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1.  Towards an integrated primary and secondary HIV prevention continuum for the United States: a cyclical process model 
Every new HIV infection is preventable and every HIV-related death is avoidable. As many jurisdictions around the world endeavour to end HIV as an epidemic, missed HIV prevention and treatment opportunities must be regarded as public health emergencies, and efforts to quickly fill gaps in service provision for all people living with and vulnerable to HIV infection must be prioritized.
We present a novel, comprehensive, primary and secondary HIV prevention continuum model for the United States as a conceptual framework to identify key steps in reducing HIV incidence and improving health outcomes among those vulnerable to, as well as those living with, HIV infection. We further discuss potential approaches to address gaps in data required for programme planning, implementation and evaluation across the elements of the HIV prevention continuum.
Our model conceptualizes opportunities to monitor and quantify primary HIV prevention efforts and, importantly, illustrates the interplay between an outcomes-oriented primary HIV prevention process and the HIV care continuum to move aggressively forward in reaching ambitious reductions in HIV incidence. To optimize the utility of this outcomes-oriented HIV prevention continuum, a key gap to be addressed includes the creation and increased coordination of data relevant to HIV prevention across sectors.
PMCID: PMC5116064  PMID: 27863535
HIV; prevention; continuum; PrEP; process model; cycle; testing
2.  Self-Reported Side Effects and Adherence to Antiretroviral Therapy in HIV-Infected Pregnant Women under Option B+: A Prospective Study 
PLoS ONE  2016;11(10):e0163079.
Antiretroviral therapy (ART) regimens containing efavirenz (EFV) are recommended as part of universal ART for pregnant and breastfeeding women. EFV may have appreciable side effects (SE), and ART adherence in pregnancy is a major concern, but little is known about ART SE and associations with adherence in pregnancy.
We investigated the distribution of patient-reported SE (based on Division of AIDS categories) and the association of SE with missed ART doses in a cohort of 517 women starting EFV+3TC/FTC+TDF during pregnancy. In analysis, SE were considered in terms of their overall frequency, by systems category, and by latent classes.
Overall 97% of women reported experiencing at least one SE after ART initiation, with 48% experiencing more than five SE. Gastrointestinal, central nervous system, systemic and skin SE were reported by 81%, 85%, 79% and 31% of women, respectively, with considerable overlap across groups. At least one missed dose was reported by 32% of women. In multivariable models, ART non-adherence was associated with systemic SE compared to other systems categories, and measures of the overall burden of SE experienced were most strongly associated with missed ART doses.
These data demonstrate very high levels of SE in pregnant women initiating EFV-based ART and a strong association between SE burden and ART adherence. ART regimens with reduced SE profiles may enhance adherence, and as countries expand universal ART for all adult patients, counseling must include preparation for ART SE.
PMCID: PMC5070813  PMID: 27760126
3.  Optimizing Antiretroviral Therapy (ART) for Maternal and Child Health (MCH): Rationale and Design of the MCH-ART Study 
Prevention of mother-to-child transmission of HIV implementation faces significant challenges globally, particularly in the context of universal lifelong antiretroviral therapy (ART) for all HIV-infected pregnant women.
We describe the rationale and methods of the Maternal and Child Health-Antiretroviral Therapy (MCH-ART) study, an implementation science project examining strategies for providing HIV care and treatment to HIV-infected women who initiate ART during pregnancy and their HIV-exposed infants.
MCH-ART is composed of 3 interrelated study designs across the antenatal and postnatal periods. Phase 1 is a cross-sectional evaluation of consecutive HIV-infected pregnant women seeking antenatal care; phase 2 is an observational cohort of all women from phase 1 who are eligible for initiation of ART following local guidelines; and phase 3 is a randomized trial of strategies for delivering ART to breastfeeding women from phase 2 during the postpartum period. During each phase, a set of study measurement visits is carried out separately from antenatal care and ART services; a maximum of 9 visits takes place from the beginning of antenatal care through 12 months postpartum. In parallel, in-depth interviews are used to examine issues of ART adherence and retention qualitatively, and costs and cost-effectiveness of models of care are examined. Separate substudies examine health outcomes in HIV-uninfected women and their HIV-unexposed infants, and the role of the adherence club model for long-term adherence and retention.
Combining observational and experimental components, the MCH-ART study presents a novel approach to understand and optimize ART delivery for MCH.
