Acceptability, facilitators, and barriers to a hypothetical HIV vaccine in the pre-exposure prophylaxis era.

Little is known about the pre-implementation context for a preventive HIV vaccine. We conducted interviews of individuals in Philadelphia recruited at Penn clinics and community-based organizations serving LGBTQ-identifying persons of color who 1) were cisgender men who had sex with men, or were transgender-identified, 2) had a sexually transmitted infection in the last 12 months, or sex with multiple partners within the last two weeks. We assessed acceptability, facilitators, and barriers to a hypothetical HIV vaccine using an integrated analysis approach. We interviewed 30 individuals between 2/2023-9/2023. Participants were supportive of an HIV vaccine and reported that they would strongly consider receiving one if one became available. Participants contextualized a hypothetical vaccine with the current HIV prevention context, primarily pre-exposure prophylaxis (PrEP), indicating that they would evaluate any future vaccine in comparison to their experience within the PrEP landscape.Reported facilitators for a hypothetical HIV vaccine included vaccine access, knowledge, and understanding; their risk for HIV exposure; and perceived benefits of the vaccine. Barriers included lack of understanding of the purpose of a vaccine, stigma surrounding HIV and sexual practices that may surface towards people who seek vaccination, and potential issues with effectiveness, side effects, or lack of availability.

Assessing Structural Racism and Discrimination Along the Pre-exposure Prophylaxis Continuum: A Systematic Review.

Structural racism and discrimination (SRD) is deeply embedded across U.S. healthcare institutions, but its impact on health outcomes is challenging to assess. The purpose of this systematic literature review is to understand the impact of SRD on pre-exposure prophylaxis (PrEP) care continuum outcomes across U.S. populations who could benefit from HIV prevention. Guided by PRISMA guidelines, we conducted a systematic review of the published literature up to September 2023 using PubMed and PsycInfo and included peer-reviewed articles meeting inclusion criteria. At least two authors independently screened studies, performed quality assessments, and abstracted data relevant to the topic. Exposure variables included race/ethnicity and any level of SRD (interpersonal, intra- and extra-organizational SRD). Outcomes consisted of any steps of the PrEP care continuum. A total of 66 studies met inclusion criteria and demonstrated the negative impact of SRD on the PrEP care continuum. At the interpersonal level, medical mistrust (i.e., lack of trust in medical organizations and professionals rooted from current or historical practices of discrimination) was negatively associated with almost all the steps across the PrEP care continuum: individuals with medical mistrust were less likely to have PrEP knowledge, adhere to PrEP care, and be retained in care. At the intra-organizational level, PrEP prescription was lower for Black patients due to healthcare provider perception of higher sex-risk behaviors. At the extra-organizational level, factors such as homelessness, low socioeconomic status, and incarceration were associated with decreased PrEP uptake. On the other hand, healthcare provider trust, higher patient education, and access to health insurance were associated with increased PrEP use and retention in care. In addition, analyses using race/ethnicity as an exposure did not consistently show associations with PrEP continuum outcomes. We found that SRD has a negative impact at all steps of the PrEP care continuum. Our results suggest that when assessing the effects of race/ethnicity without the context of SRD, certain relationships and associations are missed. Addressing multi-level barriers related to SRD are needed to reduce HIV transmission and promote health equity.

Strategies to improve outcomes of youth experiencing healthcare transition from pediatric to adult HIV care in a large U.S. city.

BACKGROUND: The healthcare transition (HCT) from pediatric to adult HIV care can be disruptive to HIV care engagement and viral suppression for youth living with HIV (YLH). METHODS: We performed qualitative interviews with 20 YLH who experienced HCT and with 20 multidisciplinary pediatric and adult HIV clinicians to assess and rank barriers and facilitators to HCT and obtain their perspectives on strategies to improve the HCT process. We used the Exploration Preparation Implementation Sustainment Framework to guide this qualitative inquiry. RESULTS: The most impactful barriers identified by YLH and clinicians focused on issues affecting the patient-clinician relationship, including building trust, and accessibility of clinicians. Both groups reported that having to leave the pediatric team was a significant barrier (ranked #1 for clinicians and #2 for YLH). The most impactful facilitator included having a social worker or case manager to navigate the HCT (listed #1 by clinicians and #2 by YLH); case managers were also identified as the individual most suited to support HCT. While YLH reported difficulty building trust with their new clinician as their #1 barrier, they also ranked the trust they ultimately built with a new clinician as their #1 facilitator. Factors reported to bridge pediatric and adult care included providing a warm handoff, medical record transfer, developing relationships between pediatric clinics and a network of youth-friendly adult clinics, and having the pediatric case manager attend the first adult appointment. Longer new patient visits, increased health communication between YLH and clinicians and sharing vetted clinician profiles with YLH were identified as innovative strategies. CONCLUSION: In this multi-disciplinary contextual inquiry, we have identified several determinants that may be targeted to improve HCT for YLH.

