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.

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.

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.

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.

Respiratory Medications in Infants <29 Weeks during the First Year Postdischarge: The Prematurity and Respiratory Outcomes Program (PROP) Consortium.

OBJECTIVE: To determine patterns of respiratory medications used in neonatal intensive care unit graduates. STUDY DESIGN: The Prematurity Respiratory Outcomes Program enrolled 835 babies <29 weeks of gestation in the first week. Of 751 survivors, 738 (98%) completed at least 1, and 85% completed all 4, postdischarge medication usage in-person/telephone parental questionnaires requested at 3, 6, 9, and 12 months of corrected age. Respiratory drug usage over the first year of life after in neonatal intensive care unit discharge was analyzed. RESULTS: During any given quarter, 66%-75% of the babies received no respiratory medication and 45% of the infants received no respiratory drug over the first year. The most common postdischarge medication was the inhaled bronchodilator albuterol; its use increased significantly from 13% to 31%. Diuretic usage decreased significantly from 11% to 2% over the first year. Systemic steroids (prednisone, most commonly) were used in approximately 5% of subjects in any one quarter. Inhaled steroids significantly increased over the first year from 9% to 14% at 12 months. Drug exposure changed significantly based on gestational age with 72% of babies born at 23-24 weeks receiving at least 1 respiratory medication but only 40% of babies born at 28 weeks. Overall, at some time in the first year, 55% of infants received at least 1 drug including an inhaled bronchodilator (45%), an inhaled steroid (22%), a systemic steroid (15%), or diuretic (12%). CONCLUSION: Many babies born at <29 weeks have no respiratory medication exposure postdischarge during the first year of life. Inhaled medications, including bronchodilators and steroids, increase over the first year.

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 .

Quantitative Evidence for Revising the Definition of Primary Graft Dysfunction after Lung Transplant.

RATIONALE: Primary graft dysfunction (PGD) is a form of acute lung injury that occurs after lung transplantation. The definition of PGD was standardized in 2005. Since that time, clinical practice has evolved, and this definition is increasingly used as a primary endpoint for clinical trials; therefore, validation is warranted. OBJECTIVES: We sought to determine whether refinements to the 2005 consensus definition could further improve construct validity. METHODS: Data from the Lung Transplant Outcomes Group multicenter cohort were used to compare variations on the PGD definition, including alternate oxygenation thresholds, inclusion of additional severity groups, and effects of procedure type and mechanical ventilation. Convergent and divergent validity were compared for mortality prediction and concurrent lung injury biomarker discrimination. MEASUREMENTS AND MAIN RESULTS: A total of 1,179 subjects from 10 centers were enrolled from 2007 to 2012. Median length of follow-up was 4 years (interquartile range = 2.4-5.9). No mortality differences were noted between no PGD (grade 0) and mild PGD (grade 1). Significantly better mortality discrimination was evident for all definitions using later time points (48, 72, or 48-72 hours; P < 0.001). Biomarker divergent discrimination was superior when collapsing grades 0 and 1. Additional severity grades, use of mechanical ventilation, and transplant procedure type had minimal or no effect on mortality or biomarker discrimination. CONCLUSIONS: The PGD consensus definition can be simplified by combining lower PGD grades. Construct validity of grading was present regardless of transplant procedure type or use of mechanical ventilation. Additional severity categories had minimal impact on mortality or biomarker discrimination.

Drawing from the Theory of Planned Behaviour to examine pre-exposure prophylaxis uptake intentions among heterosexuals in high HIV prevalence neighbourhoods in Philadelphia, Pennsylvania, USA: an observational study.

