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1.  Adherence to Preexposure Prophylaxis: Current, Emerging, and Anticipated Bases of Evidence 
Despite considerable discussion and debate about adherence to preexposure prophylaxis (PrEP) for human immunodeficiency virus (HIV), scant data are available that characterize patterns of adherence to open-label PrEP. The current evidence base is instead dominated by research on adherence to placebo-controlled investigational drug by way of drug detection in active-arm participants of large randomized controlled trials (RCTs). Important differences between the context of blinded RCTs and open-label use suggest caution when generalizing from study product adherence to real-world PrEP use. Evidence specific to open-label PrEP adherence is presently sparse but will expand rapidly over the next few years as roll-out, demonstration projects, and more rigorous research collect and present findings. The current evidence bases established cannot yet predict uptake, adherence, or persistence with open-label effective PrEP. Emerging evidence suggests that some cohorts could execute better adherence in open-label use vs placebo-controlled research. Uptake of PrEP is presently slow in the United States; whether this changes as grassroots and community efforts increase awareness of PrEP as an effective HIV prevention option remains to be determined. As recommended by multiple guidelines for PrEP use, all current demonstration projects offer PrEP education and/or counseling. PrEP support approaches generally fall into community-based, technology, monitoring, and integrated sexual health promotion approaches. Developing and implementing research that moves beyond simple correlates of either study product use or open-label PrEP adherence toward more comprehensive models of sociobehavioral and socioecological adherence determinants would greatly accelerate progress. Intervention research is needed to identify effective models of support for open-label PrEP adherence.
doi:10.1093/cid/ciu266
PMCID: PMC4060253  PMID: 24926036
study product adherence; PrEP adherence; social science; behavioral science
2.  Reasons for ART non-adherence in the Deep South: Adherence needs of a sample of HIV-positive patients in Mississippi 
AIDS care  2007;19(10):1210-1218.
HIV prevalence in the American Deep South has reached crisis proportions and greater numbers of patients are enrolling in clinical care and beginning antiretroviral therapy (ART). In order to gain maximum benefit from ART, patients must sustain high levels of adherence to demanding regimens over extended periods of time. Many patients are unable to maintain high rates of adherence and may need assistance to do so, which may be based upon an understanding of barriers to adherence for a given population. The current study sought to gain understanding of barriers to adherence for a mixed urban/rural HIV-positive patient population in Mississippi and to determine whether barriers to adherence may be specific to gender, employment, depressive symptoms or educational attainment status. Seventy-two patients who missed a dose of ART medication over the last three days endorsed the top five reasons for missing a dose as: (1) not having the medication with them, (2) sleeping through the dose time, (3) running out of the medication, (4) being busy with other things and (5) other. Reported barriers were fairly consistent across different groups, although women and those classified as having moderate to severe depressive symptoms reported different patterns of adherence barriers. Results suggest that adherence interventions implemented in the Deep South must take into account specific barriers faced by individuals within this region, where stigma, gender disparities and limited resources are prevalent.
doi:10.1080/09540120701426516
PMCID: PMC3021466  PMID: 18071964
3.  Information-Motivation-Behavioral Skills Barriers Associated with Intentional versus Unintentional ARV Non-adherence Behavior among HIV-Positive Patients in Clinical Care 
AIDS care  2010;22(8):979-987.
Since the arrival of antiretroviral (ARV) therapy, HIV has become better characterized as a chronic disease rather than a terminal illness, depending in part on one’s ability to maintain relatively high levels of adherence. Despite research concerning barriers and facilitators of ARV adherence behavior, relatively little is known about specific challenges faced by HIV-positive persons who report “taking a break” from their ARV medications. The present study employed the Information-Motivation-Behavioral Skills Model of ARV Adherence as a framework for understanding adherence-related barriers that may differentiate between non-adherent patients who report “taking a break” versus those who do not report “taking a break” from their ARV medications. A sample of 327 HIV-positive patients who reported less than 100% adherence at study baseline provided data for this research. Participants who reported “taking a break” from their HIV medications without first talking to their healthcare provider were classified as intentionally non-adherent, while those who did not report “taking a break” without first talking with their healthcare provider were classified as unintentionally non-adherent. Analyses examined differences between intentionally versus unintentionally non-adherent patients with respect to demographic characteristics and responses to the adherence-related information, motivation, and behavioral skills questionnaire items. Few differences were observed between the groups on demographics, adherence-related information or adherence-related motivation; however, significant differences were observed on about half of the adherence-related behavioral skills items. Implications for future research, as well as the design of specific intervention components to reduce intentionally non-adherent behavior, are discussed.