PMCID: PMC5113242  PMID: 27355508
HIV; antiretroviral therapy; PMTCT; integration; adherence; retention
4.  Interventions to promote adherence to antiretroviral therapy in Africa: A network meta-analysis 
The lancet. HIV  2014;1(3):e104-e111.
Structured Summary
Adherence to antiretroviral therapy (ART) is a necessary condition to the improvement of HIV patient health and public health through ART. This study sought to determine the comparative effectiveness of different interventions for improving ART adherence among HIV-infected persons living in Africa.
We searched for randomized trials that evaluated an intervention to promote antiretroviral adherence within Africa. We created a network of the differing interventions by pooling the published and individual patient data for comparable treatments and comparing them across the individual interventions using Bayesian network meta-analyses. Outcomes included self-reported adherence and viral suppression.
We obtained data on 14 randomized controlled trials, involving 7,110 patients. Interventions included daily and weekly short message service (SMS) messaging, calendars, peer supporters, alarms, counseling, and basic and enhanced standard of care (SOC). For self-reported adherence, we found distinguishable improvement in adherence compared to SOC with enhanced SOC (odds ratio [OR]: 1.46, 95% credibility interval [CrI]: 1.06–1.98), weekly SMS messages (OR:1.65; 95% CrI: 1.25–2.18), counseling and SMS combined (OR:2.07; 95% CrI: 1.22–3.53), and treatment supporters (OR:1.83; 95% CrI:1.36–2.45). We found no compelling evidence for the remaining interventions. Results were similar when using viral suppression as an outcome, although the network of evidence was sparser. Treatment supporters with enhanced SOC (OR:1.46; 95% CrI: 1.09–1.97) and weekly SMS messages (OR:1.55; 95% CrI: 1.00–2.39) were significantly superior to basic SOC.
Several recommendations for improving adherence are unsupported by the available evidence. These findings should influence guidance documents on improving ART adherence in poor settings.
PMCID: PMC5096455  PMID: 26424119
5.  Disclosing in utero HIV/ARV exposure to the HIV-exposed uninfected adolescent: is it necessary? 
The tremendous success of antiretroviral therapy has resulted in a diminishing population of perinatally HIV-infected children on the one hand and a mounting number of HIV-exposed uninfected (HEU) children on the other. As the oldest of these HEU children are reaching adolescence, questions have emerged surrounding the implications of HEU status disclosure to these adolescents. This article outlines the arguments for and against disclosure of a child's HEU status.
Disclosure of a child's HEU status, by definition, requires disclosure of maternal HIV status. It is necessary to weigh the benefits and harms which could occur with disclosure in each of the following domains: psychosocial impact, long-term physical health of the HEU individual and the public health impact. Does disclosure improve or worsen the psychological health of the HEU individual and extended family unit? Do present data on the long-term safety of in utero HIV/ARV exposure reveal potential health risks which merit disclosure to the HEU adolescent? What research and public health programmes or systems need to be in place to afford monitoring of HEU individuals and which, if any, of these require disclosure?
At present, it is not clear that there is sufficient evidence on whether long-term adverse effects are associated with in utero HIV/ARV exposures, making it difficult to mandate universal disclosure. However, as more countries adopt electronic medical record systems, the HEU status of an individual should be an important piece of the health record which follows the infant not only through childhood and adolescence but also adulthood. Clinicians and researchers should continue to approach the dialogue around mother–child disclosure with sensitivity and a cogent consideration of the evolving risks and benefits as new information becomes available while also working to maintain documentation of an individual's perinatal HIV/ARV exposures as a vital part of his/her medical records. As more long-term adult safety data on in utero HIV/ARV exposures become available these decisions may become clearer, but at this time, they remain complex and multi-faceted.
PMCID: PMC5065689  PMID: 27741954
HIV exposure; disclosure; in utero; antiretrovirals
6.  Barriers and Facilitators to Engagement of Vulnerable Populations in HIV Primary Care in New York City 
Engagement in HIV care helps to maximize viral suppression, which, in turn, reduces morbidity and mortality and prevents further HIV transmission. With more HIV cases than any other US city, New York City reported in 2012 that only 41% of all persons estimated to be living with HIV (PLWH) had a suppressed viral load, while nearly three-quarters of those in clinical care achieved viral suppression. Thus, retaining PLWH in HIV care addresses this central goal of both the US National HIV/AIDS Strategy and Governor Cuomo's plan to end the AIDS epidemic in New York State.
