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Objective Human immunodeficiency virus (HIV) prevention efficacy trials with psychiatric patients have been conducted in research settings in high-resourced countries, establishing short-term efficacy for reducing sexual risk behavior. None has been implemented within systems of care. In the last decade, overcoming this research-to-practice gap has become a focus of implementation science. This paper describes the first and only HIV Prevention intervention trial for psychiatric patients conducted in real-world outpatient psychiatric settings facilitated by trained clinic-based providers. Methods The HIV Prevention intervention, which uses the Information-Motivation-Behavioral Skills model to achieve sexual risk-reduction, was rigorously adapted to the local context and clinic services' needs. Participants from eight clinics were randomized to HIV Prevention or Health Promotion conditions. Results HIV Prevention participants showed significant improvement in Information-Motivation-Behavioral domains; in this group, behavioral intentions were associated with significantly fewer unprotected sex occasions, but reduction of unprotected sex occasions was similar in both conditions. Conclusion Our trial was conducted before implementation studies became widely funded. Transporting an intervention to a new culture or into real-world practice settings may require adaptations. Our results demonstrate that clear guidelines are needed regarding whether to conduct efficacy, effectiveness, and/or implementation research as the most appropriate next step. Clinical trial registration NCT00881699.

Objective: Human immunodeficiency virus (HIV) prevention efficacy trials with psychiatric patients have been conducted in research settings in high-resourced countries, establishing short-term efficacy for reducing sexual risk behavior. None has been implemented within systems of care. In the last decade, overcoming this research-to-practice gap has become a focus of implementation science. This paper describes the first and only HIV Prevention intervention trial for psychiatric patients conducted in real-world outpatient psychiatric settings facilitated by trained clinic-based providers. Methods: The HIV Prevention intervention, which uses the Information-Motivation-Behavioral Skills model to achieve sexual risk-reduction, was rigorously adapted to the local context and clinic services' needs. Participants from eight clinics were randomized to HIV Prevention or Health Promotion conditions. Results: HIV Prevention participants showed significant improvement in Information-Motivation-Behavioral domains; in this group, behavioral intentions were associated with significantly fewer unprotected sex occasions, but reduction of unprotected sex occasions was similar in both conditions. Conclusion: Our trial was conducted before implementation studies became widely funded. Transporting an intervention to a new culture or into real-world practice settings may require adaptations. Our results demonstrate that clear guidelines are needed regarding whether to conduct efficacy, effectiveness, and/or implementation research as the most appropriate next step. Clinical trial registration: NCT00881699.

AimTo determine the distribution of anthropometric parameter (AP)-z-scores and characterize associations between medications/serum biomarkers and AP-z-scores in pediatric Crohn's disease (CD).MethodsCD patients [< chronological age (CA) 21 years] were enrolled in a cross-sectional study. Descriptive statistics were generated for participants' demographic characteristics and key variables of interest. Paired t-tests were used to compare AP-z-scores calculated based on CA (CA z-scores) and bone age (BA) (BA z-scores) for interpretation of AP's. Linear regression was utilized to examine associations between medications and serum biomarkers with AP-z-scores calculated based on CA (n = 82) and BA (n = 49). We reported regression coefficients as well as their corresponding p-values and 95% confidence intervals.ResultsMean CA at the time of the study visit was 15.3 ± 3.5 (SD; range = 4.8-20.7) years. Mean triceps skinfold (P = 0.039), subscapular skinfold (P = 0.002) and mid-arm circumference (MAC) (P = 0.001) BA z-scores were higher than corresponding CA z-scores. Medications were positively associated with subscapular skinfold [adalimumab (P = 0.018) and methotrexate (P = 0.027)] and BMI CA z-scores [adalimumab (P = 0.029)]. Azathioprine/6-mercaptopurine were negatively associated with MAC (P = 0.045), subscapular skinfold (P = 0.014), weight (P = 0.002) and BMI (P = 0.013) CA z-scores. ESR, CRP, and WBC count were negatively associated, while albumin and IGF-1 BA z-scores were positively associated, with specific AP z-scores (P < 0.05). Mean height CA z-scores were higher in females, not males, treated with infliximab (P = 0.038). Hemoglobin (P = 0.018) was positively associated, while platelets (P = 0.005), ESR (P = 0.003) and CRP (P = 0.039) were negatively associated with height CA z-scores in males, not females.ConclusionOur results suggest poor efficacy of thiopurines and a possible sex difference in statural growth response to infliximab in pediatric CD. Prospective longitudinal studies are required.

