Development and pilot-testing of a hepatitis C reinfection prevention intervention for patients in treatment for hepatitis C infection.

•We developed a two-session behavioral intervention to prevent HCV reinfection.•The intervention was piloted at an OTP and integrated into HCV treatment.•Baseline data showed limited knowledge & application of safer injection practices.•Implementation barriers included logistics and the lack of financial incentive.•Adaptations addressed barriers, yielding a more feasible and acceptable intervention.

A new Bayesian joint model for longitudinal count data with many zeros, intermittent missingness, and dropout with applications to HIV prevention trials.

In longitudinal clinical trials, it is common that subjects may permanently withdraw from the study (dropout), or return to the study after missing one or more visits (intermittent missingness). It is also routinely encountered in HIV prevention clinical trials that there is a large proportion of zeros in count response data. In this paper, a sequential multinomial model is adopted for dropout and subsequently a conditional model is constructed for intermittent missingness. The new model captures the complex structure of missingness and incorporates dropout and intermittent missingness simultaneously. The model also allows us to easily compute the predictive probabilities of different missing data patterns. A zero-inflated Poisson mixed-effects regression model is assumed for the longitudinal count response data. We also propose an approach to assess the overall treatment effects under the zero-inflated Poisson model. We further show that the joint posterior distribution is improper if uniform priors are specified for the regression coefficients under the proposed model. Variations of the g-prior, Jeffreys prior, and maximally dispersed normal prior are thus established as remedies for the improper posterior distribution. An efficient Gibbs sampling algorithm is developed using a hierarchical centering technique. A modified logarithm of the pseudomarginal likelihood and a concordance based area under the curve criterion are used to compare the models under different missing data mechanisms. We then conduct an extensive simulation study to investigate the empirical performance of the proposed methods and further illustrate the methods using real data from an HIV prevention clinical trial.

Bayesian Modeling and Inference for Nonignorably Missing Longitudinal Binary Response Data with Applications to HIV Prevention Trials.

Missing data are frequently encountered in longitudinal clinical trials. To better monitor and understand the progress over time, one must handle the missing data appropriately and examine whether the missing data mechanism is ignorable or nonignorable. In this article, we develop a new probit model for longitudinal binary response data. It resolves a challenging issue for estimating the variance of the random effects, and substantially improves the convergence and mixing of the Gibbs sampling algorithm. We show that when improper uniform priors are specified for the regression coefficients of the joint multinomial model via a sequence of one-dimensional conditional distributions for the missing data indicators under nonignorable missingness, the joint posterior distribution is improper. A variation of Jeffreys prior is thus established as a remedy for the improper posterior distribution. In addition, an efficient Gibbs sampling algorithm is developed using a collapsing technique. Two model assessment criteria, the deviance information criterion (DIC) and the logarithm of the pseudomarginal likelihood (LPML), are used to guide the choices of prior specifications and to compare the models under different missing data mechanisms. We report on extensive simulations conducted to investigate the empirical performance of the proposed methods. The proposed methodology is further illustrated using data from an HIV prevention clinical trial.

60 Minutes for health: examining the feasibility and acceptability of a low-resource behavioral intervention designed to promote retention in HIV care.

Sustained retention in HIV medical care is a key health behavior for the long-term health of people living with HIV (PLWH). Approximately 60% of PLWH in the U.S. are poorly retained in HIV care, yet to date, the few available evidence-based retention-promoting interventions are resource and time intensive to implement. The current study describes the feasibility and acceptability of a theory-based retention-promoting intervention designed to meet the needs of a busy clinical care setting. 60 Minutes for Health reflects a low-resource single-session intervention, implemented by a health educator, to PLWH who have had a recent gap in care (≥6-months) in the past 18-months. Intervention content was informed by a situated application of the Information Motivation Behavioral Skills Model and delivered using a Motivational Interviewing-based format. The intervention uses a workbook to guide a series of activities that: (1) Identify and reduce misinformation guiding HIV care attendance. (2) Enhance motivation to maintain care via personal health goals. (3) Build skills for coping with emotional distress related to living with HIV. (4) Increase self-efficacy for navigating the logistics of maintaining care amidst competing priorities. A small feasibility pilot of this intervention protocol was conducted to assess its potential to improve retention in care and to obtain estimates for a larger-scale efficacy trial. Participants were randomized to the 60-minute intervention session (n = 8), or a theory-based time-and-attention control session focused on diet and nutrition (n = 8). Medical records were abstracted to evaluate changes in participants' retention in care status at 12- and 24-months post-intervention. Findings suggest the intervention is both feasible and acceptable to implement with poorly retained PLWH in a clinic setting. Post-intervention a larger proportion of intervention participants were retained in care (12-months: 87.5%, 24-months: 62.5%), compared control participants (12-months: 50.0%, 24-months: 25.0%). Future work should aim to evaluate a larger-scale efficacy trial.

