In June 2006, a randomized, controlled trial was launched to assess the effectiveness of the HIP program in five prenatal clinics in the San Francisco Bay Area. Participants were English-speaking women 18 years or older, less than 26-weeks pregnant, and receiving prenatal care at one of the participating clinics. The participants represent a convenience sample; they were the eligible pregnant women present in the clinics’ waiting rooms on the days (and hours) when the research assistants were at that specific site. Using a laptop computer in a private examination room, participants completed a risk assessment immediately prior to a regularly scheduled prenatal appointment. After the appointment, they completed a brief post-interview. The computer program collected demographics (including race/ethnicity) and screened for tobacco, alcohol, and drug use, and for IPV. Smoking within the previous 30 days was assessed by five questions drawn from the California Adult Tobacco Survey.24
Alcohol and drug use were assessed using tools adapted from previously published works by Mullen et al.25
and Chasnoff et al.,26
respectively. Items assessing current physical or sexual violence were adapted from the Abuse Assessment Screen,27
and inquired about violence in the year before the pregnancy and the interval since the pregnancy began. Women reporting risks were stratified by risk combination (one of 15 possible combinations of the four risky behaviors) and assigned by the computer to intervention or control groups in blocks of one, ensuring equivalent numbers of intervention and control participants for each risk combination. The post-interview assessed the occurrence of any discussions about risks in the just-completed prenatal appointment, how helpful they were to the patient, and the acceptability of the HIP program. Helpfulness was measured on a four-point scale (very helpful, helpful, not very helpful, not helpful at all). Acceptability of the program included several items, such as how much they liked using the computer program (liked very much, liked, didn’t like, didn’t like at all), how easy it was (very easy, somewhat easy, somewhat hard, very hard), and if they would have liked any more privacy (much more privacy, more privacy, enough privacy as is).
The intervention included a summary “cueing sheet” for the provider (). The cueing sheet was attached to the medical record for the provider’s use in the appointment, summarized the participant’s risk profile, and suggested possible counseling statements. All providers received a brief orientation to the use of the cueing sheets. Participants assigned to the control group completed the risk assessment and post-interview, and received the clinic’s usual care.
Discussions of risks were compared by group assignment among participants reporting IPV or smoking, with p-values obtained by Fisher’s exact tests.
All participants received a $30 gift card to a grocery or department store as compensation for completing a session. All study procedures were approved by the University of California San Francisco’s Committee on Human Research in 2006, and are under continuing review.