Intervention Study Arms Research Articles

Randomised experimental evaluation of a social media campaign to promote COVID-19 vaccination in Nigeria.

The coronavirus disease 2019 (COVID-19) pandemic has challenged public health and behaviour change programmes, and has led to the development of innovative interventions and research. In low -and middle-income countries (LMICs) such as Nigeria, new strategies to promote vaccination, increase pro-vaccination social norms, and reduce vaccine hesitancy have been deployed through social media campaigns and evaluated using digital media platforms. We conducted two randomised experimental evaluations of social media content designed to promote COVID-19 vaccination and to complement research on a nationwide vaccination promotion campaign in Nigeria run in 2022. We conducted two studies in March and August 2022 among Nigerians drawn from 31 states that had not been targeted in the aforementioned nationwide campaign. We randomised the participants to either receive the pro-vaccination social media campaign or not and collected data at pre- and post-test time points to evaluate psychosocial predictors of vaccination and vaccination outcomes following the Theory of Change based on Diffusion of Innovations; the Social Norms Theory, and the Motivation, Opportunity, Ability (MOA) framework. Data were collected through a novel intervention delivery and data collection platform through social media. We found that pro-vaccination social norms and vaccination rates increased, while vaccine hesitancy decreased among participants randomised to the social media intervention study arm. Social media campaigns are a promising approach to increasing vaccination at scale in LMICs, while social norms are an important factor in promoting vaccination, which is consistent with the Social Norms Theory. This study demonstrates the capability and potential of new social media-based data collection techniques. We describe implications for future vaccination campaigns and identify future research priorities in this area. Pan African Clinical Trial Registry: PACTR202310811597445.

Effectiveness of the SAFE eHealth Intervention for Women Experiencing Intimate Partner Violence and Abuse: Randomized Controlled Trial, Quantitative Process Evaluation, and Open Feasibility Study.

Intimate partner violence and abuse (IPVA) is a pervasive societal issue that impacts many women globally. Web-based help options are becoming increasingly available and have the ability to eliminate certain barriers in help seeking for IPVA, especially in improving accessibility. This study focused on the quantitative evaluation of the SAFE eHealth intervention for women IPVA survivors. A total of 198 women who experienced IPVA participated in a randomized controlled trial and quantitative process evaluation. Participants were largely recruited on the internet and signed up through self-referral. They were allocated (blinded for the participants) to (1) the intervention group (N=99) with access to a complete version of a help website containing 4 modules on IPVA, support options, mental health, and social support, and with interactive components such as a chat, or (2) the limited-intervention control group (N=99). Data were gathered about self-efficacy, depression, anxiety, and multiple feasibility aspects. The primary outcome was self-efficacy at 6 months. The process evaluation focused on themes, such as ease of use and feeling helped. In an open feasibility study (OFS; N=170), we assessed demand, implementation, and practicality. All data for this study were collected through web-based self-report questionnaires and automatically registered web-based data such as page visits and amount of logins. We found no significant difference over time between groups for self-efficacy, depression, anxiety, fear of partner, awareness, and perceived support. However, both study arms showed significantly decreased scores for anxiety and fear of partner. Most participants in both groups were satisfied, but the intervention group showed significantly higher scores for suitability and feeling helped. However, we encountered high attrition for the follow-up surveys. Furthermore, the intervention was positively evaluated on multiple feasibility aspects. The average amount of logins did not significantly differ between the study arms, but participants in the intervention arm did spend significantly more time on the website. An increase in registrations during the OFS (N=170) was identified: the mean amount of registrations per month was 13.2 during the randomized controlled trial and 56.7 during the OFS. Our findings did not show a significant difference in outcomes between the extensive SAFE intervention and the limited-intervention control group. It is, however, difficult to quantify the real contribution of the interactive components, as the control group also had access to a limited version of the intervention for ethical reasons. Both groups were satisfied with the intervention they received, with the intervention study arm significantly more so than the control study arm. Integrated and multilayered approaches are needed to aptly quantify the impact of web-based IPVA interventions for survivors. Netherlands Trial Register NL7108 NTR7313; https://trialsearch.who.int/Trial2.aspx?TrialID=NTR7313.

