Clinical Trial Participation Reduces Alcohol Intake, Improves HIV Outcomes in Women Regardless of Treatment Type

For women with unhealthy alcohol use, participating in a randomized controlled trial to cut alcohol use also produces positive spillover effects on HIV outcomes, according to study findings.

For women who drink more than 7 drinks per week or more than 3 drinks per occasion, study participation helped them improve viral suppression. Typically, women are less likely to achieve viral suppression than men, and unhealthy alcohol use further widens this disparity by worsening medication adherence, thus lowering rates of viral suppression and escalating disease progression.

Interestingly, participating in the trial significantly reduced drinking habits regardless of medication assignment. Of the 194 women participating in the study, 96 took daily oral naltrexone and the other 98 took placebo. After 4 months, reductions in drinking were comparable, leading the researchers to suggest that nonmedication aspects of studies, such as repeated assessments and support from research staff, can be critical interventions for reducing drinking outside of studies.

“The fact that women receiving placebo did so well is striking,” expressed the researchers.

At the beginning of the study, all women met criteria for unhealthy alcohol use and 62% met criteria for alcohol use disorder. “Only about 50% of women reported ongoing unhealthy alcohol use at 4 months, and the proportion with unhealthy alcohol use continued to drop even after medication was stopped,” noted the researchers, adding that at 7 months, 64% of the women had reduced or quit drinking.

At first, naltrexone demonstrated a greater reduction in drinking compared with placebo; however, after 4 months, there was no difference between the 2 groups.

The behavior change also resulted in benefits to HIV outcomes. Approximately two-thirds (63%) of the women had viral suppression when they enrolled in the study between 2013 and 2016. After 7 months, 74% of the women who had reduced or quit drinking achieved viral suppression compared with 54% of those who did not cut down on their alcohol use.

Reference

Cook R, Zhou Z, Miguez M, et al. Reduction in drinking associated with improved clinical outcomes in women with HIV infection and unhealthy alcohol use: results from a randomized clinical trial of oral naltrexone versus placebo [published online July 10, 2019]. Alcohol Clin Exp Res. doi: 10.1111/acer.14130.