Background Research surrounding attitudes and intentions concerning pre-exposure prophylaxis (PrEP) among at-risk heterosexuals, women and ethnic and racial minorities is needed to inform programs to scale this effective HIV prevention intervention among these populations. METHODS: The study sample includes 192 HIV-negative heterosexuals recruited from HIV testing sites operating in high HIV prevalence neighbourhoods in a mid-Atlantic city. Participants received brief educational sessions on PrEP and completed a self-administered survey assessing sociodemographic factors, HIV risk behaviours and theoretical determinants of PrEP uptake, based on the Theory of Planned Behaviour. RESULTS: Participants were majority persons of colour (86%), with a median age of 43 years. Compared with Whites, a higher percentage of Black and Brown persons had more than five sex partners (75.0%), used condoms inconsistently (85.6%) and engaged in transactional sex (84.4%). Most expressed positive PrEP attitudes and indicated intention to adopt PrEP, especially if recommended by their doctor. In a multivariable model, willingness to take PrEP if suggested by a healthcare provider (aOR: 4.17; 95% CI: 1.42-12.24) and willingness to take PrEP even if it caused side-effects (aOR: 1.98; 95% CI: 1.01-3.90) were both associated with greater PrEP adoption intentions. CONCLUSIONS: A diverse at-risk population was identified through community-based HIV testing. Low perceived HIV risk, as well as PrEP-related attitudes, subjective norms and perceived behavioural control were associated with PrEP use intentions. These factors are potential targets for interventions to increase PrEP adoption among diverse heterosexual samples.

Polymorphisms in cytochrome P450 are associated with extensive efavirenz pharmacokinetics and CNS toxicities in an HIV cohort in Botswana.

Inter-individual variability in efavirenz (EFV) pharmacokinetics and dynamics is dominantly driven by the polymorphism in cytochrome P450 (CYP) isoenzyme 2B6 516G>T. We hypothesized that additional CYP polymorphisms mediate the relationship between CYP2B6 516G>T, EFV metabolism, and clinical events. We investigated 21 SNPs in 814 HIV-infected adults initiating EFV-based therapy in Botswana for population pharmacokinetics, CNS toxicities, and treatment outcomes. Two SNPs (rs28399499 and rs28399433) showed reduced apparent oral EFV clearance. Four SNPs (rs2279345, rs4803417, rs4802101, and rs61663607) showed extensive clearance. Composite CYP2B-mediated EFV metabolism was significantly associated with CNS toxicity (p = 0.04), with extensive metabolizers reporting more and slow and very slow metabolizers reporting less toxicity after 1 month compared to intermediate metabolizers. Composite CYP2B6 metabolism was not associated with composite early treatment failure. In conclusion, our data suggest that CNS-related toxicities might not be solely the result of super-therapeutic parent EFV concentrations in HIV-infected individuals in patients of African ancestry.

Women's Healthcare Utilization Following Routine Screening for Past-Year Intimate Partner Violence in the Veterans Health Administration.

BACKGROUND: Experience of intimate partner violence (IPV) can have adverse health impacts and has been associated with elevated rates of healthcare service utilization. Healthcare encounters present opportunities to identify IPV-related concerns and connect patients with services. The Veterans Health Administration (VHA) conducts IPV screening within an integrated healthcare system. OBJECTIVE: The objectives of this study were to compare service utilization in the 6 months following IPV screening between those screening positive and negative for past-year IPV (IPV+, IPV-) and to examine the timing and types of healthcare services accessed among women screening IPV+. DESIGN: A retrospective chart review was conducted for 8888 female VHA patients across 13 VHA facilities who were screened for past-year IPV between April 2014 and April 2016. MAIN MEASURES: Demographic characteristics (age, race, ethnicity, marital status, veteran status), IPV screening response, and healthcare encounters (based on visit identification codes). KEY RESULTS: In the 6 months following routine screening for past-year IPV, patients screening IPV+ were more likely to utilize outpatient care (aOR = 1.85 [CI 1.26, 2.70]), including primary care or psychosocial care, and to have an inpatient stay (aOR = 2.09 [CI 1.23, 3.57]), compared with patients screening IPV-. Among those with any utilization, frequency of outpatient encounters within the 6-month period following screening was higher among those screening IPV+ compared with those screening IPV-. The majority of patients screening positive for past-year IPV returned for an outpatient visit within a brief time frame following the screening visit (> 70% within 14 days, >95% within 6 months). More than one in four patients screening IPV+ had an emergency department visit within the 6 months following screening. CONCLUSIONS: Women who screen positive for past-year IPV have high rates of return to outpatient visits following screening, presenting opportunities for follow-up support. Higher rates of emergency department utilization and inpatient stays among women screening IPV+ may indicate adverse health outcomes related to IPV experience.

