The three-item patient-reported instrument for retrospective adherence in resource constrained settings: reliability, validity and potential utility.

INTRODUCTION: Patient-report instruments remain the most feasible and sustainable approaches for monitoring medication adherence in clinical settings. However, questions of their reliability and validity persist. Studies suggest that the 3-item instrument for retrospective adherence (IRA) developed by Wilson et al. offers a viable option for clinically monitoring medication adherence. Here we report the reliability and validity of the IRA among patients recruited from community-based HIV clinics and antiretroviral therapy (ART) dispensaries in a resource constrained township in Cape Town, South Africa. METHODS: Women (n = 794) and men (n = 228) receiving ART completed the IRA at three time points: (a) in a face-to-face administration at enrollment (b) in1-week phone interview and (c) 1-month phone interview. Participants also provided contemporaneous blood samples for HIV viral load testing as a clinical outcome and unannounced phone-based pill counts as an objective assessment of ART adherence. RESULTS: The IRA was internally consistent and showed evidence of time stability. The IRA also demonstrated validity with respect to pill count adherence, correlates of adherence, and HIV viral load. Response operating curve analysis yielded an area under the curve of 0.646, using 75% adherence as the cut-off, with 0.637 sensitivity and 0.567 specificity. CONCLUSIONS: The IRA demonstrated reliability, construct validity and criterion validity in a resource constrained setting, supporting use of the IRA in research and clinical care.

Intersecting alcohol use and depression impedes HIV treatment in the rural South, USA.

This study tested the hypothesis that the co-occurrence of alcohol use and depressive symptoms predicts HIV suppression and antiretroviral therapy (ART) adherence among people living with HIV. Baseline cross-sectional results showed a significant interaction between depressive symptoms and alcohol use in predicting HIV suppression; individuals who drank more alcohol and had higher depressive symptoms demonstrated poorer HIV suppression relative to those who had fewer depressive symptoms. In a one-year longitudinal analysis of ART adherence, alcohol use and depressive symptoms measured in daily text-message assessments demonstrated that neither alcohol use nor depressive symptoms alone predicted ART adherence. However, the intersection of alcohol use on days when experiencing depressive symptoms did significantly predict ART non-adherence, for both moderate and heavy alcohol drinkers. Findings suggest that the co-occurrence of alcohol use and depressive symptoms is a robust predictor of poor HIV treatment outcomes.

Effects of enhanced STI partner notification counselling and provider-assisted partner services on partner referral and the incidence of STI diagnosis in Cape Town, South Africa: randomised controlled trial.

OBJECTIVES: We investigated the effects of an enhanced partner notification (PN) counselling intervention with the offer of provider-assisted referral among people diagnosed with STI in a Cape Town public clinic. METHODS: Participants were adults diagnosed with STI at a community clinic. After the standard STI consultation, participants were randomly allocated in a 1:1:1 ratio to (1) 'HE': 20 min health education; (2) 'RR': 45 min risk reduction skills counselling; or (3) 'ePN': 45 min enhanced partner notification communication skills counselling and the offer of provider-assisted referral. The primary outcome was the incidence of repeat STI diagnoses during the 12 months after recruitment, and the secondary outcome was participants' reports 2 weeks after diagnosis of notifying recent partners. Incidence rate ratios (IRRs) were used to compare the incidence rates between arms using a Poisson regression model. RESULTS: The sample included 1050 participants, 350 per group, diagnosed with STI between June 2014 and August 2017. We reviewed 1048 (99%) participant records, and identified 136 repeat STI diagnoses in the ePN arm, 138 in the RR arm and 141 in the HE arm. There was no difference in the annual incidence of STI diagnosis between the ePN and HE arms (IRR: 1.0; 95% CI 0.7 to 1.3), or between the RR and HE arms (IRR: 0.9; 95% CI 0.7 to 1.2). There was a greater chance of a partner being notified in the ePN condition compared with the HE condition, 64.3% compared with 53.8%, but no difference between the RR and HE arms. CONCLUSIONS: PN counselling and education with provider-assisted services has the potential to change the behaviour of people diagnosed with STIs, increasing the number of partners they notify by more than 10%. However, these changes in behaviour did not lead to a reduction of repeat STI diagnoses. TRIAL REGISTRATION NUMBER: PACTR201606001682364.

Brief Enhanced Partner Notification and Risk Reduction Counseling to Prevent Sexually Transmitted Infections, Cape Town, South Africa.

