Approximately 15% to 20% of U.S. women consume alcohol at hazardous levels each year;however women with HIV infection face additional health consequences. In women with HIV infection, hazardous drinking has been associated with nonadherence to medications, risky sexual behavior, and increased disease progression. Despite the documented prevalence and health consequences, there are no data on acceptability or effectiveness of pharmacologic treatment for hazardous drinking in women seen in HIV clinic settings. Thus, there is a critical need to evaluate a treatment program in this population. The primary objective of this application is to evaluate the acceptability and effectiveness of a treatment program that involves oral naltrexone and an accompanying medical management program designed to maximize adherence. The project specific aims are: (1) determine whether an alcohol treatment intervention involving naltrexone can reduce hazardous drinking in HIV-infected women, and (2) determine whether an alcohol treatment program involving naltrexone can improve clinical and behavioral outcomes in HIV-infected women. Our central hypotheses are that women randomized to the treatment program will have decreased rates of hazardous drinking and improved HIV-related outcomes such as medication adherence, disease progression, and risky sexual behavior. The study design is a randomized controlled trial involving 200 HIV-infected women with hazardous drinking, recruited from HIV clinics in Chicago and northern Florida. Women will be randomized to either an intervention group, who will receive a 6-month treatment program, or a control group that will receive similar assessments but will not the treatment. The primary study endpoints will be assessed at 3, 6 and 12-months after enrollment. The proposed work is innovative because: (1) we will target a broad spectrum of hazardous drinking, (2) pharmacologic treatment for alcohol has not been evaluated in HIV-infected women, (3) we will use computers to facilitate assessment and feedback, and (4) we will assess the impact of the alcohol intervention on HIV-related outcomes. The proposed research is significant because the therapy will be offered within HIV clinic settings to a group of persons that is significantly undertreated. In addition to determining the effectiveness of the alcohol treatment intervention, we will also identify key barriers and facilitators associated with adherence to pharmacologic treatment for alcohol in women with hazardous drinking. If our hypotheses are confirmed, the study findings would transform the approach to hazardous drinking within clinics serving HIV-infected women, and could easily be adapted to women with other types of chronic diseases.
This clinical trial of treatment for hazardous drinking in HIV-infected women has significant public health relevance. First, we will demonstrate the ability to improve outcomes related to hazardous drinking efficiently within HIV clinic settings. Second, we will identify factors related to the acceptability and feasibility of pharmacologic treatment in a group of women at increased risk for alcohol-related health outcomes.
| Cook, Robert L; Weber, Kathleen M; Mai, Dao et al. (2017) Acceptability and feasibility of a randomized clinical trial of oral naltrexone vs. placebo for women living with HIV infection: Study design challenges and pilot study results. Contemp Clin Trials 60:72-77 |
| Cook, Robert L; Cook, Christa L; Karki, Manju et al. (2016) Perceived benefits and negative consequences of alcohol consumption in women living with HIV: a qualitative study. BMC Public Health 16:263 |
| Cook, Robert L; Zhu, Fang; Belnap, Bea Herbeck et al. (2013) Alcohol consumption trajectory patterns in adult women with HIV infection. AIDS Behav 17:1705-12 |
