Search

INTRODUCTION: High social-emotional functioning, including emotion regulation and nonviolent conflict resolution, constitute developmental competencies of adolescence that promote health and well-being. We used prospective longitudinal data from a predominantly Latinx population to understand how family context and social environment risk factors for violence related to patterns of social-emotional functioning during the transition between middle school and high school. METHODS: We prospectively interviewed 599 8th graders every 6 months for 2 years. We used trajectory models to explore longitudinal patterns of emotion regulation and nonviolent problem solving and multinomial regression to distinguish how these groups were associated with family context, partner and peer gang involvement, and neighborhood social disorder. RESULTS: Youth reporting lower neighborhood disorder in 8th grade were more likely to be in the high emotion regulation trajectory group. Youth without exposure to gangs through peers and partners in 8th grade were more likely to be in the high nonviolent problem-solving skills trajectory group. Family cohesion was associated with being in the high trajectory groups for both emotional regulation and problem-solving skills. CONCLUSION: Emotion regulation and nonviolent problem-solving skills had different associations with the social environment risk factors for violence examined, indicating that mechanisms of influence and strategies for intervention may vary. The association between problem-solving skills and exposure to gangs through peers and partners shows that social norms may be important targets of change. Additionally, interventions with parents that build family cohesion during adolescence may buffer environmental exposures that shape adolescents ability to practice protective social-emotional behaviors.

BackgroundSafe consumption sites (SCS) are an evidence-based intervention to prevent drug use-related harm. In late 2014, an organisation in an undisclosed location in the USA opened an unsanctioned SCS.ObjectiveTo evaluate whether use of the unsanctioned SCS affected medical outcomes.DesignA prospective cohort study.SettingNeighbourhoods surrounding the SCS.ParticipantsPeople who injected drugs were recruited and interviewed at baseline and 6 and 12 months from 2018 to 2020.InterventionPeople using the SCS could bring pre-obtained drugs to consume via injection, which were monitored by trained staff with naloxone.Main measuresAny overdose, number of non-fatal overdoses, skin and soft tissue infections, emergency department utilisation, number of emergency department visits, hospitalisation and number of nights spent in hospital.Key resultsA total of 494 participants enrolled in the study; 59 (12%) used the SCS at least once. We used propensity score weighting to analyse the association between SCS utilisation and measures. People using the SCS were 27% (95% CI: 12-46%) less likely to visit the emergency department, had 54% (95% CI: 33-71%) fewer emergency department visits, were 32% (95% CI: 4-57%) less likely to be hospitalised, and spent 50% (95% CI: 1-85%) fewer nights in hospital. Though not significant, people using the SCS had a lower likelihood of overdosing and slightly higher likelihood of skin and soft tissue infections.ConclusionsOur findings support the use of SCS in the USA to reduce the growing burden of acute care service utilisation related to injection drug use.

In a prospective cohort study of Latinx adolescents living in an agricultural county in California, we examined perceptions of federal immigration policy and its effects on community and individual wellbeing. From May to December 2017, 565 youth responded to an open-ended item integrated into ongoing surveys. Median age was 14 (range 13-16 years), 53% female, and 94% Latinx. About 12% were immigrants, 71% children of immigrant parents, and 52% had a parent employed in farm work. Most (78%) indicated they directly experienced or observed effects of current federal immigration policies. Adolescents described anti-immigrant sentiment as heightening discrimination, isolation, fear, and mental health changes. They also perceived constraints on future educational and employment opportunities. These findings suggest that the federal immigration policy environment can negatively impact the wellbeing of youth in Latinx communities and that immigration policy should be considered a social determinant of health.

ObjectivesTo examine whether social aspects of the neighborhood environment are associated with early sexual initiation in a California agricultural community of predominantly Latinx adolescents.MethodsIn a prospective cohort study of 599 eighth graders recruited from middle schools in Salinas, California (2015-2019), participants completed five interviews over 2 years. Social environment measures included neighborhood social dynamics (neighborhood disorder, social cohesion, and social network gang exposure); experiences of discrimination; and school connectedness. We estimated associations between baseline social environment and early sexual initiation (

