Retaining Study Participants Research Articles

Thirty years later: Locating and interviewing participants of the Chicago Longitudinal Study

Retaining study participants over time is essential for longitudinal studies to prevent selection bias and to achieve their long-term goals. The present paper examines the extent to which participants can be retained in a 30-year longitudinal study when a multi-pronged approach is employed. The paper specifically describes the approach that was used to locate and interview participants of the Chicago Longitudinal Study (CLS), three decades after the study began. The CLS is a prospective cohort investigation that examines the effects of the Child–Parent Center (CPC) program, a school-based intervention for low-income children from preschool through 3rd grade. The original CLS sample included a complete cohort of 1539 children who were born in low-income areas in 1979–1980 and attended kindergarten in 1985–1986 at Chicago Public Schools. The CLS conducted a follow-up survey when participants were approximately age 35. After relatively slow initial progress, CLS researchers developed a comprehensive strategy to locate and interview participants, including: (a) adoption of detailed, manualized tracking protocol, (b) utilization of multiple search platforms, ranging from public search engines to social media, (c) assistance from state correctional facilities, and (d) neighborhood canvassing and in-person interviews. This tracking and interview process facilitated 735 completed interviews within 27 months, compared to 370 completed interviews in the 32 months prior to the launch of the comprehensive tracking protocol. Altogether, 1105 interviews were conducted, representing an effective completion rate of 76.5%. Recommendations for strengthening response rates in other longitudinal studies are discussed.

Key recruitment and retention strategies for a pilot web-based intervention to decrease obesity risk among minority youth

BackgroundInteractive Nutrition Comics for Urban Minority Youth (Intervention INC) is an innovative, web-based interactive comic tool for dietary self-management, which aims to decrease obesity risk among urban minority preadolescents. The feasibility and acceptability of Intervention INC was assessed by implementing a two-group randomized pilot study. To date, intervention studies have typically faced various barriers in recruiting and retaining study participants. The purpose of this paper is to describe recruitment and retention activities from this study and in particular, discuss challenges faced, strategies implemented, and lessons learned.MethodsBlack/AA and Latino children (ages 9–12 years) and their parent/guardian were recruited from East Harlem/Harlem, New York. Recruitment strategies included flyering in the community, having a convenient study location, providing participation incentives, and partnering with community/school-based organizations. Potential participants were screened for eligibility; enrollees completed online surveys and interviews at baseline (T1), intervention midpoint (T2), intervention end (T3), and 3-months post-intervention (T4). Retention strategies included flexible scheduling, reminder calls/texts, incremental compensation, and consistent study staff.ResultsEighty-nine enrolled dyads completed a T1 visit (August to November 2017) and were randomized to the experimental (E, n = 45) or comparison (C, n = 44) group. Enrolled dyads learned about the study through community events (39%), community flyering (34%), friend/referral (15%), or a community clinic partner (12%). T1 child demographics were mean age = 10.4 ± 1.0 years, 61% female, 62% Black and 42% Latino, and 51% overweight/obese; parent demographics were mean age = 30.8 ± 8.9 years, 94% female, and 55% Black and 45% Latino. Survey completion rates by dyad were high throughout the study: T2, 87%; T3, 89%; and T4, 84%. Average data collection per session was 65 min. Parents at T4 (n = 76) felt they received enough study information (97%) and that their questions were answered properly (80%). Eighty-one percent of children at T4 (n = 75) were very satisfied/extremely satisfied with how study staff communicated and interacted with them.ConclusionEffective recruitment strategies consisted of community events and flyering, while a variety of retention strategies were also used to successfully engage urban Black/AA and Latino families in this study. Though our findings are limited to only Latino and Black families in low-income neighborhoods, we have identified successful strategies for this specific high-risk population and potentially similar others.Trial registrationClinicalTrials.gov, NCT03165474, registered 15 May 2017

Retention in clinical trials after prison release: results from a clinical trial with incarcerated men with HIV and opioid dependence in Malaysia