We conducted 80 in-depth qualitative interviews with PLWH in four NYC populations that were identified as being inconsistently engaged in HIV medical care: African immigrants, previously incarcerated adults, transgender women, and young men who have sex with men.
Barriers to and facilitators of HIV care engagement fell into three domains: (1) system factors (e.g., patient-provider relationship, social service agencies, transitions between penal system and community); (2) social factors (e.g., family and other social support; stigma related to HIV, substance use, sexual orientation, gender identity, and incarceration); and (3) individual factors (e.g., mental illness, substance use, resilience). Similarities and differences in these themes across the four populations as well as research and public health implications were identified.
Engagement in care is maximized when the social challenges confronted by vulnerable groups are addressed; patient-provider communication is strong; and coordinated services are available, including housing, mental health and substance use treatment, and peer navigation.
PMCID: PMC4559146  PMID: 25867774
HIV care engagement; African immigrants; previously incarcerated adults; young men who have sex with men; transgender women
7.  Enhancing Lay Counselor Capacity to Improve Patient Outcomes with Multimedia Technology 
AIDS and behavior  2015;19(0 2):163-176.
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 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 Masivukeni 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.
PMCID: PMC4537057  PMID: 25566763
HIV; ART adherence; Technology; Multimedia; Task-Shifting; Intervention
8.  Factors associated with initiation of antiretroviral therapy in the advanced stages of HIV infection in six Ethiopian HIV clinics, 2012 to 2013 
Most HIV-positive persons in sub-Saharan Africa initiate antiretroviral therapy (ART) with advanced infection (late ART initiation). Intervening on the drivers of late ART initiation is a critical step towards achieving the full potential of HIV treatment scale-up. This study aimed to identify modifiable factors associated with late ART initiation in Ethiopia.
From 2012 to 2013, Ethiopian adults (n=1180) were interviewed within two weeks of ART initiation. Interview data were merged with HIV care histories to assess correlates of late ART initiation (CD4+ count <150 cells/µL or World Health Organization Stage IV).
The median CD4 count at enrolment in HIV care was 263 cells/µL (interquartile range (IQR): 140 to 390) and 212 cells/µL (IQR: 119 to 288) at ART initiation. Overall, 31.2% of participants initiated ART late, of whom 85.1% already had advanced HIV disease at enrolment. Factors associated with higher odds of late ART initiation included male sex (vs. non-pregnant females; adjusted odds ratio (aOR): 2.02; 95% CI: 1.50 to 2.73), high levels of psychological distress (vs. low/none, aOR: 1.96; 95% CI: 1.34 to 2.87), perceived communication barriers with providers (aOR: 2.42, 95% CI: 1.24 to 4.75), diagnosis via provider initiated testing (vs. voluntary counselling and testing, aOR: 1.47, 95% CI: 1.07 to 2.04), tuberculosis (TB) treatment prior to ART initiation (aOR: 2.16, 95% CI: 1.43 to 3.25) and a gap in care of six months or more prior to ART initiation (aOR: 2.02, 95% CI: 1.10 to 3.72). Testing because of partner illness/death (aOR: 0.64, 95% CI: 0.42 to 0.95) was associated with lower odds of late ART initiation.
Programmatic initiatives promoting earlier diagnosis, engagement in pre-ART care, and integration of TB and HIV treatments may facilitate earlier ART initiation. Men and those experiencing psychological distress may also benefit from targeted support prior to ART initiation.
PMCID: PMC4845592  PMID: 27113335
HIV-positive adults; antiretroviral therapy initiation; tuberculosis treatment; Ethiopia; antiretroviral therapy guidelines; implementation science
9.  The Association between Poor Antiretroviral Adherence and Unsafe Sex: Differences by Gender and Sexual Orientation and Implications for Scale-Up of Treatment as Prevention 
AIDS and behavior  2014;18(8):1541-1547.
Non-adherence to safer sex and non-adherence to ART can each have adverse health consequences for HIV-infected individuals and their sex partners, but little is known about the association of these behaviors with each other. This “dual risk” has potential negative public health consequences since non-adherence can lead to the development of resistant virus that can then be transmitted to sex partners.
