A Per-Protocol Analysis Using Inverse-Probability-of-Censoring Weights in a Randomized Trial of Initial Protease Inhibitor Versus Nonnucleoside Reverse Transcriptase Inhibitor Regimens in Children.

Protocol adherence may influence measured treatment effectiveness in randomized controlled trials. Using data from a multicenter trial (Europe and the Americas, 2002-2009) of children with human immunodeficiency virus type 1 who had been randomized to receive initial protease inhibitor (PI) versus nonnucleoside reverse transcriptase inhibitor (NNRTI) antiretroviral therapy regimens, we generated time-to-event intention-to-treat (ITT) estimates of treatment effectiveness, applied inverse-probability-of-censoring weights to generate per-protocol efficacy estimates, and compared shifts from ITT to per-protocol estimates across and within treatment arms. In ITT analyses, 263 participants experienced 4-year treatment failure probabilities of 41.3% for PIs and 39.5% for NNRTIs (risk difference = 1.8% (95% confidence interval (CI): -10.1, 13.7); hazard ratio = 1.09 (95% CI: 0.74, 1.60)). In per-protocol analyses, failure probabilities were 35.6% for PIs and 29.2% for NNRTIs (risk difference = 6.4% (95% CI: -6.7, 19.4); hazard ratio = 1.30 (95% CI: 0.80, 2.12)). Within-arm shifts in failure probabilities from ITT to per-protocol analyses were 5.7% for PIs and 10.3% for NNRTIs. Protocol nonadherence was nondifferential across arms, suggesting that possibly better NNRTI efficacy may have been masked by differences in within-arm shifts deriving from differential regimen forgiveness, residual confounding, or chance. A per-protocol approach using inverse-probability-of-censoring weights facilitated evaluation of relationships among adherence, efficacy, and forgiveness applicable to pediatric oral antiretroviral regimens.

Feasibility, Acceptability and Appropriateness of MedViewer: A Novel Hair-Based Antiretroviral Real-Time Clinical Monitoring Tool Providing Adherence Feedback to Patients and Their Providers.

Antiretroviral therapy (ART) adherence is key to achieving viral load suppression and ending the HIV epidemic but monitoring and supporting adherence using current interventions is challenging. We assessed the feasibility, acceptability and appropriateness of MedViewer (MV), a novel intervention that provides real-time adherence feedback for patients and providers using infra-red matrix-assisted laser desorption electrospray ionization (IR-MALDESI) for mass spectrometry imaging of daily ART concentrations in patients' hair. We used mixed methods to feasibility test MV at a busy Infectious Diseases (ID) clinic, enrolling 16 providers and 36 patients. Providers underwent standardized training; patients and providers watched an 8-min informational video about MV. We collected patient and provider data at baseline and within 24 h of clinic visits and, with patients, approximately 1 month after clinic visits. MedViewer was feasible, liked by patients and providers, and perceived to help facilitate adherence conversations and motivate patients to improve adherence. Trial Registration: NCT04232540.

Institutional Reform to Promote Antiracism: A Tool for Developing an Organizational Equity Action and Accountability Plan.

Racism is a public health problem. Systems, structures, policies, and practices perpetuate a culture built on racism. Institutional reform is needed to promote antiracism. This article describes 1) a tool used to develop an equity action and accountability plan (EAAP) that promotes antiracism in the Department of Health Behavior at the University of North Carolina at Chapel Hill's Gillings School of Global Public Health, 2) strategies that were developed, and 3) short-term outcomes and lessons learned. A study coordinator, not affiliated with the Department of Health Behavior, was hired to collect qualitative data that documented the lived experiences of students and alumni of color (ie, racial and ethnic minority students) over time in the department. Seeking action from faculty and departmental leadership, students engaged in collective organizing covered the department chair's office door with notes describing microaggressions, and visited faculty one-on-one to demand action. In response, 6 faculty members volunteered to form the Equity Task Force (ETF) to explicitly address students' concerns. The ETF identified priority areas for action based on 2 student-led reports, gathered resources from other institutions and the public health literature, and examined departmental policies and procedures. The ETF drafted the EAAP, solicited feedback, and revised it according to 6 priority strategies with actionable steps: 1) transform culture and climate, 2) enhance teaching, mentoring, and training, 3) revisit performance and evaluation of faculty and staff, 4) strengthen recruitment and retention of faculty of color, 5) increase transparency in student hiring practices and financial resources, and 6) improve equity-oriented research practices. This planning tool and process can be used by other institutions to achieve antiracist reform.