doi:10.1080/09540121003758630
PMCID: PMC4286200  PMID: 20552469
ARV; ART; adherence; HIV; HIV-positive; intentional
4.  Information, Motivation, and Behavioral Skills for Early Pre-ART Engagement in HIV Care among Patients Entering Clinical Care in KwaZulu-Natal, South Africa 
AIDS care  2013;25(12):1485-1490.
Little is known regarding factors implicated in early engagement and retention in HIV-care among individuals not yet eligible for antiretroviral therapy (pre-ART) in sub-Saharan Africa. Identifying such factors is critical for supporting retention in pre-ART clinical care to ensure timely ART initiation and optimize long-term health outcomes. We assessed patients’ pre-ART HIV-care related information, motivation, and behavioral skills among newly diagnosed ART-ineligible patients initiating care in KwaZulu-Natal, South Africa. The survey was interviewer-administered to eligible patients who were 18 years of age or older, newly entering care (diagnosed within the last 6-months), and ineligible for ART (CD4 count >200 cells/mm3) in one of four primary care clinical sites. Self-reported information, motivation and behavioral skills specific to retention in pre-ART HIV-care were characterized by categorizing responses into those reflecting potential strengths and those reflective of potential deficits. Information, motivation, and behavioral skills deficits sufficiently prevalent in the overall sample (i.e., ≥30% prevalent) were identified as areas in need of specific attention through intervention efforts adapted to the clinic level. Gender-based differences were also evaluated. A total of 288 patients (75% female) completed structured interviews. Across the sample, 8 information, 8 motivation, and 8 behavioral skills deficit areas were identified as sufficiently prevalent to warrant specific targeted attention. Gender differences did not emerge. The deficits in pre-ART HIV-care related information, motivation and behavioral skills that were identified suggest that efforts to improve accurate information on immune function and HIV disease are needed, as is accurate information regarding HIV treatment and transmission risk prior to ART initiation. Additional efforts to facilitate the development of social support, including positive interactions with clinic staff and decreasing community-level stigma, and to decrease structural and resource-depleting demands of HIV-care may be particularly valuable to facilitate retention in pre-ART HIV-care.
doi:10.1080/09540121.2013.775398
PMCID: PMC4196878  PMID: 23477286
Retention in HIV-care; early engagement in HIV-care; IMB; pre-ART; South Africa
5.  Participant Experiences and Facilitators and Barriers to Pill Use Among Men Who Have Sex with Men in the iPrEx Pre-Exposure Prophylaxis Trial in San Francisco 
AIDS Patient Care and STDs  2013;27(10):560-566.
Abstract
In 2010, the iPrEx study demonstrated efficacy of daily emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) pre-exposure prophylaxis (PrEP) in reducing HIV acquisition among men who have sex with men. Adherence to study product was critical for PrEP efficacy, and varied considerably, with FTC/TDF detection rates highest in the United States. We conducted a qualitative study to gain insights into the experiences of iPrEx participants in San Francisco (SF) where there was high confirmed adherence, to understand individual and contextual factors influencing study product use in this community. In 2009 and 2011, we conducted focus groups and in-depth interviews in 36 and 16 SF iPrEx participants, respectively. Qualitative analyses indicate that participants joined the study out of altruism. They had a clear understanding of study product use, and pill taking was facilitated by establishing or building on an existing routine. Participants valued healthcare provided by the study and relationships with staff, whom they perceived as nonjudgmental, and found client-centered counseling to be an important part of the PrEP package. This facilitated pill taking and accurate reporting of missed doses. Adherence barriers included changes in routine, side effects/intercurrent illnesses, and stress. Future PrEP adherence interventions should leverage existing routines and establish client-centered relationships/ environments to support pill taking and promote accurate reporting.
doi:10.1089/apc.2013.0116
PMCID: PMC3791030  PMID: 24093809
6.  An interdisciplinary framework for measuring and supporting adherence in HIV prevention trials of ARV-based vaginal rings 
Journal of the International AIDS Society  2014;17(3Suppl 2):19158.