Bronchopulmonary Dysplasia and Perinatal Characteristics Predict 1-Year Respiratory Outcomes in Newborns Born at Extremely Low Gestational Age: A Prospective Cohort Study.

OBJECTIVE: To assess the utility of clinical predictors of persistent respiratory morbidity in extremely low gestational age newborns (ELGANs). STUDY DESIGN: We enrolled ELGANs (<29 weeks' gestation) at ≤7 postnatal days and collected antenatal and neonatal clinical data through 36 weeks' postmenstrual age. We surveyed caregivers at 3, 6, 9, and 12 months' corrected age to identify postdischarge respiratory morbidity, defined as hospitalization, home support (oxygen, tracheostomy, ventilation), medications, or symptoms (cough/wheeze). Infants were classified as having postprematurity respiratory disease (PRD, the primary study outcome) if respiratory morbidity persisted over ≥2 questionnaires. Infants were classified with severe respiratory morbidity if there were multiple hospitalizations, exposure to systemic steroids or pulmonary vasodilators, home oxygen after 3 months or mechanical ventilation, or symptoms despite inhaled corticosteroids. Mixed-effects models generated with data available at 1 day (perinatal) and 36 weeks' postmenstrual age were assessed for predictive accuracy. RESULTS: Of 724 infants (918 ± 234 g, 26.7 ± 1.4 weeks' gestational age) classified for the primary outcome, 68.6% had PRD; 245 of 704 (34.8%) were classified as severe. Male sex, intrauterine growth restriction, maternal smoking, race/ethnicity, intubation at birth, and public insurance were retained in perinatal and 36-week models for both PRD and respiratory morbidity severity. The perinatal model accurately predicted PRD (c-statistic 0.858). Neither the 36-week model nor the addition of bronchopulmonary dysplasia to the perinatal model improved accuracy (0.856, 0.860); c-statistic for BPD alone was 0.907. CONCLUSION: Both bronchopulmonary dysplasia and perinatal clinical data accurately identify ELGANs at risk for persistent and severe respiratory morbidity at 1 year. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01435187.

Childhood Sexual Abuse and Sociodemographic Factors Prospectively Associated with Intimate Partner Violence Perpetration Among South African Heterosexual Men.

BACKGROUND: Intimate partner violence directed at women by men continues to be a global concern. However, little is known about the factors associated with perpetrating intimate partner violence among heterosexual men. PURPOSE: History of childhood sexual abuse and other sociodemographic variables were examined as potential factors associated with severe intimate partner violence perpetration toward women in a sample of heterosexual men in South Africa. METHODS: Longitudinal logistic generalized estimating equations examined associations of childhood sexual abuse and sociodemographic variables at baseline with intimate partner violence perpetration at subsequent time points. RESULTS: Among participants with a steady female partner, 21.81 % (190/ 871) reported perpetrating intimate partner violence in the past year at baseline. Having a history of childhood sexual abuse (p < .001), binge drinking (p = .002), being employed (p = .050), and more difficulty controlling sexual impulses in order to use a condom (p = .006) at baseline were associated with self-reported intimate partner violence perpetration in the past year at subsequent time points. CONCLUSIONS: With high levels of recent severe physical and/or sexual intimate partner violence perpetration in South Africa, comprehensive interventions are urgently needed. To more fully address gender-based violence, it is important to address associated factors, including exposure to childhood sexual abuse that could impact behavior later in life and that have long-lasting and deleterious effects on men and their female partners.

Disproportionate Mental Health Burden Associated With Past-Year Intimate Partner Violence Among Women Receiving Care in the Veterans Health Administration.