Background: Study retention is a major challenge in HIV clinical trials conducted with persons recruited from correctional facilities.Objective: To examine study retention in a trial of within-prison methadone initiation and a behavioral intervention among incarcerated men with HIV and opioid dependence in Malaysia.Methods: In this 2x2 factorial trial, 296 incarcerated men with HIV and opioid dependence were allocated to (1) an HIV risk reduction intervention, the Holistic Health Recovery Program for Malaysia (HHRP-M), (2) pre-release methadone initiation, (3) both interventions, or (4) standard care (NCT02396979). Here we estimate effects of these interventions on linkage to the study after prison release and completion of post-release study visits.Results: Most participants (68.9%) completed at least one post-release study visit but few (18.6%) completed all 12. HHRP-M was associated with a 13.5% (95% confidence interval (CI): 3.8%, 23.2%) increased probability of completing at least one post-release study visit. Although not associated with initial linkage, methadone treatment was associated with an 11% (95% CI: 2.0%, 20.6%) increased probability of completing all twelve post-release study visits. Being subject to forced relocation outside Kuala Lumpur after prison release decreased retention by 43.3% (95% CI: −51.9%, −34.8%).Conclusion: Retaining study participants in HIV clinical trials following prison release is challenging and potentially related to the broader challenges that participants experience during community reentry. Researchers conducting clinical trials with this population may want to consider methadone and HHRP as means to improve post-release retention, even in clinical trials where these interventions are not being directly evaluated.

Abstract TP300: Where Did They Go? Recruitment and Retention in the Michigan Stroke Transitions Trial (MISTT)

Background: Poor transitions adversely affect stroke survivors and contribute to readmissions and poor quality of life. More randomized trials are needed to identify effective interventions to improve patient wellbeing during the transitional period. However, the post-discharge period is complex and presents many practical challenges for transition trials when patients move between different care settings. We report on recruitment and retention challenges in the Michigan Stroke Transitions Trial (MISTT) designed to improve the transition experience of stroke survivors. Methods: MISTT, a 3 group pragmatic randomized trial, tested the efficacy of an in-home social work case management (SWCM) program and SWCM with an informational website against usual care. Eligible subjects were acute stroke patients discharged directly home or who had an expected rehab stay <4 weeks. Randomization occurred the day subjects were discharged home. Patient-centered outcomes were collected by phone 90-days later. Results: Figure 1 shows recruitment and retention data during the first 15 months. Of 242 subjects enrolled, 40 (17%) were dropped pre-randomization largely due to extended rehab stays. Of 136 subjects randomized to SWCM or SWCM+website, the intervention was not started in 14 (10%) due to early withdrawals or unwillingness to participate. A total of 188 subjects were eligible for 90 day follow-up. Lost to follow-up (n=43) occurred in 20%, 24% and 21% of the usual care, SWCM, and SWCM+Website groups, respectively. Half of the LTFU was due to patient withdrawals (n=23); reasons included study demands (n=9), protocol deviations (n=6), and deteriorating health conditions (n=5). Conclusion: The complexity of stroke transitions creates challenges for recruiting and retaining study participants in transition trials. These issues are important to consider in future study design and are relevant to understanding the validity of study results.

It’s Getting Late: Improving Completion Rates in a Hard-to-Reach Sample

Maintaining high retention rates in longitudinal survey research is critical to ensure study success and prevent bias. However, retaining study participants, particularly youth and young adults, presents challenges. This study aims to assess the efficacy of various monetary and communication strategies in retaining members of the Truth Longitudinal Cohort, a probability-based, national online panel of youth and young adults. Baseline assessments were conducted in 2014, and follow-up assessment occurred six months later. A total of 4,467 respondents did not complete the follow-up survey after approximately nine weeks and were then randomized into one of 18 experimental conditions with varying combinations of monetary incentives ($30, $40, and $50) and communications (interactive voice recording, live phone prompt, email, and postcard). Overall, 15.9% of participants assigned to the experiment completed the survey. Results indicated no significant difference in response across the three incentive conditions after adjusting for multiple comparisons. Results also showed that using multiple methods of communication was more efficacious than any single method. However, when using single methods of communication to prompt response, a mailed postcard prompt was more efficacious than any other method tested after adjusting for multiple comparisons. The findings from this study can inform the design of future strategies to reduce panel attrition and improve retention rates.