Introduction
Product adherence and its measurement have emerged as a critical challenge in the evaluation of new HIV prevention technologies. Long-acting ARV-based vaginal rings may simplify use instructions and require less user behaviour, thereby facilitating adherence. One ARV-based ring is in efficacy trials and others, including multipurpose rings, are in the pipeline. Participant motivations, counselling support and measurement challenges during ring trials must still be addressed. In previous HIV prevention trials, this has been done largely using descriptive and post-hoc methods that are highly variable and minimally evaluated. We outline an interdisciplinary framework for systematically investigating promising strategies to support product uptake and adherence, and to measure adherence in the context of randomized, blinded clinical trials.
Discussion
The interdisciplinary framework highlights the dual use of adherence measurement (i.e. to provide feedback during trial implementation and to inform interpretation of trial findings) and underscores the complex pathways that connect measurement, adherence support and enacted adherence behaviour. Three inter-related approaches are highlighted: 1) adherence support – sequential efforts to define motivators of study product adherence and to develop, test, refine and evaluate adherence support messages; 2) self-reported psychometric measures – creation of valid and generalizable measures based in easily administered scales that capture vaginal ring use with improved predictive ability at screening, baseline and follow-up that better engage participants in reporting adherence; and 3) more objective measurement of adherence – real-time adherence monitoring and cumulative measurement to correlate adherence with overall product effectiveness through innovative designs, models and prototypes using electronic and biometric technologies to detect ring insertion and/or removal or expulsion. Coordinating research along these three pathways will result in a comprehensive approach to product adherence within clinical trials.
Conclusions
Better measurement of adherence will not, by itself, ensure that future effectiveness trials will be able to address the most basic question: if the product is used per instructions, will it prevent HIV transmission? The challenges to adherence measurement must be addressed as one component of a more integrated system that has as its central focus adherence as a behaviour emerging from the social context of the user.
doi:10.7448/IAS.17.3.19158
PMCID: PMC4164000  PMID: 25224617
vaginal ring; acceptability; adherence; clinical trial research; HIV prevention; measurement
7.  Developing an adherence support intervention for patients on antiretroviral therapy in the context of the recent IDU-driven HIV/AIDS epidemic in Estonia 
AIDS care  2013;25(7):863-873.
There is limited data on and experience with interventions for antiretroviral therapy (ART) adherence support for patients on ART in Eastern Europe. We sought to identify a feasible adherence support intervention for delivery amongst HIV-positive adults receiving care in Estonia, where the HIV/AIDS epidemic has been mainly concentrated among injection drug users. Our application of intervention mapping strategies used existing literature, formative research and multidisciplinary team input to produce a brief clinic-based intervention entitled the Situated Optimal Adherence Intervention Estonia (sOAI Estonia) which uses both Next-Step Counseling and Information-Motivation-Behavioral Skills Model approach to facilitate integration of ART into the context and demands of daily life. We present the intervention development process, the resulting sOAI Estonia approach, and describe a randomized controlled trial which is underway to evaluate the intervention (results due in spring 2013).
doi:10.1080/09540121.2013.764393
PMCID: PMC3651786  PMID: 23391132
ART; HAART; adherence; intervention
8.  Feasibility, Acceptability and Preliminary Efficacy of an Online Peer-to-Peer Social Support ART Adherence Intervention 
AIDS and behavior  2013;17(6):2031-2044.
This study describes the results of an online social support intervention, called “Thrive With Me” (TWM), to improve antiretroviral therapy (ART) adherence. HIV-positive gay or bisexually-identified men self-reporting imperfect ART adherence in the past month were randomized to receive usual care (n=57) or the eight-week TWM intervention (n=67). Self-reported ART outcome measures (0–100% in the past month) were collected at baseline, post-intervention, and 1-month follow-up. Follow-up assessment completion rate was 90%. Participants rated (1–7 scale) the intervention high in information and system quality and overall satisfaction (Means≥5.0). The intervention showed modest effects for the overall sample. However, among current drug-using participants, the TWM (v. Control) group reported significantly higher overall ART adherence (90.1% v. 57.5% at follow-up; difference=31.1, p=.02) and ART taken correctly with food (81.6% v. 55.7% at follow-up; difference=47.9, p=.01). The TWM intervention appeared feasible to implement, acceptable to users, and demonstrated greatest benefits for current drug users.
