We will collect sociodemographic characteristics at screening and conduct chi-square or t-tests comparing participants and non-participants. We will supplement refusal and retention quantitative data by asking participants who refuse to participate or who do not complete the intervention about why they chose not to participate in exit interviews. We will transcribe and analyze client exit interviews and reasons for non-participation to further document barriers to acceptability and feasibility. Enrolled participants respond to a baseline assessment after they have completed screening and consent.
Participants will complete a shortened six-month survey via response to a link sent to them on their phone. If participants cannot complete the six-month survey on their own, the Study Coordinator will offer to meet them at a local library of their choice and provide a tablet to complete the survey. However, we expect this circumstance be the exception rather than the rule. The month follow-up survey will have fewer questions and will be completed after the intervention is over, Thus, completing the questions at a Bienestar testing location will not confound the outcome of interest.
For those who do not complete their HIV test for that period, we will send a text message reminder to complete the final survey at Bienestar. No drugs will be administered during this study; therefore, the data safeguarding and monitoring plan focuses primarily on confidentiality. Participants may experience psychological distress or social risks if information that is perceived to be sensitive e. Disclosing information about use of illicit drugs may pose legal risks for participants. If a participant exhibits signs of distress, the PI and site coordinator are contacted to ensure that immediate support is provided.
Study staff will be required to report adverse events AE or serious adverse events SAE to the research team, who will transmit them to the PI immediately. All the relevant information may not be available at that point. For example, a misrouting of confidential information from a Bienestar staff member to a RAND team member by email instead of a secure file transfer protocol is not a SAE, but quick action to contain the spread of information and delete it correctly can mitigate the potential damage, and some procedural changes and retraining may be needed.
Semi-structured exit interviews after the study is completed will also provide valuable feedback about the acceptability of the program to clients and the feasibility of the intervention procedures as viewed by clinic personnel. We will conduct interim data checks to ensure that certain individuals e.
Data checks will be supplemented with bi-weekly team calls in which we review recruitment and retention goals, address issues that arise in the field, and refine our strategy for moving forward. Because most of the study data are uploaded electronically, we avoid issues of double data entry. Interim data checks help ensure the accuracy of data provided. Blinding participants and staff to the study design raises several issues.
Participants will know if they are in the intervention Information plus group versus control Information only group as the former will be receiving weekly quiz options. However, with the exception of the site PI and the research analyst at RAND responsible for sending all text messages, study staff will be blinded to the data identifiers.
All data for subsequent analysis will be de-identified and only the PI and Co-Investigators will have access to the study data. In addition to simple group comparisons at each time point, we will exploit the longitudinal nature of the data by using repeated-measures and time-series techniques. This approach will allow us to examine whether self-reported sexual behaviors persist or decline similarly between the two groups. Repeated measures models will be fitted using Xtreg in the software package Stata. We will use an Analysis of Covariance ANCOVA framework to test for group differences, controlling for relevant client characteristics that are found to differentiate the groups at baseline in order to improve the precision that would result from a simple Analysis of Variance ANOVA on randomly assigned individuals.
As with any randomized trial that eliminates selection bias , the first and most direct way to evaluate the impact of an intervention is a simple comparison D of the group means in adherence levels. In small samples efficiency can be improved by controlling for differences in control variables between the groups that may arise due to chance as discussed above. The independent variables include control variables not only to improve efficiency, but also to learn about the paths through which the intervention works and to identify subgroups that are likely to particularly benefit from the intervention.
Furthermore, potential mediators of behavior, such as level of acculturation, may result in improved provider communication and hence information access. For example, some people may want to avoid being seen at a clinic or HIV testing site, but for people who can communicate with providers more easily, this cost is close to zero, and their behavior may not be altered through the intervention. We can test this effect by forming an interaction between the acculturation measure and the intervention. Continuous variables will be assessed for normality and transformed if needed.
Logit estimation will be used for binary outcome measures. We will impute missing data for some variables if an individual is still enrolled.
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When participants drop out, we will fit multiple logistic regression models to assess whether this dropout is random. Analyses will reflect these design effects in the calculation of standard errors and tests of significance. In summary, the primary purposes of our pilot study are to demonstrate the acceptability and feasibility of methods proposed for a subsequent large-scale trial, to stabilize procedures so they are replicable, and to determine important parameters with sufficient accuracy to allow reliable estimates of sample size, power, and detectable effects for the subsequent study.
