Recruitment and Retention of Pregnant Women Into Clinical Research Trials: An Overview of Challenges, Facilitators, and Best Practices

Frew, Paula M.; Saint-Victor, Diane S.; Isaacs, Margaret Brewinski; Kim, Sonnie; Swamy, Geeta K.; Sheffield, Jeanne S.; Edwards, Kathryn M.; Villafana, Tonya; Kamagate, Ouda; Ault, Kevin A.

doi:10.1093/cid/ciu726

Cited by 117 publications

(126 citation statements)

References 78 publications

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“…Effective techniques for recruiting hard to reach populations like pregnant smokers include providing an incentive [18][19][20][21] and targeting recruitment messages and materials to the population [5,[22][23][24]. Using emotion to frame messages may be an effective form of targeting.…”

Section: Discussionmentioning

confidence: 99%

Recruiting pregnant smokers from Text4baby for a randomized controlled trial of Quit4baby

Leavitt

Abroms

Johnson

et al. 2016

Behav. Med. Pract. Policy Res.

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Recruiting pregnant smokers into clinical trials is challenging since this population tends to be disadvantaged, the behavior is stigmatized, and the intervention window is limited. The purpose of this study is to test the feasibility and effectiveness of recruiting pregnant smokers into a smoking cessation trial by sending recruitment text messages to an existing subscriber list. Recruitment messages were sent to subscribers flagged as pregnant in Text4baby, a national text messaging program for pregnant women and mothers. Four recruitment messages were rotated to test the effectiveness of different emotional frames and a financial incentive. Study staff called subscribers who expressed interest to screen for eligibility and enroll eligible women. Between October 6, 2015 and February 2, 2016, 10,194 recruitment messages were sent to Text4baby subscribers flagged as pregnant, and 10.18% (1038) responded indicating interest. No significant increase in cancellation was observed compared to subscribers who received other ad hoc messages. Of respondents, 54.05% (561) were reached by phone for follow-up, and 21.97% (228) were found to be eligible. Among the eligible, 87% (199) pregnant smokers enrolled. The recruitment message with a pride emotional appeal had a significantly higher response (p = 0.02) compared to the recruitment message with no emotional appeal, but enrollment did not significantly differ between recruitment messages with different emotional appeals. The recruitment messages with a reference to financial incentive yielded higher response (p < 0.01) and enrollment (p = 0.03) compared to a recruitment message without. This study demonstrates success recruiting pregnant smokers using text message. Future studies should consider building on this approach for recruiting high-risk populations.

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Section: Discussionmentioning

confidence: 99%

Recruiting pregnant smokers from Text4baby for a randomized controlled trial of Quit4baby

Leavitt

Abroms

Johnson

et al. 2016

Behav. Med. Pract. Policy Res.

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“…A second limitation was the high drop-out rate experienced along the study, especially in the control group, resulting in a smaller sample size, larger confidence intervals of the results and lower statistical power. Conducting clinical trials in mother-infant pairs is not evident and retaining them into the study during the entire study period is challenging [32]. Since the study was conducted in one province in Belgium, the study should be repeated in other provinces and countries with a different epidemiological background, a different vaccination schedule and different vaccine compositions, before generalizations can be made.…”

Section: Limitations Of the Studymentioning

confidence: 99%

Pertussis vaccination during pregnancy in Belgium: Follow-up of infants until 1 month after the fourth infant pertussis vaccination at 15 months of age

