Comprehension of a simplified assent form in a vaccine trial for adolescents.

INTRODUCTION: Future HIV vaccine efficacy trials with adolescents will need to ensure that participants comprehend study concepts in order to confer true informed assent. A Hepatitis B vaccine trial with adolescents offers valuable opportunity to test youth understanding of vaccine trial requirements in general. METHODS: Youth reviewed a simplified assent form with study investigators and then completed a comprehension questionnaire. Once enrolled, all youth were tested for HIV and confirmed to be HIV-negative. RESULTS: 123 youth completed the questionnaire (mean age=15 years; 63% male; 70% Hispanic). Overall, only 69 (56%) youth answered all six questions correctly. CONCLUSIONS: Youth enrolled in a Hepatitis B vaccine trial demonstrated variable comprehension of the study design and various methodological concepts, such as treatment group masking.

Results of a pilot intervention trial to improve antiretroviral adherence among HIV-positive patients.

A small pilot trial of a multicomponent (behavioral strategies, simplified patient information, and social support) and multidisciplinary (cognitive-behavioral therapy and nursing) medication adherence intervention was conducted for HIV-infected adults prescribed antiretrovirals. Patients (N = 33) were randomly assigned to the intervention condition or standard care. Compared to the control group, patients in the intervention condition had significantly higher self-efficacy to communicate with clinic staff (p = .04) and to continue treatment (p = .04), were significantly more likely to be using behavioral and cognitive strategies (p = .01 and p = .04), reported significantly higher life satisfaction (p = .03), reported significantly increased feelings of social support (p = .04), and showed a trend toward an increase in taking their medications on schedule (p = .06). The intervention, however, did not appear to affect health-related anxiety or to significantly improve adherence to dose. Implications for future intervention planning are discussed.

Results of an Antiretroviral Adherence Intervention: STAR (Staying Healthy: Taking Antiretrovirals Regularly).

A randomized 2-group medication adherence intervention is evaluated with HIV-infected adults (N = 141) assessed at baseline, 3-, and 9-month follow-ups. Cognitive (self-efficacy, behavioral intent), mental health (depression, well-being), and substance use indicators were the outcome measures. In addition, a posttest-only analysis from 3 to 9 months evaluates intervention impact on antiretroviral adherence, measured through Medication Event Monitoring System and pill counts. Compared to the standard care group, the intervention group showed significant increases in adherence self-efficacy and behavioral intent at 3 and 9 months and marginal improvements in mental health. Although the standard care group had higher adherence at 3 months (no baseline data were available prior to intervention), intervention group patients showed significant increases in adherence from 3 to 9 months. Although adherence levels achieved by intervention patients may not be sufficient for virological control, this is one of the first studies to provide promising results of longer term effectiveness of a behavioral adherence intervention.

Factors associated with antiretroviral adherence among HIV-infected women with children.

HIV symptomatic or AIDS diagnosed women who had a young well child were recruited for a study investigating their adherence to antiretrovirals (N = 46). Very poor rates of adherence were found, ranging from 43% (pill count assessment) to 56% (self-report of 3-day adherence to dose). Several factors were associated with nonadherence, including alcohol use, perceived stress, having a partner and age of youngest child, poor self-efficacy to stay with treatment, and poor outcome expectancies regarding the benefits of following the treatment regimen. Interventions to assist these women in improving adherence are urgently needed.