Retention of Ethnic Participants in Longitudinal Studies.

We aimed to identify effective participant retention strategies utilized in longitudinal studies of ethnic groups, specifically those from South Asian and Chinese communities. We conducted a systematic review of the literature focusing on the retention of ethnic minorities in longitudinal studies, up until April 2017. Only peer-reviewed research was included. 11,316 citations were retrieved, of which 4808 were duplicates and 51 met the inclusion criteria. Financial incentives, involving key community members, flexible scheduling, developing trust and personal connections with participants, and having extensive participant contact information are key facilitators. We also describe our extensive experience of retaining South Asian and Chinese participants in longitudinal studies. Key retention strategies for these groups include involving family members, informing participants about potential personal and community benefits, being flexible in how and when the interviews are conducted, and providing multiple language options. There is little published evidence or direction regarding how to retain study participants from South Asian or Chinese communities. However, there can be some learning from studies focused on other ethnic groups. Establishing an evidence-based approach, including facilitators and barriers to retention of these groups in longitudinal studies would help to determine study feasibility, validity, and ultimately to reduce health disparities among South Asian or Chinese communities.

Nudges: Fun, Motivational Messages to Encourage and Reassure Parents in the HomeStyles Randomized Controlled Trial

Short, empowering messages sent to intervention study participants can motivate them to remain active in the study and continue working toward health behavior change goals. As part of the childhood obesity prevention HomeStyles randomized controlled trial, parents of preschool children were sent motivational nudges by SMS, email, and/or voice mail, per participant preference, to promote the application of the behavior changes promoted in the 4‐page mini‐magazine‐style informational guide the parent had most recently selected. The treatment group received guides designed to improve weight‐related home environment and lifestyle practices in families with preschool children whereas those in the control group received equivalent guides focusing on home safety. Parents were encouraged to focus on one guide ~every 3 to 4 weeks before selecting a new guide; nudges were sent every 4 days. Six nudges were written for each of the 12 weight‐related and 12 home safety guides; the first 4 nudges sent focused directly on the selected guide content and the last 2 nudges encouraged parents to choose a new guide. The nudges were developed by: 1) health communication experts who drafted an array of nudges for each guide, ensuring the length adhered to SMS maximums; 2) iterative cognitive testing and refinement of nudge messages with 98 English‐speaking parents; 3) in‐culture translation into Spanish and iterative cognitive testing and refinement with 92 Spanish‐speaking parents; 4) selection of nudges identified by parents as most motivational; and 5) final refinement of nudges. During cognitive testing, parents were asked to read each nudge and use a 5‐point scale to rate the overall likelihood the messages would motivate them to keep working on their goals. Overall, parents rated the nudges as very motivating (mean=4.34±0.84SD, scale 1–5). Parents especially liked nudges that contained novel ideas (“Move to the music and get active! Turn on some cool music and get your family swaying on the dance floor.”), were concise and relatable (“Eating family meals together is easier than you think! Unplug the TV and talk to each other about your day.”); parents did not prefer nudges with information incongruent with their existing mental models (e.g., a few did not believe that screen time before bed would interfere with child sleep quality), that seemed to chastise (e.g., “Maybe it's time to pay attention to your sleep patterns. Be sure to give your body the sleep it deserves!” “Make breakfast a priority! Breakfast skippers get so hungry they overeat at other meals.”), suggestions they thought would take too much effort to operationalize (e.g., “Try limiting active games and scary TV before bed. Instead, rub kids backs and read them stories.”), and deemed “catchy”. Nudges rated by parents as motivating have the potential to help retain study participants and encourage them to make changes to their lifestyles and home environments to prevent obesity and protect family health.Support or Funding InformationUSDA NIFA #2011‐68001‐30170