Experience of intimate partner violence (IPV) can lead to mental health conditions, including anxiety, depression, and unhealthy substance use. Women seen in the Veterans Health Administration (VHA) face high rates of both IPV and mental health morbidity. This study aimed to identify associations between recent IPV experience and mental health diagnoses among women VHA patients. We examined medical records data for 8,888 female veteran and nonveteran VHA patients across 13 VHA facilities who were screened for past-year IPV between April, 2014 and April, 2016. Compared with women who screened negative for past-year IPV (IPV-), those who screened positive (IPV+; 8.7%) were more than twice as likely to have a mental health diagnosis, adjusted odds ratio (AOR) = 2.27, 95% confidence interval (CI) [1.95, 2.64]; or more than two mental health diagnoses, AOR = 2.29, 95% CI [1.93, 2.72]). Screening IPV+ was also associated with significantly higher odds of each type of mental health morbidity (AOR range = 1.85-3.19) except psychoses. Over half (53.5%) of the women who screened IPV+ had a mental health diagnosis, compared with fewer than one-third (32.6%) of those who screened IPV-. Each subtype of IPV (psychological, physical, and sexual violence) was significantly associated with having a mental health diagnosis (AOR range = 2.25-2.37) or comorbidity (AOR range = 2.17-2.78). Associations remained when adjusting for military sexual trauma and combat trauma among the veteran subsample. These findings highlight the mental health burden associated with past-year IPV among female VHA patients and underscore the need to address psychological and sexual IPV, in addition to physical violence.

A comparative effectiveness education trial for lifestyle health behavior change in African Americans.

Obesity and excess weight are significant clinical and public health issues that disproportionately affect African Americans because of physical inactivity and unhealthy eating. We compared the effects of alternate behavioral interventions on obesity-related health behaviors. We conducted a comparative effectiveness education trial in a community-based sample of 530 adult African Americans. Outcomes variables were physical activity (PA) and fruit and vegetable intake. Outcomes were evaluated at baseline and 1-month following interventions about shared risk factors for cancer and cardiovascular disease (CVD) (integrated, INT) or CVD only (disease-specific). Significant increases were found in the proportion of participants who met PA guidelines from baseline (47.4%) to follow-up (52.4%) (P = 0.005). In the stratified analysis that were conducted to examine interaction between education and intervention group assignment, this effect was most apparent among participants who had ≤high school education and were randomized to INT (OR = 2.28, 95% CI = 1.04, 5.00, P = 0.04). Completing the intervention was associated with a 1.78 odds of meeting PA guidelines (95% CI = 1.02, 3.10, P = 0.04). Education about risk factors for chronic disease and evidence-based strategies for health behavior change may be useful for addressing obesity-related behaviors among African Americans.

Framing Financial Incentives to Increase Physical Activity Among Overweight and Obese Adults: A Randomized, Controlled Trial.

BACKGROUND: Financial incentive designs to increase physical activity have not been well-examined. OBJECTIVE: To test the effectiveness of 3 methods to frame financial incentives to increase physical activity among overweight and obese adults. DESIGN: Randomized, controlled trial. (ClinicalTrials.gov: NCT 02030119). SETTING: University of Pennsylvania. PARTICIPANTS: 281 adult employees (body mass index ≥27 kg/m2). INTERVENTION: 13-week intervention. Participants had a goal of 7000 steps per day and were randomly assigned to a control group with daily feedback or 1 of 3 financial incentive programs with daily feedback: a gain incentive ($1.40 given each day the goal was achieved), lottery incentive (daily eligibility [expected value approximately $1.40] if goal was achieved), or loss incentive ($42 allocated monthly upfront and $1.40 removed each day the goal was not achieved). Participants were followed for another 13 weeks with daily performance feedback but no incentives. MEASUREMENTS: Primary outcome was the mean proportion of participant-days that the 7000-step goal was achieved during the intervention. Secondary outcomes included the mean proportion of participant-days achieving the goal during follow-up and the mean daily steps during intervention and follow-up. RESULTS: The mean proportion of participant-days achieving the goal was 0.30 (95% CI, 0.22 to 0.37) in the control group, 0.35 (CI, 0.28 to 0.42) in the gain-incentive group, 0.36 (CI, 0.29 to 0.43) in the lottery-incentive group, and 0.45 (CI, 0.38 to 0.52) in the loss-incentive group. In adjusted analyses, only the loss-incentive group had a significantly greater mean proportion of participant-days achieving the goal than control (adjusted difference, 0.16 [CI, 0.06 to 0.26]; P = 0.001), but the adjusted difference in mean daily steps was not significant (861 [CI, 24 to 1746]; P = 0.056). During follow-up, daily steps decreased for all incentive groups and were not different from control. LIMITATION: Single employer. CONCLUSION: Financial incentives framed as a loss were most effective for achieving physical activity goals. PRIMARY FUNDING SOURCE: National Institute on Aging.

