Notably, findings from this report appear to be driven specifically by our binge drinking variable, as total 30-day alcohol consumption did not significantly predict any neurocognitive outcome above and beyond binge drinking. Although there are a dearth of studies examining the specific impact of binge drinking on neuropsychological outcomes compared to that of chronic drinking over a longer span of time, some evidence suggests that the repeated periods of high level of intoxication and withdrawal from binge drinking exacerbates the detrimental neurobiological effects of alcohol . Future research is needed to examine chronicity of binge drinking and whether there may be a specific threshold associated with the greatest level of CNS risk. Still, given evidence that binge drinking may be at least as detrimental to the central nervous system as alcohol dependence, public safety measures that aim to reduce binge drinking behavior may have widespread benefits, especially among older PWH. While this study has strengths in novelty, use of a comprehensive neuropsychological battery, and clinical relevance, it also has several limitations. First, the HIV/Binge group-specific sample sizes were relatively small, particularly in Binge+ groups. Although this limited our ability to examine a full factorial three-way interaction between age, HIV status, and binge drinking status, we were still able to examine the novel age by HIV/Binge group interaction with adequate statistical power. Next, our assessment of binge drinking is based solely on self-report and may be subject to error by recall bias, memory difficulties, and/or social desirability bias; however, the majority of alcohol and substance use research relies on self-report of use. In addition, while binge drinking data specifically pertained to use within the last 30 days, we do not know exact amounts of time between participants’ last binge episode and their participation in the study,rolling grow tables limiting our ability to comment on how recency relates to cognitive performance.
Future research may benefit from the use of more objective measures of alcohol use in daily life to more accurately characterize alcohol use patterns . Finally, our exclusion of participants with current non-alcohol substance use disorders limits generalizability to others with binge drinking behavior and/or alcohol use disorder among whom polysubstance use is common. In summary, the current study demonstrated detrimental additive effects of HIV and binge drinking on neurocognitive functioning, and that older adults appear to be most vulnerable to these adverse effects particularly in the neurocognitive domains of learning, delayed recall, and motor skills. Our findings support the need for clinical screening for binge drinking behavior given that many adults who engage in binge drinking behavior do not meet criteria for an AUD, as well as psychoeducation and psychosocial interventions targeting the reduction of binge drinking among older PWH. Additionally, given evidence that improvements in neurocognitive functioning may be possible after sustained sobriety following AUD recovery among HIV- populations , future work is needed to understand whether this may also be true among PWH who reduce or cease binge drinking behavior.There are significant barriers to recruiting and retaining individuals with overlapping vulnerabilities in the pregnancy or postpartum period Wetherington & Roman, 1998. This may result in challenges for generalizability and therein create a relatively sparse knowledge base about the long-term out comes for these women and their children including the environmental, mental health, physiological, and neurological factors. Filling these knowledge deficits and gaps requires ongoing assessment because research tools including those for recruitment and retention change; in addition, substance exposures in pregnancy change , thereby shifting methods to reach target populations of interest and methods to measure outcomes of inter est. It is imperative for the field to identify and address engagement in research, to ensure representation of pregnant and postpartum women that use substances.
Engagement in longitudinal studies will allow a more complete understanding of maternal and child health outcomes as a result of new and emerging trends in prenatal substance exposure. Enhanced understanding of participants’ perspectives on engagement and study participation will allow researchers to more fully address this pressing research and public health need. Prenatal exposure studies began in earnest in the 1970s, after the identification and diagnosis of fetal alcohol syndrome . Careful participant selection and comparison selection were and are necessary to classify effects of prenatal exposures. Protectionist and paternalistic regulations excluded women from health research and limited the field’s understanding about how sex and gender shape substance use and SUD . Research studies on substance exposures during pregnancy expanded rapidly in the past 30 years, in recognition of the cocaine epidemics of the 90s, and the current increases in prenatal opioid and methamphetamine exposures . Indeed, research that focused specifically on prenatal exposures and other women’s health issues has been encouraged by journal editors, policymakers, and funding agencies including the NIH Helping End Addiction Long term initiative. Despite bio-ethical, legal, and social concerns regarding the risks and benefits of research participation for pregnant and postpartum women who use alcohol and drugs , the inclusion of vulnerable populations who are marginalized or stigmatized in research on sensitive topics has not demonstrated undue harm or exposure to unacceptable risk, and in fact, has been associated with potential benefits, such as altruism, catharsis, and gained knowledge . Of course, it is important for researchers to adopt careful experimental design and safeguards that will uphold the principal of non-maleficence and protect vulnerable participants from harm . Exclusion of substance using populations may violate important bio-ethical principles of human subjects research, particularly the principles of autonomy, beneficence, and justice . Exclusion from research not only strips individuals from making decisions about their own autonomy and denies them potential benefits of participating, but also exposes them to great er societal marginalization and may ultimately place them at increased risk of harm due to deficits in critical health knowledge and exposure to inappropriate or ineffective treatments .