Among participants in the Multi-site Adherence Collaboration in HIV (MACH14) we examined, at study baseline, the association between the frequency of unprotected sex (assessed by self-report) and ART adherence (assessed by Medication Event Monitoring System, Aardex) among the sexually active participants in the five studies (N=459) that collected sexual risk behavior. The bivariate association between sexual risk behaviors and ART adherence was assessed by Pearson correlations; subsequently ANOVAs were used to evaluate the role of demographic characteristics, depression and substance use in explaining the “dual risk” outcome (sexual risk and non-adherence).
Among participants who had been sexually active, more unprotected anal/vaginal sex was weakly associated with poorer ART adherence (r = −.12, p=0.01 for the overall sample). Further analysis showed this association was driven by the heterosexual men in the sample (r = −.29, p<0.001), and was significant only for this group, and not for gay/bisexual men or for women (heterosexual and homosexual). Neither substance use nor depression accounted for the association between sexual risk and ART adherence.
HIV-infected heterosexual men who are having difficulty adhering to ART are also more likely to engage in risky sexual behaviors and therefore may benefit from counseling about these risk behaviors. We must identify procedures to screen for these risk behaviors and develop interventions, appropriately tailored to specific populations and identified risk factors, that can be integrated into routine clinical care for people living with HIV. This will become increasingly important in the context of wider access to treatment globally, including new recommendations for ART initiation earlier in a patients’ disease course (e.g., “Test and Treat” paradigms).
PMCID: PMC4016192  PMID: 24213215
ART adherence; sexual risk behavior; test-and-treat; depression; substance use
10.  The Validity of Self-Reported Medication Adherence as an Outcome in Clinical Trials of Adherence-Promotion Interventions: Findings from the MACH14 Study 
AIDS and behavior  2014;18(12):2285-2290.
In medication adherence-promotion trials, participants in the intervention arm are often cognizant of the researcher’s aim to improve adherence; this may lead to their inflating reports of their own adherence compared to control arm participants. Using data from 1,247 HIV-positive participants across eight U.S. Studies in the Multisite Adherence Collaboration on HIV (MACH14) collaboration, we evaluated the validity of self-reported adherence by examining whether its association with two more objective outcomes [1], electronically monitored adherence and [2] viral load, varied by study arm. After adjusting for potential confounders, there was no evidence of greater overestimation of self-reported adherence among intervention arm participants, supporting its potential as a trial outcome indicator.
PMCID: PMC4495040  PMID: 25280447
HIV/AIDS; Medication adherence assessment; Intervention studies; Social desirability
11.  Optimizing ART Adherence: Update for HIV Treatment and Prevention 
Current HIV/AIDS reports  2014;11(4):423-433.
Optimal adherence to antiretroviral therapy (ART) is central to achieving viral suppression and positive health outcomes in HIV-infected individuals. Virally suppressed individuals can also reduce the risk of HIV transmission to uninfected partners. Hence, adherence to ART has become both an HIV treatment and an HIV prevention strategy. However, achieving optimal ART adherence can be challenging, especially over the long term. It is increasingly important for clinicians and researchers to be abreast of the most recent developments in the field as new biomedical approaches to treatment emerge, and as guidelines for the use of pre-exposure prophylaxis (PrEP) are disseminated to providers serving HIV affected populations. Several reviews have described numerous ART adherence interventions that have been developed and/or tested with the most recent review including literature up to 2012. To augment the literature, we present a review of ART adherence interventions from 2013 – present. We included peer-reviewed journals as well as abstracts from two key conferences.
PMCID: PMC4268351  PMID: 25304006
HIV; ART; Adherence; Intervention; Review
12.  Advanced Disease at Enrollment in HIV Care in Four Sub-Saharan African Countries: Change from 2006-2011 and Multi-Level Predictors in 2011 
AIDS (London, England)  2014;28(16):2429-2438.
To examine changes between 2006 and 2011 in the proportion of HIV-positive patients newly-enrolled in HIV care with advanced disease and the median CD4+ cell count at enrollment; and identify patient-, facility-, and contextual-level factors associated with late enrollment in care in 2011.
Cross sectional over time.