BACKGROUND: Evidence-based interventions are needed to stem sexually transmitted infections (STIs). Clinic-delivered counseling remains an important avenue for effective STI prevention. METHODS: A 3-arm randomized clinical trial compared (a) STI health education control condition, (b) risk reduction counseling, and (c) enhanced partner notification counseling. Men and women (n = 1050) were recruited from an STI clinic in Cape Town, South Africa. After baseline assessments, participants were randomly allocated to receive 1 of the 3 single-session counseling interventions and were followed up for 9 months of behavioral assessments and 12 months of electronic medical records abstraction for STI clinic services. RESULTS: Sexual risk reduction counseling reported greater condom use than did the other 2 conditions during the 3 and 6 months follow-ups. In addition, women receiving risk reduction counseling were significantly less likely to have returned for STI clinic services but did not differ in the number of STI clinic visits over the year. CONCLUSIONS: Brief single-session STI prevention counseling demonstrates significant targeted outcomes. The findings suggest that counseling approaches to both increase condom use and enhance partner notification may offer more robust and sustained outcomes and should be tested in future research.

Forgoing antiretroviral therapy to evade stigma among people living with HIV, Cape Town, South Africa.

Stigma impedes HIV treatment in multiple ways, including diminished engagement in care, refusing ART, and concealing ART to evade stigma. This study disentangled the degree to which intentionally not taking ART to evade stigma influences overall non-adherence to ART. Patients receiving ART at a community clinic in Cape Town, South Africa (N = 288) completed confidential surveys of demographic and health characteristics, stigma-avoidance non-adherence, and non-stigma-related predictors of non-adherence. Results found nearly half of participants (48%) had forgone taking their ART in social settings. Hierarchically structured regression models showed that alcohol use, medication concerns, and internalized HIV stigma significantly predicted ART non-adherence, accounting for 9.9% of the variance. Stigma-avoidance non-adherence explained an additional 2.6% of the variance in ART non-adherence. The current findings extend previous research to show that stigma-avoidance independently contributes to ART non-adherence, including over and above depression and alcohol use.

Drug Use and Life Chaos as Potential Factors Contributing to HIV Viral Load among People with Lower Health Literacy.

BACKGROUND: Lower health literacy is associated with poorer health outcomes in people living with HIV (PLWH), but the explanatory mechanisms for these associations are not well understood. Factors such as drug use and life chaos may at least in part account for the relationship between lower health literacy and poor health outcomes. The current study tested the hypothesis that lower health literacy would predict drug use, which in turn would predict life chaos, and that all three factors would be related to poorer heath, defined by higher concentrations of HIV viremia. Methods: Patients receiving HIV care (N = 251) at an HIV clinic in the southeastern United States completed computerized interviews and permission to access their medical records. Process modeling tested direct and indirect effects of all variables in a serial mediation model. Results: The direct effects of lower health literacy and drug use were significantly related to HIV viremia. In addition, the indirect effect of health literacy on HIV viremia through drug use was significant. However, results did not demonstrate any effect, direct or indirect, of life chaos on HIV viremia. Conclusion: Findings from this study bolster previous research demonstrating lower health literacy and drug use as barriers to HIV care, and show that lower health literacy impacts HIV viremia, at least in part, through drug use. Interventions aimed to improve HIV treatment outcomes in lower health literacy populations may be enhanced by integrating evidence-based approaches to reducing drug use.

Alcohol-related beliefs and non-adherence to antiretroviral therapy in Cape Town, South Africa.

The life-saving effects of antiretroviral therapy (ART) in treating HIV infection are compromised by alcohol use. A growing body of research shows that both unintentional (e.g., memory lapses) and intentional (e.g., forgoing ART to avoid mixing with alcohol) contribute to ART non-adherence. Beliefs that it is harmful to mix alcohol with ART (alcohol-ART interactive toxicity beliefs) contribute to intentional non-adherence, but their role in overall adherence is not clear. This study conducted a clinic-based survey with 100 men and 193 women (mean age = 36) to examine the prevalence of alcohol-ART interactive toxicity beliefs and whether they contribute to treatment non-adherence in South Africa. One in three (36%, n = 106) participants reported no current alcohol use and 64% (n = 187) reported current alcohol use. The majority of participants, including current alcohol drinkers, endorsed beliefs that it is harmful to mix ART and alcohol, with 57% who currently drink reporting that they forgo taking ART when they are drinking. Participants reported being warned not to mix alcohol and ART from family, friends, and health care providers. In addition, 62% of participants who do not drink, as well as 36% of those who do drink, tell others not to mix alcohol and ART. Mediation modelling found that alcohol use directly predicts ART adherence, and that this relationship is partially mediated by alcohol-ART interactive toxicity beliefs. Health care providers can play a critical role in disputing interactive toxicity beliefs and encouraging patients to take ART even when they are drinking.

Alcohol-related intentional nonadherence to antiretroviral therapy among people living with HIV, Cape Town, South Africa.

