Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI)
National Institutes of Health
U.S. Department of Health and Human Services

Controlled Intervention Trials

In controlled intervention trials, a hypothesis is tested using methods designed to examine the efficacy or effectiveness of an intervention in a group or population. This phase is necessary to determine if the intervention is suitable to be tested on a larger scale.

  • Home Visiting Intervention to Improve Pregnancy Outcomes, Child Health Development, and Maternal Economic Self-Sufficiency
    National Institute on Drug Abuse (NIDA)
    This study sets out to improve pregnancy outcomes, child health and development, and maternal economic self-sufficiency for African-American women and 17-year-old first-born children. This study is designed to determine whether a home visit program can lead to less violent antisocial behavior, psychopathology, substance abuse, and HIV risk.

  • Exercise, Aging and Cognition
    National Institute on Aging (NIA)
    Evidence suggests that exercise can have a beneficial effect on cognition in older adults. Earlier intervention using exercise may prevent age-related changes in cognition. This study seeks to extend the investigation to younger individuals, aged 25 to 40 and 50 to 65.

  • Prevention of Hearing Loss Among Farmers
    National Institute on Deafness and Other Communication Disorders (NIDCD)
    Noise-induced hearing loss has a negative impact on quality of life of the affected individual; farmers are at particularly high risk for hearing loss and are underserved by programs designed to limit that risk. This trial employs a web-based intervention designed to determine the most effective way to increase farmers' use of hearing protection to prevent hearing loss.

  • Women’s Health Initiative
    National Heart Lung and Blood Institute (NHLBI)
    The Women's Health Initiative was established in 1991 to address the most common causes of death, disability, and impaired quality of life in postmenopausal women. The study includes clinical trials and interventions for the prevention of cardiovascular disease, cancer, and osteoporosis.

  • The Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial
    National Cancer Institute (NCI)
    This study is a large population-based randomized trial designed to determine the effects of screening on cancer-related deaths and secondary endpoints, such as occurrence of disease or symptoms, in adults aged 55 to 74. These efforts could ultimately lead to new prevention measures.

  • National Lung Screening Trial
    National Cancer Institute (NCI)
    This randomized trial compares the effects of two screening procedures for lung cancer in current and former heavy smokers ages 55 to 74. The purpose of this study is to examine if screening for lung cancer reduces deaths among the trial participants.

  • Prevention of Age-Related Eye Disease Using Vitamins and Minerals
    National Eye Institute (NEI)
    Age-related macular degeneration is the leading cause of vision loss in the United States for people over the age of 60. This nationwide, long-term study sets out to determine whether a modified combination of vitamins and minerals can further slow the progression of vision loss from this disease.

  • Eliminating Trachoma in Northern Ethiopia
    National Eye Institute (NEI)
    Trachoma is a bacterial infection of the eye that is currently the leading cause of preventable blindness worldwide. Trachoma primarily infects children, but its most devastating effects manifest in adulthood. The greatest successes to date have been with controlled antibiotic distribution, which avoids the cultural, political, and economic difficulties presented by effective environmental changes.  In addition to antibiotic trials and surgical intervention trials, the NIH supports studies to test the impact of building latrines and improving hygienic conditions.

  • The ASPIRE HIV Prevention Study
    National Institute of Allergy and Infectious Diseases (NIAID)
    This study, “A Study to Prevent Infection with a Ring for Extended Use,” examines the safety and effectiveness of a vaginal ring for the prevention of HIV infections in women. The trial will be launched at several sites in Africa and will enroll approximately 3500 women. If successful, this vaginal ring, which contains the antiretroviral dapivirine, can be used for HIV prevention.

  • The VOICE HIV Prevention Study
    National Institute of Allergy and Infectious Diseases (NIAID)
    This study, “Vaginal and Oral Interventions to Control the Epidemic,” was designed to evaluate the safety and effectiveness of two antiretroviral-based approaches‒daily use of oral tablets and daily use of a vaginal gel‒for preventing sexual transmission of HIV in 5,000 women. This trial also sets out to determine which of these women are more likely to apply a vaginal gel every day or take a tablet once a day.