Impact of a Multi-Institutional Initiative to Engage Students and Early-Stage Scholars From Underrepresented Racial and Ethnic Minority Groups in HIV Research: The Centers for AIDS Research Diversity, Equity, and Inclusion Pathway Initiative.

BACKGROUND: The Centers for AIDS Research Diversity, Equity, and Inclusion Pathway Initiative (CDEIPI) aims to establish programs to develop pathways for successful careers in HIV science among scholars from underrepresented racial and ethnic populations. This article describes cross-site evaluation outcomes during the first 18 months (July 2021-December 2022) across 15 programs. METHODS: The aims of the evaluation were to characterize participants, describe feasibility, challenges, and successes of the programs and provide a basis for the generalizability of best practices to Diversity, Equity, and Inclusion (DEI) programs in the United States. Two primary data collection methods were used: a quarterly programmatic monitoring process and a centrally managed, individual-level, participant quantitative and qualitative survey. RESULTS: During the first year of evaluation data collection, 1085 racially and ethnically diverse scholars ranging from the high school to postdoctoral levels applied for CDEIPI programs throughout the United States. Of these, 257 (23.7%) were selected to participate based on program capacity and applicant qualifications. Participants were trained by 149 mentors, teachers, and staff. Of the N = 95 participants responding to the individual-level survey, 95.7% agreed or strongly agreed with statements of satisfaction with the program, 96.8% planned to pursue further education, and 73.7% attributed increased interest in a variety of HIV science topics to the program. Qualitative findings suggest strong associations between mentorship, exposure to scientific content, and positive outcomes. CONCLUSIONS: These data provide evidence to support the feasibility and impact of novel DEI programs in HIV research to engage and encourage racially and ethnically diverse scholars to pursue careers in HIV science.

Centers for AIDS Research (CFAR) Diversity, Equity, and Inclusion Pathway Initiative (CDEIPI): Developing Career Pathways for Early-Stage Scholars From Racial and Ethnic Groups Underrepresented in HIV Science and Medicine.

BACKGROUND: There is an urgent need to increase diversity among scientific investigators in the HIV research field to be more reflective of communities highly affected by the HIV epidemic. Thus, it is critical to promote the inclusion and advancement of early-stage scholars from racial and ethnic groups underrepresented in HIV science and medicine. METHODS: To widen the HIV research career pathway for early-stage scholars from underrepresented minority groups, the National Institutes of Health supported the development of the Centers for AIDS Research (CFAR) Diversity, Equity, and Inclusion Pathway Initiative (CDEIPI). This program was created through partnerships between CFARs and Historically Black Colleges and Universities and other Minority Serving Institutions throughout the United States. RESULTS: Seventeen CFARs and more than 20 Historically Black Colleges and Universities and Minority Serving Institutions have participated in this initiative to date. Programs were designed for the high school (8), undergraduate (13), post baccalaureate (2), graduate (12), and postdoctoral (4) levels. Various pedagogical approaches were used including didactic seminar series, intensive multiday workshops, summer residential programs, and mentored research internship opportunities. During the first 18 months of the initiative, 257 student scholars participated in CDEIPI programs including 150 high school, 73 undergraduate, 3 post baccalaureate, 27 graduate, and 4 postdoctoral students. CONCLUSION: Numerous student scholars from a wide range of educational levels, geographic backgrounds, and racial and ethnic minority groups have engaged in CDEIPI programs. Timely and comprehensive program evaluation data will be critical to support a long-term commitment to this unique training initiative.

Development of an mHealth App to Support the Prevention of Sexually Transmitted Infections Among Black Men Who Have Sex With Men Engaged in Pre-exposure Prophylaxis Care in New Orleans, Louisiana: Qualitative User-Centered Design Study.