Did the 2015 USPSTF Abnormal Blood Glucose Recommendations Change Clinician Attitudes or Behaviors? A Mixed-Method Assessment.

BACKGROUND: In 2015, the US Preventive Services Task Force (USPSTF) revised clinical recommendations to more broadly recommend abnormal blood glucose screening and more clearly recommend referral to behavioral interventions for adults with prediabetes. OBJECTIVE: To assess the effects of the 2015 USPSTF recommendation changes on abnormal blood glucose screening and referral to behavioral interventions, and to examine physicians' perceptions of the revised recommendation. DESIGN: We utilized a sequential, dependent mixed-methods triangulation design. PARTICIPANTS: A total of 33,444 patients meeting USPSTF abnormal blood glucose screening criteria within 15 health system-affiliated primary care practices and 20 primary care physicians in North Carolina. MAIN MEASURES: We assessed monthly abnormal blood glucose screening rate and monthly referral rate to behavioral interventions. To estimate trend changes in outcomes, we used segmented linear regression analysis of interrupted time-series data. We gathered physicians' perspectives on the 2015 USPSTF abnormal blood glucose recommendation including awareness of, agreement with, adoption of, and adherence to the recommendation. To analyze qualitative data, we used directed content analysis. KEY RESULTS: There was a slight significant change in trend in abnormal blood glucose screening rates post-recommendation. There was a slight, statistically significant decrease in referral rates to behavioral interventions post-recommendation. Physicians were generally unaware of the revisions to the 2015 USPSTF abnormal blood glucose recommendation; however, once the recommendations were described, physicians agreed with the screening recommendation but felt that the behavioral intervention referral recommendation was hard to implement. CONCLUSION: The 2015 USPSTF abnormal blood glucose guideline had little to no effect on abnormal blood glucose screening or referral to behavioral interventions in North Carolina practices. Potential interventions to improve these rates could include clinical decision tools embedded in the electronic health record and better referral systems for community-based diabetes prevention programs.

Validated HIV Knowledge Scales for Use with Adults and Adolescents: A Systematic Review.

HIV knowledge - the information a person possesses about HIV - is essential for the prevention and management of HIV. Therefore, the accurate measurement of HIV knowledge is important for both science and practice. This systematic review identifies extant HIV knowledge scales that have been validated with adolescent and adult populations and summarizes the state of this research. We searched seven electronic databases, which resulted in 6,525 articles. After title/abstract and full-text review, 27 studies remained and underwent qualitative review of reported scale psychometric properties. Many studies were conducted in the last decade (n = 12), reflecting advances in scientific knowledge of HIV. Five were exclusively adolescent-based studies (sample age ≤ 18). Most studies reported reliability (n = 25) or at least one form of validity (n = 21). Future studies should develop or refine HIV knowledge scales so that they reflect recent scientific developments, use rigorous psychometric testing, and target samples that include those persons at highest risk for HIV.

"If I Get Cured, My Whole Quality of Life Will Change": Patients' Anticipated and Actualized Benefits Following Cure from Chronic Hepatitis C.

