Addressing Barriers to Retention in HIV Care for Hispanic Immigrants
Phase: NA
Conditions: HIV/AIDS
Sponsor: Massachusetts General Hospital

Official title: Retention in HIV Care for Hispanic Immigrants (ADELANTE) 
NCT number:  NCT03484117 
Document date: 4/7/2022 
 
 
 
 
 
Official title: Retention in HIV Care for Hispanic Immigrants (ADELANTE) 
NCT number:  NCT03484117 
Document date: 4/7/2022 

Official title: Retention in HIV Care for Hispanic Immigrants (ADELANTE) 
NCT number:  NCT03484117 
Document date: 4/7/2022 
 
 
Study protocol 
Randomization: At baseline we will randomly assign participants through computer-generated 
allocation sequence. We anticipate minimal risk of contamination but will survey participants 
about whether they have discussed the intervention with other participants. We considered 
alternative designs, including a waitlist control condition or an active treatment arm without the 
novela but these were deemed impractical for the pilot intervention.  
 
Baseline and exit assessment and interview visits: At baseline assessment, study staff will 
evaluate participants using instruments to measure demographics and self-perceived barriers to 
care for Hispanic immigrant populations. Study interviews to administer the questionnaires will 
last up to 4 hours and will occur in a private room at the clinic or community-based organization. 
Participants will receive $40 in gift card and $10 transportation for completing this study visit. 
Study staff will offer a meal or meal ticket and allow for breaks as needed by the participant. The 
instruments we have selected are based on published evidence of barriers to HIV care in Latino 
immigrants, our qualitative research, and framed by our adapted Andersen Model of Health 
Care Utilization. Consistent with this conceptual model, instruments will measure the 
environment (e.g. neighborhood characteristics and access to services); predisposing 
individual-level factors (e.g. acculturation, family cohesion, social position, depression, 
substance use); individual enabling factors (e.g. self-efficacy, patient activation, cultural norms); 
and perceived health care need. We have selected scales that as much as possible have been 
validated in a Spanish-speaking low-literacy population. Most of the measures have been 
developed and validated by a national epidemiological survey in Latinos led by members of the 
study team that have strong reliability and validity in Spanish-speaking populations. For scales 
that have no prior Spanish language translation, the study team composed of multi-national 
native-Spanish speaking investigators, have performed translations and reviewed the 
translations for accuracy of content. Study staff will guide the participant through questions 
administered on REDCAP. If REDCAP is not available at the time of administration, questions 
will be documented on paper and subsequently uploaded to REDCAP. Latino immigrants have 
numerous barriers that may inhibit their ability to participate in research (e.g. multiple jobs, lack 
of access to transportation, family responsibilities). In the event, that the participant cannot 
come in person for the study visit and requests to participate in the baseline or exit assessment 
and interview visits by telephone, study staff will arrange to conduct the interview by telephone 
in a private room with the conversation recorded for accuracy and fidelity. Answers to the 
questionnaires will be documented in REDCAP by study staff. While we will attempt to obtain all 
exit assessments and interviews (quantitative measurements and qualitative feedback) at week-
24, we will allow a window of approximately 2 weeks prior and 4 weeks after the week-24 date 
to accommodate participants’ availability. 
     
     CHW-delivered questionnaires: At each CHW session, the CHW will also administer a 3 item 
questionnaire covering antiretroviral adherence, perceived need for HIV care, and global effort 
needed to attend HIV visits.   
     
     Intervention evaluation: To ensure fidelity of the intervention, we will obtain client consent to 
audio record the sessions. The CHW will also provide a brief written survey for the participant to 
complete on feedback for the session. Responses will be anonymous. Study staff will also 
conduct an exit assessment and interview with participants. During the interview study staff will 
use qualitative methods to assess impressions and ideas for improvement on the intervention 
process including suitability of the instruments to assess risk factors for inconsistent HIV clinic 

Official title: Retention in HIV Care for Hispanic Immigrants (ADELANTE) 
NCT number:  NCT03484117 
Document date: 4/7/2022 
attendance. The CHW will likewise complete an exit survey to solicit feedback for improvement. 
Study staff will present de-identified results to a Latino/HIV oriented community advisory board, 
to discern the need for iterative revisions of the intervention manual and intervention design. 
Study staff will make revisions to the questionnaire content to account for participant feedback 
on acceptability of the content and feasibility based on duration to complete the questionnaire. 
We estimate a need to enroll 100 individuals to randomize 75. Estimated conservative rate of 
attrition is 30%. This sample size is consistent with recommendations for randomized pilot 
studies for preliminary estimation of effect sizes and lower bounds. The primary purpose of our 
pilot is to determine the feasibility of the intervention program and evaluation protocols, 
including treatment acceptability, data collection procedures, and expected eligibility, 
recruitment time and effort, and follow-up rates. Given the small sample size, we will not be able 
to determine intervention efficacy; rather, our analyses will be mainly descriptive and will focus 
on confidence interval estimation. The primary focus is to assess feasibility and acceptability of 
the CHW+telenovela intervention and its impact on retention in care. Study staff will measure 
attended HIV primary care visits over weeks 0-16 and 17-32 weeks as well as CD4 and HIV 
RNA from the electronic medical record at week-24 and week-48, to assess short and long-term 
effects of the intervention. To obtain further information on feasibility and acceptability of the 
instruments at baseline and exit assessment and interview visits, study staff will present 
portions of the questionnaires to a focus group of Latino HIV peer workers with extensive 
experience working with the population, drawn from local HIV-related community advisory 
boards or AIDS service organizations. Study staff will present instruments to the group and 
perform cognitive debriefing to ascertain if the items are conveying the intended meaning. We 
will also receive additional feedback on acceptability of format and content. We will also ask 
work with these community colleagues to perform back translation from Spanish to English on 
items created by the study team to confirm preservation of content. We will reimburse these 
individuals each for $40 for two hours of service. 
 
     Data analysis: We will compare baseline distributions of key demographic and outcome 
variables for comparability between intervention and control groups using nonparametric tests. 
The pre-specified primary outcome was retention in care. We defined this outcome as having at 
least one visit attended in HIV clinic at both time periods (weeks 1-16 and 17-32) post-
randomization. These definitions are consistent with consensus guidelines on visit consistency. 
Two study staff blinded to randomization allocation, extracted HIV primary care appointment 
history from the medical record with disagreements reconciled by a third reviewer. An HIV 
primary care appointment was defined as an appointment with an HIV provider, meaning a 
health care provider (e.g., physician or mid-level provider) who could prescribe antiretroviral 
treatment. The prespecified secondary outcomes were proportion with viral suppression (HIV 
RNA<200 copies/ml) and change in CD4 count (cells/microliter) from baseline to weeks-24 and 
-48 post-randomization, extracted from the medical record. Obtaining a measure of effect size 
may not be justified given the limited sample size but we will use these data to inform power 
calculations for a subsequent large-scale trial with attention to matched-arms in an R01. 
Participant sociodemographic and clinical characteristics were summarized by intervention 
allocation with Chi-square tests and t-tests. The primary outcome of RIC and secondary 
outcomes of viral suppression and CD4 count at weeks-24 and -48 were compared by group 
using Chi-square tests. Statistical significance was defined by two-sided p≤ 0.05. Analyses were 
conducted using SAS version 9.4 (SAS Institute, Cary, NC).