For time trends analyses, routinely-collected patient-level data (307,110 adults newly-enrolled in 138 HIV clinical care facilities) in Kenya, Mozambique, Rwanda and Tanzania; and for analyses of correlates, patient-level data (46,201 in 195 facilities), and facility- and population-level survey data were used. Late enrollment was defined as CD4+ count ≤350 cells/μl and/or WHO clinical stage 3/4.
Late enrollment declined from 69.9% to 57.2%, (p<0.0001); median CD4+ count increased from 242 to 292 cells/μL (ptrend<0.0001). In 2011, risk of late enrollment was significantly higher for men and non-pregnant women vs. pregnant women; patients aged >25 vs. 15-25 years; non-married vs. married; and those entering from sites other than prevention of mother to child transmission (PMTCT). More extensive HIV testing coverage in the region of a facility was significantly associated with lower risk of late enrollment.
Despite improvement, in 2011, 57% of patients entered HIV care already ART-eligible. The lower risk of late enrollment among those referred from PMTCT and in regions where HIV testing coverage was higher suggests that innovative approaches to rapidly increase testing uptake among people living with HIV prior to the development of symptoms have the potential to reduce late enrollment in care.
PMCID: PMC4361092  PMID: 25136842
13.  ‘Men usually say that HIV testing is for women’: Gender dynamics & perceptions of HIV testing in Lesotho 
Culture, health & sexuality  2014;16(8):867-882.
In Lesotho, men have lower HIV testing rates, less contact with HIV clinical settings, and less knowledge of HIV prevention than women. However, women’s HIV prevalence has consistently remained higher than men’s. This paper explores gender norms, sexual decision-making, and perceptions of HIV among a sample of Basotho men and women in order to understand how these factors influence HIV testing and prevention. Two hundred women and 30 men were interviewed in Lesotho between April–July 2011. Participants reported reluctance among women to share information about HIV prevention and testing with men, and resistance of men to engage with testing and/or prevention services. Findings demonstrate a critical need for educational initiatives for men, among other strategies to engage men with HIV testing and prevention. This study highlights how gender issues shape perceptions of HIV and sexual decision-making and underlines the importance of engaging men along with women in HIV prevention efforts. More studies are needed to determine the most effective strategies to inform and engage men.
PMCID: PMC4116609  PMID: 24854495
HIV/AIDS; gender; Lesotho; men; HIV prevention
15.  Masivukeni: Development of a Multimedia Based Antiretroviral Therapy Adherence Intervention for Counselors and Patients in South Africa 
AIDS and behavior  2013;17(6):1979-1991.
Effective medical treatment for HIV/AIDS requires patients’ optimal adherence to antiretroviral therapy (ART). In resource-constrained settings, lack of adequate standardized counseling for patients on ART remains a significant barrier to adherence. Masivukeni (“Lets Wake Up” in Xhosa) is an innovative multimedia-based intervention designed to help people living with HIV in resource-limited settings achieve and maintain high levels of ART adherence. Adapted from a couples-based intervention tested in the United States (US), Masivukeni was developed through community-based participatory research with US and South African partners and informed by Ewart’s Social Action Theory. Innovative computer-based multimedia strategies were used to translate a labor- and training-intensive intervention into one that could be readily and widely used by lay counselors with relatively little training with low-literacy patients. In this paper, we describe the foundations of this new intervention, the process of its development, and the evidence of its high acceptability and feasibility.
PMCID: PMC3674110  PMID: 23468079
HIV; ART adherence; intervention; multimedia; task-shifting
16.  Still a Hard-to-Reach Population? Using Social Media to Recruit Latino Gay Couples for an HIV Intervention Adaptation Study 
Online social networking use has increased rapidly among African American and Latino men who have sex with men (MSM), making it important to understand how these technologies can be used to reach, retain, and maintain individuals in care and promote health wellness. In particular, the Internet is increasingly recognized as a platform for health communication and education. However, little is known about how primarily Spanish-speaking populations use and engage with each other through social media platforms.
We aimed to recruit eligible couples for a study to adapt “Connect ‘n Unite” (an HIV prevention intervention initially created for black gay couples) for Spanish-speaking Latino gay couples living in New York City.
In order to successfully design and implement an effective social media recruitment campaign to reach Spanish-speaking Latino gay couples for our ongoing “Latinos en Pareja” study, our community stakeholders and research team used McGuire’s communication/persuasion matrix. The matrix guided our research, specifically each marketing “channel”, targeted “message”, and target population or “receiver”. We developed a social media recruitment protocol and trained our research staff and stakeholders to conduct social media recruitment.