BACKGROUND: Patients' motivations for undergoing direct-acting antiviral (DAA) therapy for chronic hepatitis C may include anticipation of treatment benefits not well described in the literature. AIMS: Evaluate patients' anticipated and actualized improvements in several domains of functioning before and after viral cure. METHODS: Pre-post-study utilizing in-depth interviews with 28 patients prior to, and several months after, DAA therapy. Interviews were audio-recorded, transcribed, coded, and analyzed by two qualitative experts. RESULTS: Patients had a median age of 54 years, 43% were male, 57% white, 25% had cirrhosis, and 71% were treated with sofosbuvir/ledipasvir. Pre-treatment, patients hoped for improvements in several domains including psychological, emotional, physical, social, and occupational functioning. After viral cure, increased energy and less fear of transmission were pathways to better quality of life. Psychological and emotional improvements positively affected physical, social, and occupational functioning. Social improvements were due to better mood and motivation, fewer symptoms, and reduced fear of stigma and transmission. Occupational benefits were linked to increased stamina, self-confidence, and less pain, anxiety, and stigma. Reduced fear of stigma had a pervasive impact on all life improvements after cure. Patient characteristics such as the presence of cirrhosis or psychiatric issues influence treatment motivations. Qualitative data correspond with change in pre-post-survey scores. CONCLUSIONS: Tremendous hope is placed on the ability of DAA therapy to bring about substantial improvements in life functioning after viral cure. Highly interconnected effects on quality of life worked synergistically through improved physical and psychological well-being. Stakeholders should appreciate the multi-dimensional benefits that viral eradication bestows upon individuals and society.

Willingness to participate in research among black patients with liver disease: A national cross-sectional study.

In the United States, Black people are disproportionately diagnosed with hepatitis C virus (HCV) compared with White people but are under-represented in HCV studies. In this US-based cross-sectional telephone survey study, we assessed willingness to participate (WTP) in health/medical research and attitudes and beliefs that may influence WTP among Black patients with HCV. Two hundred participants who had current or prior HCV diagnosis and self-identified as Black or African American were recruited from a national HCV cohort study and an outpatient hepatology clinic. WTP responses ranged from 1 (not at all willing) to 5 (very willing). Multivariable models were used to identify factors associated with the overall mean WTP score. In addition, an open-ended question solicited strategies to help increase research participation from the Black community. Overall, participants reported moderate WTP in research (Mean [95% Confidence Interval (CI)] = 3.78 [3.68, 3.88]). Of 13 types of research presented, participants reported lowest WTP for randomized controlled trials of medications (Mean [95% CI] = 2.31 [2.11, 2.50]). The initial multivariable model identified higher subjective knowledge of research as positively associated with WTP (Parameter estimate [95% CI] = 0.15 [0.02, 0.27]). Sensitivity analyses also identified higher perceived benefits of research as an additional factor associated with WTP. Qualitative findings indicate that greater community-based outreach efforts would increase accessibility of research opportunities. When given the opportunity to participate, Black participants with HCV reported moderate WTP in health/medical research. Research sponsors and investigators should employ community-based outreach to expand access and awareness of research opportunities.

Patient-reported outcomes 12 months after hepatitis C treatment with direct-acting antivirals: Results from the PROP UP study.

BACKGROUND & AIMS: The long-term impact of hepatitis C virus (HCV) therapy with all-oral direct-acting antivirals (DAAs) on patient-reported outcomes (PROs) has not been well-described. We characterized changes in PROs from pre-treatment to 12 months post-treatment in a real-world cohort. METHODS: PROP UP was a multi-centre observational cohort study of 1601 patients treated with DAAs at 11 US gastroenterology/hepatology practices from 2015 to 2017. PROs were evaluated pre-treatment (T1) and 12 months post-treatment (T5). A minimally important change (MIC) threshold was prespecified as >5% change in PRO scores from T1 to T5. Multivariable analyses identified predictors of change. RESULTS: Three-quarters of patients were 55 or older; 45% were female, 60% were white, 33% were black, nearly half had cirrhosis. The most commonly-prescribed DAA regimens were sofosbuvir-based (83%) and grazoprevir/elbasvir (11%). Study retention was >95%. On average, small improvements were observed at 3 months post-treatment in all PROs and sustained at 12 months post-treatment among patients with sustained virologic response (SVR). Clinically meaningful improvements were achieved in fatigue (mean change score: -3.7 [-4.2, -3.1]), sleep (mean change score: -3.1 [-3.7, -2.5]), abdominal pain (mean change score: -2.6 [-3.3, -1.9]) and functional well-being (mean change score: -7.0 [-6.0, -8.0]). Symptom improvements were generally not sustained with no SVR (n = 52). Patients with cirrhosis and MELD ≥12 had the greatest improvements in functional well-being (-12.9 [-17.6, -8.1]). CONCLUSIONS: The improvements in patient-reported outcomes reported by patients who achieved SVR following HCV DAA therapy were durable at 12 months post-treatment.

