Sarah E. Woolf-King, Ph.D. - US grants

DESCRIPTION (provided by applicant): The high prevalence of HIV/AIDS in Tanzania is a critical public health issue. Because heterosexual sex is the predominant route of transmission among this population, one way to prevent the spread of HIV is through the use of a male latex condom. Research has indicated that understanding the influence of alcohol use, gender, relationship power, and partner-type as part of a multifacted network of variables that predict condom use behavior is essential to developing targeted HIV prevention interventions that can effectively reduce the risk of new infections among high-risk populations, such as women in Tanzania. Currently, there is a complete absence of empirical research that addresses the different effects of these factors on men and women's ability to implement condom use, but a testable theory is available. The Theory of Gender and Power (TGP) will be used to generate causal hypotheses about the differential influence of alcohol use, perceived relationship power, and partner-type on men and women's self-reported difficulty implementing condom use. This project has two specific aims. The first is to conduct a formative study to create and validate experimental vignettes that can be used to provide reliable measures of perceived difficulty engaging in condom use under circumstances characterized by (a) the presence or absence of alcohol use, (b) a serious or a casual partner-type, and (c) a situation of low or equal power. The second specific aim is to conduct an experimental study using the previously described vignettes to test hypotheses generated from the TGP. Sexually active men and women from Northern Tanzania will respond to a series of vignettes that manipulate perceived relationship power, partner-type, and presence of alcohol use by indicating how "difficult" in would be to discuss, negotiate, and actually engage in condom use in each scenario. It is expected that women will report that it is most difficult to engage in condom use in situations characterized by the presence of alcohol use, a serious partner-type, and low power. Alternatively, for men, the only variable that will significantly affect difficulty implementing condom use is alcohol, such that it will be more difficult to implement condom use in a scenario where the man had been drinking. Relevance to Public Health: The results from this study will be used to further understanding of condom use behavior among a high-risk, underserved population in Northern Tanzania. This knowledge can be used to enhance the effectiveness of HIV prevention interventions and thereby reduce the incidence of HIV infection in the target population. Finally, this project can be used as a model for experimental work that improves the effectiveness of HIV prevention interventions of other populations in Sub-Saharan Africa.

DESCRIPTION (provided by applicant): Alcohol consumption in sub-Saharan Africa is a major public health concern that has received insufficient attention. The World Health Organization (WHO) estimates that although 70% of adults in sub- Saharan Africa are self-reported abstainers, the 30% who report consuming alcohol have among the highest levels of per capita consumption in the world. The heavy, episodic pattern of consumption that characterizes alcohol use in this region is associated with many negative HIV-related consequences including an increased likelihood of engaging in high risk behavior and a higher cumulative risk of onward transmission among sero-discordant partnerships. The intersection of these two epidemics underscores the urgency of increased research attention and intervention development. Research aimed at understanding how, and in what contexts, alcohol is most likely to result in high risk behavior in sub-Saharan Africa has been dominated by cross-sectional study designs that fail to capture the temporal relationship between alcohol consumption and its subsequent effect on risky behavior. The overall objective of this K01 Career Development Award is to achieve a better understanding of the relationship between event-level alcohol use and high risk behavior among HIV-positive (HIV+) African adults using cell- phone based, daily data collection techniques. The long-term goal of this application is to develop a behavioral HIV prevention intervention targeting alcohol use that can be implemented with HIV+ adults in sub-Saharan Africa and to provide the principal investigator, Dr. Woolf-King, with the skills and training necessary to successfully develop and test the efficacy of this intervention. Dr. Woolf-King is trained as a clinical psychologist with expertise in the use of laboratory-based, alcohol administration studies for determining the causal effect of event-level alcohol intoxication on the behavior of high