Long-term mediation of a sexual risk-reduction intervention for South African adolescents.

OBJECTIVE: Black adolescents in South Africa are disproportionately affected by HIV. A cluster-randomized controlled experiment examining the effects of a sexual risk-reduction intervention successfully reduced self-reported intercourse and unprotected intercourse. Based on long-term follow-up assessments, the present research examines theoretical constructs that could potentially mediate the intervention effects and how time and gender, respectively, moderated the mediation. METHOD: The behavioral outcome was measured by asking whether participants had had any vaginal sex in the past 3 months. Mediation and moderated mediation were tested based on the 3-, 6-, 12-, 42-, and 54-month postintervention outcomes. RESULTS: Three variables through which the sexual risk-reduction intervention had a significant mediated effect on the behavioral outcome were identified: abstinence career opportunities outcome expectancy (α × ß product = -0.086, 95% asymmetric confidence interval [ACI] [-0.126, -0.047]), expected parental approval of sexual intercourse (α × ß product = -0.061, [-0.102, -0.025]), and self-efficacy to avoid sexual-risk situations (α × ß product = -0.022, [-0.049, -0.001]). The moderated mediation analysis showed that gender moderated the intervention's effects on abstinence prevention outcome expectancy (B = -0.186, SEB = 0.079, p = .019), expected parental approval of sexual intercourse (B = 0.143, SEB = 0.058, p = .013), and self-efficacy to avoid sexual-risk situations (B = -0.293, SEB = 0.112, p = .009). The moderated mediation analysis also revealed that time moderated the effects of the intervention on abstinence career opportunities outcome expectancy (B = -0.293, SEB = 0.106, p = .006), self-efficacy to avoid sexual-risk situations (B = 0.335, SEB = 0.060, p < .001), and cultural myths regarding HIV transmission (B = 0.138, SEB = 0.042, p = .001); and the association between four theoretical constructs and the behavioral outcome: abstinence career opportunities outcome expectancy (B = -0.267, SEB = 0.104, p = .001), self-efficacy to refuse sex (B = -0.132, SEB = 0.043, p = .002), self-efficacy to avoid sexual-risk situations (B = -0.093, SEB = 0.055, p = .009), and HIV risk-reduction knowledge (B = -0.286, SEB = 0.134, p = .003). CONCLUSIONS: The present study identifies theoretical constructs that mediated the intervention effects on the sexual behavior among South African adolescents for an extended period of time. The findings also reveal gender differences in psychological mechanisms initiated by a sexual risk-reduction intervention and the long-term temporal dynamics of the intervention. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Relationship between Veterans Crisis Line risk rating and subsequent suicidal self-directed violence among veteran callers: A gender comparison.

BACKGROUND: Disparities in suicide rates by veteran status are particularly striking for women. Veterans Crisis Line (VCL) is a preventive strategy. OBJECTIVES: Examine the relationships and gender differences between VCL risk rating, and subsequent suicidal self-directed violence (SSDV) in the 12-months following VCL index call. METHODS: Cohort study of VCL callers in 2018. OUTCOMES: Dichotomized composite SSDV (non-fatal suicide event and/or suicide) in the 12 months following VCL call. RESULTS: Veterans with high/moderate VCL risk had significantly higher odds of SSDV (OR = 4.02, 95% CI: 3.75, 4.30). There were no gender/VCL risk interaction (p = 0.3605). We also examined the association of gender, combination of VCL risk and suicide attempt (SA) history, on SSDV. Differential odds of SSDV for gender and combined VCL risk and SA history combinations were observed (p = 0.0005). Compared to those with lower VCL risk without SA history, those with high/moderate VCL risk with SA history showed higher odds of SSDV. Magnitude was higher for men, than for women veterans. CONCLUSIONS AND RELEVANCE: Veterans Crisis Line risk assessment performs relatively stable across the gender binary and highlights potential gender differences when factoring in SA history. Combining risk assessment and attempt history may lead to effective suicide prevention strategies.

Effects of Sugary Beverage Text and Pictorial Warnings: A Randomized Trial.