Individual Versus Team-Based Financial Incentives to Increase Physical Activity: A Randomized, Controlled Trial.

BACKGROUND: More than half of adults in the United States do not attain the minimum recommended level of physical activity to achieve health benefits. The optimal design of financial incentives to promote physical activity is unknown. OBJECTIVE: To compare the effectiveness of individual versus team-based financial incentives to increase physical activity. DESIGN: Randomized, controlled trial comparing three interventions to control. PARTICIPANTS: Three hundred and four adult employees from an organization in Philadelphia formed 76 four-member teams. INTERVENTIONS: All participants received daily feedback on performance towards achieving a daily 7000 step goal during the intervention (weeks 1- 13) and follow-up (weeks 14- 26) periods. The control arm received no other intervention. In the three financial incentive arms, drawings were held in which one team was selected as the winner every other day during the 13-week intervention. A participant on a winning team was eligible as follows: $50 if he or she met the goal (individual incentive), $50 only if all four team members met the goal (team incentive), or $20 if he or she met the goal individually and $10 more for each of three teammates that also met the goal (combined incentive). MAIN MEASURES: Mean proportion of participant-days achieving the 7000 step goal during the intervention. KEY RESULTS: Compared to the control group during the intervention period, the mean proportion achieving the 7000 step goal was significantly greater for the combined incentive (0.35 vs. 0.18, difference: 0.17, 95 % confidence interval [CI]: 0.07-0.28, p <0.001) but not for the individual incentive (0.25 vs 0.18, difference: 0.08, 95 % CI: -0.02-0.18, p = 0.13) or the team incentive (0.17 vs 0.18, difference: -0.003, 95 % CI: -0.11-0.10, p = 0.96). The combined incentive arm participants also achieved the goal at significantly greater rates than the team incentive (0.35 vs. 0.17, difference: 0.18, 95 % CI: 0.08-0.28, p < 0.001), but not the individual incentive (0.35 vs. 0.25, difference: 0.10, 95 % CI: -0.001-0.19, p = 0.05). Only the combined incentive had greater mean daily steps than control (difference: 1446, 95 % CI: 448-2444, p ≤ 0.005). There were no significant differences between arms during the follow-up period (weeks 14- 26). CONCLUSIONS: Financial incentives rewarded for a combination of individual and team performance were most effective for increasing physical activity. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT02001194.

Mediation Analysis of the Efficacy of the Eban HIV/STD Risk-Reduction Intervention for African American HIV Serodiscordant Couples.

Targeting couples is a promising behavioral HIV risk-reduction strategy, but the mechanisms underlying the effects of such interventions are unknown. We report secondary analyses testing whether Social-Cognitive-Theory variables mediated the Eban HIV-risk-reduction intervention's effects on condom-use outcomes. In a multisite randomized controlled trial conducted in four US cities, 535 African American HIV-serodiscordant couples were randomized to the Eban HIV risk-reduction intervention or attention-matched control intervention. Outcomes were proportion condom-protected sex, consistent condom use, and frequency of unprotected sex measured pre-, immediately post-, and 6 and 12 months post-intervention. Potential mediators included Social-Cognitive-Theory variables: outcome expectancies and self-efficacy. Mediation analyses using the product-of-coefficients approach in a generalized-estimating-equations framework revealed that condom-use outcome expectancy, partner-reaction outcome expectancy, intention, self-efficacy, and safer-sex communication improved post-intervention and mediated intervention-induced improvements in condom-use outcomes. These findings underscore the importance of targeting outcome expectancies, self-efficacy, and safer-sex communication in couples-level HIV risk-reduction interventions.

Evaluation of a Mobile Health Approach to Tuberculosis Contact Tracing in Botswana.