BACKGROUND: The introduction of illicitly made fentanyl in the United States has slowly replaced heroin. New illicit drugs are often associated with changes in frequency and modes of administration. We assessed changes in injection frequency and smoking fentanyl in the new era of fentanyl availability in San Francisco. METHODS: We used targeted sampling to recruit 395 people who inject drugs (PWID) into an observational cohort study in San Francisco 2018-2020. We assessed changes in injection frequency, opioid injection frequency and fentanyl smoking frequency in four six-month periods. We also conducted qualitative interviews with PWID asking about motivations for injecting and smoking opioids. RESULTS: The median number of past-month injections steadily decreased by semi-annual calendar year from 92 injections in July to December 2018 to 17 injections in January to June 2020. The rate of opioid injections reduced by half (Adjusted Incidence Rate Ratio = 0.41; 95 % Confidence Interval = 0.25, 0.70; p < 0.01). The number of days smoking fentanyl was associated with fewer number of injections (X2(2) = 11.0; p < 0.01). Qualitative interviews revealed that PWIDs motivation for switching from injecting tar heroin to smoking fentanyl was related to difficulties accessing veins. After switching to smoking fentanyl, they noticed many benefits including how the drug felt, improved health, fewer financial constraints, and reduced stigma. CONCLUSION: Between 2018 and 2020, there was a shift from injecting tar heroin to smoking fentanyl in San Francisco. Reductions in injection of illicit drugs may offer public health benefit if it reduces risk of blood-borne viruses, abscesses and soft-tissue infections, and infective endocarditis.

Depression constitutes one of the greatest sources of morbidity and mortality for U.S. adolescents. Latinx are the fastest growing U.S. adolescent population, particularly in rural communities, and suffer from depression at higher rates than other racial/ethnic groups. Informed by community perspectives on adolescent health, we examined factors associated with depression among Latinx early adolescents in an agricultural community. We surveyed 599 predominantly Latinx 8th graders (12 to 15 years old) recruited from middle schools in Salinas, California. Depression was measured cross-sectionally with the Patient Health Questionnaire-8. Exposures included environmental, cultural, and family factors, assessed using validated measures. We used hierarchical logistic regression guided by Garcia Coll's Model for the Study of Developmental Competencies in Minority Children to examine associations between protective factors within each domain and depression. Eighty-six of the 599 youth (14%) scored above the clinical threshold for depression, with higher prevalence among females (19%) than males (10%), p = .001. Environmental (school connectedness and neighborhood social cohesion) and family factors were associated with a lower odds of depression (all p ≤ .01). Social cohesion in neighborhoods and family communication offered similarly strong protective associations with depression. Increased language assimilation was associated with an increased odds of depression (p = .007).

Nonprofit hospitals are required to provide “community benefits,” although this term and the associated levels of spending are not clearly defined. Over 75% of private nonprofit hospital community benefits are allocated to providing medical services for those who cannot afford care, and fewer investments are made to address structural and social determinants of health (SDOH). In particular, this spending is rarely used to redress racial inequities that shape health. In addition to spending on charity care and medical services, some private nonprofit hospitals invest in non-medical strategies to improve health outcomes. In California, private nonprofit hospitals report $12 billion in annual community benefits that include spending on non-medical strategies intended to improve health promoting conditions for vulnerable populations. This comparative case study analyzes data from organizational documents, interviews, and media communications to examine how hospital community investments in housing and workforce development are rationalized and deployed to address SDOH in Los Angeles County. Findings indicate that community-based resources are essential to align hospital investments with community need and to avoid “colorblind” decisions that emphasize socioeconomic need yet do not adequately address racialized barriers to health. Policy and practices that promote targeted capital investments and prioritize the disproportionate needs of communities of color are needed instead of colorblind hospital community investments that perpetuate racial inequities in health.

As new female-initiated HIV prevention products enter development, it is crucial to incorporate women's preferences to ensure products will be desired, accepted, and used. A discrete-choice experiment was designed to assess the relative importance of six attributes to stated choice of a vaginally delivered HIV prevention product. Sexually active women in South Africa and Zimbabwe aged 18-30 were recruited from two samples: product-experienced women from a randomized trial of four vaginal placebo forms and product-naïve community members. In a tablet-administered survey, 395 women chose between two hypothetical products over eight choice sets. Efficacy was the most important, but there were identifiable preferences among other attributes. Women preferred a product that also prevented pregnancy and caused some wetness (p

