Funder: National Institute of Mental Health
Project period: 09/30/2000 - 08/31/2004
Grant Type: Research
This three year study, "Microbicide Acceptability to Prevent HTV in High-Risk Women," will explore with women at high risk of HIV or other sexually transmitted infection (STI), their level of preparedness for microbicidal products, the personal, sociocultural and contextual factors that affect their willingness to try or adopt such methods, and their reasons for choosing among alternative approaches to reducing STIs including HIV. This study will: 1) explore the acceptability of different microbicidal prevention methods among women at high risk of contracting or transmitting HIV through unprotected sex; 2) identify contextual factors that affect acceptability and use of microbicide products, including ethnic/cultural beliefs, peer norms, personal risk (e.g., drug use, prostitution, abusive partners), economic conditions, social settings, partners and partner relationships, and concern for reproduction; and 3) test acceptability of four trial microbicidal products in a voluntary group of high risk women stratified by ethnicity and examine factors associated with specific preferences. The study will take place in Hartford, Connecticut, where risk of HIV infection, especially among women of color, continues to be among the highest in the country. The target population will include 400 drug-using women, female sex workers and sex partners of drug-using men, high-risk teens, and drug-using men and/or partners of drug-using women, and will be approximately 33% African/Caribbean Americans, 33% Puerto Ricans/Latinos, and 33% Whites/other ethnic groups. The applicant will use a combination of qualitative (focus group elicitation techniques and in-depth semi-structured interviews) and quantitative (survey) methods to assess microbicide preparedness and acceptability in the target populations. In the first six months, elicitation techniques in six focus groups will provide information about use of contraceptive methods similar to microbicidal products currently under development, and conditions and factors affecting preferences and utilization. In months 6-30, the applicant will conduct a survey with 300 high risk women to assess factors associated with contraceptive choices and experiences, and willingness to participate in limited trials of available microbicide products. A subset of 100 women from the survey sample will be invited to use and report on four trial microbicide products that have undergone successful Phase I or Phase II clinical trials. Women volunteering for the substudy will use each product for two weeks, maintain use logs, and report their experiences in a structured interview the end of each two week period. The applicant will conduct analyses of covariance to detect differences in dependent measures for the four microbicides as well as logistic and multiple regression analyses investigating predictors of microbicide acceptability.