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 outcomes 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 interest. It is imperative for the field to identify and address engagement in research,cannabis grow equipment 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 bioethical, 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 bioethical 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 greater 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 exposed 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 substance exposure correspond to increasing health risks and adverse 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 the research design, and ethical issues associated with risk and benefits of participation and involvement with the criminal justice or child welfare system. In particular, 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,cannabis cultivation technology 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.The current qualitative study is one arm of the 5-site consortium to improve understanding, from a qualitative perspective, the continuum of engagement of low- and high risk participants in research. This manuscript focuses on the results of the distinct needs and responses of high-risk participants. Specifically, the objectives in this analysis were to address important factors that impact best practices in promoting longitudinal research to high-risk participants, enrolling high-risk participants in research, and retaining high-risk participants in research studies.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.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 , neurodevelopmental, and biospecimen 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 according 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 codebook focused on broad themes influenced by the semi-structured interview guide. Thematic analysis was used to define specific themes within the broader categories . The codebook was developed using an agreed upon coding scheme with themes not being predetermined but rather emerging from the data. Upon completion of the codebook, 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 reliability 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. Specifically, calculating the percentage of comments from participants related to specific themes allowed the research team to ensure that themes discussed in the current paper were saturated or were discussed frequently in focus group/individual interviews. Therefore, relying on percent of comments strengthens demonstration of saturation in the current study. Further, the majority of qualitative data were collected from individual interviews rather than a focus group , which allows for a more in-depth conversation. Specifically, during individual interviews, comments were able to be probed deeply with rich content emerging throughout the qualitative data, rather than simple agreement or disagreement that often emerges from focus group data collection. Additionally, the fact that both primary researchers as well as consortium partners were involved in developing the focus group/individual interview guide is a strength, increasing the likelihood that the items on the interview guide validly and comprehensively captured the intent of the research aims.Other suggested locations included bus stops , billboards , and grocery/ convenience stores . Participants also reported that child-friendly locations and educational settings were good locations to share study information. One participant explained, “Maybe flyers at childcare centers and stuff like that, where they have the younger school-aged kids from infant to whatever. I know a lot of moms frequent those places.” When participants were asked about locations they would trust the most to receive information, it was disclosed that medical offices such as doctor offices/clinics, state agencies , and educational settings were considered most trustworthy. Participants also discussed the type of material they would recommend using to promote research studies with participants explaining they would use commercials , brochures , and radio to share information about research studies. It was also reported that using news/newspapers , online marketing strategies , and sharing information through word of mouth would be most effective. In terms of the individuals that would be best to share research study information, participants stated that study information would best come from medical personnel , friends , family members , other participants , and professionals .