: Introduction: Oral pre‐exposure prophylaxis (PrEP) has the potential to reduce HIV acquisition among adolescent girls and young women (AGYW) in sub‐Saharan Africa, a priority population for epidemic control. However, intimate partner violence (IPV) and low relationship power can create significant challenges to PrEP use. The Tu'Washindi intervention aimed to increase PrEP use by addressing relationship‐ and violence‐related barriers among AGYW enrolled in the DREAMS Initiative in Siaya County, Kenya. Methods: Our multi‐level, community‐based intervention was piloted in a cluster‐randomized controlled trial conducted at six DREAMS sites from April to December 2019 (NCT03938818). Three intervention components were delivered over 6 months: an eight‐session empowerment‐based support club, community sensitization targeted towards male partners and a couples’ PrEP education event. Participants were ages 17–24, HIV negative and either eligible for, or already taking, PrEP. Over 6 months of follow‐up, we assessed IPV (months 3 and 6) and PrEP uptake and continuation (month 6) through interviewer‐administered questionnaires; PrEP adherence was assessed with Wisepill electronic monitoring devices. These outcomes were compared using adjusted Poisson and negative binomial regression models. Results: We enrolled 103 AGYW with median age of 22 years (IQR 20–23); one‐third were currently taking PrEP and 45% reported IPV in the past 3 months. Retention was 97% at month 6. Compared to the control arm, intervention arm participants were more likely to initiate PrEP, if not already using it at enrolment (52% vs. 24%, aRR 2.28, 95% CI 1.19–4.38, p = 0.01), and those taking PrEP had more days with device openings (25% of days vs. 13%, aRR 1.94, 95% CI 1.16–3.25, p = 0.01). Twenty percent of participants reported IPV during follow‐up. There were trends towards fewer IPV events (aIRR 0.66, 95% CI 0.27–1.62, p = 0.37) and fewer events resulting in injury (aIRR 0.21, 95% CI 0.04–1.02, p = 0.05) in the intervention versus control arm. Conclusions: Tu'Washindi shows promise in promoting PrEP uptake and adherence among AGYW without concomitant increases in IPV; however, adherence was still suboptimal. Further research is needed to determine whether these gains translate to increases in the proportion of AGYW with protective levels of PrEP adherence and to evaluate the potential for the intervention to reduce IPV risk., INTRODUCTION Adolescent girls and young women (AGYW; ages 15–24) in sub‐Saharan Africa are disproportionately affected by HIV. More than one in four new HIV acquisitions in this region are among [...]

PurposeTo investigate time trade-off (TTO) utility values in patients with noninfectious uveitis and determine whether patient demographics and clinical characteristics are associated with utility scores.DesignTime trade-off utility analysis.MethodsSetting: A tertiary care uveitis center in San Francisco, California, USA.Patient populationOne hundred and four consecutive adults with noninfectious uveitis, enrolled between November 2016 and February 2017.Main outcome measuresTTO utility values, as collected by an interviewer-guided survey. Information regarding general health, ocular symptoms, and religion was also collected and medical record review was conducted to record anatomic location of uveitis, disease activity, visual acuity, and treatments. Multivariable regression analysis with backward selection was used to identify variables associated with TTO values.ResultsMedian TTO score was 0.975 (interquartile range [IQR]: 0.8-1.0), corresponding to trading a median 1.28 years of remaining life for healthy eyes (IQR: 0-6.29). Regression analysis revealed that worse eye visual acuity, >6 months of oral corticosteroid use, and current antidepressant use were associated with lower TTO scores (P = .008, P = .006, P = .008, respectively), controlling for age and sex. In particular, patients who had been taking oral corticosteroids for more than 6 months, regardless of dose, were 10.5 times more likely to trade 20% or more years of remaining life (TTO ≤0.8) than patients not taking oral corticosteroids (95% confidence interval: 2.3, 48.1; P = .002).ConclusionsPatients with noninfectious uveitis had measurable, though modest, reductions in quality of life, as assessed by TTO, and these decreases were significantly associated with visual acuity in the worse eye and long-term oral corticosteroid use.