doi:10.1007/s10461-013-0469-1
PMCID: PMC3674213  PMID: 23553347
antiretroviral adherence; Internet-based intervention; social support; men who have sex with men
9.  Strategies for Promoting Adherence to Antiretroviral Therapy: A Review of the Literature 
The success of antiretroviral therapy (ART) for HIV infection, though widespread and resounding, has been limited by inadequate adherence to its unforgiving regimens, especially over the long term. This article summarizes the literature on behavioral interventions to promote ART adherence and highlights some of the most recent and innovative research on patient education and case management, modified directly observed therapy, contingency management, interventions emphasizing social support, and novel technologies to promote awareness. Research in the area of adherence in pediatric HIV infection and in resource-constrained international settings also is considered. Although adherence interventions have been successful in experimental trials, they may not be feasible or adaptable given the constraints of real-world clinics arid community-based settings. Implementation and dissemination of adherence interventions needs increased attention as ART adherence research moves beyond its first decade. We conclude with suggestions for incorporating research findings into clinical practice.
PMCID: PMC4059830  PMID: 18945394
10.  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.
Description
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.
Methods
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
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.
doi:10.7326/0003-4819-156-11-201206050-00419
PMCID: PMC4044043  PMID: 22393036
11.  HIV Stigma Mechanisms and Well-Being among PLWH: A Test of the HIV Stigma Framework 
AIDS and behavior  2013;17(5):1785-1795.
The current work evaluates the HIV Stigma Framework in a sample of 95 people living with HIV recruited from an inner-city clinic in the Bronx, NY. To determine the contributions of each HIV stigma mechanism (internalized, enacted, and anticipated) on indicators of health and well-being, we conducted an interviewer-delivered survey and abstracted data from medical records. Results suggest that internalized stigma associates significantly with indicators of affective (i.e., helplessness regarding, acceptance of, and perceived benefits of HIV) and behavioral (i.e., days in medical care gaps and ARV non-adherence) health and well-being. Enacted and anticipated stigma associate with indicators of physical health and well-being (i.e., CD4 count less than 200 and chronic illness comorbidity respectively). By differentiating between HIV stigma mechanisms, researchers may gain a more nuanced understanding of how HIV stigma impacts health and well-being and better inform targeted interventions to improve specific outcomes among people living with HIV.
doi:10.1007/s10461-013-0437-9
PMCID: PMC3664141  PMID: 23456594
HIV; stigma; HIV Stigma Framework; health; discrimination
12.  A proposal for quality standards for measuring medication adherence in research 
AIDS and behavior  2013;17(1):284-297.
A decade after widespread recognition that adherence to medication regimens is key to antiretroviral (ARV) effectiveness, considerable controversy remains regarding a “gold standard” for adherence measurement. Each adherence measurement approach has strengths and weaknesses and each rests on specific assumptions. The range of assumptions regarding adherence measurement and the diversity with which each approach is implemented strongly suggest that the evaluation of a particular measure outside of the context in which it was used (e.g. the study’s operational protocol) may result in undeserved confidence or lack of confidence in study results. The purpose of this paper is to propose a set of best practices across commonly used measurement methods. Recommendations regarding what information should be included in published reports regarding how adherence was measured are provided to promote improvement in the quality of measurement of medication adherence in research.
doi:10.1007/s10461-012-0172-7
PMCID: PMC3434290  PMID: 22407465
Adherence measurement; Adherence self-report; Electronic monitoring devices; Pill-count; Pharmacy refill
13.  No Evidence of Sexual Risk Compensation in the iPrEx Trial of Daily Oral HIV Preexposure Prophylaxis 
PLoS ONE  2013;8(12):e81997.
Objective
Preexposure prophylaxis (PrEP) with emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) reduced HIV acquisition in the iPrEx trial among men who have sex with men and transgender women. Self-reported sexual risk behavior decreased overall, but may be affected by reporting bias. We evaluated potential risk compensation using biomarkers of sexual risk behavior.
