Impact of an adherence intervention on the effectiveness of tenofovir gel in the CAPRISA 004 trial.

High adherence is important in microbicide trials, but no adherence interventions to date have demonstrated empiric improvements in microbicide adherence or effectiveness. Approximately midway during the CAPRISA 004 trial, we implemented a novel adherence intervention (Adherence Support Program-ASP), based on an Information-Motivation-Behavioral Skills model and incorporating a Motivational Interviewing approach. We assessed the impact of the ASP on adherence and tenofovir gel effectiveness using a before-and-after comparison. Of the 889 women in the trial, 774 contributed 486.1 women-years of follow-up pre-ASP and 828 contributed 845.7 women-years of follow-up post-ASP. Median adherence rose from 53.6 % pre-ASP to 66.5 % post-ASP. Detectable tenofovir levels increased from 40.6 % pre-ASP to 62.5 % post-ASP in 64 women who had paired tenofovir drug samples. Gel effectiveness improved post-ASP; HIV incidence in the tenofovir gel arm was 24 % lower pre-ASP compared to 47 % lower post-ASP. Following implementation of the ASP, microbicide adherence improved with a concomitant increase in the effectiveness of tenofovir gel.

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.

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.

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.

Facilitation and Preferred Models for Delivering Substance Use Disorder Treatment in HIV Clinics: Results From a Multisite Randomized Trial.

BACKGROUND: Integrated addiction treatment in HIV clinics is associated with improved outcomes, yet it is offered inconsistently and with variable models of care. We sought to evaluate the impact of Implementation Facilitation ("Facilitation") on clinician and staff preference for provision of addiction treatment in HIV clinics with on-site resources (all trained or designated on-site specialist) versus outside resources (outside specialist or refer out). METHODS: From July 2017 to July 2020, surveys assessed clinician and staff preferences for addiction treatment models during control (ie, baseline), intervention, evaluation, and maintenance phases in 4 HIV clinics in the Northeast United States. RESULTS: During the control phase, among 76 respondents (response rate, 58%), the proportions who preferred treatment with on-site resources for opioid use disorder (OUD), alcohol use disorder (AUD), and tobacco use disorder (TUD) were 63%, 55%, and 63%, respectively. Compared with control, there were no significant differences in preferred model during the intervention and evaluation phases except for AUD where there was an increased preference for treatment with on-site resources in the intervention versus control phase. Compared with control, during the maintenance phase, a higher proportion of clinicians and staff preferred providing addiction treatment with on-site resources versus outside resources: OUD, 75% (odds ratio [OR; 95% confidence interval {CI}], 1.79 [1.06-3.03]); AUD, 73% (OR [95% CI], 2.23 [1.36-3.65]), and TUD, 76% (OR [95% CI], 1.88 [1.11-3.18]). CONCLUSIONS: The findings from this study lend support for "Facilitation" as a strategy to enhance clinician and staff preference for integrated addiction treatment in HIV clinics with on-site resources.

Patients' perspectives of medications for addiction treatment in HIV clinics: A qualitative study.

BACKGROUND: While substance use disorders (SUD) disproportionately impact people with HIV (PWH), HIV clinics inconsistently provide evidence-based medications for addiction treatment (MAT). Patient receptivity to MAT is critical to enhance addiction treatment in these settings. However, we know little from patients about how to best integrate MAT into HIV clinics. METHODS: This qualitative study used four focus groups informed by the Promoting Action on Research Implementation in Health Services framework to identify barriers and facilitators to receiving opioid, alcohol, and tobacco use disorder care in HIV clinics. The study population included 28 patients with HIV and SUD receiving care at one of four HIV clinics in the northeastern United States. Focus groups were recorded and transcribed for content analysis. The study also performed a brief survey assessing demographics and behaviors. RESULTS: Focus groups revealed several major themes related to MAT in HIV clinics. Barriers included stigma around MAT, knowledge deficits about available MAT options and the impact of substance use on PWH, concerns about medication side effects, substance use screening without adequate clinician follow-up, and peers who discouraged MAT. Facilitators included recognition of substance use as a threat to overall health, integrated care from HIV clinicians, and support for addiction treatment from peers with lived experience. CONCLUSIONS: Efforts to enhance MAT in HIV clinics should include patient education to help them recognize addiction as a chronic disease with available medication treatment options; clinician and staff training to promote integrated, multidisciplinary screening and treatment; and thoughtful inclusion of peers with lived experience.

