A randomized controlled trial of Native CHOICES: Impact on alcohol-exposed pregnancy risk reduction among American Indian and Alaska Native women

Background: Prevention of alcohol-exposed pregnancy (AEP) involves reducing risky alcohol consumption among women at-risk for pregnancy, using effective contraception among women drinking at risky levels to prevent pregnancy, or both. This study presents the outcomes of a randomized controlled trial assessing the efficacy of Native CHOICES, a culturally tailored adaptation of the CHOICES intervention, among American Indian/Alaska Native (AI/AN) women. Methods: AI/AN women aged 18–44 who were at-risk for an AEP were randomly assigned in a 1:1 ratio to either the Native CHOICES intervention or a waitlist control group. Native CHOICES comprised two sessions of motivational interviewing and an elective contraception counseling session. Data were collected at baseline, and 6 weeks, 3 months, and 6 months postbaseline. Due to the pandemic, the intervention was at times delivered remotely. Results: A total of 404 women participated: 199 in the control group and 205 in the intervention group. Sixty-seven percent of the intervention group received the intervention in-person, and 33% participated by telephone or video call. Sixty-four percent of women completed all follow-up visits. At the six-month follow-up, the intervention did not demonstrate a significant impact on AEP risk compared with the control arm when analyzing all the data (RR = 0.94; 95% confidence interval [CI]: 0.83–1.07). However, an exploratory subgroup analysis showed evidence of a reduction in AEP risk among participants who completed the study in-person before the COVID-19 pandemic (RR = 0.79; 95% CI: 0.63–0.98), which was not observed during or after the pandemic (RR = 1.06; 95% CI: 0.91–1.24). Conclusions: The Native CHOICES intervention did not show evidence of effectiveness overall. However, exploratory analyses offer some evidence that the intervention was effective prior to the pandemic.