There are currently few BE-based interventions in HIV prevention; to our knowledge such interventions have not been used to specifically support the retention of HIV prevention information and increase HIV testing frequency. A key characteristic of our program design is compatibility with any other HIV prevention activities that may be implemented during the course of the study.
Product | Information, Incentives and the Economics of Control
Thus, rather than being tied to specific content like other interventions, we will create a framework and build a line of interactive communication through which the most up-to-date prevention information will be disseminated and at-risk individuals will be motivated to engage and stay connected with HIV-related care irrespective of the structural barriers they face. Further, given the potential impact of results from this trial, the dissemination strategy includes a diverse set of audiences and multiple dissemination channels such as peer-reviewed journal articles, conferences, as well as community focused events to relay key findings of our research.
To address any remaining challenges, the study team will meet regularly to find acceptable solutions, which we will also discuss with Bienestar and its Community Advisory Committee. If we demonstrate that this BE-informed, mobile technology-based intervention is acceptable, feasible, and cost-effective, it will establish a new way of providing incentives to improve HIV prevention outcomes. Protocol version: Final version as of 12 November Recruitment dates: The date of first enrollment was 31 May and participants are currently being recruited and enrolled through 9 May NIMH has no role in the design or conduct of the study or in the interpretation and dissemination of the findings.
NIMH can be contacted at 1—— toll-free or nimhinfo nih. SL conceived of and led the design of the study, led the drafting of the manuscript, and gave final approval of the manuscript; SM, ACD, and JB contributed to the design of the study and the drafting of the manuscript, and gave final approval of the manuscript; AK and RG contributed to the drafting of the manuscript and gave final approval of the manuscript.
All authors read and approved the final manuscript. Manuscripts reporting studies involving human participants, human data, or human tissue must:. Include a statement on ethics approval and consent even where the need for approval was waived : ATTACHED The work covered in this manuscript has been conducted with the ethical approval of all relevant participants.
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. Sebastian Linnemayr, Phone: , Email: gro. Sarah MacCarthy, Phone: , Email: gro. Alice Kim, Phone: , Email: gro. Rebecca Giguere, Phone: , Email: ude. Alex Carballo-Dieguez, Phone: , Email: ude.
Joanna L. Barreras, Phone: , Email: gro. National Center for Biotechnology Information , U. Journal List Trials v. Published online Oct 5.
Barreras 4. Barreras 4 Bienestar Human Services, Inc. Author information Article notes Copyright and License information Disclaimer. Corresponding author. Received Jan 5; Accepted Aug This article has been cited by other articles in PMC. Trial registration ClinicalTrials. Setting Bienestar is a community-based organization offering culturally tailored and linguistically appropriate programs and services to a predominately Latino population.
Open in a separate window. Measures: study acceptability and feasibility Acceptability e.
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Measures: health outcomes Enrolled participants respond to a baseline assessment after they have completed screening and consent. Table 1 Health outcomes and measures of interest. Development and psychometric evaluation of the brief HIV knowledge questionnaire hiv-kq Development of a short acculturation scale for Hispanics.
Hispanic Journal of Behavioral Sciences. Mental health Kessler, RC et al. Short screening scales to monitor population prevalences and trends in non-specific psychological distress. Psychological Medicine.
Decentralization, Hierarchies, and Incentives: A Mechanism Design Perspective
Behavioral Economics Linnemayr et al. Behavioral Economics and Health. Data safeguarding and monitoring plan No drugs will be administered during this study; therefore, the data safeguarding and monitoring plan focuses primarily on confidentiality. Discussion There are currently few BE-based interventions in HIV prevention; to our knowledge such interventions have not been used to specifically support the retention of HIV prevention information and increase HIV testing frequency.
Trial status Protocol version: Final version as of 12 November Enrollment status: Active.
Acknowledgements We would like to thank Mary Vaiana for her careful review of the manuscript. Notes Ethics approval and consent to participate Manuscripts reporting studies involving human participants, human data, or human tissue must: Include a statement on ethics approval and consent even where the need for approval was waived : ATTACHED The work covered in this manuscript has been conducted with the ethical approval of all relevant participants.
Consent for publication Not applicable.
Competing interests The authors declare that they have no competing interests. References 1. Using a mobile health intervention to support HIV treatment adherence and retention among patients at risk for disengaging with care. Acceptability and feasibility of a cell phone support intervention for youth living with HIV with nonadherence to antiretroviral therapy.