardless of session attendance. Aim 1. We will use repeated-measures logistic regression for our 
primary HIV testing and PrEP dichotomous outcomes. Aim 2. For secondary outcomes (e.g., coping, 
internalize stigma) on which the coping intervention shows significant effects, to test mediation we will 
compare: (a) Aim 1 models, adding baseline measures of hypothesized mediators; and (b) the same 
models as in (a), adding post-intervention measures of hypothesized mediators. We will examine 
whether including post-intervention mediators in (b) decreases the coefficient for intervention effects 
on the outcome relative to the corresponding coefficient from (a). We will test interactions between 
each moderator and intervention group in the models for Aim 1.