Findings:
This study presents baseline data analysis from a planned trauma-informed intervention trial, involving 104 women living with HIV (WLHIV) and receiving care in an HIV ambulatory care clinic in San Francisco. The association of trauma with health outcomes is examined and implications for interventions to improve outcomes are considered. A large majority of participants (97.1%) had experienced lifetime trauma. Rates of current PTSD, depression, anxiety, tobacco use, and drug use were also elevated compared to the general population. The majority (54.8%) of participants scored low on quality of life and 79.5% taking HIV medications had an undetectable viral load. There was a significant association between number of lifetime traumatic events and likelihood of having a depressive disorder, anxiety disorder, PTSD, or substance abuse diagnosis. Trauma was significantly associated with poor quality of life with White women having significantly lower scores compared to women of color. However, White women and older women were more likely to have an undetectable viral load. There was not a significant association between lifetime trauma and having an undetectable viral load.

Strengths and limitations:
The results of this study confirm findings from previous studies that demonstrate high rates of lifetime trauma and its negative effect on physical health and psychosocial functioning among WLHIV. These findings will be used to inform the development of trauma-informed interventions and program design for WLHIV receiving care in an HIV ambulatory care setting. Similarly, findings from a parallel study examining the effect on staff of working with a traumatized population will augment implementation of a trauma-informed approach. Trauma has been studied as a syndemic condition contributing to both HIV acquisition as well as health outcomes. This study’s exclusive focus on women fills a gap in syndemic research in this understudied population. Several measures of trauma were used including lifetime trauma, recent trauma and childhood trauma using the Adverse Childhood Experience (ACE) instrument. This granular examination of trauma will better inform interventions to address specific kinds of traumatic experiences. However, other types of trauma were not included such as racism and having a history of being in foster care or prison. There may have been additional types of trauma that were also not measured. This study’s cross-sectional design limits interpretation of causality. The small sample size and location in an urban setting limits generalizability to rural areas that are deeply affected by HIV.

Relevance:
This study addresses both the national priority to achieve 90% HIV viral load suppression among people living with HIV (PLWH) as well as a central, patient-centered priority to have a better quality of life. It is especially significant that even though most women were taking antiretroviral medications and had an undetectable viral load, the majority reported poor quality of life. The positive association between trauma and depression, anxiety, PTSD, stigma, and alcohol and drug use suggests possible mediating factors as targets for specific interventions that may in turn lead to improved morbidity and mortality. Trauma was significantly negatively associated with taking and adhering to antiretroviral medications which play an essential role along the HIV continuum of care. The negative effect of alcohol and substance use disorders on HIV health outcomes is well-documented. The higher than expected rates of substance use found in this study suggest the need for not only trauma-informed care but also integrated substance use treatment. The study fulfills an unmet need to more deeply understand the role of trauma in health outcomes among WLHIV, an understudied population with a near-universal experience of trauma at some point in their lifetime. The planned intervention study will be the first prospective examination of the effect of trauma-informed care on HIV-related health outcomes.

Type of study: This study was a cross-sectional analysis of baseline data from a planned prospective intervention trial of trauma-informed care in WLHIV.

Findings:
In this double-blind trial testing the efficacy and safety of varenicline, 179 daily smokers living with HIV/AIDS and recruited through a University-based and a community-based HIV ambulatory care clinic were randomized (1:1) to receive a 12 week course of either varenicline or placebo. Participants were taking antiretroviral medications and had an HIV viral load of <1000 copies/ml and CD4+ count of >200 cells/mm. Participants with a self-reported history of psychosis or suicide attempt, or unstable or untreated current alcohol/substance abuse were excluded. Primary outcome measures: Participants in the varenicline arm achieved significantly higher 7-day point prevalence abstinence rates (p=.001) at Week 12 compared to placebo. There was no significant difference in 7-day point prevalence abstinence rates between varenicline vs placebo at Week 24. Secondary outcome measures: Participants in the varenicline arm were significantly more likely to be abstinent at Week 18 (p=.02). Continuous abstinence rates between Weeks 9-12 were significantly greater in the varenicline arm compared to placebo (p=.003). While this positive effect was also evident at Weeks 9-18 (p=0.05), the difference in continuous abstinence rates was no longer significant at Weeks 9-24. There was no significant difference in the number or severity of adverse events, including depression, suicidality, and adverse HIV-related outcomes, between the varenicline and placebo groups.

Strengths and limitations:
This is the first randomized placebo-controlled clinical trial in the U.S. to test varenicline for smoking cessation in PLWH. Only one other similar trial, conducted in France, has been done. Other strengths are as follows: follow-up 12 weeks after completion of the varenicline/placebo trial, verification of abstinence with biochemical, CO, measurement, good retention rates, and the addition of behavioural smoking cessation counselling. The inclusion of reported psychiatric adverse events is especially significant for mental health clinicians. Exclusion of participants with a history of psychosis or a suicide attempt and unstable or untreated substance abuse limits generalizability to these populations. Study recruitment at the start of the study in 2012 had stricter eligibility criteria due to varenicline safety concerns at that time. Thus, the target sample was not reached, and the study was powered for only the primary outcome measures. The inclusion of relative healthy participants who were motivated to quit smoking at one site in the U.S. also limits generalizability to a less healthy population and to other geographic regions. The study may have been limited by adherence rates that were not high enough to demonstrate a statistically significant benefit of varenicline at Week 24.

Relevance:
Study findings are highly relevant for mental health providers caring for PLWH. PLWH have substantially higher rates of tobacco use compared to the general population and smoking is responsible for significant morbidity and mortality in PLWH. “Tobacco cessation among PLWH could save 265,000 life-years, would yield greater life-years saved than hepatitis C treatment or antiretroviral therapy for those with higher CD4+ T-cell counts and can yield health benefits up to 10 years after diagnosis.” Depressive and anxiety disorders, neurocognitive impairment, and other substance use disorders are overrepresented in PLWH. Not identifying or undertreating these mental health conditions may both complicate smoking cessation and adherence to cessation treatments as well as increase the risk of smoking relapse. Additionally, both patients and providers may be hesitant about using varenicline due to concerns about neuropsychiatric adverse effects. Mental health providers are well positioned to address these concerns and to assist PLWH in efforts to quit smoking. They are not only trained in addictions-related psychotherapeutic interventions but may also offer support and guidance about the use of varenicline in psychologically vulnerable PLWH. The findings of this study are consistent with varenicline trials among HIV-negative smokers with serious mental illness.

Type of study: This was a randomized placebo-controlled efficacy and safety trial of varenicline for smoking cessation in PLWH.