INTRODUCTION: Multiple U.S. localities have introduced legislation requiring sugar-sweetened beverage (SSB) warnings. This study effects of different warning designs on beverage selections and perceptions. STUDY DESIGN: The study was an RCT. SETTING/PARTICIPANTS: An online virtual convenience store and survey were used with a nationally representative sample of primary caregivers of 6-11-year-olds (n=961). Data were collected in January 2020 and analyzed in May-July 2020. INTERVENTION: Participants were randomized to view SSBs with 1 of 4 front-of-package label designs: (1) no-warning control, (2) health-related text warning, (3) sugar pictorial warning (image of beverage sugar content in cubes/teaspoons/packets with health-related warning text), or (4) health pictorial warning (image of possible health consequences of overconsuming SSBs with health-related warning text). MAIN OUTCOME MEASURES: Outcomes included participants' beverage choice for their child and perceptions of beverages, their assigned labels, and warning policies. RESULTS: Proportionally fewer participants chose a SSB in the sugar pictorial warning condition (-13.4 percentage points; 95% CI= -21.6 to -0.1 percentage points; p=0.007) and in the health pictorial warning condition (-14.7 percentage points; 95% CI= -22.8 to -0.1 percentage points; p=0.004) compared to the control. Sugar pictorial warnings led to more accurate added-sugar content estimates than all conditions and greater label trust and support for sugar-sweetened beverage warning policies than health pictorial warnings. CONCLUSIONS: SSB warning policies may be most effective if they mandate images of beverages' added sugar content accompanied by warning text. TRIAL REGISTRATION: This study is registered at www. CLINICALTRIALS: gov NCT03648138.

The impact of Medicaid funding structures on inequities in health care access for Latinos in New York, Florida, and Puerto Rico.

OBJECTIVE: To study the impact of Medicaid funding structures before and after the implementation of the Affordable Care Act (ACA) on health care access for Latinos in New York (Medicaid expansion), Florida (Medicaid non-expansion), and Puerto Rico (Medicaid block grant). DATA SOURCES: Pooled state-level data for New York, Florida, and Puerto Rico from the 2011-2019 Behavioral Risk Factor Surveillance System and data from the 2011-2019 American Community Survey and Puerto Rico Community Survey. STUDY DESIGN: Cross-sectional study using probit with predicted margins to separately compare four health care access measures among Latinos in New York, Florida, and Puerto Rico (having health insurance coverage, having a personal doctor, delayed care due to cost, and having a routine checkup). We also used difference-in-differences to measure the probability percent change of having any health insurance and any public health insurance before (2011-2013) and after (2014-2019) the ACA implementation among citizen Latinos in low-income households. DATA COLLECTION: The sample consisted of Latinos aged 18-64 residing in New York, Florida, and Puerto Rico from 2011 to 2019. PRINCIPAL FINDINGS: Latinos in Florida had the lowest probability of having health care access across all four measures and all time periods compared with those in New York and Puerto Rico. While Latinos in Puerto Rico had greater overall health care access compared with Latinos in both states, health care access in Puerto Rico did not change over time. Among citizen Latinos in low-income households, New York had the greatest post-ACA probability of having any health insurance and any public health insurance, with a growing disparity with Puerto Rico (9.7% any [1.6 SE], 5.2% public [1.8 SE]). CONCLUSIONS: Limited Medicaid eligibility (non-expansion of Florida's Medicaid program) and capped Medicaid funds (Puerto Rico's Medicaid block grant) contributed to reduced health care access over time, particularly for citizen Latinos in low-income households.

Variation in call volume to the Veterans Crisis Line by women and men veterans prior to and following onset of the COVID-19 pandemic.

OBJECTIVES: To identify trends in volume of calls to the Veterans Crisis Line (VCL) around the onset of the COVID-19 pandemic. METHODS: Analysis of call frequency from VCL administrative records for all veteran contacts calling on their own behalf with gender identified from January 1, 2018 through December 31, 2020. Interrupted time series analysis used to identify potential impact of COVID-19 pandemic on call volume by women and men veteran contacts. RESULTS: Call volume to VCL from veterans increased over time, for both women and men veterans, with no significant change in call volume by women contacts following the onset of the COVID-19 pandemic and a decrease in calls by men contacts associated with COVID-19 onset. Call volume varied by month with patterns similar in years prior to and following COVID-19 onset. CONCLUSIONS: The onset of the COVID-19 pandemic in 2020 was not associated with a spike in calls by veterans to VCL. The pandemic may have led to an increase in calls by some as well as a decrease in calls by others, leveling out the overall volume trends.