Design and methods
Sexual practices were assessed at baseline and quarterly thereafter; perceived treatment assignment and PrEP efficacy beliefs were assessed at 12 weeks. Among participants with ≥1 follow-up behavioral assessment, sexual behavior, syphilis, and HIV infection were compared by perceived treatment assignment, actual treatment assignment, and perceived PrEP efficacy.
Results
Overall, acute HIV infection and syphilis decreased during follow-up. Compared with participants believing they were receiving placebo, participants believing they were receiving FTC/TDF reported more receptive anal intercourse partners prior to initiating drug (12.8 vs. 7.7, P = 0.04). Belief in receiving FTC/TDF was not associated with an increase in receptive anal intercourse with no condom (ncRAI) from baseline through follow-up (risk ratio [RR] 0.9, 95% confidence interval [CI]: 0.6–1.4; P = 0.75), nor with a decrease after stopping study drug (RR 0.8, 95% CI: 0.5–1.3; P = 0.46). In the placebo arm, there were trends toward lower HIV incidence among participants believing they were receiving FTC/TDF (incidence rate ratio [IRR] 0.8, 95% CI: 0.4–1.8; P = 0.26) and also believing it was highly effective (IRR 0.5, 95% CI: 0.1–1.7; P = 0.12).
Conclusions
There was no evidence of sexual risk compensation in iPrEx. Participants believing they were receiving FTC/TDF had more partners prior to initiating drug, suggesting that risk behavior was not a consequence of PrEP use.
doi:10.1371/journal.pone.0081997
PMCID: PMC3867330  PMID: 24367497
14.  An Agenda for Advancing the Science of Implementation of Evidence-Based HIV Prevention Interventions 
AIDS and behavior  2009;13(3):424-429.
In the past 25 years, a tremendous amount of time and resources have been committed to developing evidence-based HIV prevention interventions. More recently, there have been noteworthy efforts to develop an infrastructure and related policies to promote the dissemination (i.e., “the targeted distribution of information and intervention materials to a specific public health or clinical practice audience”) of evidence-based interventions. Despite these advances, however, we have had comparatively little success in the effective implementation (i.e., “the use of strategies to adopt and integrate evidence-based health interventions and change practice patterns within specific settings”) of such interventions in everyday practice or community settings. The objective of the current paper is to highlight select and initial areas of research that are critically needed to advance the state-of-the-science of implementation of HIV prevention interventions in our broader efforts to curb the epidemic worldwide.
doi:10.1007/s10461-009-9556-8
PMCID: PMC3771660  PMID: 19360464
Implementation; HIV/AIDS; Prevention; Intervention; Dissemination
15.  Engagement in HIV Medical Care and Technology Use among Stimulant-Using and Nonstimulant-Using Men who have Sex with Men 
AIDS Research and Treatment  2013;2013:121352.
Aims of this study were to assess the associations between stimulant use and attitudes toward and engagement in HIV medical care and to examine technology use among stimulant-using and nonstimulant-using men who have sex with men (MSM). HIV-positive MSM (n = 276; mean age = 42 years; 71% white, non-Hispanic; 43% with college degree) completed an online survey in 2009. Most men (69%) had not missed any scheduled HIV medical appointments in the past year, while 23% had missed at least one, and 9% had not attended any appointments. Stimulant use was significantly associated with not attending any HIV medical appointments in the unadjusted model (relative risk ratio (RRR) = 2.84, 95% CI [1.07, 7.58]), as well as in models adjusted for demographic (RRR = 3.16, 95% CI [1.13, 8.84]) and psychosocial (RRR = 3.44, 95% CI [1.17, 10.15]) factors (Ps < 0.05). Fewer stimulant-using than non-stimulant-using men rated HIV medical care a high priority (57% versus 85%; P < 0.01). Few significant differences were found in online social networking or mobile phone use between stimulant-using and non-stimulant-using MSM, even when stratified by engagement in HIV care. Findings indicate that stimulant use is uniquely associated with nonengagement in HIV medical care in this sample, and that it may be possible to reach stimulant-using MSM using online social networking and mobile technologies.
doi:10.1155/2013/121352
PMCID: PMC3705882  PMID: 23864944
16.  Understanding the Behavioral Determinants of Retention in HIV Care: A Qualitative Evaluation of a Situated Information, Motivation, Behavioral Skills Model of Care Initiation and Maintenance 
AIDS Patient Care and STDs  2012;26(6):344-355.