Clinical trials supported by the Tinnitus Research Consortium: Lessons learned, the Southern Illinois University experience

The Tinnitus Research Consortium funded three clinical trials investigating treatments for chronic bothersome tinnitus at Southern Illinois University School of Medicine. The trials were designed to measure the subjective changes in tinnitus distress using standardized questionnaires and objective changes in tinnitus loudness using psychophysical matching procedures. The results of the first two trials have been published and are summarized here. The first trial investigated the effect of gabapentin on the loudness and annoyance of tinnitus in adults with chronic bothersome tinnitus with and without a history of acoustic trauma. A small but significant number of subjects reported decreased tinnitus annoyance that corresponded with a decrease in objective measures of tinnitus loudness during active drug treatment with a washout effect during placebo treatment. The second trial compared the effect of tinnitus retraining therapy (TRT) on adults with normal to near-normal hearing and chronic bothersome tinnitus to treatment with general counseling without acoustic enrichment. Significant improvements in tinnitus severity, but not in objective psychometric measures of tinnitus loudness, occurred in both treatment groups, however a greater effect was observed in the TRT group compared with the control group. The third trial is nearing completion and investigates the long-term results of tinnitus retraining therapy on chronic bothersome tinnitus in adults with hearing loss. Significant lessons and observations on conducting tinnitus clinical trials were learned from these three trials. The challenges of recruiting and retaining study participants is discussed. More importantly, the reliability and stability of the Tinnitus Handicap Inventory (THI) over long intervals is presented. The implications of this variability for the design and interpretation of future tinnitus studies is discussed.This article is part of a Special Issue entitled <Tinnitus>.

Loss to follow-up among infants in a study of isoniazid prophylaxis (P1041) in South Africa

To assess risk factors for loss to follow-up (LFU) from the IMPAACT P1041 study, an isoniazid (INH) prophylaxis study conducted in southern Africa. Infants in two cohorts, human immunodeficiency virus-infected (HIV+) and HIV-exposed but non-infected (HIV-), were randomized to INH or placebo for 96 weeks. LFU was evaluated at week 96. Of 1351 infants, 12.9% were LFU (10.4% HIV+, 14.7% HIV-); 65% of the HIV+ cohort was asymptomatic. Among HIV+ infants, large household size (>6 vs. <4 members, P = 0.035) and presence of an elder (≥55 years, P = 0.05) were associated with better retention. Although attenuated in adjusted analysis, these associations held among HIV- infants. Among HIV- infants, having a younger mother increased the risk (P = 0.008) and maternal history of TB reduced the risk of LFU, the latter by nearly 70% (P = 0.048 univariate, 0.09 adjusted). LFU was largely due to inability to contact the participant (58% HIV+, 30% HIV-), and inability to attend the clinic and withdrawal of consent (HIV-). Household support was an important factor in participant retention, particularly for the non-HIV-infected cohort, as young maternal age was a risk factor for LFU. Retaining study participants from this mobile population can be challenging and may warrant additional support.

Reasons for Staying as a Participant in the Environmental Determinants of Diabetes in the Young (TEDDY) Longitudinal Study.

To assess parents' opinions about their participation in the longitudinal, multicenter study - The Environmental Determinants of Diabetes in the Young (TEDDY) consortium. A survey was given to parents who had been in the study for ≥ 1 year. Parents rated the importance of different reasons for staying in TEDDY and how well different study components were working. Parents were also asked if they had suggestions for making TEDDY better and if they ever had thought of leaving TEDDY and if so, why. Out of the 3336 eligible families, 2000 completed the survey (59.1%); most (77.6%) were mothers. Survey completion was more common in European than US TEDDY sites and was associated with greater maternal education, more accurate perceptions about their child's risk of type 1 diabetes, longer participation in TEDDY and excellent attendance at TEDDY visits. "Having someone watching the child for development of T1DM" was most important reason given for staying in the study; other important reasons included "Helping science discover causes of diabetes" and "Getting child's antibody results". Most parents were very satisfied with the different components of TEDDY and had not thought of leaving the study. A minority (24%) of parents acknowledged some thoughts of leaving TEDDY and cited the blood draws, being too busy/not having enough time, the demanding protocol, and food diaries as their reasons for considering leaving. The study highlights factors important for successful implementation of demanding, longitudinal protocols. Friendly, devoted, skilled and knowledgeable staff with continuity makes the family comfortable. Keeping parents involved and informed on study progress is essential as is making procedures as smooth and painless as possible. Although the study is international the survey results were convergent across countries suggesting that the results have relevance to other similar studies to retain study participants.

