Regarding Research: Women Consider Clinical Trials

The objective of this project was to present a "snapshot" of women's physical and emotional reasons for accepting or declining participation in research and to make recommendations to better recruit women into clinical trials.

Using a convenience sampling, 62 HIV+ women were recruited during the first half of 1996 to complete a 10-page self-administered survey. Surveys continue to come in and will be added to the database.

Of the initial 62 women surveyed, most were African-American or Anglo primarily living in northern California and New York state. About 3/4 of them lived in cities and 1/4 in small towns or rural areas. Almost 70% of the women have post high school education or training. Thirty percent have participated in a research study, primarily observational (no drugs) or Phase II of a drug study. Many help care for an HIV+ relative or friend, some in addition to their own children. The factors which did not appear to affect participation were: length of diagnosis or symptoms, age, ethnicity, number of children, income, hours worked, mode of transportation or insurance.

Residence was a significant indicator of research participation with aproximately 70% of city dwellers in a study versus 30% in rural areas. Education was a strong factor. None of 4 women with less than a 10th grade education, and only 3 of 14 women with 10th to 12th grade education had ever participated in a study.

However, 16 of 42 women with higher education had been participants. Research participants cited newsletters and magazines as their primary sources of treatment information. Non-participants cited their health care provider as primary resource and newsletters as second.

When asked what factors made enrollment difficult, both participants and non-participants most often referenced fear of taking an experimental drug (23.1% and 48.7% respectively). When asked what factors might encourage enrollment, participants and non-participants agreed that increasing knowledge of HIV in women is a primary factor. Participants also prioritized being treated with respect, the study being well explained, free health care, good location, and a desire to help others as additional motivators. Non-participants also listed good location, explanation of the study and provider recommendation as motivators.

Conclusions

It's important to continue to address exclusionary research criteria, and physical needs such as child care and transportation. Consider emotional needs (to be treated with respect isn't too much to ask). Be more creative about outreach to women. Whenever possible, take research ideas to women through their providers, meetings and support groups. Explain studies in non-research terms, defining how they will increase knowledge not just about a single treatment or theory, but about women living with HIV.