Care processes and racial/ethnic differences in family reports of end-of-life care among Veterans: A mediation analysis.

BACKGROUND: Bereaved family members of racial/ethnic minority Veterans are less likely than families of White Veterans to provide favorable overall ratings of end-of-life (EOL) care quality; however, the underlying mechanisms for these differences have not been explored. The objective of this study was to examine whether a set of EOL care process measures mediated the association between Veteran race/ethnicity and bereaved families' overall rating of the quality of EOL care in VA medical centers (VAMCs). METHODS: A retrospective, cross-sectional analysis of linked Bereaved Family Survey (BFS), administrative and clinical data was conducted. The sample included 17,911 Veterans (mean age: 73.7; SD: 11.6) who died on an acute or intensive care unit across 121 VAMCs between October 2010 and September 2015. Mediation analyses were used to assess whether five care processes (potentially burdensome transitions, high-intensity EOL treatment, and the BFS factors of Care and Communication, Emotional and Spiritual Support, and Death Benefits) significantly affected the association between Veteran race/ethnicity and a poor/fair BFS overall rating. RESULTS: Potentially burdensome transitions, high-intensity EOL treatment, and the three BFS factors of Care and Communication, Emotional and Spiritual Support, and Death Benefits did not substantially mediate the relationship between Veteran race/ethnicity and poor/fair overall ratings of quality of EOL care by bereaved family members. CONCLUSIONS: The reasons underlying poorer ratings of quality of EOL care among bereaved family members of racial/ethnic minority Veterans remain largely unexplained. More research on identifying potential mechanisms, including experiences of racism, and the unique EOL care needs of racial and ethnic minority Veterans and their families is warranted.

Gender differences in veterans' use of the Veterans Crisis Line (VCL): Findings from VCL call data.

OBJECTIVE: To compare characteristics of calls to the Veterans Crisis Line (VCL) by caller gender and identify potentially unique needs of women callers. METHOD: Retrospective review of clinical data collected during VCL calls, comparing call characteristics between women and men veteran callers. RESULTS: The data included 116,029 calls by women veterans and 651,239 calls by men veterans between January 1, 2018-December 31, 2019. Timing (hour/day/season) of VCL calls was similar between women and men callers. We observed gender differences in reason for call, with the most salient differences in reasons related to interpersonal violence, including sexual trauma (e.g., military sexual trauma as reason for call - prevalence ratio (PR) for women vs. men = 9.13, 95% CI = 8.83, 9.46). Women callers were also more likely than men callers to screen positive for suicide risk (PR = 1.28, 95% CI = 1.26, 1.29), receive a higher suicide risk assessment rating (PR = 1.05, 95% CI = 1.02, 1.07), and be referred to a VA Suicide Prevention Coordinator for follow-up (PR = 1.09, 95% CI = 1.09, 1.11). CONCLUSIONS: Analysis of VCL call data indicated both similarities and differences across genders in call characteristics, including interpersonal relationships and experiences of abuse and assault as particularly salient factors prompting women veterans' calls to VCL. This study also suggests the presence of increased suicide risk among women versus men veteran VCL callers.

Limited Risk Compensation Among Women Who Inject Drugs: Results From the Project Sexual Health Equity Preexposure Prophylaxis Demonstration Study in Philadelphia.

ABSTRACT: The impact of preexposure prophylaxis uptake on sexual and injection-related behaviors among women who inject drugs is poorly understood. Over 24 weeks, preexposure prophylaxis uptake among women who inject drugs was associated with increased sharing of injection equipment but not syringes and no changes in condomless sex, providing limited evidence of risk compensation in this vulnerable population.

Effects of a Health Promotion Intervention on Physical Activity in African American Men Living with HIV: Randomized Controlled Trial.