IntroductionAdherence to HIV prevention methods is a challenge, particularly for young women in Sub-Saharan Africa. End-user research during product development can inform modifiable factors to increase future uptake and adherence.MethodsPreferences for four vaginally inserted placebo HIV prevention methods were assessed among Zimbabwean and South African young women using a crossover clinical design. For each of months 1 to 4, participants were asked to use a pre-coitally inserted film, insert (vaginal tablet) and gel once/week for a month, and a monthly ring in a randomly assigned sequence. Participants subsequently chose one preferred product to use as directed for the final study month. Women ranked the four products from most preferred to least preferred at enrolment and after trying all products.ResultsA total of 200 women aged 18 to 30 (mean 23) were enrolled; 178 (89%) completed follow-up. At baseline, 41% of participants selected the gel as their most preferred product and 61% selected the ring as least preferred. During the crossover period, most (82% to 85%) self-reported using each product at least once a week, although only half the time with sex. Objective biomarker data confirmed adequate use of all products. After trying each product, rankings changed with the film, ring, insert and gel being selected by 29%, 28%, 26% and 16% respectively. Choice varied significantly by country (p

Mpox disproportionately impacts Black people and young adults, yet the beliefs and knowledge of mpox among groups at elevated risk remain unclear. Therefore, we assessed mpox knowledge among Black young adults to inform public health efforts. We surveyed a sample (n = 330) of young Black adults (aged 18–29 years) in Alabama, Georgia, and North Carolina using nine true-or-false questions to assess their mpox knowledge. Correct response rates varied (26%–96%). Approximately 26% were unaware of the mpox vaccine, and almost 21% incorrectly thought the chickenpox vaccine conferred protection against mpox. Females demonstrated statistically significantly higher mpox knowledge than males across 33% of indicators. There were no statistically significant differences between states, suggesting that a regional approach may be suitable to improve knowledge. Findings underscore the importance of education and public health initiatives to address mpox knowledge gaps, particularly among Black young adults, to improve public health preparedness. [ABSTRACT FROM AUTHOR]

PurposeTo evaluate the changes in quality of life in noninfectious uveitis patients treated with 2 of the most commonly prescribed antimetabolite treatments.DesignSecondary analysis of a multicenter, block-randomized clinical trial.MethodsEighty patients at Aravind Eye Hospitals in Madurai and Coimbatore, India, with noninfectious intermediate, posterior, or panuveitis were randomized to receive oral methotrexate, 25 mg weekly, or oral mycophenolate mofetil, 1 g twice daily, and were followed up monthly for 6 months. Best-corrected visual acuity, Indian Vision Function Questionnaire (IND-VFQ), and Medical Outcomes Study 36-item Short Form Survey (SF-36) were obtained at enrollment and at 6 months (or prior, in the event of early treatment failure).ResultsIND-VFQ scores, on average, increased by 9.2 points from trial enrollment to 6 months (95% confidence interval [CI]: 4.9, 13.5, P = .0001). Although the SF-36 physical component summary score did not significantly differ over the course of the trial, the mental component summary score decreased by 2.3 points (95% CI: -4.4, -0.1, P = .04) and the vitality subscale decreased by 3.5 points (95% CI: -5.6, -1.4, P = .001). Quality-of-life scores did not differ between treatment arms. Linear regression modeling showed a 3.2-point improvement in IND-VFQ score for every 5-letter improvement in visual acuity (95% CI: 1.9, 4.3; P < .001).ConclusionsAlthough uveitis treatment was associated with increased vision and vision-related quality of life, patient-reported physical health did not change after 6 months of treatment, and mental health decreased. Despite improved visual outcomes, uveitis patients receiving systemic immunosuppressive therapy may experience a deterioration in mental health-related quality of life.

PurposeTo conduct a Bayesian analysis of a randomized clinical trial (RCT) for non-infectious uveitis using expert opinion as a subjective prior belief.MethodsA RCT was conducted to determine which antimetabolite, methotrexate or mycophenolate mofetil, is more effective as an initial corticosteroid-sparing agent for the treatment of intermediate, posterior, and pan-uveitis. Before the release of trial results, expert opinion on the relative effectiveness of these two medications was collected via online survey. Members of the American Uveitis Society executive committee were invited to provide an estimate for the relative decrease in efficacy with a 95% credible interval (CrI). A prior probability distribution was created from experts' estimates. A Bayesian analysis was performed using the constructed expert prior probability distribution and the trial's primary outcome.ResultsA total of 11 of the 12 invited uveitis specialists provided estimates. Eight of 11 experts (73%) believed mycophenolate mofetil is more effective. The group prior belief was that the odds of treatment success for patients taking mycophenolate mofetil were 1.4-fold the odds of those taking methotrexate (95% CrI 0.03-45.0). The odds of treatment success with mycophenolate mofetil compared to methotrexate was 0.4 from the RCT (95% confidence interval 0.1-1.2) and 0.7 (95% CrI 0.2-1.7) from the Bayesian analysis.ConclusionsA Bayesian analysis combining expert belief with the trial's result did not indicate preference for one drug. However, the wide credible interval leaves open the possibility of a substantial treatment effect. This suggests clinical equipoise necessary to allow a larger, more definitive RCT.