Among South African university students, HIV prevalence is lower than in age-peers, but at 3.8% it is not negligible. We examined prevalence of factors potentially associated with HIV risk, focusing on partnership characteristics and consistent condom use. We hypothesised that contraceptive-related factors, for example, desire to prevent pregnancy and not using hormonal contraceptives, would be positively associated with consistent condom use. Data were drawn from a representative interviewer-administered survey of 2nd to 4th year students conducted during registration at a university campus in KwaZulu-Natal. Of 576 students, 218 (83 women, 135 men) reported vaginal intercourse in the past 2 months. Of these, 7% of women and 43% of men reported past-year concurrent partnerships, and 24% knew/ suspected partner non-monogamy. Although reported condom use at last intercourse was 90%, 2-month consistent use was 53% (women) and 73% (men). Reported hormonal contraception use was low (women: 36.8%; men: 16.7%), and 68% used condoms for dual protection. In gender-stratified multivariable analyses, consistent condom use was higher for men who reported their partner did not use (vs. used) hormonal contraception (aOR = 5.84; 95%CI = 2.71, 12.57; p < 0.001) and who reported using condoms for dual protection (vs. single protection) (aOR = 2.46; 95%CI = 1.43, 4.25; p = 0.001). No contraception-related factors were associated with consistent condom use among women. Sexual partnership characteristics potentially place sexually active university students at high HIV risk and should be investigated further. Among men, but not women, contraceptive concerns were associated with consistent condom use. Promoting condoms for dual protection may resonate with students and should be continued.Keywords: concurrent partners, condom use, dual protection, sexual partnerships, sexual risk behaviours, South Africa, young adults

This article summarizes published findings from Project LINKS. A total of 500 men who have sex with men were recruited through Respondent Driven Sampling into this study on factors associated with HIV infection. Among participants, 24.5 % identified as gay, 36.2 % as bisexual, 21.9 % as heterosexual, and 17.4 % as "other"; 33 % reported having sex with men, women, and transgender women during the prior two months. Prevalence of HIV, Hepatitis B, and syphilis was 17.3 %, 22.9 %, and 20.5 %, respectively; rates were significantly higher among participants who only had male sex partners. Over two-thirds of participants reported unprotected anal or vaginal intercourse during the prior two months, and 52 %had never been tested for HIV. Twenty-five percent reported heavy drinking, and 34 % reported poly-drug use during the past two months. Eighteen percent of participants reported a sexual experience prior to the age of thirteen with a partner who was at least four years older. Acceptability of microbicides and HIV home testing was high.

Given the high prevalence of mental health (MH) and substance abuse problems in low-to-middle income countries, the scarcity of MH professionals and the negative impact of psychiatric disorders on caregivers of young children, there is significant need for brief evidence-based screening tools for lay counselors to assist with MH assessment. This study aimed to validate a brief screening tool to assess psychiatric and substance use disorders, the Client Diagnostic Questionnaire (CDQ), in South Africa (SA).Data are from a longitudinal study of health and psychosocial needs in preschool children in SA. Participants included 322 Zulu-speaking, female caregivers. Following procedures of the US CDQ validation study, lay counselors interviewed participants using the translated Zulu CDQ. Subsequently a psychologist conducted a full psychiatric assessment guided by the CDQ questions. Analyses examined sensitivity, specificity and overall accuracy, comparing lay counselor and psychologist assessment.Sensitivity (73%), specificity (81%) and overall accuracy (79%) were good for the variable indicating presence of 'any diagnosis.' Among those cases identified by the psychologist as having any psychiatric diagnosis, over 70% were correctly identified by lay counselors using the CDQ (i.e., positive predictive value was greater than 70%). The false positive rate was relatively low (19%). Specificity for 'any disorder' (including substance use) and 'any psychiatric disorder' were 81% and 79%.The isiZulu CDQ is a sensitive and valid MH diagnostic screener that can be used by lay counselors with limited MH training to identify those in need of treatment and target extremely scarce MH professionals. Copyright © 2016 John WileySons, Ltd.South Africa (SA), a country heavily impacted by poverty, HIV and the legacy of Apartheid, has a high prevalence of mental health (MH) and substance abuse problems. In SA and other low-and-middle-income-countries (LMIC) there is a dearth of MH professionals. This study examined use and validity of the Client Diagnostic Questionnaire (CDQ), a brief diagnostic MH screening tool designed for use by lay counselors in HIV-affected populations. Comparing lay counsellor diagnoses on the CDQ to clinician assessment, sensitivity, specificity and overall accuracy were good at the level of 'any diagnosis.' The CDQ can be used effectively in SA and other LMIC with limited MH services to enable appropriate and efficient referral of individuals in primary care settings, supporting caregivers and the children in their care.