HIV and its treatment with antiretroviral therapy increase the risk of noncommunicable diseases (NCDs) tied to physical inactivity. Older African American men are also at high risk for NCDs. We tested the efficacy of a theory-based intervention to increase adherence to federal aerobic and muscle-strengthening physical activity (PA) guidelines among African American men aged 40 years and older living with HIV. We randomized African American men aged 40 years and older living with HIV to a three-session social cognitive theory-informed health promotion intervention targeting PA or a one-session health awareness control condition. The primary outcome was PA guideline adherence assessed (self-reported) preintervention, immediate postintervention, and 3, 6, and 12 months postintervention. Secondary outcomes were the number of days on which participants reported moderate-intensity aerobic PA, vigorous-intensity aerobic PA, and muscle-strengthening PA in the past 7 days. Of 302 participants, 255 completed the 12-month postintervention measures. Generalized estimated equation logistic regression indicated that the health promotion intervention participants had higher odds of meeting PA guidelines than health awareness control participants, adjusting for baseline adherence (p = 0.011). Health promotion intervention participants also reported more muscle-strengthening PA (p = 0.001), vigorous-intensity aerobic PA (p = 0.049), and moderate-intensity aerobic PA (p = 0.010) than control participants. The rise in self-reported adherence to PA guidelines and improvements in muscle-strengthening and aerobic PA considered separately suggest that a relatively brief behavioral intervention can increase PA among African American men aged 40 years and older living with HIV and potentially curb their risk of NCDs that PA can prevent.

The Other US Border: Health Insurance Coverage Among Latino Immigrants In Puerto Rico.

Puerto Rico is a US territory and a popular destination for Latino immigrants in the Caribbean. Even with few language and cultural barriers, however, many Latino immigrants in Puerto Rico are uninsured. Using data from the 2014-19 Puerto Rico Community Survey, we examined inequities in health insurance coverage for non-Puerto Rican Latinos ages 18-64 living in Puerto Rico according to citizenship status and Latino subgroup (Dominican, Cuban, Mexican, and other Latino). After controlling for potential confounders, we found that noncitizen Dominicans had a significantly lower probability of having any health insurance (57.2 percent) and having any private insurance (31.5 percent). Regardless of similarities in culture and language, Latino immigrants on the island, particularly Dominicans, experience major health insurance coverage inequities. Considering that Puerto Rico's immigration system is regulated by US federal statute, both federal and local policy makers should acknowledge and focus on reducing these immigrant disparities in health insurance coverage.

Perceived Discrimination and Hypertension Risk Among Participants in the Multi-Ethnic Study of Atherosclerosis.

Background Black Americans have a higher risk of hypertension compared with White Americans. Perceived discrimination is a plausible explanation for these health disparities. Few studies have examined the impact of perceived discrimination on the incidence of hypertension among a racially diverse sample. Our study examined associations of everyday and lifetime discrimination with incidence of hypertension and whether these associations varied by sex, discrimination attribution, and racial residential segregation. Methods and Results The study included 3297 Black, Hispanic, Chinese, and White participants aged 45 to 84 years from the Multi-Ethnic Study of Atherosclerosis who were without hypertension at exam 1 (2000-2002) and who completed at least 1 of 5 follow-up exams (2002-2018). Cox proportional hazards regression was used to estimate associations of perceived discrimination with incident hypertension. Over the follow-up period, 49% (n=1625) of participants developed hypertension. After adjustment for age, sex, socioeconomic status, hypertension risk factors, and study site, Black participants reporting any lifetime discrimination (compared with none) were more likely to develop hypertension (hazard ratio [HR], 1.35; 95% CI, 1.07-1.69). In fully adjusted models, everyday discrimination (high versus low) was associated with a lower risk for hypertension among Hispanic participants (HR, 0.73; 95% CI, 0.55-0.98). Statistically significant interactions of perceived discrimination (everyday and lifetime) with sex, discrimination attribution, and racial residential segregation were not observed. Conclusions This study suggests that lifetime, but not everyday discrimination is associated with incident hypertension in Black Americans.

