A Pilot Intervention to Improve Coping With Discrimination and Adherence Among HIV-Positive Latino MSM
Phase: NA
Conditions: HIV
Sponsor: RAND

 
 
 
 
 
 
Siempre Seguiré: A Pilot Intervention to Improve Coping With Discrimination 
and Adherence Among HIV-Positive Latino MSM 
February 1, 2019 
 
 

1. Background and Rationale  
PROTOCOL SUMMARY  
HIV-related disparities in diagnosis and disease outcomes persist among Latinos, and Latinos living with 
HIV show a lower percentage of viral suppression compared to the general HIV-positive population. A 
growing body of work suggests that stigma and discrimination contribute to health disparities, especially 
among people living with HIV, who may experience discrimination due to multiple stigmatized identities 
related to HIV-serostatus, race/ethnicity, and sexual orientation. Internalized stigma and discrimination 
may lead to health-related disparities by increasing detrimental physiological stress responses, resulting 
in maladaptive coping and poor health behaviors, including non-adherence to treatment. Moreover, the 
chronic stress of discrimination may weaken immune function, leading to worse HIV outcomes, including 
increased HIV viral load.  
In the proposed research, we will integrate adherence skills-building strategies into a recently developed 
intervention, Siempre Seguiré, a 7-session group cognitive behavioral therapy (CBT) intervention for HIV-
positive Latino men who have sex with men (LMSM) that aims to improve adaptive coping responses to 
discrimination. We hypothesize that the intervention will improve coping responses to discrimination 
and HIV treatment adherence. 
2. Objectives  
This objectives of this study are: (1) to modify and refine Siempre Seguiré, a newly developed culturally 
congruent CBT group intervention for HIV-positive LMSM, to include strategies for antiretroviral 
treatment adherence and retention in HIV care; and (2) to conduct a small randomized pilot of Siempre 
Seguiré to examine feasibility and acceptability, as well as to explore preliminary effects on: (a) coping 
responses to discrimination; and (b) antiretroviral treatment adherence, viral load suppression, and HIV 
care retention, among LMSM living with HIV. 
3. Study Design  
This randomized controlled trial builds on a pilot trial of the Siempre Seguiré intervention. We will 
conduct 4 intervention groups and 4 wait-list control groups of 15 participants each (n=120). After 
participants complete the baseline assessment, we will randomize them into the intervention and wait- 
list control groups. We will provide the program to any interested control participants shortly after the 
6-month follow-up surveys are completed. Our proposed sample size (60/condition) is consistent with 
those recommended for small intervention tests in staged intervention development.  
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 AIDS service organizations (ASOs) (in waiting areas, on bulletin 
boards), fliers disseminated by Bienestar staff (e.g., case managers) 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 Latinos.  
Participants will be eligible if they are ≥18 years-old, are HIV-positive (verified by medication bottles or 
copies of laboratory results), were biologically male at birth and identify as male, identify as Latino, and 
report having sex with men in the past 12 months. To maximize chances of showing effects, participants 
must also either be not on antiretroviral treatment (ART) OR not fully engaged in care (i.e., less than 2 
visits in the past 12 months) and/or missed at least 1 ART dose in the past month. Transgender women 
will not be included because they face discrimination regarding gender identity, which would 
necessitate a differently tailored intervention. 
Procedures  
The Siempre Seguiré 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 LMSM 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 HIV-positive LMSM). Both facilitators are matched on client 
ethnicity to increase credibility and trust.  
The intervention will utilize several unique counseling techniques.  
Psychoeducation: All participants will receive basic HIV and adherence education. We will raise 
awareness about disparities and discrimination (e.g., links between discrimination and nonadherence) 
and address 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 
Latino communities, and how stigma can be a barrier to seeking support, accessing healthcare, and 
adherence.  
Cognitive Behavioral Therapy (CBT): CBT, one of the most widely used and well-supported treatment 
approaches for improving mental health and health behaviors, including ART adherence, is well-suited 
as a change strategy for MSM and people of color. 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; nonadherence) 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 take all of my medications”). 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 use similar participant surveys to those in the pilot, which we found to be feasible (and not 
overly burdensome) for participants to complete in about 90 minutes as well as psychometrically sound 
(as evidenced by the internal consistency reliabilities presented below). We will administer 3 survey 
waves [baseline, 1-week post-intervention (~4-months post-baseline), 6-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 for appointment attendance in the last year from 
medical records, from which we will examine whether the participant had at least one HIV medical care 
visit in each 6-month period over the last 12 months, with a minimum of 60 days between visits. 
Participants will list all prescribed ART medications using medication bottles (brought to the interview). 
Adherence will be measured continuously and electronically from baseline to 6-month follow-up with 
the Medication Event Monitoring System (MEMS). At baseline (~2 months prior to the first intervention 
session, to allow time for any reactance to the MEMS assessment to decrease prior to the intervention), 
interviewers will assist clients with dispensing the medication with the most complex dosing schedule or 
the base medication of the regimen if all medications have the same schedule (e.g., non-nucleoside 
reverse transcriptase inhibitor, protease inhibitor, integrase inhibitor), into a MEMS bottle. Monthly 
from 2-6-months post-baseline, interviewers will download adherence data and participants will report 
instances in which the cap was not used as intended in the past 2 weeks (how often the bottle was 
opened without removing a dose, a dose was taken from a source other than the bottle, such as a 
pillbox, and whether multiple doses were removed at a time and “pocketed” for later ingestion). Data 
for the past two weeks at each time-point will be adjusted using these responses for a more valid 
assessment. MEMS software calculates the percentage of total scheduled doses actually taken, which 
will be dichotomized at ≥85% of doses taken at each time-point, following research suggesting that 
moderate adherence has clinically significant effects. We will assess self-reported adherence using items 
validated against viral load and pill counts: number of doses missed last week; percentage of prescribed 
medications taken last month (on a visual analogue scale), and ability to take all medications as 
prescribed in the past 4 weeks. We will obtain HIPAA consent to extract the last two viral load values 
from medical records. Viral load suppression will be defined as <200 copies of virus per milliliter of blood 
plasma.  
For process evaluation purposes, we will record number of intervention sessions attended per 
participant, and participants will complete a brief survey after each session on facilitator clarity, 
preparedness, and likeability, and utility of session content. Facilitators and a research team observer 
will complete post-session evaluation forms to assess session flow, areas for improvement, and whether 
key elements and activities were covered adequately; this will allow us to assess whether some activities 
need to be shortened or eliminated. After the last session, we will conduct 60-minute qualitative 
debriefing exit interviews with intervention participants, which will be transcribed and translated. Topics 
will include general reactions to the program (content, format, logistics), and reasons for any 
intervention non-participation or discontinuation. We will elicit suggestions for improvement (e.g., what 
topics to add). We will develop a codebook listing key themes related to program feedback and 
suggestions for improvement. Using Dedoose (a qualitative data management program), two coders will 
mark text areas with each code. We will measure coder consistency in 20% of participants’ responses, 