Multimedia technologies offer powerful tools to increase capacity of health workers to deliver standardized, effective, and engaging antiretroviral medication adherence counseling. Masivukeni—is an innovative multimedia-based, computer-driven, lay counselor-delivered intervention designed to help people living with HIV in resource-limited settings achieve optimal adherence. This pilot study examined medication adherence and key psychosocial outcomes among 55 non-adherent South African HIV+ patients, on antiretroviral therapy (ART) for at least 6 months, who were randomized to receive either Masivukeni or standard of care (SOC) counseling for ART non-adherence. At baseline, there were no significant differences between the SOC and Masivukeni groups on any outcome variables. At post-intervention (approximately 5–6 weeks after baseline), -clinic-based pill count adherence data available for 20 participants (10 per intervention arm) showed a 10 % improvement for—participants and a decrease of 8 % for SOC participants. Masivukeni participants reported significantly more positive attitudes towards disclosure and medication social support, less social rejection, and better clinic–patient relationships than did SOC participants. Masivukeni shows promise to promote optimal adherence and provides preliminary evidence that multimedia, computer-based technology can help lay counselors offer better adherence counseling than standard approaches.

Objective—As prenatal genetic testing (GT) and Preimplantation Genetic Diagnosis (PGD) use increase, providers in many specialties may play roles in patient discussions and referrals. Hence, we examined key aspects of neurologists’ and psychiatrists’ views and approaches. Study Design—We surveyed attitudes and practices among 163 neurologists and 372 psychiatrists. Results—24.9% of neurologists and 31.9% of psychiatrists had discussed prenatal GT with patients, but 95.3% didn’t feel comfortable discussing PGD; only 2.9% discussed it; and only 1.8% had patients ask about PGD. Most would refer for PGD for Huntington’s disease (HD) and Tay-Sachs, fewer for Cystic Fibrosis (CF), and fewer still for autism, Alzheimer’s (AD), or gender selection for family balancing; in each of these cases, psychiatrists > neurologists. Providers who’d refer for PGD for HD, CF, or gender selection differed from others in proportions of patients with insurance, were more likely to have undergone a GT themselves, and be concerned about discrimination. Conclusions—These data, the first to examine how neurologists and psychiatrists view PGD, suggest they don’t feel comfortable discussing PGD, but have strong views about its use. Potential PGD use is associated with concerns about discrimination, and less experience with GT. These data highlight needs for enhancing education about these technologies among various providers.

Objective: To compare websites of agencies that broker the services of women who provide human eggs for in vitro fertilization versus clinics that recruit egg providers. Study design: We examined 207 websites, of which 128 were egg provider agency 40%) or clinic (60%) websites that recruited providers online. We compared them regarding several variables related to adherence to American Society for Reproductive Medicine (ASRM) guidelines. Results: According to their respective websites, agencies were more likely than clinics to mention ASRM guidelines, be located in the West/Pacific, indicate compensation, offer a fee range, set their minimum > $5,000, specify preferable traits, cap provider age at 31, require an education minimum, allow both parties to meet, discuss short-term risks, and not acknowledge a possible cancer risk. Only 25.5% of agencies and 19.5% of clinics mention psychological/emotional risks, and 11.8% and 5.2%, respectively, mention risk to future fertility. Conclusion: This research, the first to systematically compare several key aspects of egg provider agencies versus clinics, suggests it significant differences in adherence to guidelines, raising several concerns and suggesting needs for consideration of improved monitoring and regulation by ASRM or others.