Effect of Implementation Facilitation to Promote Adoption of Medications for Addiction Treatment in US HIV Clinics: A Randomized Clinical Trial.

Importance: Medications for addiction treatment (MAT) are inconsistently offered in HIV clinics. Objective: To evaluate the impact of implementation facilitation (hereafter referred to as "facilitation"), a multicomponent implementation strategy, on increasing provision of MAT for opioid use disorder (MOUD), alcohol use disorder (MAUD), and tobacco use disorder (MTUD). Design, Setting, and Participants: Conducted from July 26, 2016, through July 25, 2020, the Working with HIV Clinics to adopt Addiction Treatment using Implementation Facilitation (WHAT-IF?) study used an unblinded, stepped wedge design to sequentially assign each of 4 HIV clinics in the northeastern US to cross over from control (ie, baseline practices) to facilitation (ie, intervention) and then evaluation and maintenance periods every 6 months. Participants were adult patients with opioid, alcohol, or tobacco use disorder. Data analysis was performed from August 2020 to September 2022. Interventions: Multicomponent facilitation. Main Outcomes and Measures: Outcomes, assessed using electronic health record data, were provision of MAT among patients with opioid, alcohol, or tobacco use disorder during the evaluation (primary outcome) and maintenance periods compared with the control period. Results: Among 3647 patients, the mean (SD) age was 49 (12) years, 1814 (50%) were Black, 781 (22%) were Hispanic, and 1407 (39%) were female; 121 (3%) had opioid use disorder, 126 (3%) had alcohol use disorder, and 420 (12%) had tobacco use disorder. Compared with the control period, there was no increase in provision of MOUD with facilitation during the evaluation period (243 patients [27%; 95% CI, 22%-32%] vs 135 patients [28%; 95% CI, 22%-35%]; P = .59) or maintenance period (198 patients [29%; 95% CI, 22%-36%]; P = .48). The change in provision of MAUD from the control period to the evaluation period was not statistically significant (251 patients [8%; 95% CI, 5%-12%] vs 112 patients [13%; 95% CI, 8%-21%]; P = .11); however, the difference increased and became significant during the maintenance period (180 patients [17%; 95% CI, 12%-24%]; P = .009). There were significant increases in provision of MTUD with facilitation during both the evaluation (810 patients [33%; 95% CI, 30%-36%] vs 471 patients [40%; 95% CI, 36%-45%]; P = .005) and maintenance (643 patients [38%; 95% CI, 34%-41%]; P = .047) periods. Conclusions and Relevance: In this randomized clinical trial, facilitation led to increased provision of MTUD, delayed improvements in MAUD, and no improvements in MOUD in HIV clinics. Enhanced strategies, potentially including clinic and patient incentives, especially for MOUD, may be needed to further increase provision of MAT in HIV clinics. Trial Registration: ClinicalTrials.gov Identifier: NCT02907944.

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.

Prevalence of and barriers to dual-contraceptive methods use among married men and women living with HIV in India.

OBJECTIVE: To describe the prevalence and correlates of dual-contraceptive methods use (condoms and an effective pregnancy prevention method) and barriers to their use among married persons living with HIV (PLHIV) in India. METHODS: We conducted a quantitative survey (93 men, 97 women), 25 in-depth interviews, seven focus groups, and five key informant interviews. RESULTS: Prevalence of dual-contraceptive method use increased from 5% before HIV diagnosis to 23% after diagnosis (P < 0.001). Condoms were the most common contraceptive method, with prevalence increasing from 13% before diagnosis to 92% after diagnosis (P < 0.001). Barriers to using noncondom contraceptives were lack of discussion about noncondom contraceptives by health care providers, lack of acceptability of noncondom contraceptives among PLHIV, and lack of involvement of husbands in family planning counseling. CONCLUSION: There is a need for interventions, including training of health care providers, to increase dual-contraceptive methods use among married PLHIV.