Improving intimate partner violence interventions requires understanding pathways to change among couples participating in these interventions. This article presents qualitative data from 18 males and 16 females who participated in a combined behavioral economics (contingency management) and cognitive behavioral therapy alcohol and violence reduction intervention trial in Bengaluru, India. Results confirmed several theorized pathways of change, as well as identified further mechanisms through which the intervention supported the change. These included the emotional impacts of incentives, perceived and actual accountability via breathalyzers and family involvement, and enhanced support gained through counseling skills. Findings reveal critical insights into intervention design for future implementation. [ABSTRACT FROM AUTHOR]

With new pre-exposure prophylaxis (PrEP) modalities for HIV prevention becoming available, understanding how adolescent girls and young women (AGYW) navigate through PrEP options is essential, including factors underlying their choice. Through 16 focus group discussions (FGDs) and 52 in-depth interviews (IDIs) from REACH, an open-label crossover study in which AGYW were allocated 1:1 (between 06 February 2019 and 18 March 2020) to receive oral PrEP for six months and the dapivirine ring for six months, in a randomized sequence, followed by a 6-month period where either product (or neither) could be chosen, we explored decision-making process and product choice, using a mixed inductive-deductive analytical approach. Key themes included the desire to remain HIV-negative and weighing product attributes through experiential learning. Product triability appeared important in informing product choice as individual circumstances changed or assuaging side effects with a given product. Approved biomedical prevention innovations may also benefit from hands-on experience to help with adoption and use during real-world implementation. Furthermore, support from trusted providers will remain critical as AGYW contemplate navigating through PrEP options and choice. [ABSTRACT FROM AUTHOR]

PurposeTo report outcomes of Vogt-Koyanagi-Harada (VKH) disease from a clinical trial of antimetabolite therapies.DesignSubanalysis from an observer-masked randomized clinical trial for noninfectious intermediate, posterior, and panuveitis.Methodssetting: Clinical practice at Aravind Eye Hospitals, India.Patient populationForty-three of 80 patients enrolled (54%) diagnosed with VKH.InterventionPatients were randomized to either 25 mg oral methotrexate weekly or 1 g mycophenolate mofetil twice daily, with a corticosteroid taper.Main outcome measuresPrimary outcome was corticosteroid-sparing control of inflammation at 5 and 6 months. Secondary outcomes included visual acuity, central subfield thickness, and adverse events. Patients were categorized as acute (diagnosis ≤3 months prior to enrollment) or chronic (diagnosis >3 months prior to enrollment).ResultsTwenty-seven patients were randomized to methotrexate and 16 to mycophenolate mofetil; 30 had acute VKH. The odds of achieving corticosteroid-sparing control of inflammation with methotrexate were 2.5 times (95% CI: 0.6, 9.8; P = .20) the odds with mycophenolate mofetil, a difference that was not statistically significant. The average improvement in visual acuity was 12.5 Early Treatment Diabetic Retinopathy Study (ETDRS) letters. On average, visual acuity for patients with acute VKH improved by 14 more ETDRS letters than those with chronic VKH (P < .001), but there was no difference in corticosteroid-sparing control of inflammation (P = .99). All 26 eyes with a serous retinal detachment at baseline resolved, and 88% achieved corticosteroid-sparing control of inflammation.ConclusionsThe majority of patients treated with antimetabolites and corticosteroids were able to achieve corticosteroid-sparing control of inflammation by 6 months. Although patients with acute VKH gained more visual improvement than those with chronic VKH, this did not correspond with a higher rate of controlled inflammation.