To examine compliance with ethical guidelines of the American Society for Reproductive Medicine (ASRM) regarding trait-based payment variation, presentation of risks, and minimum recruitment age.In June 2010, we systematically examined 207 websites, of which 102 were egg donor agency or IVF clinic websites that both recruited online and displayed compensation amounts.The Internet.None.Not applicable.Mention of increased payment for particular donor traits, recruitment age less than 21 years, noting risks to donors.Of the 102 sites, considerable numbers were noncompliant with ASRM's guidelines that prohibit varying compensation based on a donor's traits (34%), and recommend an age of 21 years or older (41%), and presentation of risks alongside compensation (56%). Trait-based payment variation was associated with being an agency rather than a clinic, location in the West, not being endorsed by ASRM or Society of Assisted Reproductive Technology (SART), and referring to ASRM's guidelines about compensation. Of sites mentioning traits, prior donation success was the most commonly paid for trait (64%).Our data, the first to systematically analyze agency and clinic websites reveal that many do not follow ASRM's guidelines. These data have critical implications for policy, practice, and research, suggesting needs for consideration of possible changes in guidelines, and/or improvements in compliance and monitoring by ASRM or others.

Objectives: We investigated how often journal articles reporting on human HIV research in four developing world countries mention any institutional review boards (IRBs) or research ethics committees (RECs), and what factors are involved. Methods: We examined all such articles published in 2007 from India, Nigeria, Thailand and Uganda, and coded these for several ethical and other characteristics. Results: Of 221 articles meeting inclusion criteria, 32.1% did not mention IRB approval. Mention of IRB approval was associated with: biomedical (versus psychosocial) research (P = 0.001), more sponsor‐country authors (P = 0.003), sponsor‐country corresponding author (P = 0.047), mention of funding (P < 0.001), particular host‐country involved (P = 0.002), journals having sponsor‐country editors (P < 0.001), and journal stated compliance with International Committee of Medical Journal Editors (ICMJE) guidelines (P = 0.003). Logistic regression identified 3 significant factors: mention of funding, journal having sponsor‐country editors and research being biomedical. Conclusions: One‐third of articles still do not mention IRB approval. Mention varied by country, and was associated with biomedical research, and more sponsor country involvement. Recently, some journals have required mention of IRB approval, but allow authors to do so in cover letters to editors, not in the article itself. Instead, these data suggest, journals should require that articles document adherence to ethical standards.

Objectives The purpose of Project Gel was to determine the safety and acceptability of rectal microbicides in young men who have sex with men (MSM) and transgender women (TGW) at risk of HIV infection. Methods MSM and TGW aged 18–30 years were enrolled at three sites; Pittsburgh, PA; Boston, MA; and San Juan, PR. Stage 1A was a cross-sectional assessment of sexual health and behavior in MSM and TGW. A subset of participants from Stage 1A were then enrolled in Stage 1B, a 12-week evaluation of the safety and acceptability of a placebo rectal gel. This was followed by the final phase of the study (Stage 2) in which a subset of participants from Stage 1B were enrolled into a Phase 1 rectal safety and acceptability evaluation of tenofovir (TFV) 1% gel. Results 248 participants were enrolled into Stage 1A. Participants’ average age was 23.3 years. The most common sexually transmitted infection (STIs) at baseline were Herpes simplex (HSV)-2 (16.1% by serology) and rectal Chlamydia trachomatis (CT) (10.1% by NAAT). 134 participants were enrolled into Stage 1B. During the 12 week period of follow-up 2 HIV, 5 rectal CT, and 5 rectal Neisseria gonorrhea infections were detected. The majority of adverse events (AEs) were infections (N = 56) or gastrointestinal (N = 46) and were mild (69.6%) or moderate (28.0%). Of the participants who completed Stage 1B, 24 were enrolled into Stage 2 and randomized (1:1) to receive TFV or placebo gel. All participants completed Stage 2. The majority of AEs were gastrointestinal (N = 10) and of mild (87.2%) or moderate (10.3%) severity. Conclusions In this study we were able to enroll a sexually active population of young MSM and TGW who were willing to use rectal microbicides. TFV gel was safe and acceptable and should be further developed as an alternative HIV prevention intervention for this population.