Readiness to Provide Medications for Addiction Treatment in HIV Clinics: A Multisite Mixed-Methods Formative Evaluation.

BACKGROUND: We sought to characterize readiness, barriers to, and facilitators of providing medications for addiction treatment (MAT) in HIV clinics. SETTING: Four HIV clinics in the northeastern United States. METHODS: Mixed-methods formative evaluation conducted June 2017-February 2019. Surveys assessed readiness [visual analog scale, less ready (0-<7) vs. more ready (≥7-10)]; evidence and context ratings for MAT provision; and preferred addiction treatment model. A subset (n = 37) participated in focus groups. RESULTS: Among 71 survey respondents (48% prescribers), the proportion more ready to provide addiction treatment medications varied across substances [tobacco (76%), opioid (61%), and alcohol (49%) treatment medications (P values < 0.05)]. Evidence subscale scores were higher for those more ready to provide tobacco [median (interquartile range) = 4.0 (4.0, 5.0) vs. 4.0 (3.0, 4.0), P = 0.008] treatment medications, but not significantly different for opioid [5.0 (4.0, 5.0) vs. 4.0 (4.0, 5.0), P = 0.11] and alcohol [4.0 (3.0, 5.0) vs. 4.0 (3.0, 4.0), P = 0.42] treatment medications. Median context subscale scores ranged from 3.3 to 4.0 and generally did not vary by readiness status (P values > 0.05). Most favored integrating MAT into HIV care but preferred models differed across substances. Barriers to MAT included identification of treatment-eligible patients, variable experiences with MAT and perceived medication complexity, perceived need for robust behavioral services, and inconsistent availability of on-site specialists. Facilitators included knowledge of adverse health consequences of opioid and tobacco use, local champions, focus on quality improvement, and multidisciplinary teamwork. CONCLUSIONS: Efforts to implement MAT in HIV clinics should address both gaps in perspectives regarding the evidence for MAT and contextual factors and may require substance-specific models.

Information-motivation-behavioral skills barriers associated with intentional versus unintentional ARV non-adherence behavior among HIV+ patients in clinical care.

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 among 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.

Working with HIV clinics to adopt addiction treatment using implementation facilitation (WHAT-IF?): Rationale and design for a hybrid type 3 effectiveness-implementation study.

BACKGROUND: Tobacco, alcohol and opioid misuse are associated with substantial morbidity and mortality among people with HIV (PWH). Despite existence of evidence-based counseling and medications for addiction, these treatments are infrequently offered in HIV clinics. The Working with HIV clinics to adopt Addiction Treatment using Implementation Facilitation (WHAT-IF?) study was conducted to address this implementation challenge. The study's goals were to conduct a formative evaluation of barriers to and facilitators of implementing addiction treatment for PWH followed by an evaluation of the impact of Implementation Facilitation (IF) on promoting adoption of addiction treatments and clinical outcomes. METHODS: The study was conducted at four HIV clinics in the northeast United States, using a hybrid type 3 effectiveness-implementation stepped wedge design and guided by the Promoting Action on Research Implementation in Health Services Research (PARiHS) framework. A mixed-methods approach was used to identify evidence, context, and facilitation-related barriers to and facilitators of integration of addiction treatments into HIV clinics and to help tailor IF for each clinic. An evaluation was then conducted of the impact of IF on implementation outcomes, including provision of addiction treatment (primary outcome), organizational and clinician and staff readiness to adopt addiction treatment, and changes in organizational models of care used to deliver addiction treatment. The evaluation also included IF's impact on effectiveness outcomes, specifically HIV-related outcomes among patients eligible for addiction treatment. CONCLUSIONS: Results will generate important information regarding the impact of IF as a reproducible strategy to promote addiction treatment in HIV clinics.