Predictors of Retention in an Online Follow-up Study of Men Who Have Sex With Men

BackgroundIn the past 10 years, the Internet has emerged as a venue for men who have sex with men (MSM) to meet sex partners. Because online sex seeking has increased among MSM, Internet-based human immunodeficiency virus (HIV) prevention interventions are of interest. However, few online studies to date have demonstrated an ability to retain study participants, specifically MSM of color, in longitudinal online studies.ObjectiveThe current analysis examines data from a 3-month online prospective study of MSM to determine the association of race and incentive level with two retention outcomes: (1) agreeing to participate in a follow-up survey and providing an email address and (2) linking into the follow-up survey at the follow-up time point.MethodsInternet-using MSM were recruited through banner advertisements on MySpace.com. White, black, and Hispanic participants from 18 to 35 years of age were randomized to an offer of enrollment in an online follow-up survey at four levels of incentive (US $0, US $5, US $10, and US $20). Multivariable logistic regression models were used to estimate the odds of the two outcome measures of interest controlling for additional independent factors of interest.ResultsOf eligible participants, 92% (2405/2607) agreed to participate in the follow-up survey and provided an email address. Hispanic men had decreased odds (adjusted odds ratio [OR] = 0.66, 95% confidence interval [CI] 0.47-0.92) of agreeing to participate in the follow-up survey compared with white men. Men reporting unprotected anal intercourse with a male sex partner in the past 12 months had increased odds of agreeing to participate in the follow-up survey (adjusted OR = 1.42, 95% CI 1.05-1.93). Of the participants who provided an email address, 22% (539/2405) linked into the follow-up survey at the 3-month follow-up time point. The odds of linking into the follow-up survey for black men were approximately half the odds for white men (adjusted OR = 0.47, 95% CI 0.35-0.63). Participants who were offered an incentive had increased odds of linking into the follow-up survey (adjusted OR = 1.29, 95% CI 1.02-1.62). Email addresses provided by participants that were used for online financial management and email accounts that were checked daily were associated with increased odds of linking into the follow-up survey (adjusted OR = 1.97, 95% CI 1.54-2.52; adjusted OR = 1.51, 95% CI 1.22-1.87, respectively).ConclusionsThis analysis identified factors that predicted retention in an online, prospective study of MSM. Hispanic and black study participants were less likely to be retained in the study compared with white study participants. Because these men bear the greatest burden of HIV incidence among MSM in the United States, it is critical that new research methods be developed to increase retention of these groups in online research studies.

Strategies and ethical considerations for the recruitment of young men who have sex with men: challenges of a vaccination trial in Mexico