BACKGROUND: Sexual health disparities exist for Black men who have sex with men (BMSM) in New Orleans, Louisiana. Rates of sexually transmitted infections (STIs) are high for both BMSM and those taking HIV pre-exposure prophylaxis (PrEP). OBJECTIVE: In this study, we introduced an existing PrEP adherence app to new potential users-BMSM engaged in PrEP care in New Orleans-to guide app adaptation with STI prevention features and tailoring for the local context. METHODS: Using a user-centered design, we conducted 4 focus group discussions (FGDs), with interim app adaptations from December 2020 to March 2021. During the FGDs, a video of the app, app website, and mock-ups were shown to participants. We asked about facilitators of and barriers to STI prevention in general, current app use, impressions of the existing app, new app features to potentially facilitate STI prevention, and how the app should be tailored for BMSM. We used applied qualitative thematic analysis to identify themes and needs of the population. RESULTS: Overall, 4 FGDs were conducted with 24 BMSM taking PrEP. We grouped themes into 4 categories: STI prevention, current app use and preferences, preexisting features and impressions of the prep'd app, and new features and modifications for BMSM. Participants noted concern about STIs and shared that anxiety about some STIs was higher than that for others; some participants shared that since the emergence of PrEP, little thought is given to STIs. However, participants desired STI prevention strategies and suggested prevention methods to implement through the app, including access to resources, educational content, and sex diaries to follow their sexual activity. When discussing app preferences, they emphasized the need for an app to offer relevant features and be easy to use and expressed that some notifications were important to keep users engaged but that they should be limited to avoid notification fatigue. Participants thought that the current app was useful and generally liked the existing features, including the ability to communicate with providers, staff, and each other through the community forum. They had suggestions for modifications for STI prevention, such as the ability to comment on sexual encounters, and for tailoring to the local context, such as depictions of iconic sights from the area. Mental health emerged as an important need to be addressed through the app during discussion of almost all features. Participants also stressed the importance of ensuring privacy and reducing stigma through the app. CONCLUSIONS: A PrEP adherence app was iteratively adapted with feedback from BMSM, resulting in a new app modified for the New Orleans context and with STI prevention features. Participants gave the app a new name, PCheck, to be more discreet. Next steps will assess PCheck use and STI prevention outcomes.

Enhancing Diversity and Inclusion in Clinical Trials.

Women and people from most racial and ethnic groups in the United States have historically been under-represented in clinical trials of investigational medical products. Inadequate representation of these groups may lead to an incomplete understanding of the safety and efficacy of new drugs, devices, biologics, and vaccines, and limit the generalizability of trial findings. As a result, new medical products may not be beneficial to all people who need them, and existing inequities in outcomes among various population groups may remain unchanged or worsen, or new disparities may arise. Although much work has focused on study-level strategies, research organizations must make systemic changes to how clinical trials are envisioned and implemented to achieve sustainable support for diversity and inclusion in clinical trials. The Clinical Trials Transformation Initiative (CTTI) conducted interviews with leaders at institutions that conduct clinical trials to explore perspectives on organizational-level practices that promote diversity and inclusion in clinical trials. Leaders described motivations, such as an ethical and moral imperative; organizational practices, such as staff investment and resource allocation; perceived return on investments, such as better science; and deterrents, such as cost and time. The CTTI also convened an expert meeting to discuss the interview findings and provide guidance. We present the interview findings and expert guidance in a framework that describes four key areas-commitment, partnerships, accountability, and resources-on sustaining organizational-level approaches for improving diversity and inclusion in clinical trials, with the ultimate goal of advancing health equity. Institutions who conduct and support clinical trials should implement organizational-level approaches to improve equitable access and diverse patient participation in clinical trials.

IMPaCT: A Pilot Randomized Trial of an Intervention to Reduce Preterm Birth Among Non-Hispanic Black Patients at High Risk.

Introduction: Preterm birth is a major cause of neonatal morbidity and mortality rate. Non-Hispanic black patients disproportionately experience preterm birth and nonadherence to evidence-based preventive measures. Interventions tailored to non-Hispanic black birthing individuals (NHBBIs) that address barriers to preterm birth preventions are urgently needed. Methods: Together with a community-engaged multidisciplinary stakeholder group, we developed an intervention to improve adherence to preterm birth preventions among black pregnant patients with prior preterm birth. The intervention included the following: (1) preterm birth prevention education, (2) an employment navigation toolkit, and (3) encouragement text messages. We piloted the intervention by recruiting self-identified non-Hispanic black patients at or before 20 weeks of gestation with a prior preterm birth and randomizing them to the intervention or an active control. The primary outcomes were feasibility and acceptability. Our secondary outcomes were preliminary efficacy based on birth outcomes, patient experience, and pregnancy-specific anxiety (PSA). Descriptive statistics, analysis of verbatim survey responses, Wilcoxon signed rank, and Fisher's exact were used to describe and compare quantitative and qualitative data. Results: We identified 53 individuals who met the inclusion criteria, 35 were reachable remotely and 30 were enrolled and randomized. More than 80% (n=26) were retained throughout the study, and 100% of participants identified at least one intervention component as helpful. In this small pilot, there were no detectable differences in adherence to preterm birth preventive recommendations. No difference in preterm births, other pregnancy, or patient experience outcomes was detected between the intervention and active control participants. Discussion: The intervention is feasible and acceptable. Larger, appropriately powered studies are needed to assess whether the intervention will decrease PSA and reduce preterm birth. This trial was registered with ClinicalTrials.gov (NCT04933812).