As a result, in just 1 month, we recruited all of our subjects (N=14 couples, that is, N=28 participants) and reached more than 35,658 participants through different channels. One of the major successes of our social media recruitment campaign was to build a strong stakeholder base that became involved early on in all aspects of the research process—from pilot study writing and development to recruitment and retention. In addition, the variety of “messages” used across different social media platforms (including Facebook, the “Latinos en Pareja” study website, Craigslist, and various smartphone applications such as Grindr, SCRUFF, and Jack’d) helped recruit Latino gay couples. We also relied on a wide range of community-based organizations across New York City to promote the study and build in the social media components.
Our findings highlight the importance of incorporating communication technologies into the recruitment and engagement of participants in HIV interventions. Particularly, the success of our social media recruitment strategy with Spanish-speaking Latino MSM shows that this population is not particularly “hard to reach”, as it is often characterized within public health literature.
PMCID: PMC4019772  PMID: 24763130
social media; online recruitment strategies; Spanish-speaking Latino men who have sex with men (MSM); Latino gay couples; Latino MSM; HIV prevention
17.  PrEP in substance abuse treatment: a qualitative study of treatment provider perspectives 
To examine substance abuse treatment providers’ views on engaging clients in Pre-exposure Prophylaxis (PrEP) care and research trials.
Thirty-six medical and counseling service providers in six New York City outpatient substance abuse treatment programs participated in semi-structured qualitative interviews. Thematic content analysis was conducted by three coders, independently.
Providers’ perspectives toward PrEP were characterized by six salient themes: 1) Limited PrEP awareness. 2) Ambivalence about PrEP; 3) Perception of multiple challenges to delivery; 4) Uncertainty about clients’ ability to be adherent to medication; 5) Concerns about medication safety/side effects; and 6) Perception of multiple barriers to conducting clinical trials.
Despite anticipated challenges, providers supported the introduction of PrEP in outpatient substance abuse treatment. Comprehensive training for providers is needed and should include PrEP eligibility criteria, strategies to support adherence and medication monitoring guidelines. Linkages between substance abuse treatment and primary care and/or enhancement of capacity within clinics to offer PrEP may help facilitate PrEP delivery. When conducting research in outpatient clinics, it is particularly important to protect client confidentiality.
PMCID: PMC4298071  PMID: 25575428
PrEP; Substance abuse treatment; Providers’ perspectives; Integration of HIV prevention; Substance abuse treatment
18.  Heterogeneity among studies in rates of decline of ART adherence over time: Results from the MACH14 study 
To use electronic drug monitoring to determine if adherence to HIV antiretroviral therapy changes over time, whether changes are linear, and how the declines vary by study.
We conducted a longitudinal study of pooled data from 11 different studies of HIV infected adults using antiretroviral therapy. The main outcome was antiretroviral therapy adherence (percent of prescribed doses taken) measured by electronic drug monitoring. We modeled and compared changes in adherence over time using repeated measures linear mixed effects models and generalized additive mixed models. Indicator variables were used to examine the impact of individual studies, and the variation across studies was evaluated using study-specific parameter estimates calculated by using interaction terms of study and time.
The mean age of the subjects was 41 years, 35% were female, most had high school education or less, and 46% were African-American. In generalized additive mixed models, adherence declined over time. The generalized additive mixed models further suggested that the decline was non-linear, and in both sets of models there was considerable study-to-study variability in how adherence changed over time.
Findings may not be generalizable to non-US populations or to patients not in clinical studies.
Although overall antiretroviral therapy adherence declined with time, not all studies showed declines, and a number of patterns of change were seen. Studies that identify clinical and organizational factors associated with these different patterns are needed. Models of changes in adherence with time should take account of possible non-linear effects.