An agenda for advancing the science of implementation of evidence-based HIV prevention interventions.

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.

The information-motivation-behavioral skills model of ART adherence in a Deep South HIV+ clinic sample.

High levels of adherence to antiretroviral therapy (ART) are critical to the management of HIV, yet many people living with HIV do not achieve these levels. There is a substantial body of literature regarding correlates of adherence to ART, and theory-based multivariate models of ART adherence are emerging. The current study assessed the determinants of adherence behavior postulated by the Information-Motivation-Behavioral Skills model of ART adherence in a sample of 149 HIV-positive patients in Mississippi. Structural equation modeling indicated that ART-related information correlated with personal and social motivation, and the two sub-areas of motivation were not intercorrelated. In this Deep South sample, being better informed, socially supported, and perceiving fewer negative consequences of adherence were independently related to stronger behavioral skills for taking medications, which in turn associated with self-reported adherence. The IMB model of ART adherence appeared to well characterize the complexities of adherence for this sample.

Attitudes toward needle-sharing and HIV transmission risk behavior among HIV+ injection drug users in clinical care.

Risky behavior related to injection drug use accounts for a considerable proportion of incident HIV infection in the United States. Large numbers of injection drug users (IDUs) currently receive antiretroviral therapy in clinical settings and are accessible for risk-reduction interventions to reduce transmission of drug-resistant HIV and spread of HIV to uninfected others. The current study examined attitudes toward needle- or equipment-sharing among 123 HIV-positive IDUs in clinical care in an effort to understand the dynamics of such behavior and to create a basis for clinic-based risk-reduction interventions. Results indicate that at baseline, participants who reported extremely negative attitudes toward needle-sharing were less likely to have shared during the past month than those with less-extreme negative attitudes. Demographic, behavioral, and attitudinal variables were entered into a logistic regression model to examine needle-sharing group membership among HIV-positive IDUs. Being female and having less-extreme negative attitudes toward sharing were independent and significant correlates of sharing behavior. Interventions targeting needle-sharing attitudes deployed within the clinical care setting may be well-positioned to reduce HIV transmission among HIV-positive IDUs.

An information-motivation-behavioral skills (IMB) model-based HIV prevention intervention for truck drivers in India.

The incidence of HIV/AIDS in India is increasing drastically, and truck drivers are seen as critical sources of HIV transmission due to their high rates of unprotected sex with multiple partners. An intervention based on the Information-Motivation-Behavioral Skills (IMB) model was compared to an information-only control condition in a randomized trial. IMB constructs were assessed among 250 male truck drivers immediately prior to and following implementation of the intervention, and sexual and condom use behaviors were assessed approximately 10 months later. The intervention consisted of a single-session group workshop with 5 interactive activities designed to address HIV prevention-related IMB constructs and to motivate condom use. Findings showed mixed support for the effectiveness of the intervention. There was an effect of the IMB intervention on attitudes, norms, behavioral skills, and intentions specific to condom use with marital partners, but no effects on constructs related to non-marital partners. There was some evidence of greater condom use with marital and non-marital partners at behavioral follow-up for participants in the IMB condition, and effects on condom use with marital partners were mediated by changes in IMB constructs. These findings provide initial evidence for the effectiveness of theoretically-based approaches to HIV prevention in India.

Sexual risk behaviour among HIV-positive individuals in clinical care in urban KwaZulu-Natal, South Africa.

We assessed the incidence and predictors of unprotected sex among 152 HIV-positive patients in clinical care in KwaZulu-Natal, South Africa. Nearly 50% were sexually active; 30% of those reported unprotected sex. Alcohol use during sex, reporting forced sex, sex with a perceived HIV-positive partner, and sex with a casual partner predicted more unprotected sex, whereas HIV status disclosure was related to less unprotected sex. These findings highlight the need for linking HIV prevention and care in Africa.