Behavioural interventions to promote physical activity in a multiethnic population at high risk of diabetes: PROPELS three-arm RCT

Type 2 diabetes is a leading cause of mortality globally and accounts for significant health resource expenditure. Increased physical activity can reduce the risk of diabetes. However, the longer-term clinical effectiveness and cost-effectiveness of physical activity interventions in those at high risk of type 2 diabetes is unknown. To investigate whether or not Walking Away from Diabetes (Walking Away) - a low-resource, 3-hour group-based behavioural intervention designed to promote physical activity through pedometer use in those with prediabetes - leads to sustained increases in physical activity when delivered with and without an integrated mobile health intervention compared with control. Three-arm, parallel-group, pragmatic, superiority randomised controlled trial with follow-up conducted at 12 and 48 months. Primary care and the community. Adults whose primary care record included a prediabetic blood glucose measurement recorded within the past 5 years [HbA1c ≥ 42 mmol/mol (6.0%), < 48 mmol/mol (6.5%) mmol/mol; fasting glucose ≥ 5.5 mmol/l, < 7.0 mmol/l; or 2-hour post-challenge glucose ≥ 7.8 mmol/l, < 11.1 mmol/l] were recruited between December 2013 and February 2015. Data collection was completed in July 2019. Participants were randomised (1 : 1 : 1) using a web-based tool to (1) control (information leaflet), (2) Walking Away with annual group-based support or (3) Walking Away Plus (comprising Walking Away, annual group-based support and a mobile health intervention that provided automated, individually tailored text messages to prompt pedometer use and goal-setting and provide feedback, in addition to biannual telephone calls). Participants and data collectors were not blinded; however, the staff who processed the accelerometer data were blinded to allocation. The primary outcome was accelerometer-measured ambulatory activity (steps per day) at 48 months. Other objective and self-reported measures of physical activity were also assessed. A total of 1366 individuals were randomised (median age 61 years, median body mass index 28.4 kg/m2, median ambulatory activity 6638 steps per day, women 49%, black and minority ethnicity 28%). Accelerometer data were available for 1017 (74%) and 993 (73%) individuals at 12 and 48 months, respectively. The primary outcome assessment at 48 months found no differences in ambulatory activity compared with control in either group (Walking Away Plus: 121 steps per day, 97.5% confidence interval -290 to 532 steps per day; Walking Away: 91 steps per day, 97.5% confidence interval -282 to 463). This was consistent across ethnic groups. At the intermediate 12-month assessment, the Walking Away Plus group had increased their ambulatory activity by 547 (97.5% confidence interval 211 to 882) steps per day compared with control and were 1.61 (97.5% confidence interval 1.05 to 2.45) times more likely to achieve 150 minutes per week of objectively assessed unbouted moderate to vigorous physical activity. In the Walking Away group, there were no differences compared with control at 12 months. Secondary anthropometric, biomechanical and mental health outcomes were unaltered in either intervention study arm compared with control at 12 or 48 months, with the exception of small, but sustained, reductions in body weight in the Walking Away study arm (≈ 1 kg) at the 12- and 48-month follow-ups. Lifetime cost-effectiveness modelling suggested that usual care had the highest probability of being cost-effective at a threshold of £20,000 per quality-adjusted life-year. Of 50 serious adverse events, only one (myocardial infarction) was deemed possibly related to the intervention and led to the withdrawal of the participant from the study. Loss to follow-up, although the results were unaltered when missing data were replaced using multiple imputation. Combining a physical activity intervention with text messaging and telephone support resulted in modest, but clinically meaningful, changes in physical activity at 12 months, but the changes were not sustained at 48 months. Future research is needed to investigate which intervention types, components and features can help to maintain physical activity behaviour change over the longer term. Current Controlled Trials ISRCTN83465245. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 77. See the NIHR Journals Library website for further project information.