Intention to initiate and uptake of PrEP among women who injects drugs in a demonstration project: an application of the theory of planned behavior.

Some women who inject drugs (WWID) would benefit from pre-exposure prophylaxis (PrEP), yet there are few studies of issues related to uptake in real-world settings. In this study, participants (n = 95) were offered PrEP and responded to items measuring PrEP-related attitudes, norms, and perceived behavioral control based on the Theory of Planned Behavior. We tested associations with intention to initiate PrEP and uptake. Most WWID (88%) intended to initiate PrEP and 78% accepted a prescription. Compared to WWID who did not express PrEP intentions, those who did were less concerned about attitudinal and perceived behavioral control constructs such as temporary (75% vs. 36%, p = 0.01) and long-term (63% vs. 27%, p = 0.05) side effects, negative interactions with their birth control (93% vs. 38%, p < 0.01), their ability to take a daily pill (80% vs. 36%, p < 0.01), and the cost of PrEP (87% vs. 36%, p < 0.01). WWID who went on to take PrEP had fewer concerns with subjective norms constructs such as talking to health care providers about sex (91% vs. 65%, p < 0.01) and drug use (88% vs. 55%, p < 0.01) compared to those who did not. Attitudes and perceived behavioral control influenced intention while subjective norms had a greater impact on actual uptake.

Predictors of Willingness to Diffuse PrEP Information within Ego-Centric Networks of Women Who Inject Drugs.

Little is known about how social networks among women who inject drugs (WWID) can be leveraged to increase awareness about pre-exposure prophylaxis (PrEP). We tested the hypothesis that interpersonal characteristics influence willingness of WWID to communicate PrEP information with peers. Forty WWID ≥ 18 years completed social network surveys. Participants named on average 9.3 (SD = 3.3) network members, resulting in 375 unique relationships. WWID were willing to share PrEP information with 83% of network members. Participants had higher odds of willingness to share information within relationships when the network member was female, homeless and perceived to be at risk for HIV. Among relationships with family members and transactional sex clients, stronger emotional closeness was associated with higher odds of willingness to share information. Peer interventions where WWID share PrEP information with peers may be an efficient approach to increase PrEP awareness among this vulnerable population.

Motivations for PrEP-Related Interpersonal Communication Among Women Who Inject Drugs: A Qualitative Egocentric Network Study.

A qualitative egocentric social network approach was taken to explore motivations for pre-exposure prophylaxis (PrEP)-related communication between women who inject drugs and network members. Eligible participants were HIV-negative, 18 years or older, and participating in a PrEP demonstration project in Philadelphia, PA, USA. The study employed content analysis of in-depth interviews to identify themes related to contextual and relational factors impacting PrEP communication within networks. Participants (n = 20) named on average three network members, resulting in a total of 57 unique relationships. PrEP conversations occurred within 30 of the 57 relationships, and motivations were to benefit others, to benefit themselves, and due to a sense of obligation. Some conversations also occurred when a peer unexpectedly found their pills. Taking a qualitative approach to network analysis provided a nuanced understanding of how interpersonal characteristics motivated PrEP conversations. Network interventions that facilitate information diffusion and social support may increase PrEP uptake and adherence among women who inject drugs.

Integrating HIV Preexposure Prophylaxis With Community-Based Syringe Services for Women Who Inject Drugs: Results From the Project SHE Demonstration Study.