A population-based and longitudinal study of sexual behavior and multidrug-resistant HIV among patients in clinical care.

BACKGROUND: Population-based and longitudinal information regarding sexual risk behavior among patients with multidrug resistant (MDR) HIV and their sexual partners is of great public health and clinical importance. OBJECTIVE: To characterize the HIV sexual risk behaviors of patients with and without drug-resistant HIV in the clinical care setting over time. MEASUREMENTS: 393 HIV-positive patients completed questionnaires of self-reported sexual risk behaviors at approximate 6-month intervals extending over 24 months. HIV viral load and genotypic drug resistance obtained during the same time points were matched to the behavioral data. Multidrug resistance was defined as having resistance to 2 or 3 antiretroviral (ARV) drug classes. RESULTS: In serial cross-sectional analyses, 393 patients (44% female and 79% heterosexual) contributed 919 matched behavioral and virologic results over the 24 months of data collection. Of these, 250 patients (64%) reported having sex during at least 1 survey period resulting in greater than 10,000 sexual events with more than 1000 partners. Unprotected sexual behavior was reported by 45% of sexually active patients, resulting in 34% of all sex events that exposed 29% of all partners. Of these patients with unprotected sexual events, 31% had HIV drug resistance--11.6% with resistance to 2 classes of ARVs (2-class), and 1.8% with 3-class ARV resistance at the time of a sexual risk event. Close to 1000 or 28% of all unprotected sexual events involved resistant strains (11% of these with resistance to 2 classes and 0.2% with 3-class resistance, exposing 20% of unprotected sexual partners to resistant HIV (8% to 2-class and 0.6% to 3-class resistance). In longitudinal analysis among the 78 patients who reported a cumulative total of 12 months of sexual history and had resistance testing, 38% reported engaging in unprotected sexual behavior. There was substantial and complex variation in the distribution of unprotected sexual events and in the detection of resistance over time. CONCLUSION: In this study of HIV sexual risk and resistance over time among HIV-infected patients in clinical care, a substantial proportion engaged in unprotected sex and had drug-resistant HIV, frequently exposing partners to 1- or 2-class resistant HIV strains. However, relatively few exposures involved 3-class resistance. The dynamics of sexual risk behavior and HIV drug resistance are complex and vary over time and urgently require both general and targeted interventions to reduce transmission of resistant HIV.

Antiretroviral resistance and high-risk transmission behavior among HIV-positive patients in clinical care.

BACKGROUND: HIV-positive patients receiving antiretroviral therapy (ART) who engage in HIV transmission behaviors may harbor and transmit drug-resistant HIV. However, little is known about the risk behaviors of these patients, potential partners exposed and the relationship of these to ART resistance. OBJECTIVE: To determine the relationship of HIV drug resistance and continuing HIV transmission risk behavior among HIV-positive patients in care. METHODS: A retrospective, cross-sectional study of HIV transmission risk behavior and HIV drug resistance data from 333 HIV-positive patients. RESULTS: Among a diverse population of 333 HIV-positive patients, 75 (23%) had unprotected sex during the previous 3-months, resulting in 1126 unprotected sexual events with 191 partners of whom 155 were believed by patients to be HIV-negative or of unknown status. Eighteen of the 75 (24%) had resistant HIV and 207 unprotected sexual events, exposing 18% of the HIV- or status unknown partners. There was no difference in the proportion of patients engaging in unprotected sex who had undetectable viral load (VL) (22%): VL > 400 copies/ml without resistance (20%) and VL > 400 copies/ml with resistance (26%). Resistance and risk behavior was predicted only by lower mental health scores (odds ratio, 10.3; 95% confidence interval, 1.7-18.6). CONCLUSION: A substantial minority (23%) of patients in clinical care engaged in HIV sexual transmission risk behavior. A small subset of these also had ART-resistant HIV. However, this core group (approximately 5% of all patients) accounted for a large number of high-risk HIV transmission events with resistant virus, exposing a substantial number of partners.

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.