Person: Safren, Steven A.
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Publication Psychosocial Predictors of Non-Adherence and Treatment Failure in a Large Scale Multi-National Trial of Antiretroviral Therapy for HIV: Data from the ACTG A5175/PEARLS Trial
(Public Library of Science, 2014) Safren, Steven A.; Biello, Katie B.; Smeaton, Laura; Mimiaga, Matthew J.; Walawander, Ann; Lama, Javier R.; Rana, Aadia; Nyirenda, Mulinda; Kayoyo, Virginia M.; Samaneka, Wadzanai; Joglekar, Anjali; Celentano, David; Martinez, Ana; Remmert, Jocelyn E.; Nair, Aspara; Lalloo, Umesh G.; Kumarasamy, Nagalingeswaran; Hakim, James; Campbell, Thomas B.Background: PEARLS, a large scale trial of antiretroviral therapy (ART) for HIV (n = 1,571, 9 countries, 4 continents), found that a once-daily protease inhibitor (PI) based regimen (ATV+DDI+FTC), but not a once-daily non-nucleoside reverse transcriptase inhibitor/nucleoside reverse transcriptase inhibitor (NNRTI/NRTI) regimen (EFV+FTC/TDF), had inferior efficacy compared to a standard of care twice-daily NNRTI/NRTI regimen (EFV+3TC/ZDV). The present study examined non-adherence in PEARLS. Methods: Outcomes: non-adherence assessed by pill count and by self-report, and time to treatment failure. Longitudinal predictors: regimen, quality of life (general health perceptions = QOL-health, mental health = QOL-mental health), social support, substance use, binge drinking, and sexual behaviors. “Life-Steps” adherence counseling was provided. Results: In both pill-count and self-report multivariable models, both once-a-day regimens had lower levels of non-adherence than the twice-a-day standard of care regimen; although these associations attenuated with time in the self-report model. In both multivariable models, hard-drug use was associated with non-adherence, living in Africa and better QOL-health were associated with less non-adherence. According to pill-count, unprotected sex was associated with non-adherence. According to self-report, soft-drug use was associated with non-adherence and living in Asia was associated with less non-adherence. Both pill-count (HR = 1.55, 95% CI: 1.15, 2.09, p<.01) and self-report (HR = 1.13, 95% CI: 1.08, 1.13, p<.01) non-adherence were significant predictors of treatment failure over 72 weeks. In multivariable models (including pill-count or self-report nonadherence), worse QOL-health, age group (younger), and region were also significant predictors of treatment failure. Conclusion: In the context of a large, multi-national, multi-continent, clinical trial there were variations in adherence over time, with more simplified regimens generally being associated with better adherence. Additionally, variables such as QOL-health, regimen, drug-use, and region play a role. Self-report and pill-count adherence, as well as additional psychosocial variables, such QOL-health, age, and region, were, in turn, associated with treatment failure.
Publication Ensuring It Works: A Community-Based Approach to HIV Prevention Intervention Development for Men Who Have Sex with Men in Chennai, India
(Guilford Publications, 2012) Thomas, Beena; Mimiaga, Matthew J.; Mayer, Kenneth; Closson, Elizabeth F.; Johnson, Carey V.; Menon, Sunil; Mani, Jamuna; Vijaylakshmi, R.; Dilip, Meenalochini; Betancourt, Theresa; Safren, Steven A.Men who have sex with men (MSM) in India have an HIV seroprevalence 22 times greater than the country’s general population and face unique challenges that may hinder the effectiveness of current HIV prevention efforts. To obtain an understanding of the logistical and sociocultural barriers MSM experience while accessing HIV prevention services, focus groups and key informant interviews were conducted with 55 MSM in Chennai, India. Qualitative data were analyzed using descriptive qualitative content analysis. Sixty-five percent of participants identified as kothi (receptive partners), 9% as panthi (insertive partners), 22% as double decker (receptive and insertive), and 4% did not disclose. Themes included: (a) fatigue with current HIV risk reduction messages; (b) increased need for non-judgmental and confidential services; and (c) inclusion of content that acknowledges individual and structural-level determinants of risk such as low self-esteem, depression, and social discrimination. MSM interventions may benefit from approaches that address multilevel psychosocial factors, including skills building and strategies to foster self-acceptance and increased social support.
