HIV This Week

Murphy DA, Hoffman D, Seage GR 3rd, Belzer M, Xu J, Durako SJ, Geiger M; Adolescent Trials Network for HIV/AIDS Interventions. Improving comprehension for HIV vaccine trial information among adolescents at risk of HIV. AIDS Care 2007;19:42-51.

Murphy and colleagues developed a simplified version of the HIVNET prototype HIV vaccine process for adolescents at risk of HIV by:(1) reducing the reading level; (2) reorganizing; (3) adding illustrations; and (4) obtaining focus group feedback. Then adolescents (N = 187) in three cities were randomly assigned to the standard or simplified version. Adolescents receiving the simplified version had significantly higher comprehension scores (80% correct vs. 72% correct), with 37% of items significantly more likely to be answered correctly. They were also significantly more likely to recall study benefits and procedures. Overall, adolescents were less willing to participate in a potential HIV vaccine trial after presentation than prior to presentation. The authors indicate that it would be feasible for adolescents to participate in a vaccine trial, as simplification of vaccine information, combined with illustrations to depict key concepts, resulted in improved scores for adolescents on the comprehension and recall test.

Editors’ note: Conducting HIV vaccine trials in adolescents is important because they would potentially be prioritized for an efficacious product. However, researchers should anticipate more difficulty in recruiting as they make the necessary efforts to simplify information to ensure that consent is fully informed.

Brogly S, Read JS, Shapiro D, Stek A, Tuomala R. Participation of HIV-infected pregnant women in research in the United States. AIDS Res Hum Retroviruses 2007;23:51-3.

Previous studies suggested that some groups of HIV-infected women were underrepresented in studies of antiretrovirals (ARVs). Brogly and colleagues assessed rates of and reasons for nonenrollment in a U.S. prospective cohort study (protocol P1025), and differences in the characteristics of HIV-infected pregnant women who were and were not enrolled. Forty-one percent of women invited to participate were not enrolled. Clinic-related reasons for nonenrollment included staffing or site resources (26.7% of women) and clinician refusal because of the woman's nonadherence to prenatal care and/or poor research candidacy (10.8%). Patient-related reasons for nonenrollment included unavailability of women for enrollment (e.g., difficulty enrolling during labour/delivery, loss of clinic contact) (20.3%), refusal because of mistrust (10.1%), refusal because of time requirements (8.3%), refusal because of distance to the clinic (4.7%), and spontaneous abortion (4.7%). P1025 participants (N = 530) were significantly more likely to be Hispanic (32.1% vs. 19.8%), and less likely to be non-Hispanic black), to present in the first or second trimester for prenatal care (91.5% vs. 77.6%), and to be ARV-naive (32.8% vs. 23.0%) than nonparticipants (N = 2222). This high rate of nonenrollment can bias study results and generate findings that are applicable only to particular groups of women. The authors conclude that efforts should be taken to design protocols that facilitate enrollment of HIV-infected pregnant women.

Editors’ note: The reasons for difficulty in recruiting pregnant women into this multicentre cohort have a universal ring to them: mistrust, lack of time, distance and, of course, being in labour.