The importance of recruiting and retaining study participants from minority groups is well recognized; however, there are no established rules for recruitment as its success depends on the setting and population. To describe and analyze recruitment strategies, ethical considerations, and recruitment outcomes from a study to evaluate the efficacy the Human Papilloma Virus vaccine in young men who have sex with men (MSM). The recruitment settings were university and community sites in the state of Morelos, Mexico. Eligibility requirement were men between 18 and 23 years old, who were free of anal-genital lesions as confirmed by clinical exploration, HIV negative, with no history of sexual relations with female partners and with fewer than five male lifetime sexual partners. Recruitment goals were 25 study participants in a four and a half month period. In addition to traditional recruitment strategies (flyers and media advertising, specific training of the recruitment team and adequate choice of recruitment sites)-engagement of local leaders in the MSM community formed a crucial part of the strategy. Special consideration was given to confidentiality and respect for study participants and a Bill of Participant Rights was developed as an explicit commitment to respect and acceptance. In total 723 MSM were initially contacted, 243 filled out the recruitment questionnaire, of which 151 met the criteria to be invited to the clinical examination. After clinical examination and interviews with the recruitment team, 131 fulfilled the inclusion criteria, of whom 73 were enrolled in the study - nearly triple the recruitment goal. Among the initial recruitment strategies (application of the screening questionnaire) attending meetings with MSM activist organizations was the most successful (326), followed by recruitment at bars and dance clubs (107). The recruitment strategies should be formally evaluated for their effectiveness to identify those which are most successful. In addition, future studies should consider the evaluation of study participants' perceptions of the recruitment strategies. Recruiting MSM in a developing country such as Mexico presented multiple challenges. We recommend that future studies actively engage the local MSM community and pay special attention to designing recruitment strategies that guarantee the confidentiality of and respect for participants.

Innovative approaches to cohort retention in a community-based HIV/STI prevention trial for socially marginalized Peruvian young adults

The conduct of longitudinal clinical trials must involve effective strategies to retain study participants in order to ensure internal validity, adequate statistical power and generalizability of results. In a large trial in Peru, we implemented various retention strategies to maintain high participation rates over time. Novel participant retention strategies were used to follow highly marginalized populations for two years because traditional locator information, such as telephone numbers and official identification (eg, passport, driver's license, the local equivalent of a social security number) were often unreliable or unavailable. These strategies included detailed preliminary ethnographic research to identify the behaviours of key target groups, approaches to develop strong informal bonds between project staff and participants outside of study settings, and methods to enhance positive participant attitudes towards the study. The overall study retention rate after two years was 84%, even though only 26% of the study populations supplied complete locator information (telephone, address and the names of two friends). The retention strategies used were labour intensive and iterative, which could prove difficult to replicate. The two-year retention rate in this study was sufficient to maintain required sample sizes. The methods used to maintain contact with the populations were labour intensive, low tech and adequate for these populations and could be used to retain study participants in other marginalized, urban, low-income areas.

Strategies for retaining study participants in behavioral intervention trials: Retention experiences of the nih behavior change consortium

Failing to retain an adequate number of study participants in behavioral intervention trials poses a threat to interpretation of study results and its external validity. This qualitative investigation describes the retention strategies promoted by the recruitment and retention committee of the Behavior Change Consortium, a group of 15 university-based sites funded by the National Institutes of Health to implement studies targeted toward disease prevention through behavior change. During biannual meetings, focus groups were conducted with all sites to determine barriers encountered in retaining study participants and strategies employed to address these barriers. All of the retention strategies reported were combined into 8 thematic retention categories. Those categories perceived to be most effective for retaining study participants were summarized and consistencies noted among site populations across the life course (e.g., older adults, adults, children, and adolescents). Further, possible discrepancies between site populations of varying health statuses are discussed, and an ecological framework is proposed for use in future investigations on retention.

Beginning with the application in mind: Designing and planning health behavior change interventions to enhance dissemination

Failing to retain an adequate number of study participants in behavioral intervention trials poses a threat to interpretation of study results and its external validity. This qualitative investigation describes the retention strategies promoted by the recruitment and retention committee of the Behavior Change Consortium, a group of 15 university-based sites funded by the National Institutes of Health to implement studies targeted toward disease prevention through behavior change. During biannual meetings, focus groups were conducted with all sites to determine barriers encountered in retaining study participants and strategies employed to address these barriers. All of the retention strategies reported were combined into 8 thematic retention categories. Those categories perceived to be most effective for retaining study participants were summarized and consistencies noted among site populations across the life course (e.g., older adults, adults, children, and adolescents). Further, possible discrepancies between site populations of varying health statuses are discussed, and an ecological framework is proposed for use in future investigations on retention.