Exclusive breast-feeding promotion among HIV-infected women in South Africa: an Information-Motivation-Behavioural Skills model-based pilot intervention.

OBJECTIVE: Exclusive breast-feeding (EBF) provides optimal nutrition for infants and mothers. The practice of EBF while adhering to antiretroviral medication decreases the risk of mother-to-child transmission of HIV from approximately 25 % to less than 5 %. Thus the WHO recommends EBF for the first 6 months among HIV-infected women living in resource-limited settings; however, EBF rates remain low. In the present study our aim was to design and implement a pilot intervention promoting EBF among HIV-infected women. DESIGN: The Information-Motivation-Behavioural Skills (IMB) model was applied in a brief motivational interviewing counselling session that was tested in a small randomized controlled trial. SETTING: Pietermaritzburg, South Africa, at two comparable rural public health service clinics. SUBJECTS: Sixty-eight HIV-infected women in their third trimester were enrolled and completed baseline interviews between June and August 2014. Those randomized to the intervention arm received the IMB-based pilot intervention directly following baseline interviews. Follow-up interviews occurred at 6 weeks postpartum. RESULTS: While not significantly different between trial arms, high rates of intention and practice of EBF at 6-week follow-up were reported. Findings showed high levels of self-efficacy being significantly predictive of breast-feeding initiation and duration regardless of intervention arm. CONCLUSIONS: Future research must account for breast-feeding self-efficacy on sustaining breast-feeding behaviour and leverage strategies to enhance self-efficacy in supportive interventions. Supporting breast-feeding behaviour through programmes that include both individual-level and multi-systems components targeting the role of health-care providers, family and community may create environments that value and support EBF behaviour.

Cross-cultural adaptation of instruments assessing breastfeeding determinants: a multi-step approach.

BACKGROUND: Cross-cultural adaptation is a necessary process to effectively use existing instruments in other cultural and language settings. The process of cross-culturally adapting, including translation, of existing instruments is considered a critical set to establishing a meaningful instrument for use in another setting. Using a multi-step approach is considered best practice in achieving cultural and semantic equivalence of the adapted version. We aimed to ensure the content validity of our instruments in the cultural context of KwaZulu-Natal, South Africa. METHODS: The Iowa Infant Feeding Attitudes Scale, Breastfeeding Self-Efficacy Scale-Short Form and additional items comprise our consolidated instrument, which was cross-culturally adapted utilizing a multi-step approach during August 2012. Cross-cultural adaptation was achieved through steps to maintain content validity and attain semantic equivalence in the target version. Specifically, Lynn's recommendation to apply an item-level content validity index score was followed. The revised instrument was translated and back-translated. To ensure semantic equivalence, Brislin's back-translation approach was utilized followed by the committee review to address any discrepancies that emerged from translation. RESULTS: Our consolidated instrument was adapted to be culturally relevant and translated to yield more reliable and valid results for use in our larger research study to measure infant feeding determinants effectively in our target cultural context. CONCLUSIONS: Undertaking rigorous steps to effectively ensure cross-cultural adaptation increases our confidence that the conclusions we make based on our self-report instrument(s) will be stronger. In this way, our aim to achieve strong cross-cultural adaptation of our consolidated instruments was achieved while also providing a clear framework for other researchers choosing to utilize existing instruments for work in other cultural, geographic and population settings.

HIV prevention counseling intervention delivered during routine clinical care reduces HIV risk behavior in HIV-infected South Africans receiving antiretroviral therapy: the Izindlela Zokuphila/Options for Health randomized trial.