Awareness of and attitudes toward pre-exposure prophylaxis among African American women living in low-income neighborhoods in a Southeastern city.

African American women in the South are disproportionately affected by HIV but have often been ignored in HIV prevention efforts, including in the rollout of pre-exposure prophylaxis (PrEP). To inform strategies to promote PrEP awareness and access in this population, we conducted a venue-based community survey with 53 African American women living in low-income neighborhoods of a Southeastern city to understand women's knowledge of and attitudes toward PrEP. Awareness of PrEP was very low (37%) with only 16% being aware that PrEP is used for HIV prevention. The vast majority of women (85%) reported that they would use or would consider using PrEP, most frequently citing a general interest in HIV prevention or a lack of awareness of their partners' HIV status as motivations for their interest. Some women expressed concerns about side effects or low perceived HIV risk as disincentives for PrEP use. Information regarding side effects and HIV risk assessments will be needed to ensure the acceptable delivery of PrEP in this population.

Medication Non-adherence in a Prospective, Multi-center Cohort Treated with Hepatitis C Direct-Acting Antivirals.

BACKGROUND: The prevalence and risk factors for non-adherence to direct-acting antivirals (DAAs) for chronic hepatitis C virus (HCV) in clinical practice settings are under-studied. OBJECTIVES: (1) To quantify DAA non-adherence in the total cohort and among subgroups with and without mental health conditions, alcohol use, and substance use, and (2) to investigate patient- and treatment-level risk factor non-adherence. DESIGN: Prospective, observational cohort study. PARTICIPANTS: A total of 1562 patients receiving DAAs between January 2016 and October 2017 at 11 US medical centers including academic and community practices. MAIN MEASURES: Self-reported medication non-adherence, defined as any missed doses in the past 7 days, surveyed early (T2: at 4 ± 2 weeks) and late in treatment (T3: 2-3 weeks prior to end of treatment). Non-adherence to post-treatment follow-up visits was defined as absence of lab results after DAA therapy completion. KEY RESULTS: Of 1447 patients, 162 (11%) reported non-adherence at T2 or T3. Medical records indicated 262 (17%) of the 1562 participants had not returned for post-treatment visits. At baseline, 37% of patients reported mental health conditions, 15% reported alcohol use, and 23% reported using substances in the previous year. Baseline characteristics associated with DAA non-adherence included alcohol use (OR 1.96), younger age (< 35 years vs. > 55 years: OR 3.40), non-white race (OR > 2.26), and DAA treatment cohort, but not substance use or mental health condition. Non-adherence to follow-up exhibited association with younger age and a higher baseline overall symptom burden. Among 1287 patients with evaluable sustained virologic response (SVR) data, 53 patients (4%) did not achieve SVR. The bivariate correlation between adherence and SVR was negligible (r = 0.01). CONCLUSIONS: DAA non-adherence was low and SVR rates were high. Mental health conditions, substance use, and alcohol use should not disqualify patients from DAA therapy. Patients with alcohol use disorder before DAA therapy initiation may benefit from targeted on-treatment support.

Preferences for Pre-exposure Prophylaxis Service Delivery Among Female Sex Workers in Malawi: A Discrete Choice Experiment.

Female sex workers (FSW) in Malawi have among the highest HIV prevalence estimates worldwide. Daily oral pre-exposure prophylaxis (PrEP) is an effective HIV prevention method, yet preferences for PrEP delivery among FSW are lacking. Eight focus group discussions, a literature review, and cognitive interviews were conducted to identify modifiable PrEP delivery attributes and inform discrete-choice experiment (DCE) development for FSW in Lilongwe. Enrolled FSW received an interviewer-assisted DCE. Data were analyzed using mixed logit regression. Dispensing location was most preferred, followed by the provision of additional services. Women preferred receiving PrEP at family planning clinics or non-governmental organization run drop-in centers. Cervical cancer screening was the most preferred additional service, while pregnancy testing and partner risk reduction counseling were less valued. This study was the first study to examine PrEP delivery preferences in Malawi using DCE-a powerful elicitation tool to apply to other key populations at risk for HIV.