Abstract
The current study provides a qualitative test of a recently proposed application of an Information, Motivation, Behavioral Skills (IMB) model of health behavior situated to the social-environmental, structural, cognitive-affective, and behavioral demands of retention in HIV care. Mixed-methods qualitative analysis was used to identify the content and context of critical theory-based determinants of retention in HIV care, and to evaluate the relative fit of the model to the qualitative data collected via in-depth semi-structured interviews with a sample of inner-city patients accessing traditional and nontraditional HIV care services in the Bronx, NY. The sample reflected a diverse marginalized patient population who commonly experienced comorbid chronic conditions (e.g., psychiatric disorders, substance abuse disorders, diabetes, hepatitis C). Through deductive content coding, situated IMB model-based content was identified in all but 7.1% of statements discussing facilitators or barriers to retention in HIV care. Inductive emergent theme identification yielded a number of important themes influencing retention in HIV care (e.g., acceptance of diagnosis, stigma, HIV cognitive/physical impairments, and global constructs of self-care). Multiple elements of these themes strongly aligned with the model's IMB constructs. The convergence of the results from both sets of analysis demonstrate that participants' experiences map well onto the content and structure of the situated IMB model, providing a systematic classification of important theoretical and contextual determinants of retention in care. Future intervention efforts to enhance retention in HIV care should address these multiple determinants (i.e., information, motivation, behavioral skills) of self-directed retention in HIV care.
doi:10.1089/apc.2011.0388
PMCID: PMC3366334  PMID: 22612447
17.  Technology use and reasons to participate in online social networking websites for people living with HIV in the US 
AIDS and behavior  2012;16(4):900-910.
It is unknown if online social networking technologies are already highly integrated among some people living with HIV (PLWH) or have yet to be adopted. To fill this gap in understanding, 312 PLWH (84% male, 69% white) residing in the US completed on online survey in 2009 of their patterns of social networking and mobile phone use. Twenty-two persons also participated in one of two online focus groups. Results showed that 76% of participants with lower adherence to HIV medication used social networking websites/features at least once a week. Their ideal online social networking health websites included one that facilitated socializing with others (45% of participants) and relevant informational content (22%), although privacy was a barrier to use (26%). Texting (81%), and to a lesser extent mobile web-access (51%), was widely used among participants. Results support the potential reach of online social networking and text messaging intervention approaches.
doi:10.1007/s10461-012-0164-7
PMCID: PMC3454490  PMID: 22350832
Online social network; mobile phone; online survey; online focus group; people living with HIV
18.  Microbicide clinical trial adherence: insights for introduction 
After two decades of microbicide clinical trials it remains uncertain if vaginally- delivered products will be clearly shown to reduce the risk of HIV infection in women and girls. Furthermore, a microbicide product with demonstrated clinical efficacy must be used correctly and consistently if it is to prevent infection. Information on adherence that can be gleaned from microbicide trials is relevant for future microbicide safety and efficacy trials, pre-licensure implementation trials, Phase IV post-marketing research, and microbicide introduction and delivery. Drawing primarily from data and experience that has emerged from the large-scale microbicide efficacy trials completed to-date, the paper identifies six broad areas of adherence lessons learned: (1) Adherence measurement in clinical trials, (2) Comprehension of use instructions/Instructions for use, (3) Unknown efficacy and its effect on adherence/Messages regarding effectiveness, (4) Partner influence on use, (5) Retention and continuation and (6) Generalizability of trial participants' adherence behavior. Each is discussed, with examples provided from microbicide trials. For each of these adherence topics, recommendations are provided for using trial findings to prepare for future microbicide safety and efficacy trials, Phase IV post-marketing research, and microbicide introduction and delivery programs.
doi:10.7448/IAS.16.1.18505
PMCID: PMC3619032  PMID: 23561044
vaginal microbicides; HIV prevention; clinical trial adherence
19.  Antiretroviral Adherence Interventions: Translating Research Findings to the Real World Clinic 
Current HIV/AIDS reports  2010;7(1):44-51.