PMCID: PMC4212649  PMID: 24225904
human immunodeficiency virus; highly active antiretroviral therapy; medication adherence; patient compliance; longitudinal studies; meta-analysis
19.  Overcoming Biological, Behavioral and Structural Vulnerabilities: New Directions in Research to Decrease HIV Transmission in Men who have Sex with Men 
Men who have sex with men, including transgender women, comprise a heterogeneous group of individuals, whose sexual behaviors and gender identities may varying widely between cultures and among individuals. Their sources of increased vulnerability to HIV are diverse, including the increased efficiency of HIV transmission via unprotected anal intercourse, sexual role versatility, asymptomatic sexually transmitted infections, as well as behavioral factors that may be associated with condomless sex with multiple partners. Societal stigmatization of homosexual behavior and gender non-conformity may result in internalized negative feelings that lead to depression, other affective disorders, and substance use, which in turn are associated with increased risk taking behaviors. Social stigma and punitive civil environments may lead to delays in seeking HIV and STD screening, and later initiation of antiretroviral therapy. The iPrEX study demonstrated that chemoprophylaxis can decrease HIV acquisition in MSM, and the HPTN 052 study established the biological plausibility that earlier initiation of HAART can decrease HIV transmission to uninfected partners. Despite these advances, MSM remain among the most significantly HIV-affected population in resource rich and limited settings. New studies will integrate enhanced understanding of the biology of enhanced rectal transmission of HIV and the focused use of antiretrovirals for prevention with culturally-tailored approaches that address the potentiating social and behavioral factors associated with enhanced HIV spread among MSM.
PMCID: PMC3740716  PMID: 23764630
Men who have sex with men; Transgender Women; HIV Prevention; HIV Transmission
21.  Guidelines for Improving Entry Into and Retention in Care and Antiretroviral Adherence for Persons With HIV: Evidence-Based Recommendations From an International Association of Physicians in AIDS Care Panel 
Annals of internal medicine  2012;156(11):817-294.
After HIV diagnosis, timely entry into HIV medical care and retention in that care are essential to the provision of effective antiretroviral therapy (ART). ART adherence is among the key determinants of successful HIV treatment outcome and is essential to minimize the emergence of drug resistance. The International Association of Physicians in AIDS Care convened a panel to develop evidence-based recommendations to optimize entry into and retention in care and ART adherence for people with HIV.
A systematic literature search was conducted to produce an evidence base restricted to randomized, controlled trials and observational studies with comparators that had at least 1 measured biological or behavioral end point. A total of 325 studies met the criteria. Two reviewers independently extracted and coded data from each study using a standardized data extraction form. Panel members drafted recommendations based on the body of evidence for each method or intervention and then graded the overall quality of the body of evidence and the strength for each recommendation.
Recommendations are provided for monitoring of entry into and retention in care, interventions to improve entry and retention, and monitoring of and interventions to improve ART adherence. Recommendations cover ART strategies, adherence tools, education and counseling, and health system and service delivery interventions. In addition, they cover specific issues pertaining to pregnant women, incarcerated individuals, homeless and marginally housed individuals, and children and adolescents, as well as substance use and mental health disorders. Recommendations for future research in all areas are also provided.
PMCID: PMC4044043  PMID: 22393036
22.  Exploring the Utility of the Montreal Cognitive Assessment to Detect HIV-Associated Neurocognitive Disorder: The Challenge and Need for Culturally Valid Screening Tests in South Africa 
The Clinical neuropsychologist  2013;27(3):437-454.
There is a strong need in South Africa for neuropsychological tests that can help detect HIV-associated neurocognitive disorder (HAND) in the country’s 5.6 million people living with HIV. Yet, South African neuropsychologists are challenged to do so, as few neuropsychological tests or batteries have been developed or adapted for, and normed on, South Africa’s linguistically, culturally, educationally, and economically diverse population. The purpose of this study was to explore the utility of the Montreal Cognitive Assessment to detect HIV-associated neurocognitive impairment among a sample of HIV+ and HIV-Black, Xhosa-speaking South Africans. HIV+ participants performed significantly worse overall and specifically in the domains of visuospatial, executive, attention, and language (confrontation naming). Regression analysis indicated that HIV status and education were the strongest predictors of total scores. Floor effects were observed on cube drawing, rhinoceros naming, serial 7’s, and one abstraction item, suggesting those items might not be useful in this population. While the Montreal Cognitive Assessment holds promise to help detect HAND in South Africa, it will likely need modification before it can be normed and validated for this population. Findings from this study may help neuropsychologists working with similar populations.
PMCID: PMC3631431  PMID: 23336183
HIV; neuropsychology; screening; cross-cultural; South Africa; low-literacy; low-education
23.  HIV-negative Men-who-Have-Sex-with-Men who Bareback are Concerned about HIV Infection: Implications for HIV Risk Reduction Interventions 
Archives of sexual behavior  2012;42(2):279-289.