Tuberculosis (TB) contact tracing is typically conducted in resource-limited settings with paper forms, but this approach may be limited by inefficiencies in data collection, storage, and retrieval and poor data quality. In Botswana, we developed, piloted, and evaluated a mobile health (mHealth) approach to TB contact tracing that replaced the paper form-based approach for a period of six months. For both approaches, we compared the time required to complete TB contact tracing and the quality of data collected. For the mHealth approach, we also administered the Computer System Usability Questionnaire to 2 health care workers who used the new approach, and we identified and addressed operational considerations for implementation. Compared to the paper form-based approach, the mHealth approach reduced the median time required to complete TB contact tracing and improved data quality. The mHealth approach also had favorable overall rating, system usefulness, information quality, and interface quality scores on the Computer System Usability Questionnaire. Overall, the mHealth approach to TB contact tracing improved on the paper form-based approach used in Botswana. This new approach may similarly benefit TB contact tracing efforts in other resource-limited settings.

Increased mucosal CD4+ T cell activation in rhesus macaques following vaccination with an adenoviral vector.

UNLABELLED: The possibility that vaccination with adenovirus (AdV) vectors increased mucosal T cell activation remains a central hypothesis to explain the potential enhancement of HIV acquisition within the Step trial. Modeling this within rhesus macaques is complicated because human adenoviruses, including human adenovirus type 5 (HAdV-5), are not endogenous to macaques. Here, we tested whether vaccination with a rhesus macaque-derived adenoviral vector (simian adenovirus 7 [SAdV-7]) enhances mucosal T cell activation within rhesus macaques. Following intramuscular SAdV-7 vaccination, we observed a pronounced increase in SAdV-7-specific CD4(+) T cell responses in peripheral blood and, more dramatically, in rectal mucosa tissue. Vaccination also induced a significant increase in the frequency of activated memory CD4(+) T cells in SAdV-7- and HAdV-5-vaccinated animals in the rectal mucosa but not in peripheral blood. These fluctuations within the rectal mucosa were also associated with a pronounced decrease in the relative frequency of naive resting CD4(+) T cells. Together, these results indicate that peripheral vaccination with an AdV vector can increase the activation of mucosal CD4(+) T cells, potentially providing an experimental model to further evaluate the role of host-vector interactions in increased HIV acquisition after AdV vector vaccination. IMPORTANCE: The possibility that vaccination with a human adenovirus 5 vector increased mucosal T cell activation remains a central hypothesis to explain the potential enhancement of human immunodeficiency virus (HIV) acquisition within the Step trial. In this study, we tested whether vaccination with a rhesus macaque-derived adenoviral vector in rhesus macaques enhances mucosal CD4(+) T cell activation, the main cell target of simian immunodeficiency virus (SIV)/HIV. The results showed that vaccination with an adenoviral vector indeed increases activation of mucosal CD4(+) T cells and potentially increases susceptibility to SIV infection.

Mediation of an efficacious HIV risk reduction intervention for South African men.

"Men, Together Making a Difference!" is an HIV/STD risk-reduction intervention that significantly increased self-reported consistent condom use during vaginal intercourse compared with a health-promotion attention-control intervention among men (N = 1181) in Eastern Cape Province, South Africa. The present analyses were designed to identify mediators of the intervention's efficacy. The potential mediators were Social Cognitive Theory (SCT) constructs that the intervention targeted, including several aspects of condom-use self-efficacy, outcome expectancies, and knowledge. Mediation was assessed using a product-of-coefficients approach where an α path (the intervention's effect on the potential mediator) and a ß path (the potential mediator's effect on the outcome of interest, adjusting for intervention) were estimated independently in a generalized estimating equations framework. Condom-use negotiation self-efficacy, technical-skill self-efficacy, and impulse-control self-efficacy were significant mediators. Although not mediators, descriptive norm and expected friends' approval of condom use predicted subsequent self-reported condom use, whereas the expected approval of sexual partner did not. The present results suggest that HIV/STD risk-reduction interventions that draw upon SCT and that address self-efficacy to negotiate condom use, to apply condoms correctly, and to exercise sufficient control when sexually aroused to use condoms may contribute to efforts to reduce sexual risk behavior among South African men. Future research must examine whether approaches that build normative support for condom use among men's friends are also efficacious.