Increasing numbers of perinatally HIV (PHIV+)-infected youth are surviving into adulthood with better access to treatment. However, few studies examine positive outcomes in the face of adversity (resilience) for PHIV+ youth. Social Action Theory (SAT) provided the theoretical framework for this study of PHIV + youth in South Africa (SA), allowing examination of contextual, social, and self-regulatory factors that influence behavioral health. Data were from youth and caregiver baseline interviews, simply pooled from a pilot (N=66) and larger (n=111) randomized control trial (RCT) of the VUKA Family program. For this analysis, outcomes included emotional and behavioral functioning (total difficulties), and prosocial behaviors. Potential SAT correlates included socio-demographics; caregiver health and mental health; parent-child relationship factors; stigma, and child coping, support; and self-esteem. Regression analyses adjusted for age, gender, and study revealed significant associations at the contextual, social, and self-regulation level. Lower total child difficulties scores were associated with lower caregiver depression (β = 3.906,p < .001), less caregiver-reported communication about difficult issues (β = 1.882, p = .009) and higher youth self-esteem (β = -0.119, p = .020). Greater prosocial behaviors were associated with greater caregiver-reported communication (β = 0.722, p = .020) and child use of wishful thinking for coping (β = 5.532, p = .009). Less youth depression was associated with higher caregiver education (β =−0.399, p = .010), greater caregiver supervision (β = −1.261, p = .012), more social support seeking (β = −0.453, p = .002), higher youth self-esteem (β = −0.067, p < .001), lower internalized stigma (β = 0.608, p = .040), and child use of resignation for coping (β = 1.152, p = .041). Our data support evidence-based family interventions that also promote youth self-regulation skills to enhance the health and mental health of PHIV+ youth.

Background Timely linkage to care by newly-diagnosed HIV+ individuals remains a significant challenge to achieving UNAIDS 90-90-90 goals. Current World Health Organization (WHO) guidelines recommend initiating anti-retroviral treatment (ART) regardless of CD4+ count, with priority given to those with CD4+

Trials to assess microbicide safety require strict adherence to prescribed regimens. If adherence is suboptimal, safety cannot be adequately assessed. MTN-017 was a phase 2, randomized sequence, open-label, expanded safety and acceptability crossover study comparing 1) daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), 2) daily use of reduced-glycerin 1% tenofovir (RG-TFV) gel applied rectally, and 3) RG-TFV gel applied before and after receptive anal intercourse (RAI)—if participants had no RAI in a week, they were asked to use two doses of gel within 24 hours. Product use was assessed by mixed methods including unused product return count, text messaging reports, and qualitative plasma TFV pharmacokinetic (PK) results. Convergence interviews engaged participants in determining the most accurate number of doses used based on product count and text messaging reports. Client-centered adherence counseling was also used. Participants (N = 187) were men who have sex with men and transgender women enrolled in the United States (42%), Thailand (29%), Peru (19%) and South Africa (10%). Mean age was 31.4 years (range 18–64 years). Based on convergence interviews, over an 8-week period, 94% of participants had ≥80% adherence to daily tablet, 41% having perfect adherence; 83% had ≥80% adherence to daily gel, 29% having perfect adherence; and 93% had ≥80% adherence to twice-weekly use during the RAI-associated gel regimen, 75% having perfect adherence and 77% having ≥80% adherence to gel use before and after RAI. Only 4.4% of all daily product PK results were undetectable and unexpected (TFV concentrations

Objective: A cross-sectional study was conducted to determine if in-school physical activity (PA) varied by age, gender, weight and asthma status, participation in physical education (PE), outdoor recess, and other in-school PA among urban schoolchildren with asthma. Methods: PA was measured by tri-axial accelerometers. Height and mass were measured and overweight defined as BMI ≥85th percentile. Asthma impairment and risk were assessed as per national guidelines, and asthma status variable with three categories (mild, moderate, and severe) was created. Multivariable generalized linear mixed models adjusting for clustering due to school and student were fitted to identify variables predictive of PA. Results: 108 children with asthma participated. Children spent 374 minutes in school, of which 253 minutes were sedentary, 105 minutes in light PA, and 16 minutes in moderate-to-vigorous PA (MVPA). Only 3 participants reached the recommended ≥30 minutes/day of MVPA. Multivariable analysis revealed age, gender, participation in PE class, outdoor recess, and other in-school PA as independent predictors of PA. BMI and asthma status were not associated with PA. Conclusions: Children with asthma were mostly sedentary at school. Older children and girls were particularly at risk for inactivity. PE, recess, and other in-school PA participation are modifiable factors that should be targeted in school-based interventions aimed at increasing PA in this population. Refereed/Peer-reviewed