aiming for κ≥.70. Following coding, study PIs will examine all coded passages and compile a list of key 
intervention feedback.  
5. Statistical Analysis  
Consistent with R34 guidelines, our primary purposes are to develop the intervention and collect 
preliminary data regarding feasibility and acceptability; conducting formal statistical tests of outcomes 
or attempting to obtain a measure of effect size is not justified with a limited sample size. Thus, the 
proposed analyses are meant to be exploratory, to aid in planning for a full RCT. We do not expect to 
have sufficient statistical power to adequately examine program effects in multivariate models. 
However, we will explore bivariate effects in the proposed analyses, and will also examine use of a small 
set of covariates.  
We will explore whether the program improves coping responses to discrimination; reduces medical 
mistrust, distress, and internalized stigma; improves adherence and retention in care; and increases 
rates of viral suppression in the intervention vs. control group. We will use generalized linear mixed 
models, i.e., a repeated-measures linear regression approach to predict coping with data collected at 
baseline and 4- and 6-month follow-up that compares differences between intervention and control 
means over time. We will employ a parallel repeated-measures logistic regression approach to predict 
optimal adherence (i.e., dichotomous adherence, ≥85% of doses taken) with electronic monitoring data 
collected at baseline and 2, 4, and 6-month follow-up. We will conduct logistic regressions predicting 
viral load (dichotomized as suppressed vs. not suppressed) at 6-months post-baseline with dichotomized 
baseline viral load. We will use similar repeated-measures linear models to examine intervention effects 
on the other secondary outcomes, as well as on linear adherence (percentage of prescribed doses 
taken) and log viral load change from baseline. We will select covariates from variables that are 
hypothesized on the basis of theory and previous research to predict outcome variables (see Fig. 1), and 
for which we find support for hypotheses in bivariate baseline analyses. We will use intention-to-treat 
analysis, i.e., we will analyze participants according to the condition to which they were randomized, 
regardless of their subsequent session attendance. We will account for all participants who responded 
to the baseline survey, regardless of follow-up survey or item completion, using nonresponse weighting 
or multiple imputation, as appropriate. Because each participant will complete the baseline survey prior 
to randomization, we will compare follow-up survey respondents with nonrespondents on 
demographics and medical variables. If we have high survey participation and find significant differences 
between respondents and nonrespondents, we will use inverse predicted probability nonresponse 
weights (and use linearization to correct estimated standard errors if there are modest deviations from 
standard statistical inference assumptions). We will address item nonresponse through multiple 
imputation.