Increasing pre-exposure prophylaxis (PrEP) in primary care: A study protocol for a multi-level intervention using the multiphase optimization strategy (MOST) framework.

BACKGROUND: In the United States, over 1.2 million people are living with HIV. This disease disproportionately affects men who have sex with men (MSM), people of color, youth and young adults, and transgender individuals. Pre-exposure prophylaxis (PrEP) is an effective HIV prevention method. Barriers exist for both primary care providers (PCPs) to prescribe PrEP and prevent patients from initiating PrEP. METHODS: This study, MOST: PrEP, follows the multiphase optimization strategy (MOST) framework. The purpose is to identify a multi-level intervention among patients and PCPs to increase PrEP prescriptions in primary care. First, feedback will be obtained from providers and patients via focus groups, then, suggestions related to the context-specific (provider and individual level) factors of intervention component delivery will be incorporated. Subsequently, a rigorous experiment will be conducted using a 24 factorial design focusing on priority populations for PrEP initiation. Provider components include computer-based simulation training and a best practice alert. Patient components include a tailored PrEP educational video and HIV risk assessment. Finally, the facilitators and barriers to implementing the intervention components will be qualitatively examined. CONCLUSION: In this protocol paper, we describe the one of the first known multilevel MOST optimization trial in healthcare. Intervention components are to be delivered to patients and providers in a large healthcare system, based in an HIV Ending the Epidemic priority jurisdiction. If effective, this multi-level approach could be disseminated to providers and patients in other large healthcare systems to make a significant impact on HIV prevention.

Effects of Two Group Prenatal Care Interventions on Mental Health: An RCT.

INTRODUCTION: Perinatal depression and anxiety cost the U.S. health system $102 million annually and result in adverse health outcomes. Research supports that cognitive behavioral therapy improves these conditions, but barriers to obtaining cognitive behavioral therapy have prevented its success in pregnant individuals. In this study, the impact of a cognitive behavioral therapy-based intervention on anxiety, depression, stress, healthy lifestyle beliefs, and behaviors in pregnant people was examined. STUDY DESIGN: This study used a 2-arm RCT design, embedded in group prenatal care, with one arm receiving a cognitive behavioral therapy-based Creating Opportunities for Personal Empowerment program and the other receiving health promotion content. SETTING/PARTICIPANTS: Black and Hispanic participants (n=299) receiving prenatal care from 2018 to 2022 in New York and Ohio who screened high on 1 of 3 mental health measures were eligible to participate. INTERVENTION: Participants were randomized into the manualized Creating Opportunities for Personal Empowerment cognitive behavioral therapy-based program, with cognitive behavioral skill-building activities delivered by advanced practice nurses in the obstetrical setting. MAIN OUTCOME MEASURES: Outcomes included anxiety, depression, and stress symptoms using valid and reliable tools (Generalized Anxiety Disorder scale, Edinburgh Postnatal Depression Scale, and Perceived Stress Scale). The Healthy Lifestyle Beliefs and Behaviors Scales examined beliefs about maintaining a healthy lifestyle and reported healthy behaviors. RESULTS: There were no statistically significant differences between groups in anxiety, depression, stress, healthy beliefs, and behaviors. There were significant improvements in all measures over time. There were statistically significant decreases in anxiety, depression, and stress from baseline to intervention end, whereas healthy beliefs and behaviors significantly increased. CONCLUSIONS: Both cognitive behavioral therapy and health promotion content embedded in group prenatal care with advanced practice nurse delivery improved mental health and healthy lifestyle beliefs and behaviors at a time when perinatal mood generally worsens. TRIAL REGISTRATION: This study is registered with clinicaltrials.gov NCT03416010.

A randomized controlled trial of a tailored navigation intervention to promote breast and cervical cancer screening among intergenerational Southeast Asian women.

Background: Cancer is the leading cause of death for Southeast Asian women in the U.S. Southeast Asian women have significantly high rates of breast and cervical cancers, yet are least likely to obtain regular mammography and Pap testing of all racial/ethnic groups in the U.S. Objectives: The purpose of this study is to compare a tailored navigation intervention delivered by bilingual and bicultural Community Health Advisors to information and reminder only to increase age-appropriate breast and cervical cancer screening completion among Southeast Asian women. Methods: The Southeast Asian Women's Health Project study will enroll 232 Cambodian, Filipino, Lao, and Vietnamese women who are not up to date with their breast and cervical cancer screenings. Women randomized to navigation will receive the intervention for 10 weeks. Women in the information group will be mailed information on mammography and Pap testing only. All participants will be contacted post-enrollment to assess screening completion. Discussion: We will examine intervention efficacy, predictors of each intervention group, and the influence of intergenerational exchange of breast and cervical cancer screening information between mothers and daughters. We will disseminate study results locally to the community, nationally at conferences, and through peer-reviewed journals.