CONTEXT: Sustainable interventions are needed to minimize HIV risk behavior among people living with HIV (PLWH) in South Africa on antiretroviral therapy (ART), a significant proportion of whom do not achieve viral suppression. OBJECTIVE: To determine whether a brief lay counselor delivered intervention implemented during routine care can reduce risky sex among PLWH on ART. DESIGN: Cluster-randomized 16 HIV clinical care sites in KwaZulu Natal, South Africa, to intervention or standard of care. SETTING: Publicly funded HIV clinical care sites. PATIENTS: One thousand eight hundred ninety-one PLWH on ART received the HIV prevention counseling intervention (n = 967) or standard-of-care counseling (n = 924). INTERVENTION: Lay counselors delivered a brief intervention using motivational interviewing strategies based on the Information-Motivation-Behavioral (IMB) Skills model during routine clinical care. MAIN OUTCOME MEASURES: Number of sexual events without a condom in the past 4 weeks with partners of any HIV status, and with partners perceived to be HIV negative or HIV-status unknown, assessed at baseline, 6, 12, and 18 months. RESULTS: Intervention participants reported significantly greater reductions in HIV risk behavior on both primary outcomes, compared with standard-of-care participants. Differences in sexually transmitted infection incidence between arms were not observed. CONCLUSIONS: Effective behavioral interventions, delivered by lay counselors within the clinical care setting, are consistent with the strategy of linking HIV care and HIV prevention and integrating biomedical and behavioral approaches to stemming the HIV epidemic. TRIAL REGISTRATION: Not applicable.

HIV stigma and unprotected sex among PLWH in KwaZulu-Natal, South Africa: a longitudinal exploration of mediating mechanisms.

Social and structural factors including HIV stigma are theorized to drive global disparities in HIV prevalence. This study tests whether HIV self-stigma, or experiences of stigma at the individual level, is associated with engagement in unprotected sex among people living with HIV (PLWH) in KwaZulu-Natal, South Africa, where 37.4% of adults are living with HIV compared with 0.8% worldwide. It further explores whether depressive symptoms, HIV status disclosure to sex partners, and/or condom use attitudes mediate potential associations between HIV self-stigma and unprotected sex. Participants, including 924 PLWH, were recruited from primary care clinics and completed baseline, 6-, 12-, and 18-month survey assessments between 2008 and 2011. Hierarchical linear modeling analyses were used to examine longitudinal within-subjects associations between HIV self-stigma, mediators, and unprotected sex with both HIV-negative/unknown and HIV-positive partners. Results demonstrate that HIV self-stigma was prospectively associated with greater likelihood of unprotected sex with HIV-negative/unknown partners. None of the variables explored significantly mediated this association. HIV self-stigma was also prospectively associated with greater likelihood of unprotected sex with HIV-positive partners via the mediators of greater depressive symptoms and more negative condom use attitudes. The current study suggests that HIV self-stigma undermines HIV secondary prevention and care efforts among PLWH in KwaZulu-Natal. It is therefore critical to address HIV stigma at the social/structural level to reduce HIV self-stigma at the individual level and ultimately curb global disparities in HIV prevalence. In the absence of widespread social/structural change, interventions that treat depressive symptoms and encourage more positive condom use attitudes despite the existence of HIV stigma may buffer associations between HIV self-stigma and unprotected sex with HIV-positive partners among PLWH in KwaZulu-Natal.

HIV transmission risk behavior among HIV-positive patients receiving antiretroviral therapy in KwaZulu-Natal, South Africa.

The aim of this investigation was to identify factors associated with HIV transmission risk behavior among HIV-positive women and men receiving antiretroviral therapy (ART) in KwaZulu-Natal, South Africa. Across 16 clinics, 1,890 HIV+ patients on ART completed a risk-focused audio computer-assisted self-interview upon enrolling in a prevention-with-positives intervention trial. Results demonstrated that 62 % of HIV-positive patients' recent unprotected sexual acts involved HIV-negative or HIV status unknown partners. For HIV-positive women, multivariable correlates of unprotected sex with HIV-negative or HIV status unknown partners were indicative of poor HIV prevention-related information and of sexual partnership-associated behavioral skills barriers. For HIV-positive men, multivariable correlates represented motivational barriers, characterized by negative condom attitudes and the experience of depressive symptomatology, as well as possible underlying information deficits. Findings suggest that interventions addressing gender-specific and culturally-relevant information, motivation, and behavioral skills barriers could help reduce HIV transmission risk behavior among HIV-positive South Africans.