Challenges for accessing and maintaining good quality of HIV care among men who have sex with men living with HIV in China: a qualitative study with key stakeholders.

HIV care in China is shifting toward a community-based model involving a wide range of stakeholders. We aimed to understand key stakeholders' perceived challenges of providing high-quality care for men who have sex with men (MSM) living with HIV. In-depth interviews were conducted with a diverse sample of stakeholders (N = 17) in two Chinese cities, including providers, policymakers, and community workers. Interviews focused on stakeholders' challenges in HIV-related work and perceived barriers for MSM in accessing and maintaining HIV care. Thematic analysis strategies were used. Three cross-cutting themes related to accessibility and quality of care (QoC) emerged. First, MSM- and HIV-related stigma were perceived to increase the risk of MSM dropping out of care. While acknowledging stigma, some providers also expressed discriminatory views such as stereotypes of the MSM community. Second, stakeholders expressed concerns about QoC including healthcare workforce shortages, limited training opportunities, and high work stress while facing increasingly unmet needs from clients. Third, stakeholders shared challenges in mobilizing community resources to expand HIV care including unclear division of responsibility and strict auditing. Supportive policies and resources may be needed to bolster China's primary care workforce and MSM-competent care and, more broadly, high QoC for sexual and gender minority patients.

Female adherence self-efficacy before and after couple HIV testing and counseling within Malawi's Option B+ program.

Adherence self-efficacy, belief in one's ability to adhere to daily medication, is strongly associated with antiretroviral therapy (ART) adherence and preventing mother-to-child HIV transmission. Couple-based interventions could enhance self-efficacy and adherence. We assessed the relationship between couple HIV testing and counseling (cHTC) and adherence self-efficacy using a 100-point culturally-adapted adherence self-efficacy scale (ASES). Secondarily, we explored the relationship between ASES and ART adherence. Ninety HIV-positive pregnant women at an antenatal clinic in Lilongwe, Malawi were enrolled in an observational cohort study. They were assessed with ASES immediately before and one month after receiving cHTC. Median ASES scores were 100 (IQR 95, 100) before and 100 (IQR 99, 100) after cHTC; there was a significant median difference (p = 0.02) for participants before and after cHTC. This change in ASES scores was associated with the odds of self-reported ART adherence in the full population (OR 1.1, p = 0.01), and there was a trend in the same direction for participants with imperfect baseline ASES scores (OR 1.1, p = 0.2). In our population, adherence self-efficacy and ART adherence were both quite high, and those who had room to improve in self-efficacy may have benefited from cHTC, which in turn could impact ART adherence and ultimately mother-to-child transmission.

Patient-reported symptoms during and after direct-acting antiviral therapies for chronic hepatitis C: The PROP UP study.