Integrating ART adherence support technologies in the care of pregnant and postpartum people with HIV: a qualitative study.

BACKGROUND: We have a limited understanding on how to best integrate technologies to support antiretroviral therapy (ART) adherence in routine HIV care. METHODS: We conducted semi-structured interviews with multidisciplinary providers caring for pregnant and postpartum people with HIV and asked providers about their perspectives on utilizing adherence support technologies such as text messages, video check-ins with providers or automated with facial recognition for directly-observed-therapy, signaling pill bottle, and signaling pill to support ART adherence. Each approach generated an adherence report. The interview instrument was guided by the Consolidated Framework for Implementation Research and included questions on the implementation climate, barriers, and facilitators to the clinical integration of the adherence approach and strategies that could be used to maximize this integration. The order of adherence support technologies was randomized to minimize bias. We used a modified grounded theory to develop the coding structure and two coders applied the codebook to the transcripts after establishing strong inter-rater reliability with 20% of interviews (kappa = 0.82). RESULTS: Between March and December 2020, we conducted 26 in-depth, semi-structured interviews with providers who weighed several factors when considering each approach, including the approach's effect on patient-provider interaction in and outside of the clinic visit, timing for and duration of the approach's utility, threat of disclosing status, and added burden to providers (e.g., needing to act on generated information) or to patients (e.g., needing to hide the signaling pills, responding to text messages). Providers' most preferred approach was text-messages, and the least preferred was the signaling pill. Barriers to acceptability varied by approach and included perceived surveillance, violation of privacy, added time demand for providers, potential inaccuracy of the adherence data generated, and negative impact on the patient-provider relationship, particularly if the approach was perceived as coercive. Payers anticipated regulatory hurdles with unfamiliar approaches, particularly the signaling pill and signaling pill bottle. Facilitators included strengthened therapeutic alliance, predictable reminder mechanisms, and options for customization according to patient preference. CONCLUSIONS: Our study elucidates barriers and facilitators to integrating technology-based adherence support approaches in clinical care to support adherence of pregnant and postpartum people with HIV.

Preexposure Prophylaxis Acceptability Among Pregnant Individuals and Implications for Human Immunodeficiency Virus Prevention.

OBJECTIVE: To understand perspectives on and preferences for preexposure prophylaxis (PrEP) for pregnant individuals who are at risk for human immunodeficiency virus (HIV) infection. METHODS: In this qualitative study, we purposively sampled and conducted in-depth interviews with pregnant participants at risk of HIV infection (indicated by a recent sexually transmitted infection [STI]) from a U.S. urban obstetrics clinic. Interview questions focused on perceived HIV risk, knowledge and perceptions of PrEP, and preferences for different PrEP formulations. We coded data using deductive and inductive codes, created matrices to explore patterns in findings, and wrote memos to interpret emergent themes. RESULTS: Twenty patients were enrolled. Median age of the participants was 24 years (interquartile range 19-26 years), 95.0% were African American, 65.0% were high school graduates, and 70.0% had unplanned pregnancies. Participants had low knowledge of PrEP and most saw themselves at low to no risk of HIV acquisition, despite their recent STI. Further, participants' low HIV risk perception and medication safety concerns reduced PrEP acceptability. Moreover, very few had discussed PrEP with their obstetrician-gynecologists (ob-gyns) during antenatal care, which further affected perceived acceptability. However, participants who did discuss PrEP with their ob-gyns had favorable perceptions of it. These participants indicated that they would choose a formulation based on individual preferences, which were largely shaped by perceived ease of use, acceptability, and prior experience with other medication regimens. CONCLUSION: Obstetrician-gynecologists may play an important role in increasing pregnant individuals' knowledge of and access to PrEP during pregnancy among those who are at risk of HIV acquisition. To maximize uptake and adherence during this time, PrEP formulations should be tailored to individual preferences. Prevention of HIV during this critical life transition is important not only for the long-term health and well-being of pregnant individuals and their infants, but to the plan to end the HIV epidemic in the United States by 2030.