The success of potent combination antiretroviral therapy (ART) for HIV infection is compromised primarily by failure to maintain optimal levels of adherence over the long term. Recent reviews suggest behavioral interventions to promote ART adherence can have significant effects, but these tend to be small and to diminish over time; sustained improvements in biomarkers are particularly elusive. In this article, we update current reviews, focusing specifically on the 13 studies evaluating behavioral interventions to promote ART adherence published since September 2007. We describe the range of intervention strategies employed and qualitatively summarize findings of their efficacy. In conclusion, we consider implications and offer strategies for enhancing adherence in clinic-based HIV care prior to ART initiation, at initiation, and over the course of treatment.
doi:10.1007/s11904-009-0037-5
PMCID: PMC3607373  PMID: 20425057
HIV/AIDS; ART; Adherence; Interventions; Review
20.  Development and Pilot Testing of a Standardized Training Program for a Patient-Mentoring Intervention to Increase Adherence to Outpatient HIV Care 
AIDS Patient Care and STDs  2012;26(3):165-172.
Abstract
Although peer interventionists have been successful in medication treatment-adherence interventions, their role in complex behavior-change approaches to promote entry and reentry into HIV care requires further investigation. The current study sought to describe and test the feasibility of a standardized peer-mentor training program used for MAPPS (Mentor Approach for Promoting Patient Self-Care), a study designed to increase engagement and attendance at HIV outpatient visits among high-risk HIV inpatients using HIV-positive peer interventionists to deliver a comprehensive behavioral change intervention. Development of MAPPS and its corresponding training program included collaborations with mentors from a standing outpatient mentor program. The final training program included (1) a half-day workshop; (2) practice role-plays; and (3) formal, standardized patient role-plays, using trained actors with “real-time” video observation (and ratings from trainers). Mentor training occurred over a 6-week period and required demonstration of adherence and skill, as rated by MAPPS trainers. Although time intensive, ultimate certification of mentors suggested the program was both feasible and effective. Survey data indicated mentors thought highly of the training program, while objective rating data from trainers indicated mentors were able to understand and display standards associated with intervention fidelity. Data from the MAPPS training program provide preliminary evidence that peer mentors can be trained to levels necessary to ensure intervention fidelity, even within moderately complex behavioral-change interventions. Although additional research is needed due to limitations of the current study (e.g., limited generalizability due to sample size and limited breadth of clinical training opportunities), data from the current trial suggest that training programs such as MAPPS appear both feasible and effective.
doi:10.1089/apc.2011.0248
PMCID: PMC3326443  PMID: 22248331
21.  Adherence Support Approaches in Biomedical HIV Prevention Trials: Experiences, Insights and Future Directions from Four Multisite Prevention Trials 
AIDS and Behavior  2013;17(6):2143-2155.
Adherence is a critical component of the success of antiretroviral-based pre-exposure prophylaxis (PrEP) in averting new HIV-infections. Ensuring drug availability at the time of potential HIV exposure relies on self-directed product use. A deeper understanding of how to best support sustained PrEP adherence remains critical to current and future PrEP efforts. This paper provides a succinct synthesis of the adherence support experiences from four pivotal PrEP trials—Centre for the AIDS Programme of Research in South Africa (CAPRISA) 004, FEM-PrEP, Iniciativa Prophylaxis (iPrEx), and Vaginal and Oral Interventions to Control the Epidemic (VOICE). Notwithstanding variability in the design, population/cohort, formulation, drug, dosing strategy, and operationalization of adherence approaches utilized in each trial, the theoretical basis and experiences in implementation and monitoring of the approaches used by these trials provide key lessons for optimizing adherence in future research and programmatic scale-up of PrEP. Recommendations from across these trials include participant-centered approaches, separating measurement of adherence from adherence counseling, incorporating tailored strategies that go beyond education, fostering motivation, and addressing the specific context in which an individual incorporates and negotiates PrEP use.