Information, motivation, and behavioral skills for early pre-ART engagement in HIV care among patients entering clinical care in KwaZulu-Natal, South Africa.

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 aged 18 years or older, newly entering care (diagnosed within the last six-months), and ineligible for ART (CD4 count > 200 cells/mm(3)) 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, eight information, eight motivation, and eight 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.

Understanding HIV transmission risk behavior among HIV-infected South Africans receiving antiretroviral therapy: an information--motivation--behavioral skills model analysis.

OBJECTIVE: The current study applied the Information-Motivation-Behavioral Skills (IMB) model (Fisher & Fisher, 1992; Fisher & Fisher, 1993) to identify factors associated with human immunodeficiency virus (HIV) transmission risk behavior among HIV-infected South Africans receiving antiretroviral therapy (ART), a population of considerable significance for curtailing, or maintaining, South Africa's generalized HIV epidemic. METHODS: HIV prevention information, HIV prevention motivation, HIV prevention behavioral skills, and HIV transmission risk behavior were assessed in a sample of 1,388 South Africans infected with HIV and receiving ART in 16 clinics in KwaZulu-Natal, South Africa. RESULTS: Findings confirmed the assumptions of the IMB model and demonstrated that HIV prevention information and HIV prevention motivation work through HIV prevention behavioral skills to affect HIV transmission risk behavior in this population. Subanalyses confirmed these relationships for HIV transmission risk behavior overall and for HIV transmission risk behavior with partners perceived to be HIV-negative or HIV-status unknown. A consistent pattern of gender differences showed that for men, HIV prevention information and HIV prevention motivation may have direct links with HIV preventive behavior, whereas for women, the effect of HIV prevention motivation works through HIV prevention behavioral skills to affect HIV preventive behavior. CONCLUSION: These IMB model-based findings suggest directions for HIV prevention interventions with South African men and women living with HIV and on ART as an important component of overall strategies to contain South Africa's generalized HIV epidemic.

Relative efficacy of a pregnancy, sexually transmitted infection, or human immunodeficiency virus prevention-focused intervention on changing sexual risk behavior among young adults.

OBJECTIVES: Despite findings suggesting that young adults are more concerned about experiencing an unplanned pregnancy or contracting a sexually transmitted infection (STI) than becoming human immunodeficiency virus (HIV) infected, no empirical work has investigated whether the specific focus of an intervention may be more or less efficacious at changing sexual behavior. PARTICIPANTS: Participants were 198 college students randomized to 1 of 4 conditions: pregnancy intervention, STI intervention, HIV intervention, or a control condition during 2008-2009. METHODS: The authors compared the efficacy of 3 theory-based, sexual risk-reduction interventions that were exactly the same except for an exclusive focus on preventing pregnancy, STI, or HIV. Condom use and risky sexual behavior were assessed at baseline and 4-week and 8-week follow-up. RESULTS: Participants exposed to the pregnancy or STI interventions reported greater condom use and less risky sexual behavior than those exposed to the HIV intervention. CONCLUSIONS: The focus of sexual risk-reduction interventions may lead to differential behavior change among young adults.

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.

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.

Counsellor-delivered HIV risk reduction intervention addresses safer sex barriers of people living with HIV in KwaZulu-Natal, South Africa.

This study developed an HIV risk reduction intervention for people living with HIV (PLWH) obtaining care at primary healthcare clinics in KwaZulu-Natal, South Africa by (1) conducting elicitation research to understand the dynamics of risk behaviour among PLWH, (2) modifying an existing HIV risk reduction intervention based on research findings and (3) conducting a pilot study to evaluate feasibility, acceptability and fidelity of the modified intervention implemented by trained lay counsellors at a rural clinic in KwaZulu-Natal. A total of 61 healthcare providers and 77 HIV+ patients from four primary healthcare clinics participated in 14 focus groups and 20 individual interviews to identify informational, motivational and behavioural skills (IMB) factors contributing to PLWH's sexual risk behaviour. Elicitation research findings were incorporated into a revised version of Options for Health, an evidence-based risk reduction intervention for PLWH in clinical care. In a 5-day training, lay counsellors learned strategies to address IMB barriers to safer sex identified in elicitation research. The revised intervention, which was implemented by six counsellors with 39 patients, was feasible to implement, acceptable to patients and counsellors, and implemented with good fidelity. This study makes an important contribution towards development of a theory-based HIV risk reduction intervention for PLWH linking prevention with treatment in South Africa.