Outcome expectancies toward adherence to antiretroviral therapy for pregnant and postpartum women with HIV.

OBJECTIVES: Adherence to antiretroviral therapy and retention in care significantly drop for women with HIV during the postpartum period. We have a limited understanding of how outcome expectancies influence maternal adherence and retention in care. METHODS: Women with HIV from an urban academic clinic completed in-depth interviews in the third trimester and at 3 to 9 months postpartum to evaluate outcome expectancies, facilitators, and barriers to antiretroviral therapy adherence and retention in care. Interviews were audio-recorded and analyzed for content. A codebook was created using deductive (based on the theory of reasoned action approach) and inductive (based on emergent themes) codes. RESULTS: We conducted 21 interviews with 12 women during pregnancy and 9 women during postpartum period. Participants had a mean age of 31 (standard deviation = 5.7) and most were African American (75%). Outcome expectancies centered mostly around pediatric health to prevent perinatal transmission of HIV and to be healthy to raise their children. Other outcome expectancies included preventing transmission of HIV to their partners. Social support from partners served as a strong facilitator as they helped routinize pill-taking behaviors, provided reminders, and decreased social isolation. Barriers to antiretroviral therapy adherence included depression, the disruption of scheduling routines, and the physical demands associated with the postpartum period. These barriers were accentuated for women with multiple children. CONCLUSION: Women's commitment to pediatric health was the primary motive for antiretroviral therapy adherence. Partners also served an important role. These findings suggest that interventions linking pediatric and maternal health, and partner support can improve maternal HIV treatment in the postpartum period.

Racial/Ethnic Differences in COVID-19 Vaccine Hesitancy Among Health Care Workers in 2 Large Academic Hospitals.

IMPORTANCE: Significant differences in hesitancy to receive COVID-19 vaccination by race/ethnicity have been observed in several settings. Racial/ethnic differences in COVID-19 vaccine hesitancy among health care workers (HCWs), who face occupational and community exposure to COVID-19, have not been well described. OBJECTIVE: To assess hesitancy to COVID-19 vaccination among HCWs across different racial/ethnic groups and assess factors associated with vaccine hesitancy. DESIGN, SETTING, AND PARTICIPANTS: This survey study was conducted among HCWs from 2 large academic hospitals (ie, a children's hospital and an adult hospital) over a 3-week period in November and December 2020. Eligible participants were HCWs with and without direct patient contact. A 3-step hierarchical multivariable logistic regression was used to evaluate associations between race/ethnicity and vaccine hesitancy controlling for demographic characteristics, employment characteristics, COVID-19 exposure risk, and being up to date with routine vaccinations. Data were analyzed from February through March 2021. MAIN OUTCOMES AND MEASURES: Vaccine hesitancy, defined as not planning on, being unsure about, or planning to delay vaccination, served as the outcome. RESULTS: Among 34 865 HCWs eligible for this study, 12 034 individuals (34.5%) completed the survey and 10 871 individuals (32.2%) completed the survey and reported their race/ethnicity. Among 10 866 of these HCWs with data on sex, 8362 individuals (76.9%) were women, and among 10 833 HCWs with age data, 5923 individuals (54.5%) were younger than age 40 years. (Percentages for demographic and clinical characteristics are among the number of respondents for each type of question.) There were 8388 White individuals (77.2%), 882 Black individuals (8.1%), 845 Asian individuals (7.8%), and 449 individuals with other or mixed race/ethnicity (4.1%), and there were 307 Hispanic or Latino individuals (2.8%). Vaccine hesitancy was highest among Black HCWs (732 individuals [83.0%]) and Hispanic or Latino HCWs (195 individuals [63.5%]) (P < .001). Among 5440 HCWs with vaccine hesitancy, reasons given for hesitancy included concerns about side effects (4737 individuals [87.1%]), newness of the vaccine (4306 individuals [79.2%]), and lack of vaccine knowledge (4091 individuals [75.2%]). The adjusted odds ratio (aOR) for vaccine hesitancy was 4.98 (95% CI, 4.11-6.03) among Black HCWs, 2.10 (95% CI, 1.63-2.70) among Hispanic or Latino HCWs, 1.48 (95% CI, 1.21-1.82) among HCWs with other or mixed race/ethnicity, and 1.47 (95% CI, 1.26-1.71) among Asian HCWs compared with White HCWs (P < .001). The aOR was decreased among Black HCWs when adjusting for employment characteristics and COVID-19 exposure risk (aOR, 4.87; 95% CI, 3.96-6.00; P < .001) and being up to date with prior vaccines (aOR, 4.48; 95% CI, 3.62-5.53; P < .001) but not among HCWs with other racial/ethnic backgrounds. CONCLUSIONS AND RELEVANCE: This study found that vaccine hesitancy before the authorization of the COVID-19 vaccine was increased among Black, Hispanic or Latino, and Asian HCWs compared with White HCWs. These findings suggest that interventions focused on addressing vaccine hesitancy among HCWs are needed.