Publication Depression and Diabetes Treatment Nonadherence: A Meta-Analysis
(American Diabetes Association, 2008) Gonzalez, Jeffrey S.; Peyrot, Mark; McCarl, Lauren; Collins, Erin Marie; Serpa, Luis; Mimiaga, Matthew J.; Safren, Steven A.OBJECTIVE—Depression is common in patients with diabetes and is associated with worse treatment outcomes. Its relationship to treatment adherence, however, has not been systematically reviewed. We used meta-analysis to examine the relationship between depression and treatment nonadherence in patients with type 1 and type 2 diabetes. RESEARCH DESIGN AND METHODS—We searched MEDLINE and PsycINFO databases for all studies published by June 2007 and reviewed references of published articles. Meta-analytic procedures were used to estimate the effect size r in a random effects model. Significance values, weighted effect sizes, 95% CIs, and tests of homogeneity of variance were calculated. RESULTS—Results from 47 independent samples showed that depression was significantly associated with nonadherence to the diabetes treatment regimen (z = 9.97, P < 0.0001). The weighted effect size was near the medium range (r = 0.21, 95% CI 0.17–0.25). Moderator analyses showed that the effect was significantly larger in studies that measured self-care as a continuous versus categorical variable (P = 0.001). Effect sizes were largest for missed medical appointments and composite measures of self-care (r values = 0.31, 0.29). Moderation analyses suggest that effects for most other types of self-care are also near the medium range, especially in studies with stronger methodologies. CONCLUSIONS—These findings demonstrate a significant association between depression and treatment nonadherence in patients with diabetes. Studies that used stronger methodologies had larger effects. Treatment nonadherence may represent an important pathway between depression and worse diabetes clinical outcomes.
Publication Intimacy versus Isolation: A Qualitative Study of Sexual Practices among Sexually Active HIV-Infected Patients in HIV Care in Brazil, Thailand, and Zambia
(Public Library of Science, 2015) Closson, Elizabeth F.; Mimiaga, Matthew J.; Sherman, Susan G.; Tangmunkongvorakul, Arunrat; Friedman, Ruth K.; Limbada, Mohammed; Moore, Ayana T.; Srithanaviboonchai, Kriengkrai; Alves, Carla A.; Roberts, Sarah; Oldenburg, Catherine E.; Elharrar, Vanessa; Mayer, Kenneth; Safren, Steven A.The success of global treatment as prevention (TasP) efforts for individuals living with HIV/AIDS (PLWHA) is dependent on successful implementation, and therefore the appropriate contribution of social and behavioral science to these efforts. Understanding the psychosocial context of condomless sex among PLWHA could shed light on effective points of intervention. HPTN 063 was an observational mixed-methods study of sexually active, in-care PLWHA in Thailand, Zambia, and Brazil as a foundation for integrating secondary HIV prevention into HIV treatment. From 2010–2012, 80 qualitative interviews were conducted with PLWHA receiving HIV care and reported recent sexual risk. Thirty men who have sex with women (MSW) and 30 women who have sex with men (WSM) participated in equal numbers across the sites. Thailand and Brazil also enrolled 20 biologically-born men who have sex with men (MSM). Part of the interview focused on the impact of HIV on sexual practices and relationships. Interviews were recorded, transcribed, translated into English and examined using qualitative descriptive analysis. The mean age was 25 (SD = 3.2). There were numerous similarities in experiences and attitudes between MSM, MSW and WSM across the three settings. Participants had a high degree of HIV transmission risk awareness and practiced some protective sexual behaviors such as reduced sexual activity, increased use of condoms, and external ejaculation. Themes related to risk behavior can be categorized according to struggles for intimacy and fears of isolation, including: fear of infecting a sex partner, guilt about sex, sexual communication difficulty, HIV-stigma, and worry about sexual partnerships. Emphasizing sexual health, intimacy and protective practices as components of nonjudgmental sex-positive secondary HIV prevention interventions is recommended. For in-care PLWHA, this approach has the potential to support TasP. The overlap of themes across groups and countries indicates that similar intervention content may be effective for a range of settings.