Racial Disparities in Medication Adherence between African American and Caucasian Patients With Systemic Lupus Erythematosus and Their Associated Factors.

OBJECTIVE: Medication nonadherence is more common in African Americans compared with Caucasians. We examined the racial adherence gaps among patients with systemic lupus erythematosus (SLE) and explored factors associated with nonadherence. METHODS: Cross-sectional data were obtained from consecutive patients prescribed SLE medications seen at an academic lupus clinic between August 2018 and February 2019. Adherence was measured using both self-report and pharmacy refill data. High composite adherence was defined as having both high self-reported adherence and high refill rates. Covariates were patient-provider interaction, patient-reported health status, and clinical factors. We compared adherence rates by race and used race-stratified analyses to identify factors associated with low composite adherence. RESULTS: Among 121 patients (37% Caucasian, 63% African American), the median age was 44 years (range 22-72), 95% were female, 51% had a college education or more, 46% had private insurance, and 38% had high composite adherence. Those with low composite adherence had higher damage scores, patient-reported disease activity scores, and more acute care visits. High composite adherence rate was lower among African Americans compared with Caucasians (30% vs 51%, P = 0.02), and the gap was largest for those taking mycophenolate (26% vs 75%, P = 0.01). Among African Americans, low composite adherence was associated with perceiving fewer "Compassionate respectful" interactions with providers and worse anxiety and negative affect. In contrast, among Caucasians, low composite adherence was only associated with higher SLE medication regimen burden and fibromyalgia pain score. CONCLUSION: Significant racial disparities exist in SLE medication adherence, which likely contributes to racial disparities in SLE outcomes. Interventions may be more effective if tailored by race, such as improving patient-provider interaction and mental health among African Americans.

Assessment of the Perceived Acceptability of an Early Enrollment Strategy Using Advance Consent in Health Care-Associated Pneumonia.

Importance: Better treatment options are needed in life-threatening infections, including health care-associated pneumonia. Enrolling patients in antibacterial clinical trials before diagnosis may circumvent existing time-to-enrollment constraints. However, the acceptability of an early enrollment strategy using advance consent is unknown. Objective: To assess the perceived acceptability of an early enrollment strategy for enrolling patients in an antibacterial clinical trial before a pneumonia diagnosis. Design, Setting, and Participants: This qualitative, descriptive study used semistructured telephone interviews. Framed within a planned noninferiority pneumonia antibiotic trial, an early enrollment strategy was described and perceptions were assessed. Using this strategy, patients give consent to enroll before developing pneumonia, to be monitored by study staff, and to be randomly assigned a study antibiotic if pneumonia develops. All interviews were audiorecorded, transcribed verbatim, and analyzed using applied thematic analysis. Fifty-two key stakeholders from across the United States, including 18 patients at risk of pneumonia, 12 caregivers, 10 representatives of institutional review boards, 7 investigators, and 5 study coordinators, were interviewed from June 20 to August 19, 2016. Main Outcomes and Measures: Perceived acceptability of the early enrollment strategy. Results: Among the 52 stakeholders interviewed (ages 29-75 years; 14 women), patients and caregivers expressed no concerns about patients being approached about participation before developing pneumonia; however, some patients may experience anxiety on learning about their risk for pneumonia. No concerns with study staff accessing patients' medical records were expressed. The clarity of consent information was important for understanding the study rather than having the condition under investigation. Among patients, caregivers, and institutional review board representatives, preferences varied regarding opt-out and precedent autonomy procedures. Nearly all patients would be willing to join a trial using the early enrollment strategy and caregivers would be willing to provide proxy consent. Institutional review board representatives were supportive of the strategy and made recommendations for the study protocol, primarily around informed consent. Investigators and study coordinators believed the strategy would not be burdensome and offered suggestions to ensure its feasibility. Conclusion and Relevance: Results of the study suggest that the early enrollment strategy is acceptable. Future research should evaluate whether the strategy improves enrollment rates in registrational pneumonia trials and in trials of other acute infection syndromes with narrow enrollment windows and/or patients with transient decisional incapacity.