Understanding Drivers of Coronavirus Disease 2019 Vaccine Hesitancy Among Blacks.

BACKGROUND: Coronavirus disease 2019 (COVID-19) has disproportionately affected communities of color, with black persons experiencing the highest rates of disease severity and mortality. A vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has the potential to reduce the race mortality gap from COVID-19; however, hesitancy toward the vaccine in the black community threatens vaccine uptake. METHODS: We conducted focus groups with black barbershop and salon owners living in zip codes of elevated COVID-19 prevalence to assess their attitudes, beliefs, and norms around a COVID-19 vaccine. We used a modified grounded theory approach to analyze the transcripts. RESULTS: We completed 4 focus groups (N = 24 participants) in July and August 2020. Participants were an average age of 46 years, and 89% were black non-Hispanic. Hesitancy against the COVID-19 vaccine was high due to mistrust in the medical establishment, concerns with the accelerated timeline for vaccine development, limited data on short- and long-term side effects, and the political environment promoting racial injustice. Some participants were willing to consider the vaccine once the safety profile is robust and reassuring. Receiving a recommendation to take the vaccine from a trusted healthcare provider served as a facilitator. Health beliefs identified were similar to concerns around other vaccines and included the fear of getting the infection with vaccination and preferring to improve one's baseline physical health through alternative therapies. CONCLUSIONS: We found that hesitancy of receiving the COVID-19 vaccine was high; however, provider recommendation and transparency around the safety profile might help reduce this hesitancy.

HIV Pre-Exposure Prophylaxis for Conception Among HIV Serodiscordant Couples in the United States: A Cohort Study.

Practice guidelines on pre-exposure prophylaxis (PrEP) for HIV serodiscordant couples recommend PrEP when the viral load of the partner living with HIV is either detectable or unknown. However, adherence to combination antiretroviral therapy is inconsistent, and research has found that individuals vulnerable to HIV place value on additional protective barriers. We conducted a prospective cohort study to assess the feasibility, perceptions, and adherence associated with periconceptional PrEP use among females without HIV and their male partners living with HIV across four academic medical centers in the United States. We performed descriptive statistics, McNemar's test of marginal homogeneity to assess discordance in female/male survey responses, and Spearman's correlation to determine associations between dried blood spot levels and female self-reported adherence to PrEP. We enrolled 25 women without HIV and 24 men living with HIV (one male partner did not consent to the study). Women took PrEP for a median of 10.9 months (interquartile range 3.8-12.0) and were generally adherent. In total, 87% of women (20/23) had a dried blood spot with >700 fmol/punch or ≥4 doses/week, 4% (1/23) at 350-699 fmol/punch or 2-3 doses/week, and 9% (2/23) at <350 fmol/punch or <2 doses/week (correlation between drug levels and adherence is based on prior data). Dried blood spot levels closely aligned with self-reported adherence (Spearman's rho = 0.64, p = 0.001). There were 10 pregnancies among 8 participants, 4 of which resulted in spontaneous abortions. There was one preterm delivery (36 5/7 weeks), no congenital abnormalities, and no HIV transmissions. Ten couples (40%) were either lost to follow-up or ended the study early. Overall, women attempting conception with male partners living with HIV in the United States are interested and able to adhere to PrEP as an additional tool for safer conception.

Assessing the Acceptability of a Peer Mentor Mother Intervention to Improve Retention in Care of Postpartum Women Living with HIV.