Decision making about anti-TNF therapy: A pilot trial of a shared decision-making intervention

ObjectiveWe conducted a pre-post pilot trial to determine the feasibility and acceptability of a multi-component intervention (pre-clinic letter, shared decision making cards and follow-up phone call) designed to facilitate SDM in pediatric inflammatory bowel disease (IBD). MethodsWe recruited physicians (n = 11) caring for IBD patients and families (n = 36) expected to discuss anti-tumor necrosis treatment. We measured feasibility and acceptability of the intervention, observed SDM, perceived SDM, decision conflict, and regret. Medical records were used to assess clinical outcomes, time to decision and adherence. We compared all outcomes between the usual care and intervention study arms. ResultsTwo out of three intervention components were feasible. Visit length increased significantly in the intervention arm. Parents and patients rated the intervention as acceptable, as did most physicians. The intervention was associated with a higher-level of observed SDM. There was no difference perceived SDM, decision conflict, regret or quality of life outcomes between arms. Physician global assessment improved over time in the intervention arm. ConclusionsThis pilot trial provides important guidance for developing a larger scale trial of a modified intervention. Practice implicationsOverall, our intervention shows promise in supporting SDM and engaging both parents and patients in pediatric IBD decisions.

A pilot randomized trial of five financial incentive strategies to increase study enrollment and retention rates

BackgroundEnrollment and retention difficulties remain major barriers to conducting clinical trials. Financial incentives may promote clinical trial enrollment, however delivery methods to maximize enrollment, maximize retention, and minimize cost remains uncertain. MethodsWe conducted a single-blind, web-based randomized controlled trial of five financial incentive strategies on enrollment and retention rates in a longitudinal study of advance directives among community-dwelling older adults. Participants were eligible to receive a fixed total financial incentive, but the disbursement amounts at each study timepoint (baseline, 2-weeks, 4-weeks, and 6-weeks) differed between study arms. At each timepoint, participants completed a different advance directive. We conducted an intention-to-treat analysis for the primary and secondary outcomes of enrollment and retention. Results1803 adults were randomized to one of five incentive strategies: constant n = 361; increasing n = 357; U-shaped n = 361; surprise n = 360; self-select n = 364. Overall, 989 (54.9%) participants elected to enroll in the advance directive study. There were no differences in enrollment rates between the control (constant 53.5%) and any of the four intervention study arms (increasing 54.3%, p = 0.81; U-shaped 57.3%, p = 0.30; surprise 56.9%, p = 0.35; and self-select 52.2%, p = 0.73). There were no differences in retention rates between the control (constant 2.1%) and any of the four intervention study arms (increasing 5.2%, p = 0.09; U-shaped 3.9%, p = 0.23; surprise 2.4%, p = 0.54; self-select 2.1%, p = 0.63). ConclusionsFinancial incentive programs for trial enrollment informed by behavioral economic insights were no more effective than a constant-payment approach in this web-based pilot study.

Parental predictors of HPV vaccine initiation among low-income Hispanic females aged 11–17 years

PurposeHispanic women experience a disproportionate burden of cervical cancer morbidity and mortality compared to non-Hispanic women. Increasing HPV vaccination among Hispanic adolescents can help alleviate disparities. This study aimed to identify parental psychosocial predictors associated with HPV vaccine initiation and correlates of parental intentions to obtain the vaccine for their Hispanic adolescent daughters aged 11–17 years. MethodsThis study is part of a larger three-arm randomized controlled trial testing the effectiveness of interventions to increase HPV vaccination. Parents of adolescent females were recruited in community clinics where we conducted baseline surveys. We obtained electronic medical records six months after baseline to assess vaccination status. Multilevel logistic regression was used to identify correlates of parental intentions to vaccinate and predictors of HPV vaccine initiation. Analyses with initiation as the outcome also controlled for intervention study arm. The Integrated Behavioral Model guided selection of psychosocial and outcome variables. ResultsOur sample (n = 765) consisted mostly of mothers with less than a high school education born outside of the U.S. Forty-one percent had a household income less than $15,000. Most daughters had public or private insurance. Twenty-one percent initiated the HPV vaccine series. Correlates of intention to vaccinate intention included subjective norms related to daughter’s doctor (AOR = 1.04; 95% CI 1.01–1.07), belief that the vaccine is safe (AOR = 1.38; 95% CI 1.06–1.78), self-efficacy to obtain the vaccine for their daughter (AOR = 2.39; 95% CI 1.52–3.77), and parental concern about vaccine side effects (AOR = 0.73; 95% CI 0.60–0.89). Intentions predicted initiation (AOR = 2.01; 95% CI 1.10–5.26); concern about sexual disinhibition decreased the odds of having a vaccinated daughter at follow-up (AOR = 0.66; 95% CI 0.47–0.92). DiscussionParental intention and concerns about sexual disinhibition predict vaccine initiation. Further research is needed to explore the role of intention as a potential mediator between psychosocial variables and vaccination status.