The emergence of barebacking (intentional unprotected anal intercourse in situations where there is risk of HIV infection) among men who have sex with men (MSM) has been partially attributed to a decrease in HIV-related concerns due to improved anti-retroviral treatment. It is important to understand the level of concern these men have regarding HIV infection because it can affect their interest in risk reduction behaviors as well as their possible engagement in risk reduction interventions. As part of a study on MSM who use the Internet to seek sexual partners, 89 ethnic and racially diverse men who reported never having an HIV-positive test result completed an in-depth qualitative interview and a computer-based quantitative assessment. Of the 82 men who were asked about concerns of HIV infection during the qualitative interviews, 30 expressed “significant concern” about acquiring HIV, while 42 expressed “moderate concern,” and 10 expressed “minimal concern. Themes that emerged across the different levels of concern were their perceptions of the severity of HIV infection, having friends who are HIV positive, and their own vulnerability to HIV infection. However, these themes differed depending on the level of concern. Among the most frequently mentioned approaches to decrease risk of HIV infection, participants mentioned avoiding HIV-positive sex partners, limiting the number of partners with whom they barebacked, and not allowing partners to ejaculate inside their rectum. Findings suggest that many MSM who bareback would be amenable to HIV prevention efforts that do not depend solely on condom use.
PMCID: PMC3408545  PMID: 22218787
gay men; HIV prevention; HIV concerns; HIV optimism; raw sex
24.  Exploring the venue’s role in risky sexual behavior among gay and bisexual men: An event-level analysis from a national online survey in the U.S 
Archives of sexual behavior  2011;42(2):291-302.
Venue-based characteristics (e.g., alcohol in bars, anonymous chat online, dark/quiet spaces in bathhouses) can impact how men who have sex with men (MSM) negotiate sex and HIV-associated risk behavior. We sought to determine the association between HIV-associated risk factors and the venues where MSM met their most recent new (first-time) male sex partner, using data from a 2004–2005 national online anonymous survey of MSM in the U.S (n = 2865). Most men (62%) met their partner through the Internet. Among those reporting anal sex during their last encounter (n = 1,550), half had not used a condom. In multivariate modeling, and among men reporting anal sex during their last encounter, venue where partner was met was not associated with unprotected anal intercourse (UAI). Nevertheless, venue was related to other factors that contextualized men’s sexual encounters. For example, HIV status disclosure was lowest among men who met their most recent partner in a park, outdoors, or other public place and highest among men who met their most recent partner online. Alcohol use prior to/during last sexual encounter was highest among men who met their most recent partner in a bathhouse or a bar/club/party/event. These data suggest it is possible to reach men online who seek sex in many different venues, thus potentially broadening the impact of prevention messages delivered in virtual environments. Although not associated with UAI, venues are connected to social-behavioral facets of corresponding sexual encounters, and may be important arenas for differential HIV and STI education, treatment, and prevention.
PMCID: PMC3684013  PMID: 22012413
Sex venues; gay and bisexual men; Internet; HIV status disclosure; alcohol; condom use
25.  Strategies Used in the Detection of Acute/Early HIV Infections. The NIMH Multisite Acute HIV Infection Study: I 
AIDS and behavior  2009;13(6):1037-1045.
Acute/early HIV infection plays a critical role in onward HIV transmission. Detection of HIV infections during this period provides an important early opportunity to offer interventions which may prevent further transmission. In six U.S. cities, persons with acute/early HIV infection were identified using either HIV RNA testing of pooled sera from persons screened HIV antibody negative or through clinical referral of persons with acute or early infections. Fifty-one cases were identified and 34 (68%) were enrolled into the study; 28 (82%) were acute infections and 6 (18%) were early infections. Of those enrolled, 13 (38 %) were identified through HIV pooled testing of 7,633 HIV antibody negative sera and 21 (62%) through referral. Both strategies identified cases that would have been missed under current HIV testing and counseling protocols. Efforts to identify newly infected persons should target specific populations and geographic areas based on knowledge of the local epidemiology of incident infections.
PMCID: PMC2785898  PMID: 19495954
Acute HIV infection; nucleic acid amplification tests; HIV RNA testing; early detection of acute HIV infection

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