Perceptions of Equipoise, Risk-Benefit Ratios, and "Otherwise Healthy Volunteers" in the Context of Early-Phase HIV Cure Research in the United States: A Qualitative Inquiry.

Early-phase HIV cure research is conducted against a background of highly effective antiretroviral therapy, and involves risky interventions in individuals who enjoy an almost normal life expectancy. To explore perceptions of three ethical topics in the context of HIV cure research-(a) equipoise, (b) risk-benefit ratios, and (c) "otherwise healthy volunteers"-we conducted 36 in-depth interviews (IDIs) with three groups of purposively selected key informants: clinician-researchers ( n = 11), policy-makers and bioethicists ( n = 13), and people living with HIV (PLWHIV; n = 12). Our analysis revealed variability in perceptions of equipoise. Second, most key informants believed there was no clear measure of risk-benefit ratios in HIV cure research, due in part to the complexity of weighing (sometimes unknown) risks to participants and (sometimes speculative) benefits to science and society. Third, most clinician-researchers and policy-makers/bioethicists viewed potential HIV cure study participants as "otherwise healthy volunteers," but this perception was not shared among PLWHIV in our study.

Research on HIV cure: Mapping the ethics landscape.

In an essay, Karine Dubé and coauthors discuss the ethics of preclinical and clinical studies relevant to achieving an HIV cure.

Contraceptive service delivery in Kenya: A qualitative study to identify barriers and preferences among female sex workers and health care providers.

OBJECTIVE: Female sex workers (FSWs) need access to contraceptive services, yet programs often focus on HIV prevention and less on the broader sexual and reproductive health needs of FSWs. We aimed to identify barriers to accessing contraceptive services among FSWs and preferences for contraceptive service delivery options among FSWs and health care providers (HCPs) in order to inform a service delivery intervention to enhance access to and use of contraceptives for FSWs in Kenya. STUDY DESIGN: Twenty focus group discussions were conducted with FSWs and HCPs in central Kenya. RESULTS: Three barriers were identified that limited the ability of FSWs to access contraceptive services: (1) an unsupportive clinic infrastructure, which consisted of obstructive factors such as long wait times, fees, inconvenient operating hours and perceived compulsory HIV testing; (2) discriminatory provider-client interactions, where participants believed negative and differential treatment from female and male staff members impacted FSWs' willingness to seek medical services; and (3) negative partner influences, including both nonpaying and paying partners. Drop-in centers followed by peer educators and health care facilities were identified as preferred service delivery options. CONCLUSIONS: FSWs may not be able to regularly access contraceptive services until interpersonal (male partners) and structural (facilities and providers) barriers are addressed. Alternative delivery options, such as drop-in centers coupled with peer educators, may be an approach worth evaluating. IMPLICATIONS STATEMENT: An unsupportive clinic infrastructure, discriminatory provider-client interactions and negative partner influences are barriers to FSWs accessing the contraception services they need. Alternative service delivery options, such integrating contraceptive service delivery at drop-in centers designed for FSWs and information delivery through peer educators, might provide improved access and better service quality to FSWs seeking contraception.

Perceptions of voluntary medical male circumcision among circumcising and non-circumcising communities in Malawi.