doi:10.1007/s10461-013-0429-9
PMCID: PMC3672509  PMID: 23435697
PrEP; Microbicides; Adherence; Intervention; Counseling; Clinical trials; HIV prevention
22.  Development and Implementation of a Culturally Tailored Diabetes Intervention in Primary Care 
Diabetes education for ethnic minorities should address variations in values underlying motivations, preferences, and behaviors of individuals within an ethnic group. This paper describes the development and implementation of a culturally tailored diabetes intervention for Puerto Rican Americans that can be delivered by a health care paraprofessional and implemented in routine clinical care. We describe a formative process, including interviews with providers, focus groups with patients and a series of multidisciplinary collaborative workshops used to inform intervention content. We highlight the intervention components and link them to a well-validated health behavior change model. Finally, we present support for the intervention’s clinical effects, feasibility, and acceptability and conclude with implications and recommendations for practice. Lessons learned from this process should guide future educational efforts in routine clinical care.
doi:10.1007/s13142-011-0064-9
PMCID: PMC3569725  PMID: 23412908
Culturally tailored; diabetes; behavior change; primary care; Puerto Rican
23.  Early Retention in HIV Care and Viral Load Suppression: Implications for a Test and Treat Approach to HIV Prevention 
Background
Following HIV diagnosis and linkage to care, achieving and sustaining viral load (VL) suppression has implications for patient outcomes and secondary HIV prevention. We evaluated factors associated with expeditious VL suppression and cumulative VL burden among patients establishing outpatient HIV care.
Methods
Patients initiating HIV medical care from January 2007-October 2010 at the University of Alabama at Birmingham and University of Washington were included. Multivariable Cox proportional hazards and linear regression models were used to evaluate factors associated with time to VL suppression (<50 copies/mL) and cumulative VL burden, respectively. Viremia copy-years (VCY), a novel area under the longitudinal VL curve measure, was used to estimate 2-year cumulative VL burden from clinic enrollment.
Results
Among 676 patients, 63% achieved VL<50 copies/mL in a median 308 days. In multivariable analysis, patients with more time-updated “no show” visits experienced delayed VL suppression (HR=0.83 per “no show” visit, 95%CI=0.76,0.91). In multivariable linear regression, visit non-adherence was independently associated with greater cumulative VL burden (log10VCY) during the first two years in care (Beta coefficient=0.11 per 10% visit non-adherence, 95%CI=0.04-0.17). Across increasing visit adherence categories, lower cumulative VL burden was observed (mean ± standard deviation log10 copy × years/mL); 0-79% adherence: 4.6 ± 0.8; 80-99% adherence: 4.3 ± 0.7; and 100% adherence: 4.1 ± 0.8 log10 copy × years/mL, respectively (P<0.01).
Conclusions
Higher rates of early retention in HIV care are associated with achieving VL suppression and lower cumulative VL burden. These findings are germane for a test and treat approach to HIV prevention.
doi:10.1097/QAI.0b013e318236f7d2
PMCID: PMC3237801  PMID: 21937921
HIV; Viral load; Retention in care; Adherence; Engagement in care
24.  Prevention Needs of HIV-Positive Men and Women Awaiting Release from Prison 
AIDS and behavior  2012;16(1):108-120.
Greater understanding of barriers to risk reduction among incarcerated HIV+ persons reentering the community is needed to inform culturally tailored interventions. This qualitative study elicited HIV prevention-related information, motivation and behavioral skills (IMB) needs of 30 incarcerated HIV+ men and women awaiting release from state prison. Unmet information needs included risk questions about viral loads, positive sexual partners, and transmission through casual contact. Social motivational barriers to risk reduction included partner perceptions that prison release increases sexual desirability, partners’ negative condom attitudes, and HIV disclosure-related fears of rejection. Personal motivational barriers included depression and strong desires for sex or substance use upon release. Behavioral skills needs included initiating safer behaviors with partners with whom condoms had not been used prior to incarceration, disclosing HIV status, and acquiring clean needles or condoms upon release. Stigma and privacy concerns were prominent prison context barriers to delivering HIV prevention services during incarceration.
doi:10.1007/s10461-011-9962-6
PMCID: PMC3428225  PMID: 21553252
Prison; Incarceration; HIV prevention; HIV-positive; Qualitative
25.  Qualitative Assessment of Barriers and Facilitators to HIV Treatment 
doi:10.1016/j.jana.2010.11.001
PMCID: PMC3117967  PMID: 21277804
Deep South; engagement in care; HIV infection; qualitative research

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