risk men, college students, and African American adults. Dr. Woolf-King's long-term goal is to become a successful NIH-funded behavioral scientist with international expertise in alcohol's relationship to HIV. She has proposed a combination of didactic and applied research activities, under the mentorship of experts in the field, to provide her with the following skills necessary to accomplish this goal: (1) the design and analysis of longitudinal event-level research, (2) the use of biological data to estimate the accuracy of self-reported behavior, and (3) the development of behavioral HIV prevention intervention development. The proposed research consists of three specific aims and will be conducted in conjunction with Dr. Judy Hahn's ongoing NIH/NIAAA-funded (R01 and U01) cohorts of ART-na¿ve, HIV+ African adults. Aim 1: Enhance our understanding of the event-level association between alcohol consumption and high risk behavior among HIV+ adults in Africa. We will accomplish this aim by: (a) conducting a prospective, event-level study with 100 HIV+ men (n= 50) and women (n =50) who report consuming alcohol in the last three months, (b) assessing the situational and relationship-level aspects of high risk events over a six- week period using interactive voice response (IVR) technology, and (c) using a theory-guided conceptual framework and advanced multilevel modeling to determine the extent to which individual, situational, and relationship-leve variables work together to explain the association between alcohol use and risky behavior. Aim 2: Estimate the accuracy of self-reported high risk behavior using biological data.. We will accomplish this aim by: (a) using a qualitative test for Prostate Specific Antigen (PSA), an indicator of recent (i.e., last 24 hours) semen exposure that can be reliably recovered from self-administered vaginal swabs, (b) comparing these PSA tests to self-report of risky behavior in the last 24 hours, and (c) using women with positive PSA tests to estimate self-report bias. Aim 3: Develop a plan for an intervention targeting alcohol use and high risk behavior that incorporates event-level data collected with IVR. We will accomplish this aim by: (a) conducting brief qualitative exit interviews with a sub-group of participants in the event-level study to assess the feasibility and acceptability of IVR as a self-monitoring device, (b) using an existing alcohol use risk reduction intervention to guide us in translating these self-monitoring data into personalized feedback that highlights the within-person variability in alcohol's relationship to risky behavior and (c) ultimately developing a new brief, patient-centered HIV risk-reduction intervention for high risk, alcohol consuming HIV+ adults in Africa. These research activities will culminate in the submission of an R34 as part of NIAAA's Behavioral and Integrative Treatment Development Program, during the 4th year of the K-award period, to further develop and pilot test the intervention that emerges from these specific aims. This will lead directly to the submission of an R01 to conduct a full Randomized Controlled Trial (RCT) of the intervention to determine its efficacy. The career development and research activities proposed in this K01 application will lay the foundation for Dr. Woolf-King's career as successful, independent, NIH-funded behavioral scientist with the skills to conduct a wide-range of research on alcohol's relationship to the HIV epidemic, both domestically and internationally.

Abstract Alcohol consumption at hazardous levels is associated with negative consequences on nearly every step of the HIV care continuum. It is a critical factor in HIV treatment that, if unaddressed, significantly contributes to onward transmission and poor treatment outcomes. Alcohol interventions for people living with HIV (PLWH) in the United States (US) have shown mixed results, and no alcohol intervention for PLHW has shown long-term reductions in heavy drinking or a significant impact on HIV-related outcomes. One hypothesized reason for this limited success is the failure of these interventions to address the multiple overlapping problems (e.g., co- morbid mental health conditions, behavioral health needs) of PLWH who are hazardous drinkers. Innovative alcohol intervention strategies that can have an impact on these multiple behavioral health needs, in a format that can be feasibly delivered in the context of HIV care, are needed. Brief Acceptance and Commitment Therapy (ACT) is a promising intervention for HIV-infected hazardous drinkers. ACT is a transdiagnostic treatment that uses mindfulness skills and values-guided behavioral action plans to impact a broad array of psychological symptoms. ACT has shown efficacy for treatment of anxiety, depression, chronic pain, and substance use, making