Introduction: Existing biomedical HIV prevention options, though highly effective, present substantial adherence challenges. End-user input on early-stage design of new HIV prevention approaches is critical to yielding products that achieve high uptake and adherence. The iPrevent Study examined youths' preferences for key attributes of long-acting Pre-Exposure Prophylaxis (PrEP), with a focus on characteristics pertinent to product delivery alongside key modifiable product attributes. Methods: A discrete choice experiment was conducted with female and male youth aged 18 to 24 in two high-density communities in Cape Town, South Africa during the period July 2017 to January 2019. Sexually active, PrEP-naive youth were recruited using population-based sampling; targeted sampling was used to enrol men who have sex with men (MSM). In a series of nine questions, participants were asked to choose between two hypothetical products composed of five attributes (form, dosing frequency, access, pain, insertion site). We used a random-parameters logit model to estimate preference weights and trade-offs among product alternatives. We examined differences across three subgroups: females, men who have sex with only women (MSW) and MSM. Results: A total of 807 participants (401 female) were enrolled with a median age of 21 years. Males included 190 MSM. Most youth had tested for HIV (95%) and reported being HIV-negative (91%). Across all groups, duration of effectiveness was the most important attribute, with strong preference for less frequent dosing. Injections were favoured over implants, though these preferences were strongest for females and MSM. Females preferred a product offered at a health clinic and disliked pharmacy access; all groups preferred the arm as the insertion site. Youth were willing to trade their preferred product form for longer duration. Conclusions: Youth indicated strong preferences for longer duration products. Each attribute nonetheless influenced preferences, offering insight into trade-offs that inform long-acting PrEP development. Keywords: HIV prevention; long-acting pre-exposure prophylaxis; discrete choice experiment; acceptability; adolescent girls and young women; men who have sex with men, 1 | INTRODUCTION End-user input on early stage design of new HIV prevention approaches is critical to yielding products that achieve high uptake and adherence. As evidenced by multiple clinical [...]

PurposeTo assess whether cigarette smoking is associated with the development of uveitis in a population-based setting.DesignRetrospective, population-based, case-control study.ParticipantsPatients aged ≥ 18 years who were seen at a Kaiser Permanente Hawaii clinic between January 1, 2006, and December 31, 2007. Analysis included 100 confirmed incident uveitis cases, 522 randomly selected controls from the general Kaiser Hawaii population, and 528 randomly selected controls from the Kaiser Hawaii ophthalmology clinic.MethodsInternational Classification of Diseases, 9th revision (ICD-9), diagnosis codes were used to identify possible uveitis cases. A uveitis fellowship-trained ophthalmologist then conducted individual chart review to confirm case status. Multivariate logistic regression models were used to evaluate the association between smoking and uveitis, adjusting for age, sex, race, and socioeconomic status.Main outcome measuresDevelopment of uveitis.ResultsCurrent smokers had a 1.63 (95% confidence interval [CI], 0.88-3.00; P = 0.12) and 2.33 (95% CI, 1.22-4.45; P = 0.01) times greater odds of developing uveitis compared with those who never smoked using the general and ophthalmology control groups, respectively. The association was even stronger with noninfectious uveitis, which yielded odds ratios of 2.10 (95% CI, 1.10-3.99; P = 0.02) and 2.96 (95% CI, 1.52-5.77; P = 0.001) using the general and ophthalmology control groups, respectively.ConclusionsCigarette smoking is significantly associated with new-onset uveitis within a population-based setting. The association was stronger for noninfectious uveitis. Given the well-established risks of smoking with regard to other inflammatory disorders, these results reaffirm the importance of encouraging patients to avoid or cease smoking.

ObjectiveTo compare the relative effectiveness of methotrexate and mycophenolate mofetil for noninfectious intermediate uveitis, posterior uveitis, or panuveitis.DesignMulticenter, block-randomized, observer-masked clinical trial.ParticipantsEighty patients with noninfectious intermediate, posterior, or panuveitis requiring corticosteroid-sparing therapy at Aravind Eye Hospitals in Madurai and Coimbatore, India.InterventionPatients were randomized to receive 25 mg weekly oral methotrexate or 1 g twice daily oral mycophenolate mofetil and were monitored monthly for 6 months. Oral prednisone and topical corticosteroids were tapered.Main outcome measuresMasked examiners assessed the primary outcome of treatment success, defined by achieving the following at 5 and 6 months: (1) ≤0.5+ anterior chamber cells, ≤0.5+ vitreous cells, ≤0.5+ vitreous haze and no active retinal/choroidal lesions in both eyes, (2) ≤10 mg of prednisone and ≤2 drops of prednisolone acetate 1% a day, and (3) no declaration of treatment failure because of intolerability or safety. Additional outcomes included time to sustained corticosteroid-sparing control of inflammation, change in best spectacle-corrected visual acuity, resolution of macular edema, adverse events, subgroup analysis by anatomic location, and medication adherence.ResultsForty-one patients were randomized to methotrexate and 39 to mycophenolate mofetil. A total of 67 patients (35 methotrexate, 32 mycophenolate mofetil) contributed to the primary outcome. Sixty-nine percent of patients achieved treatment success with methotrexate and 47% with mycophenolate mofetil (P = 0.09). Treatment failure from adverse events or tolerability was not different by treatment arm (P = 0.99). There were no differences between treatment groups in time to corticosteroid-sparing control of inflammation (P = 0.44), change in best spectacle-corrected visual acuity (P = 0.68), or resolution of macular edema (P = 0.31).ConclusionsThere was no statistically significant difference in corticosteroid-sparing control of inflammation between patients receiving methotrexate or mycophenolate mofetil. However, there was a 22% difference in treatment success favoring methotrexate.