INTRODUCTION: To guide future preexposure prophylaxis (PrEP) implementation for women who inject drugs (WWID), a population increasingly represented in new HIV cases in the United States, we present results from a demonstration project integrated within a syringe services program (SSP) in Philadelphia, PA. METHODS: WWID ≥18 years were educated about and offered 24 weeks of daily PrEP. Participants completed surveys and clinical assessments at baseline and at weeks 1, 3, 12, and 24. We used descriptive statistics to estimate feasibility/acceptability, engagement in the care cascade, HIV/sexually transmitted diseases (STI) and pregnancy, issues of safety/tolerability, and preferences/satisfaction with PrEP services. Multivariable logistic regression with generalized estimating equations was used to identify factors associated with PrEP uptake and retention. RESULTS: We recruited 136 WWID. Of those, 95 were included in the final sample, and 63 accepted a PrEP prescription at week 1. Uptake was associated with greater baseline frequency of SSP access [adjusted odds ratio (aOR) = 1.85; 95% confidence interval (CI): 1.24 to 2.77], inconsistent condom use (aOR = 3.38; 95% CI: 1.07 to 10.7), and experiencing sexual assault (aOR = 5.89; 95% CI: 1.02, 33.9). Of these 95, 42 (44.2%) were retained at week 24. Retention was higher among women who reported more frequent baseline SSP access (aOR = 1.46; 95% CI: 1.04 to 2.24). Self-reported adherence was high but discordant with urine-based quantification of tenofovir. Baseline STI prevalence was 17.9%; there were 2 HIV seroconversions and 1 pregnancy. Safety/tolerability issues were uncommon, and acceptability/satisfaction was high. CONCLUSIONS: Integrating PrEP with SSP services is feasible and acceptable for WWID. This suggests that daily PrEP is a viable prevention tool for this vulnerable population.

State and Local Government Expenditures and Infant Mortality in the United States.

BACKGROUND AND OBJECTIVES: Evidence suggests that government expenditures on non-health care services can reduce infant mortality, but it is unclear what types of spending have the greatest impact among groups at highest risk. Thus, we sought to quantify how US state government spending on various services impacted infant mortality rates (IMRs) over time and whether spending differentially reduced mortality in some subpopulations. METHODS: A longitudinal, repeated-measures study of US state-level infant mortality and state and local government spending for the years 2000-2016, the most recent data available. Expenditures included spending on education, social services, and environment and housing. Using generalized linear regression models, we assessed how changes in spending impacted infant mortality over time, overall and stratified by race and ethnicity and maternal age group. RESULTS: State and local governments spend, on average, $9 per person. A $0.30 per-person increase in environmental spending was associated with a decrease of 0.03 deaths per 1000 live births, and a $0.73 per-person increase in social services spending was associated with a decrease of 0.02 deaths per 1000 live births. Infants born to mothers aged <20 years had the single greatest benefit from an increase in expenditures compared with all other groups. Increased expenditures in public health, housing, parks and recreation, and solid waste management were associated with the greatest reduction in overall IMR. CONCLUSIONS: Investment in non-health care services was associated with lower IMRs among certain high-risk populations. Continued investments into improved social and environmental services hold promise for further reducing IMR disparities.

Framing Social Comparison Feedback With Financial Incentives for Physical Activity Promotion: A Randomized Trial.

BACKGROUND: Social comparison feedback is often used in physical activity interventions but the optimal design of feedback is unknown. METHODS: This 4-arm, randomized trial consisted of a 13-week intervention period and 13-week follow-up period. During the intervention, 4-person teams were entered into a weekly lottery valued at about $1.40/day and contingent on the team averaging ≥7000 steps per day. Social comparison feedback on performance was delivered weekly for 26 weeks, and varied by reference point (50th vs 75th percentile) and forgiveness in use of activity data (all 7 d or best 5 of 7 d). The primary outcome was the mean proportion of participant-days achieving the 7000-step goal. RESULTS: During the intervention period, the unadjusted mean proportion of participant-days that the goal was achieved was 0.47 (95% confidence interval [CI]: 0.38 to 0.56) in the 50th percentile arm, 0.38 (95% CI: 0.30 to 0.37) in the 75th percentile arm, 0.40 (95% CI: 0.31 to 0.49) in the 50th percentile with forgiveness arm, and 0.47 (95% CI: 0.38 to 0.55) in the 75th percentile with forgiveness arm. In adjusted models during the intervention and follow-up periods, there were no significant differences between arms. CONCLUSIONS: Changing social comparison feedback did not impact physical activity.

Applying the Behavioral Model for Vulnerable Populations to Pre-Exposure Prophylaxis Initiation Among Women Who Inject Drugs.