BACKGROUND & AIMS: A comprehensive analysis of changes in symptoms and functioning during and after direct-acting antiviral (DAA) therapy for chronic hepatitis C virus (HCV) infection has not been conducted for patients treated in real-world clinical settings. Therefore, we evaluated patient-reported outcomes (PROs) in a diverse cohort of patients with HCV treated with commonly prescribed DAAs. METHODS: PROP UP is a US multicenter observational study of 1,601 patients with HCV treated with DAAs in 2016-2017. PRO data were collected at baseline (T1), early on-treatment (T2), late on-treatment (T3) and 3-months post-treatment (T4). PRO mean change scores were calculated from baseline and a minimally important change (MIC) threshold was set at 5%. Regression analyses investigated patient and treatment characteristics independently associated with PRO changes on-treatment and post-treatment. RESULTS: Of 1,564 patients, 55% were male, 39% non-white, 47% had cirrhosis. Sofosbuvir/ledipasvir was prescribed to 63%, sofosbuvir/velpatasvir to 21%, grazoprevir/elbasvir to 11%, and paritaprevir/ombitasvir/ritonavir + dasabuvir to 5%. During DAA therapy, mean PRO scores improved slightly in the overall cohort, but did not reach the 5% MIC threshold. Between 21-53% of patients experienced >5% improved PROs while 23-36% experienced >5% worse symptoms. Of 1,410 patients with evaluable sustained virologic response (SVR) data, 95% achieved SVR. Among those with SVR, all mean PRO scores improved, with the 5% MIC threshold met for fatigue, sleep disturbance, and functioning well-being. Regression analyses identified subgroups, defined by age 35-55, baseline mental health issues and a higher number of health comorbidities as predictors of PRO improvements. CONCLUSIONS: In real-world clinical practices, we observed heterogeneous patient experiences during and after DAA treatment. Symptom improvements were more pronounced in younger patients, those with baseline mental health issues and multiple comorbidities. LAY SUMMARY: Patients who received direct-acting antiviral medications for hepatitis C at several liver centers in the US did not generally experience significant changes in baseline symptoms during treatment. We observed a full range of patient experiences with some patients experiencing substantial symptom improvements, yet others experiencing less improvements and some even experiencing a worsening of symptoms. The 1,346 patients who were cured of hepatitis C experienced improvements in fatigue, sleep disturbance, and functional well-being, and trends for improved pain and depression; whereas the 64 who were not cured experienced minimal improvements. Clinicaltrial.gov: NCT02601820.

The Relationship Between Economic Deprivation, Housing Instability and Transactional Sex Among Women in North Carolina (HPTN 064).

Transactional sex is associated with socioeconomic disadvantage and HIV risk but few studies in the United States (US) have examined both individual and area-level predictors of transactional sex or distinguished transactional sex from sex work. We combined data from HIV Prevention Trials Network 064 study and the US Census to estimate prevalence ratios (PR) for the relationship between census-level and individual measures of economic deprivation and housing instability on transactional sex in 417 women in North Carolina. Increased transactional sex was associated with food insecurity (PR 1.86; 95%; CI 1.57, 2.19), housing instability (PR 1.33; 95% CI 1.11, 1.59), substance abuse (PR 1.90; 95% CI 1.64, 2.19) and partner incarceration (PR 1.32; 95% CI 1.09, 1.61). Census-level indicators were not associated with transactional sex, adjusted for individual-level covariates. Interventions should support housing stability and financial opportunities among southern African American women to reduce HIV risk, particularly among women with incarcerated partners.

Underutilization of HIV Testing Among Men with Incarceration Histories.

Annual HIV testing is recommended for individuals at high risk of infection, specifically incarcerated populations. Incarcerated men carry a higher lifetime risk of acquiring HIV than the general population, yet little is known about their HIV testing behaviors. We collected Audio Computer Assisted Self Interview data for 819 men entering a state prison in North Carolina. We assessed correlates of previous HIV testing, including stigmatizing attitudes and beliefs, and explored two outcomes: (1) ever HIV tested before current incarceration, and (2) recency of last HIV test. Eighty percent had been HIV tested before; of those, 36% reported testing within the last year. Being African American, having education beyond high school, prior incarceration, and higher HIV knowledge increased odds of ever having tested. Results of this study highlight the need to expand HIV testing and education specific to incarcerated populations. Additionally, efforts should be made to monitor and encourage repeat screening.

Drug Use Mediates the Relationship Between Depressive Symptoms and Adherence to ART Among Recently Incarcerated People Living with HIV.

Depression is a known risk factor for antiretroviral therapy (ART) non-adherence, but little is known about the mechanisms explaining this relationship. Identifying these mechanisms among people living with HIV (PLHIV) after release from prison is particularly important, as individuals during this critical period are at high risk for both depression and poor ART adherence. 347 PLHIV recently released from prison in North Carolina and Texas were included in analyses to assess mediation of the relationship between depressive symptoms at 2 weeks post-release and ART adherence (assessed by unannounced telephone pill counts) at weeks 9-21 post-release by the hypothesized explanatory mechanisms of alcohol use, drug use, adherence self-efficacy, and adherence motivation (measured at weeks 6 and 14 post-release). Indirect effects were estimated using structural equation models with maximum likelihood estimation and bootstrapped confidence intervals. On average, participants achieved 79% ART adherence. The indirect effect of depression on adherence through drug use was statistically significant; greater symptoms of depression were associated with greater drug use, which was in turn associated with lower adherence. Lower adherence self-efficacy was associated with depressive symptoms, but not with adherence. Depression screening and targeted mental health and substance use services for depressed individuals at risk of substance use constitute important steps to promote adherence to ART after prison release.