Reduced keratin expression in colorectal neoplasia and associated fields is reversible by diet and resection

BackgroundPatients with adenomatous colonic polyps are at increased risk of developing further polyps suggesting field-wide alterations in cancer predisposition. The current study aimed to identify molecular alterations in the normal...

A randomised controlled trial to assess the effectiveness of a nurse-led palliative care intervention for HIV positive patients on antiretroviral therapy: recruitment, refusal, randomisation and missing data.

BackgroundDespite the life threatening nature of an HIV diagnosis and the multidimensional problems experienced by this patient population during antiretroviral therapy, the effectiveness of a palliative care approach for HIV positive patients on ART is as yet unknown.FindingsA randomised controlled trial (RCT) was conducted in a sample of 120 HIV positive patients on ART in an urban clinic in Mombasa, Kenya. The intervention was a minimum of seven sessions of multidimensional, person-centred care, given by HIV nurses trained in the palliative care approach over a period of 5 months. Rates of recruitment and refusal, the effectiveness of the randomisation procedure, trial follow-up and attrition and extent of missing data are reported.120 patients (60 randomised to control arm, 60 randomised to intervention arm) were recruited over 5.5 months, with a refusal rate of 55.7%. During the study period, three participants died from cancer, three withdrew (two moved away and one withdrew due to time constraints). All of these patients were in the intervention arm: details are reported. There were five additional missing monthly interviews in both the control and intervention study arm, bringing the total of missing data to 26 data points (4.3%).DiscussionThe quality and implications of these data are discussed extensively and openly, including the effect of full and ethical consent procedures, respondent burden, HIV stigma, accurate randomisation, patient safety and the impact of the intervention. Data on recruitment randomisation, attrition and missing data in clinical trials should be routinely reported, in conjunction with the now established practice of publishing study protocols to enhance research integrity, transparency and quality. Transparency is especially important in cross cultural settings, in which the sources of funding and trial design are often not based in the country of data collection. Findings reported can be used to inform future RCTs in this area.Trial registrationClinicaltrials.gov NCT01608802.

Preference-based electronic decision aid to promote colorectal cancer screening: Results of a randomized controlled trial

Objective Despite the burden of colorectal cancer and improved health care outcomes with early detection and treatment, screening rates among eligible adults are low. We previously developed through a series of studies an interactive electronic tool, Colorectal Web, to promote colorectal cancer screening. Method From May 2002 to December 2003, we conducted a randomized controlled trial of Colorectal Web compared to a standard Web site on colorectal cancer screening in urban, suburban, and rural communities in Michigan with high colorectal cancer burden. Study participants were age 50 years and older, with no previous colorectal cancer screening. Major outcome was screened for colorectal cancer by 24 weeks post-intervention. Results 174 eligible adults were randomized and participated. Immediately post-intervention, Colorectal Web participants were significantly more likely to have a preferred colorectal cancer screening method, but this difference did not persist at subsequent follow-up. Eighty-nine participants had been screened for colorectal cancer by 24 weeks post-intervention. The probability of being screened for the Colorectal Web intervention study arm compared to the control is OR = 3.23 (2.73–3.50 95% Confidence Interval). Conclusion Colorectal Web is more effective than a standard colorectal cancer Web site at prompting previously unscreened individuals to choose a preferred colorectal cancer screening test and to be screened for colorectal cancer.