This study used Behavioral Model for Vulnerable Populations (BMVP) to identify factors associated with pre-exposure prophylaxis (PrEP) initiation among women who inject drugs (WWID) when PrEP was offered at a syringe services program (SSP). Participants (n = 89) were WWID, $ge18 years, and eligible for PrEP. Most (69) initiated PrEP. Chi square and t tests were used to identify bivariate relationships between BMVP factors and PrEP initiation. A greater proportion of PrEP initiators (compared to non-initiators) reported sexual assault, frequent SSP attendance, earning $ge$5,000 annually and inconsistent condom use. Findings can inform the development of gender-specific strategies to promote PrEP among WWID.

Respiratory medication use in extremely premature (<29 weeks) infants during initial NICU hospitalization: Results from the prematurity and respiratory outcomes program.

BACKGROUND: The use of medications to treat respiratory conditions of extreme prematurity is often based upon studies of adults or children over 2 years of age. Little is known about the spectrum of medications used or dosing ranges. To inform the design of future studies, we conducted a prospective analysis of respiratory medication exposure among 832 extremely low gestational age neonates. METHODS: The prematurity and respiratory outcomes program (PROP) enrolled neonates less than 29-week gestation from 6 centers incorporating 13 clinical sites. We collected recorded daily "respiratory" medications given along with dosing information through 40-week postmenstrual age or neonatal intensive care unit discharge if earlier. RESULTS: PROP participants were exposed to a wide range of respiratory medications, often at doses beyond published recommendations. Nearly 50% received caffeine and furosemide beyond published recommendations for cumulative dose. Those who developed bronchopulmonary dysplasia were more likely to receive treatment with respiratory medications. However, more than 30% of PROP subjects that did not develop bronchopulmonary dysplasia also were treated with diuretics, systemic steroids, and other respiratory medications. CONCLUSION: Extremely preterm neonates in PROP were exposed to high doses of medications at levels known to generate significant adverse effects. With limited evidence for efficacy, there is an urgent need for controlled trials in this vulnerable patient population.

A combination intervention addressing sexual risk-taking behaviors among vulnerable women in Uganda: study protocol for a cluster randomized clinical trial.

BACKGROUND: Sub-Saharan Africa (SSA) has the highest number of people living with HIV/AIDS, with Nigeria, South Africa, and Uganda accounting for 48% of new infections. A systematic review of the HIV burden among women engaged in sex work (WESW) in 50 low- and middle-income countries found that they had increased odds of HIV infection relative to the general female population. Social structural factors, such as the sex work environment, violence, stigma, cultural issues, and criminalization of sex work are critical in shaping sexually transmitted infection (STI)/HIV risks among WESW and their clients in Uganda. Poverty is the most commonly cited reason for involvement in sex work in SSA. Against this backdrop, this study protocol describes a randomized controlled trial (RCT) that tests the impact of adding economic empowerment to traditional HIV risk reduction (HIVRR) to reduce new incidence of STIs and HIV among WESW in Rakai and the greater Masaka regions in Uganda. METHODS: This three-arm RCT will evaluate the efficacy of adding savings, financial literacy and vocational training/mentorship to traditional HIVRR on reducing new incidence of STI infections among 990 WESW across 33 hotspots. The three arms (n = 330 each) are: 1) Control group: only HIVRR versus 2) Treatment group 1: HIVRR plus Savings plus Financial Literacy (HIVRR + S + FL); and 3) Treatment group 2: HIVRR plus S plus FL plus Vocational Skills Training and Mentorship (V) (HIVRR + S + FL + V). Data will be collected at baseline (pre-test), 6, 12, 18 and 24-months post-intervention initiation. This study will use an embedded experimental mixed methods design where qualitative data will be collected post-intervention across all conditions to explore participant experiences. DISCUSSION: When WESW have access to more capital and/or alternative forms of employment and start earning formal income outside of sex work, they may be better able to improve their skills and employability for professional advancement, thereby reducing their STI/HIV risk. The study findings may advance our understanding of how best to implement gender-specific HIV prevention globally, engaging women across the HIV treatment cascade. Further, results will provide evidence for the intervention's efficacy to reduce STIs and inform implementation sustainability, including costs and cost-effectiveness. TRIAL REGISTRATION: ClinicalTrials.gov , ID: NCT03583541 .