Background: Many women living with HIV (WLWH) experience poor postpartum retention in HIV care. There are limited evidence-based interventions in the United States aimed at increasing retention of WLWH postpartum; however, evidence from low-resource settings suggest that women who receive peer mentoring experience higher retention and viral suppression postpartum. Methods: We conducted 15 semistructured interviews with pregnant or postpartum women from an urban U.S. clinic to assess factors influencing maternal adherence to antiretroviral therapy (ART) and retention in HIV care. We then assessed the acceptability of a peer intervention in mitigating barriers to sustain adherence and retention in care postpartum. Interviews were audio taped, transcribed, and analyzed. Codes were developed and applied to all transcripts, and matrices were used to facilitate comparisons across different types of participants. Results: Participants included low-income black and Hispanic women with a mean age of 31 years (range 22-42). Social support and concern for infants' well-being were strong facilitators for engaging in care. Psychosocial challenges, such as stigma and isolation, fear of disclosure, and depression, negatively influenced adherence to ART and engagement in care. Regardless of their level of adherence to ART, women felt that peer mentoring would be an acceptable intervention to reinforce skill-related ART adherence and sustain engagement in care after delivery. Conclusion: A peer mentor mother program is a promising intervention that can improve the care continuum of pregnant and postpartum women in the United States. Messaging that maximizes maternal support and women's motivation to keep their infant healthy may leverage retention in care postpartum.

Evaluating outcomes of mother-infant pairs using dolutegravir for HIV treatment during pregnancy.

OBJECTIVES: Dolutegravir (DTG), a second-generation integrase inhibitor, is an effective treatment for HIV but its safety and efficacy are not well established in pregnancy. Here, we assess maternal and infant outcomes of mother-infant pairs using DTG-containing regimens during pregnancy. METHODS: We performed a retrospective cohort analysis of pregnant women with HIV on DTG from two urban clinics in the United States, 2015-2018. Maternal outcomes included viral suppression (viral load of <20 copies/ml prior to delivery), development of resistance, and tolerability to DTG. Infant outcomes included preterm delivery (birth at <37 weeks), small for gestational age (SGA, weight <10th percentile), infant HIV status at birth, birth defect(s), and Appearance, Pulse, Grimace, Activity, Respiration (APGAR) scores. We performed a trend analysis to assess DTG use over time. RESULTS: A total of 66 women used DTG during pregnancy and the proportion on DTG increased each year: in 2015, 8% (5/60) of women were on DTG, versus 22% (15/67) in 2016, 42% (30/71) in 2017, and 59% (16/27) in 2018 (P < 0.05). Among women who delivered (n = 57), 77.2% were undetectable at delivery. There were no drug resistance and no reported side effects during pregnancy. Infants had a mean APGAR score of 8 (SD 1.5) at 1 min and 9 (SD 0.8) at 5 min; 31.6% were born prematurely and 15.8% were SGA, and 2 infants had a birth defect. No cases of HIV transmission occurred. CONCLUSION: Our findings suggest that DTG can be an effective treatment during pregnancy. Infant outcomes (preterm deliveries and birth defects) need to be investigated in larger studies.

Improving postpartum retention in care for women living with HIV in the United States.

: Research findings have consistently demonstrated that women living with HIV in the United States and globally experience declines in medication adherence and retention in care after giving birth. A number of studies have identified factors associated with postpartum retention in care, but the evidence base for interventions to address the problem and close this gap in the HIV care continuum is limited. Furthermore, the majority of studies have been conducted in low-resource or moderate-resource countries and may be less applicable or require adaptation for use in high resource countries. In the United States, up to two-thirds of women drop out of care after delivery and are unable to maintain or achieve viral suppression postpartum, at a time when maternal and pediatric health are closely linked. We conducted a critical review of the literature to identify existing gaps regarding maternal retention in the United States and conceptualize the problem through the lens of the integrated and ecological models of health behavior. This review describes existing barriers and facilitators to retention in HIV care postpartum from published studies and suggests steps that can be taken, using a multilevel approach, to improve maternal retention. We propose five core action steps related to increasing awareness of the problem of poor postpartum retention, addressing needs for improved care coordination and case management, and using novel approaches to adapt and implement peer support and technology-based interventions to improve postpartum retention and clinical outcomes of women living with HIV.