Maertens

Caboré

Huygen

et al. 2016

Vaccine

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Vaccination of pregnant women with a pertussis containing vaccine is a recommended strategy in some industrialized countries, to protect young infants from severe disease. One of the effects of the presence of high titers of passively acquired maternal antibodies in young infants is blunting of immune responses to infant vaccination. We present infant immune responses to a fourth pertussis containing vaccine dose at 15 months of age, as a follow-up of previously presented data. In a prospective cohort study, women were either vaccinated with an acellular pertussis vaccine (Boostrix(®)) during pregnancy (vaccine group) or received no vaccine (control group). All infants were vaccinated with Infanrix Hexa(®) according to the standard Belgian vaccination schedule (8/12/16 weeks, 15 months). We report results from blood samples collected before and 1 month after the fourth vaccine dose. Immunoglobulin G (IgG) antibodies against pertussis toxin (PT), filamentous hemagglutinin (FHA), pertactin (Prn), tetanus toxoid (TT) and diphtheria toxoid (DT) were measured using commercially available ELISA tests. Antibody levels were expressed in International Units per milliliter. Demographic characteristics were similar in the vaccine and control group. Before the fourth vaccine dose, significantly lower antibody titers were measured in the vaccine group compared to the control group for anti-Prn IgG (p=0.003) and anti-DT IgG (p=0.023), with a steep decay of antibody titers since post-primary vaccination. One month after the fourth dose, antibody titers were only significantly lower in the vaccine group for anti-PT IgG (p=0.006). For all antigens, there was a rise in antibody titer after the fourth vaccine dose. The present results indicate still a minor blunting effect 1 month after a fourth vaccine dose for anti-PT antibodies. However, a good humoral immune response on all measured antigens was elicited in both groups of children. The clinical significance of such blunting effect is yet unknown. Clinicaltrials.gov identifier: NCT01698346.

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“…The majority of studies ( n = 13) in this review were case studies. The remaining studies included quantitative design (Bloom et al., ; Chandra et al., ; Geist, ; Glik et al., ; Goytia et al., ; Patterson et al., ); qualitative design (Boutain & McNees, ; Burkhalter et al., ; Collignon, Men, & Tan, ; Honeycutt et al., ; Johnson et al., ; Radermacher, Karunarathna, Grace, & Feldman, ; Taras et al., ); systematic review (Frew et al., ); and mixed‐method design (Houston et al., ; Kakietek et al., ; Kelaher et al., ; Laborde, Brannock, Breland‐Noble, & Parrish, ; Riehman et al., ).…”

Section: Resultsmentioning

confidence: 99%

A systematic review of components of community-based organisation engagement

Adebayo

Salerno

Francillon

et al. 2018

Health Soc Care Community

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Community-based organisations (CBOs) are important for eliminating health disparities globally and translating research findings to inform interventions. Engagement is an integral part of partnerships between CBOs and community health researchers and impacts the quality and quantity of any desired outcome. Despite the acknowledged benefits of community-based organisation engagement (CBOE), there are variations in its operationalisation and paucity in the understanding of its use in community-scientific partnerships. To further understand CBOE, the aim of this study was to synthesise published literature relevant to the definitions and applications of CBOE and identify its key components. A systematic search was conducted in March 2017, and updated in June 2017. Keywords were varied to account for international differences in spelling and word usage. Five major databases, MEDLINE, PubMed, CINAHL, PsycINFO and Google Scholar, were used to identify potential research studies. A total of 32 studies were included in this review. Following the analysis of the literature, four salient themes emerged as components of CBOE: (1) Need (a consensus between all the parties in a partnership on the importance of a specified project and its proposed benefits to a target community); (2) Partnership Dynamics (the workings of a relationship between a CBO and a scientific/academic stakeholder); (3) Resources (include but are not limited to: personnel, money, work space, expertise and equipment); and (4) Outcomes (products of the partnership). This review provides a foundation for future research in applying CBOE to translational research and interventions. This analysis will assist community health researchers in planning partnerships with CBOs, and make necessary adjustments to improve study outcomes. Appropriate application of the components of CBOE in partnerships will assist researchers in addressing health disparities.

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Recruitment and Retention of Pregnant Women Into Clinical Research Trials: An Overview of Challenges, Facilitators, and Best Practices

Cited by 117 publications

References 78 publications

Recruiting pregnant smokers from Text4baby for a randomized controlled trial of Quit4baby

Recruiting pregnant smokers from Text4baby for a randomized controlled trial of Quit4baby

Pertussis vaccination during pregnancy in Belgium: Follow-up of infants until 1 month after the fourth infant pertussis vaccination at 15 months of age

A systematic review of components of community-based organisation engagement

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