it a promising approach for hazardous drinkers. The overall objective of this application is to adapt an existing brief ACT intervention developed for smoking cessation, and pilot test its feasibility and acceptability for PLWH who are hazardous drinkers. We hypothesize that the resulting intervention will be preliminarily associated with decreased alcohol use, improved ART adherence, decreased symptoms of depression, anxiety, and drug use, and increased acceptance?a known mechanism of change in ACT. The specific aims are as follows: Aim 1?we will adapt an existing brief ACT intervention for HIV-infected hazardous drinkers (ACT-AU). We will accomplish this aim by: Modifying a 5-session, telephone-delivered ACT intervention for smoking cessation via iterative multidisciplinary team meetings, focus group discussions with HIV clinic patients (N = 15-20), and qualitative interviews with HIV clinic providers (N = 5-10). Aim 2?we will conduct a pilot comparative effectiveness randomized clinical trial (RCT) of ACT-AU compared to a brief alcohol intervention previously shown to reduce drinking days among HIV-infected women. We will accomplish this aim by: Randomly assigning N = 74 HIV-infected hazardous drinkers (50% women) to the intervention developed in Aim 1, or a brief alcohol intervention similar in length and frequency of treatment sessions. We will assess feasibility, acceptability, and preliminary trial outcomes. Alcohol use and ART adherence will be assessed via both self-report and biomarkers at 6-weeks and 6-months post-randomization; preliminary changes in acceptance as well as symptoms of anxiety and depression, and drug use will also be examined 6- weeks and 3 and 6-months post-randomization. The proposed research will provide essential pilot data for a R01 application to conduct a full-scale RCT to determine the comparative efficacy of ACT-AU.  

Abstract The COVID-19 pandemic has had a significant impact on the mental health and alcohol use of the United States (US) general population, and has disproportionately affected people living with HIV (PLWH). Alcohol consumption and stress are both critical factors in HIV treatment that, if unaddressed, can significantly contribute to onward transmission and poor treatment-related outcomes. Alcohol interventions for PLWH in the US have shown mixed results. One hypothesized reason for this limited success is the failure of these interventions to address the multiple overlapping problems (e.g., co-morbid mental health conditions, stress, behavioral health needs) of PLWH who are hazardous drinkers. Innovative alcohol intervention strategies that can have an impact on these multiple behavioral health needs, in a format that can be feasibly delivered in the context of HIV care, are needed, especially in the context of the COVID-19 pandemic. Brief Acceptance and Commitment Therapy (ACT) is a promising intervention for HIV-infected hazardous drinkers. ACT is a transdiagnostic treatment that uses mindfulness skills and values-guided behavioral action plans to impact a broad array of psychological symptoms. ACT has shown efficacy for treatment of anxiety, depression, chronic pain, and substance use, and is thus a promising approach for PLWH who are hazardous drinkers and coping with additional stress related to the COVID-19 pandemic. We are proposing to expand our ongoing, NIAAA- funded (R34AA026246), pilot RCT of a telephone-delivered ACT intervention for PLWH by applying for an administrative supplement in response to the Notice of Special Interest on Stress Management in Relation to COVID-19 (NOT-AT-20-011). The overall objective of this application is to use the infrastructure of our ongoing pilot RCT (NCT0397406) to collect preliminary data on the level of stress experienced by PLWH during the COVID-19 pandemic, and to determine if participants in the RCT find the stress management techniques in our ACT intervention useful and applicable for the management of COVID-related stress. The specific aims are as follows: Aim 1: Incorporate objective and self-reported measures of stress into the pilot RCT. We will accomplish this aim by: adding general and pandemic-specific self-report measures of stress, and self- collected samples of salivary cortisol to all study visits, including a newly added 12-month follow-up. Aim 2: Determine the feasibility and acceptability of ACT as a telephone-based stress management intervention for PLWH during the COVID-19 pandemic. We will accomplish this aim by modifying our treatment manuals to incorporate COVID-19 related stress, and examining stress-related RCT outcomes by treatment condition. This administrative supplement will provide important information on COVID-related stress among PLWH, and provide data on the feasibility and potential efficacy of telephone-delivered ACT for stress management.