Pilot test of an emotional education intervention component for sexual risk reduction.

OBJECTIVE: Emotions are key predictors of sexual risk behavior but have been largely ignored in theory-based intervention development. The present study aims to evaluate whether the addition of an emotional education intervention component to a traditional social-cognitive safer sex intervention increases intervention efficacy, compared with both a social-cognitive only intervention and a no intervention control condition. METHODS: Young adults were randomized in small groups to receive the social-cognitive-emotional (SCE) intervention, the social-cognitive (SC) intervention, or standard of care. RESULTS: Analyses of data from 176 participants indicated that intervention arms reported similar increased condom use compared with the no intervention control arm at 3 months' postintervention (ß = .06, p = .41, d = 0.08). However, at 6 months' postintervention, individuals in the SCE intervention arm reported increased condom use compared with both the SC intervention (ß = .27, p = .04, d = 0.38) and control arms (ß = .37, p < .01; d = 0.56), demonstrating preliminary evidence that the addition of an emotional education component may facilitate sustained behavior change. CONCLUSIONS: An emotional education intervention module has the potential to facilitate sustained behavior change at delayed follow-up. Additional research is necessary to replicate findings in a larger sample and to determine the mediators of emotional education intervention efficacy.

Computer-based intervention in HIV clinical care setting improves antiretroviral adherence: the LifeWindows Project.

We evaluated the efficacy of LifeWindows, a theory-based, computer-administered antiretroviral (ARV) therapy adherence support intervention, delivered to HIV + patients at routine clinical care visits. 594 HIV + adults receiving HIV care at five clinics were randomized to intervention or control arms. Intervention vs. control impact in the intent-to-treat sample (including participants whose ARVs had been entirely discontinued, who infrequently attended care, or infrequently used LifeWindows) did not reach significance. Intervention impact in the On Protocol sample (328 intervention and control arm participants whose ARVs were not discontinued, who attended care and were exposed to LifeWindows regularly) was significant. On Protocol intervention vs. control participants achieved significantly higher levels of perfect 3-day ACTG-assessed adherence over time, with sensitivity analyses maintaining this effect down to 70% adherence. This study supports the utility of LifeWindows and illustrates that patients on ARVs who persist in care at clinical care sites can benefit from adherence promotion software.

Understanding HIV disclosure: a review and application of the Disclosure Processes Model.

HIV disclosure is a critical component of HIV/AIDS prevention and treatment efforts, yet the field lacks a comprehensive theoretical framework with which to study how HIV-positive individuals make decisions about disclosing their serostatus and how these decisions affect them. Recent theorizing in the context of the Disclosure Processes Model has suggested that the disclosure process consists of antecedent goals, the disclosure event itself, mediating processes and outcomes, and a feedback loop. In this paper, we apply this new theoretical framework to HIV disclosure in order to review the current state of the literature, identify gaps in existing research, and highlight the implications of the framework for future work in this area.

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.

A brief culturally tailored intervention for Puerto Ricans with type 2 diabetes.

UNLABELLED: The information-motivation-behavioral skills (IMB) model of health behavior change informed the design of a brief, culturally tailored diabetes self-care intervention for Puerto Ricans with type 2 diabetes. Participants (n = 118) were recruited from an outpatient, primary care clinic at an urban hospital in the northeast United States. ANCOVA models evaluated intervention effects on food label reading, diet adherence, physical activity, and glycemic control (HbA1c). At follow-up, the intervention group was reading food labels and adhering to diet recommendations significantly more than the control group. Although the mean HbA1c values decreased in both groups ( INTERVENTION: 0.48% vs. CONTROL: 0.27% absolute decrease), only the intervention group showed a significant improvement from baseline to follow-up (p < .008), corroborating improvements in diabetes self-care behaviors. Findings support the use of the IMB model to culturally tailor diabetes interventions and to enhance patients' knowledge, motivation, and behavior skills needed for self-care.