Adherence and retention in clinical trials: a community-based approach.

BACKGROUND: The Community Health Advisor (CHA) model has been widely used to recruit rural and low-income, mostly African American women into clinical and behavioral research studies. However, little is known about its effectiveness in promoting retention and adherence of such women in clinical trials. METHODS: The Community-Based Retention Intervention Study evaluated the effectiveness of a community-based intervention strategy using the CHA model and the empowerment theory to improve the retention and adherence of minority and low-income women in clinical trials. The research strategy included the training and use of the volunteer CHAs as research partners. The target population included women participating in the University of Alabama at Birmingham clinical site of the Atypical Squamous Cells of Undetermined Significance-Low-Grade Squamous Intraepithelial Lesion (ASCUS-LSIL) Triage Study (ALTS), a multicenter, randomized clinical trial. Two communities in Jefferson County, Alabama, that were matched according to population demographics were identified and randomly assigned to either an intervention group or a control group. Thirty community volunteers were recruited to be CHAs and to implement the intervention with the ALTS trial participants. In total, 632 ALTS participants agreed to participate in the project, including 359 in the intervention group, which received CHA care, and 273 in the control group, which received standard care. RESULTS: Adherence rates for scheduled clinic visits were significantly higher in the intervention group (80%) compared with the control group (65%; P < .0001). CONCLUSIONS: The results indicate that volunteer CHAs can be trained to serve as research partners and can be effective in improving the retention and adherence of minority and low-income women in clinical trials.

The development of a community action plan to reduce breast and cervical cancer disparities between African-American and White women.

The purpose of this project was to establish a coalition of academic, state, and community-based organizations to develop a community action plan (CAP) to eliminate breast and cervical cancer morbidity and mortality disparities between African-American (AA) and Caucasian women. The project targeted rural and urban low-income AA women in Alabama. Based on the logic model, community capacity building was implemented, followed by the development of a community-driven CAP. For community capacity building, a coalition comprising 12 organizations was established, and a network of 84 community volunteers was formed. Community needs assessments identified 3 levels of barriers to breast and cervical cancer screening: 1) individual, 2) community systems, and 3) healthcare provider. Based on these findings, a community-driven CAP was developed. Our results indicate that a coalition of diverse organizations can partner and develop CAPs to improve the health of their communities.

Scales measuring psychosocial antecedents of coital initiation among adolescents in a rural southern state.

The psychometric properties of psychosexual scales designed to examine intentions toward sexual intercourse were examined. Participants from 22 schools in central Alabama provided data on demographics, knowledge, attitudes, beliefs, and intentions toward sexual intercourse. Theoretical constructs from Theory of Reasoned Action and Social Cognitive Theory guided the development of items assessing psychosocial aspects of sexual intercourse. Findings indicated that approximately half of the conceptual items (13 items) loaded on four factors. The four scales were (a) Coital Intentions, (b) Attitudes toward Negative Sexual Outcomes, (c) Social Norms toward Premature Sex, and (d) Self-efficacy of Sexual Refusal Skills. These factors showed adequate independence and explained 46% of the variance in the data. Cronbach alpha ranged from .69 to .78. Scales show acceptable evidence for evaluation; however, additional research from other geographical districts and other ethnic groups is needed to confirm their generalizability.

Retention of under-served women in clinical trials: a focus group study.

More information is needed to understand how women view their participation in clinical trials. As part of the formative evaluation phase of a 4-year National Cancer Institute funded study, researchers associated with the "Community Retention Intervention Study" (CRIS) conducted focus groups to identify additional data on the underlying issues regarding the retention and compliance of under-served women in clinical trials. Six focus groups were conducted: 3 were age-based, and 3 involved participants of the Women's Health Initiative (WHI) clinical trial component in Birmingham, Alabama. A total of 62 women, between 18 and 87 years of age, participated in the sessions: 79% were African-American and 52% reported incomes below dollar 20,000. The qualitative data analysis revealed that women were more inclined to participate in a clinical trial if they, or a family member, would benefit. Non-compliance with study protocols was generally a result of complications or unwanted side effects of treatments. Focus group data were used to develop retention and compliance strategies for the CRIS study. Findings suggest that focus group data can be used effectively to develop retention and compliance strategies specific to under-served women.

Sources of social support: adolescents with cancer.

PURPOSE/OBJECTIVES: To evaluate how a cancer diagnosis affects adolescents' perceived sources of social support, amount of support needed, and level of satisfaction with support compared to an age-matched, healthy, adolescent group. DESIGN: Cross-sectional, comparative, nonrandom survey. SETTING: Summer camp for adolescents with cancer and a rural high school in the southeastern United States. SAMPLE: Adolescents with a diagnosis of cancer (n = 64) and age-matched, healthy adolescents (n = 115). METHODS: Subjects completed the Social Support Questionnaire, Perceived Social Support From Family Scale, Perceived Social Support From Friends Scale, and demographic information forms. MAIN RESEARCH VARIABLES: Sources of social support, amount of support perceived, and level of satisfaction with support. FINDINGS: Adolescents with cancer perceived social support coming from both friends and family and reported high levels of support satisfaction from each source. Compared to healthy adolescents, those with cancer reported similar support sources and satisfaction levels; however, adolescents with cancer perceived parental relationships as more supportive. CONCLUSIONS: Similarities between healthy adolescents and those with cancer regarding social support were more prevalent than differences. The social benefits of camp settings for chronically ill children should be explored further. IMPLICATIONS FOR NURSING: Nurses and other healthcare professionals should allow adolescents in the healthcare setting every opportunity to maintain their social networks of friends and family by encouraging visitation, providing social opportunities in the hospital, and emphasizing the importance of attending school when medically able.

Coital status and perceptions about sexual abstinence refusal skills.

PURPOSE: To compare perceptions and use of sexual refusal skills. METHODS: A voluntary, anonymous sample of ninth and tenth grade students (N = 2256) reported their perceptions about and use of sexual refusal skills that had been taught in school. Forty-four percent of the students classified themselves as virgins, 18% reported one sexual partner, and 38% reported multiple sex partners. Coital status groups were compared on measures addressing refusal skills using Chi-square tests. RESULTS: Approximately one-third of the students reported using refusal skills either a lot or a little, with virgins more likely to indicate that they used refusal skills a lot. Virgins also were least likely to say that they should have used the refusal skills or that they didn't feel like using refusal skills. Furthermore, virgins were most likely to state that they didn't need to use refusal skills. One partner and multiple partner groups were more likely to indicate that they had not been taught refusal skills. CONCLUSIONS: The majority of students did not use the refusal skills taught to them in school; however, all coital status groups used the refusal skills in some capacity. Differences between the virgin and sexually experienced groups present challenges for instructors and curriculum developers. Some of the commonly held assumptions about refusal skill curricula may not be true.