Three randomised controlled trials in Africa indicated that voluntary medical male circumcision (VMMC) is an effective method to reduce a man's risk of becoming infected through sex with an HIV-positive female partner. The success of recent public health initiatives to increase numbers of circumcised men in Malawi has been very limited. We conducted in-depth interviews and focus group discussions (FGDs) with men, women and male adolescents from non-circumcising and circumcising communities in southern Malawi to better understand their beliefs about male circumcision and the promotion of VMMC for HIV prevention. Results revealed that beliefs about male circumcision, in general, are strongly mediated by Malawian culture and history. Participants have attempted to develop a new meaning for circumcision in light of the threat of HIV infection and the publicised risk reduction benefits of VMMC. Several study participants found it difficult to distinguish VMMC from traditional circumcision practices (jando and lupanda), despite awareness that the new form of circumcision was an expression of (western) modern medicine performed largely for public health purposes. Greater recognition of background cultural beliefs and practices could inform future efforts to promote medical male circumcision as an HIV prevention strategy in this context.

Widow cleansing and inheritance among the Luo in Kenya: the need for additional women-centred HIV prevention options.

INTRODUCTION: The customs of widow cleansing and widow inheritance are practiced in several communities throughout sub-Saharan Africa. In the Nyanza Province of Kenya, according to tradition, Luo widows are expected to engage in sexual intercourse with a "cleanser," without the use of a condom, in order to remove the impurity ascribed to her after her husband's death. Luo couples, including widows, are also expected to engage in sex preceding specific agricultural activities, building homes, funerals, weddings, and other significant cultural and social events. Widows who are inherited for the purpose of fulfilling cultural obligation have a higher prevalence of HIV than those who remain un-inherited or are inherited for the purpose of companionship. METHODS: As part of a larger descriptive qualitative study to inform study procedures for FEM-PrEP, an HIV prevention pre-exposure prophylaxis clinical trial, we conducted 15 semi-structured interviews (SSIs) with widows, 15 SSIs with inheritors, and four focus group discussions with widows in the Bondo and Rarieda districts in Nyanza Province to explore the HIV risk context within widow cleansing and inheritance practices. Thematic qualitative analysis was used to analyze the data. RESULTS: The majority of widows reported in the demographic questionnaire being inherited, and most widows in the SSIs described participating in the cleansing ritual. We identified two main themes related to HIV prevention within the context of widow cleansing and inheritance: 1) widows must balance limiting their risk for HIV infection with meeting cultural expectations and ensuring that their livelihood needs are met, and 2) sexual abstinence undermines cultural expectations in widowhood while the use of condoms is deemed inappropriate in fulfilling culturally prescribed sexual rituals, and is often beyond the widow's ability to negotiate. CONCLUSIONS: Women-controlled HIV prevention methods such as antiretroviral-based oral pre-exposure prophylaxis, vaginal gels, and vaginal rings are needed for HIV-negative widows who engage in sexual rituals related to widowhood.

Experimental evaluation of rodent exclusion methods to reduce hantavirus transmission to residents in a Native American community in New Mexico.

We conducted a pilot study to evaluate the efficacy of rodent proofing continuously occupied homes as a method for lowering the risk for hantavirus pulmonary syndrome (HPS) among residents of a Native American community in northwestern New Mexico. Rodent proofing of dwellings was paired with culturally appropriate health education. Seventy homes were randomly assigned to treatment or control categories. Treatment homes were rodent-proofed by sealing openings around foundations, doors, roofs, and pipes and repairing screens and windows. Repairs to each dwelling were limited to $500 US. After repairs were completed, 15-20 snap traps were placed in each treatment and control home and checked approximately every 2 days for an average of 3-4 weeks. During 23,373 trap nights, one house mouse (Mus musculus) was captured in one treatment home, and 20 mice (16 deer mice, Peromyscus maniculatus, two Pinyon mice, Peromyscus truei, and two unidentified mice) were captured in five control homes (one house had 14 captures, two had two captures, and two had one capture). Trap success was 0.01% in treatment homes and 0.15% in controls. Intensity of infestation (mean number of mice captured per infested home) was 1 in treatment homes and 4 in controls. Observations of evidence of infestation (feces, nesting material, gnaw marks, or reports of infestation by occupant) per 100 days of observation were 1.2 in treatment homes and 3.1 in controls. Statistical power of the experiment was limited because it coincided with a period of low rodent abundance (August-November 2000). Nevertheless, these results suggest that inexpensive rodent proofing of occupied rural homes can decrease the frequency and intensity of rodent intrusion, thereby reducing the risk of HPS among rural residents in the southwestern United States.