Validity of Social Support Scales Utilized Among HIV-Infected and HIV-Affected Populations: A Systematic Review.

Social support enhances self-management and prevention of behaviors and is typically assessed using self-report scales; however, little is known about the validity of these scales in HIV-infected or affected populations. This systematic review aims to identify available validated social support scales used in HIV-infected and HIV-affected populations. A systematic literature search using key search terms was conducted in electronic databases. After rounds abstract screenings, full-text reviews, and data abstraction 17 studies remained, two of which assessed multiple social support scales, which increased number of scales to 19. Most scales assessed positive social support behaviors (n = 18). Most scales assessed perceived social support (n = 14) compared to received social support. Reliability ranged from 0.67 to 0.97. The most common forms of validation reported were content validity and construct validity and the least was criterion-related validity. Future research should seek to build evidence for validation for existing scales used in HIV-infected or HIV-affected populations.

Antiretroviral Adherence Following Prison Release in a Randomized Trial of the imPACT Intervention to Maintain Suppression of HIV Viremia.

Many people living with HIV (PLWH) pass through correctional facilities each year, a large proportion of whom do not maintain viral suppression following release. We examined the effects of imPACT, an intervention designed to promote post-release viral suppression, on antiretroviral therapy (ART) adherence. PLWH awaiting release from prisons in two southern states were randomized to imPACT (consisting of motivational interviewing, care linkage coordination, and text message medication reminders) versus standard care (SC). ART adherence, measured by unannounced monthly telephone pill counts, was compared between study arms over 6 months post-release. Of 381 participants eligible for post-release follow-up, 302 (79%) completed ≥ 1 of 6 possible pill counts (median: 4; IQR 1-6). Average adherence over follow-up was 80.3% (95% CI 77.5, 83.1) and 81.0% (78.3, 83.6) of expected doses taken in the imPACT and SC arms, respectively. There was no difference between arms when accounting for missing data using multiple imputation (mean difference = - 0.2 percentage points [- 3.7, 3.3]), controlling for study site and week of follow-up. Of the 936 (40.9%) pill counts that were missed, 212 (22.7%) were due to re-incarceration. Those who missed pill counts for any reason were more likely to be unsuppressed, suggesting that they had lower adherence. However, missingness was balanced between arms. Among PLWH released from prison, ART adherence averaged > 80% in both study arms over 6 months-a level higher than seen with most other chronic diseases. However, missing data may have led to an overestimate of adherence. Factors independent of the intervention influence ART adherence in this population and should be identified to inform future targeted interventions.

The impact of HIV couple testing and counseling on social support among pregnant women and their partners in Lilongwe, Malawi: an observational study.

Couples HIV testing and counseling (couple counseling) promotes safer sexual behaviors, increases communication between couples, and decreases HIV transmission. However, the impact of couple counseling on social support, critical for persons living with HIV, has not been examined. Ninety couples with a recently tested HIV-positive pregnant woman (female-positive couples) and 47 couples with a recently tested HIV-negative pregnant woman (female-negative couples) were enrolled in an observational study at an antenatal clinic in Malawi. Each couple member was assessed immediately before and one month after couple counseling for partner, family, and peer social support using the Multidimensional Scale of Perceived Social Support. Before couple counseling, social support was lower among women than men in both female-positive couples (ß = -10.00, p < .01) and female-negative couples (ß = -8.43, p < .01). After couple counseling, social support increased for women in female-positive couples (ß = 4.01, p < .01) and female-negative couples (ß = 4.69, p < .01) but not for men in either type of couple. Couple counseling could be an effective strategy to increase social support for women, including those with recent HIV diagnoses.