Unfortunately, prenatal exposures to alcohol, tobacco, and other drugs are rising , with 1 in 4 pregnancies ex posed to tobacco , alcohol consumption , or illicit drug use . Specifically, opioid exposed pregnancies have increased from 1.5 to 6.5 per 1000 pregnancies . Yet, cannabis exposures are the most prevalent drug exposure, with nearly 7–8% reported exposure in the first trimester . Rising rates of sub stance exposure correspond to increasing health risks and ad verse outcomes at great societal cost and burden to systems of health care and social services, as well as criminal justice. Notably, researchers involved in the NIDA-funded Perinatal-20 Treatment Research Demonstration Program that focused on SUD treatment for pregnant and postpartum women identified seven clinical factors that contributed to significant difficulty and complexity in the recruitment and retention of women in substance use treatment research, including as follows: severity of SUD, legal system involvement, housing instability, interpersonal relationship challenges, parenting responsibilities, employment challenges, and need for more intensive services. These difficulties with recruitment and retention contribute to additional complications for research, including biased samples of convenience recruited through referrals from social and health agencies, limited sample diversity, deviations from there search design, and ethical issues associated with risk and benefits of participation and involvement with the criminal justice or child welfare system. In particular,growing rack when research designs do not involve the possibility of direct benefit due to participation , it is important to understand the unique reasons and motivations that drive decision-making about research participation . Due to all of the aforementioned factors that potentially inhibit the inclusion and engagement of high-risk participants , it is imperative to understand the motivations for engagement in research among high-risk participants, focusing specifically on understanding motivation for research participation, factors that influence decision-making about participation, and barriers to participation.The current study reports results from a qualitative research study conducted as part of an 18-month, multi-site pilot study aimed to develop and demonstrate feasibility of an experimental design for a 10-year, prospective, longitudinal investigation of normative childhood brain development, beginning in pregnancy. A major aim of the 10-year study will be to determine factors that alter brain development including prenatal exposure to opioids and other psychoactive substances, as well as other prenatal and childhood environmental exposures. This goal necessitates recruiting pregnant women previously or currently using substances, as well as a large group of pregnant women who are at low risk of prenatal substance use. Two of the primary aims of the pilot are developing and testing recruitment and retention strategies and addressing ethical and legal challenges of conducting research with a stigmatized and vulnerable population.Individual interviews and one focus group were conducted with a total of 41 women . Women were at high-risk of prenatal or postnatal substance use and were identified through medical clinics, other research study involvement, or SUD treatment programs.
Recruitment took place across five sites in the USA located in California, Georgia, New Mexico, Ohio, and Oklahoma . High-risk pregnant and postpartum women were defined in the current study as a parenting or pregnant woman who had used alcohol and tobacco and/or had a current or past history of SUD. Some participants were currently receiving SUD treatment. Contact was made through trained research personnel located at each specific site with 41 total participants taking part in the current study. Only one focus group that included five women was combined with the individual interviews. The one focus group was conducted in New Mexico prior to group restrictions imposed due to COVID-19.Qualitative methods for the research team, study design, and analysis followed the guidelines recommended by Tong, Sainsbury, and Craig . Qualitative study recruitment began with sites contacting participants in person or by phone and describing the current study and qualitative interview process. All women who expressed interest in participating were scheduled for either a focus group or individual interview depending on whether the interview took place prior to or following COVID-19 restrictions regarding in-person gatherings. Interviews conducted during the COVID-19 restrictions were conducted individually by phone. All participants gave oral informed consent. During the consent process, a brief overview of the qualitative study and all safety measures taken to ensure confidentiality were discussed. Trained qualitative research assistants collected all qualitative data from March 2020 through June 2020. Before engaging in focus groups/individual phone interviews, all participants completed an in-person or online survey that included a demographic questionnaire and watched a short video describing the protocols planned for the larger, longitudinal study including neuroimaging , neuro developmental, and bio-specimen collection. For the focus group, snacks were provided. Participants received a $50–75 incentive for their participation, and this varied based on site. All focus groups and individual interviews were audio-recorded and lasted approximately 45–60 min. Transcription work was conducted by qualitative team members or a transcription company, with team members crosschecking all transcripts to verify accuracy. During the transcription process, all identifying information was removed to ensure privacy. All procedures were approved by the sIRB for the 5-site consortium.Focus group and individual interview guides for the current project were developed by the first author, in conjunction with the evaluation team and other sites within the research consortium reviewing and revising the guide as needed. Focus group and individual interviews were coded individually and combined for data analysis. All coding and data analysis was conducted at one site. Recordings were transferred securely ac cording to IRB-approved methods. It is important to note that focus group and individual data themes were examined a priori and themes were congruent and therefore data were merged.Qualitative data was analyzed using the NVivo© 11 software. Five qualitative researchers worked together to develop a code book focused on broad themes influenced by the semi structured interview guide.The code book was developed using an agreed upon coding scheme with themes not being predetermined but rather emerging from the data. Upon completion of the code book, two teams consisting of two qualitative researchers coded all transcriptions using developed coding templates. Cleaning of data took place as needed . Once coded, inter-coder re liability was established using simple percent agreement, which is a commonly used method for assessing reliability in qualitative studies . Average inter-coder reliability was over 85%. In the “Results” section, themes are described in more detail. The validity of the current research findings are enhanced by several design factors such as the calculation of salient factors using percentage of comments and the team-based approach used for coding.