We assessed if acceptability of the dapivirine vaginal ring for HIV prevention differed among the subgroup of women who reported engaging in transactional sex prior to enrollment in MTN-020/ASPIRE (phase III trial in Malawi, South Africa, Uganda, and Zimbabwe, 2012-2015; n = 2629). Transactional sex was defined as receipt of money, goods, gifts, drugs, or shelter in exchange for sex in the past year. Dimensions of acceptability included: ease of use and physical sensation in situ, impacts on sex, partner's opinion, and likelihood of future use. We used Poisson regression models with robust standard errors to compare risk of acceptability challenges by baseline history of transactional sex. At product discontinuation, women exchanging sex found the ring comfortable (90%), easy to insert (92%) and nearly all (96%) were likely to use the ring in the future. Women who had exchanged sex were more likely to report feeling the ring during sex (ARR 1.43, 95% CI: 1.09, 1.89; p = 0.01) and slightly more likely to mind wearing the ring during menses (ARR 1.22, 95% CI: 1.01, 1,46; p = 0.04) and during sex (ARR 1.22, 95% CI: 1.02, 1.45; p = 0.03). Messaging and counseling should include enhanced support for use during sex and menses to support optimal use. [ABSTRACT FROM AUTHOR]

Introduction: Preventing HIV and unintended pregnancies are key global health priorities. To inform product rollout and to understand attributes of future multipurpose prevention technologies (MPT) associated with preference and use, we evaluated three placebo delivery forms: daily oral tablets, a monthly vaginal ring, and two monthly intramuscular injections in TRIO, a five-month study among young Kenyan and South African women. Methods: HIV-negative, sexually active, non-pregnant women aged 18 to 30 were enrolled and randomized to use each placebo delivery form for one month (stage l).Then, participants chose one product to use for two additional months (stage 2). We assessed safety, product ranking, choice, and use. We examined demographic and behavioural correlates of choice and, reciprocally, unwillingness to use in the future with logistic regression models. Results: 277 women enrolled, 249 completed stage 1 and 246 completed stage 2. Median age was 23 years, 49% were Kenyan and 51% were South African. Three participants became pregnant during the study and one participant HlV-seroconverted. There were 18 product-related adverse events, six tablets-related, 11 ring-related, and one injection-related. After trying each product, 85% preferred a TRIO product over condoms. Injections were chosen most (64%, 95% confidence interval (Cl) 58%, 70%; p < 0.001), and by more South Africans than Kenyans (odds ratio (OR) 2.01, 95% Cl: 1.17, 3.43; p = 0.01). There was no significant difference in choosing tablets versus ring (21%, 95% Cl: 16%, 26% vs. 15%, 95% Cl: 11%, 20%; p = 0.11). Tablet and ring adherence, based on direct observations and self-reports, improved over time. However, participants' self-reported use of tablets did not match objective data from the electronic dose monitoring device. Participants were fully compliant with injections. Conclusion: In this population at risk for HIV and pregnancy, all participants agreed to choose and use a placebo MPT delivery form. A majority of participants preferred TRIO products to male condoms, an existing MPT. Injections were most liked and best used, however, they are years away from reaching the clinics. In the meantime, expanding the availability of tablets and giving access to rings can begin to fulfill the promise of choice for HIV prevention technologies and inform the development of suitable delivery forms as MPT. Keywords: multipurpose prevention technologies; end-user research; HIV prevention; product preference; contraception; Africa, 1 | INTRODUCTION Sexually active women at risk for HIV also need to prevent unintended pregnancies. In sub-Saharan Africa, 40% to 60% of pregnancies remain unintended [1,2]; likewise, young women [...]