Alcohol use may have significant negative impacts on individuals' ability to remain adherent to antiretroviral therapy (ART), and may also yield other negative psychosocial, health-related, and behavioral outcomes. In addition, false beliefs about the consequences of mixing alcohol with ART use may cause individuals to avoid taking ART when drinking (alcohol-related ART avoidance). Although research conducted in the U.S. and Europe has reported on alcohol-ART avoidance, the current study presents among the first quantitative evidence of alcohol-related intentional ART nonadherence in South Africa. Patients receiving ART from a community clinic in Cape Town (N = 441) completed anonymous surveys of alcohol use, ART adherence, and alcohol-ART avoidance. Results showed that 292 (66%) participants reported current alcohol use; 25% who use alcohol believed that people who drink should stop taking ART when they are drinking and 24% stop their own ART when drinking. Alcohol-ART avoidance mediated the association between alcohol use and ART adherence. Results were robust when controlling for participant age, gender, current care status, and first- versus second-line ART. We found alcohol-ART avoidance may threaten successful ART in South Africa. Corrective messages that take a harm reduction approach to maximize ART adherence when drinking should be implemented in existing clinical services.

Population Density and AIDS-Related Stigma in Large-Urban, Small-Urban, and Rural Communities of the Southeastern USA.

AIDS stigmas delay HIV diagnosis, interfere with health care, and contribute to mental health problems among people living with HIV. While there are few studies of the geographical distribution of AIDS stigma, research suggests that AIDS stigmas are differentially experienced in rural and urban areas. We conducted computerized interviews with 696 men and women living with HIV in 113 different zip code areas that were classified as large-urban, small-urban, and rural areas in a southeast US state with high-HIV prevalence. Analyses conducted at the individual level (N = 696) accounting for clustering at the zip code level showed that internalized AIDS-related stigma (e.g., the sense of being inferior to others because of HIV) was experienced with greater magnitude in less densely populated communities. Multilevel models indicated that after adjusting for potential confounding factors, rural communities reported greater internalized AIDS-related stigma compared to large-urban areas and that small-urban areas indicated greater experiences of enacted stigma (e.g., discrimination) than large-urban areas. The associations between anticipated AIDS-related stigma (e.g., expecting discrimination) and population density at the community-level were not significant. Results suggest that people living in rural and small-urban settings experience greater AIDS-related internalized and enacted stigma than their counterparts living in large-urban centers. Research is needed to determine whether low-density population areas contribute to or are sought out by people who experienced greater AIDS-related stigma. Regardless of causal directions, interventions are needed to address AIDS-related stigma, especially among people in sparsely populated areas with limited resources.

Unannounced phone-based pill counts for monitoring antiretroviral medication adherence in South Africa.

BACKGROUND: Unannounced phone-based pill counts (UPC) are an objective measure of medication adherence that may be used in resource limited settings. The current study reports the feasibility and validity of UPC for monitoring antiretroviral therapy (ART) adherence among people living with HIV in South Africa. People living with HIV (N = 434) in an economically impoverished township and receiving ART for at least 3-months completed: two UPC in a one-month period; measures of clinic and medication experiences; and provided blood samples for HIV viral load and CD4 testing. Analyses compared two methods for managing values of over-dosing (> 100%), specifically censoring values to 100% (> 100% = 100%) vs. subtracting over-dosing from two months of perfect adherence (200% - > 100% value). RESULTS: Findings showed that two UPC calls were successfully completed with 91% of participants in a one-month period. The average number of call attempts needed to reach participants was 2.4. Results showed that lower UPC adherence was significantly associated with male gender, alcohol use, higher HIV viral loads, lower CD4 cell counts, running out of ART, and intentionally not taking ART. Comparisons of methods for adjusting over-dosing found subtraction yielding a better representation of the data than censoring. CONCLUSIONS: UPC were demonstrated feasible and valid with patients receiving ART in a resource limited setting and offers a viable method for objectively measuring ART adherence in these settings.

Subjective well-being and COVID-19 prevention practices among people living with HIV in Cape Town, South Africa.

COVID-19 poses significant threats to the health of people with underlying chronic conditions, including people living with HIV. The association between subjective well-being and practicing COVID-19 preventive behaviours among people living with HIV is yet to be empirically tested. The objective of the current study was to test the hypothesis that subjective well-being would be associated with engaging in greater COVID-19 preventive behaviours. A sample of 200 women and 72 men (mean age 38.1, SD = 10.4) receiving HIV treatment at a clinic in Cape Town, South Africa completed interview administered surveys of health behaviours and three dimensions of subjective well-being: emotional, social and psychological well-being. Hierarchical regression models were performed to test subjective well-being as predictors of COVID-19 preventive behaviours adjusting for age, sex, education, TB history, antiretroviral therapy adherence, and concern about contracting COVID-19. Results showed that psychological well-being, along with concerns over COVID-19, predicted greater COVID-19 preventive behaviours over and above the other variables in the model, accounting for 9.2% of the variance. Results support incorporating interventions to foster psychological well-being into existing clinical services for people living with HIV to improve clusters of health behaviours.

Comparative effects of telephone versus in-office behavioral counseling to improve HIV treatment outcomes among people living with HIV in a rural setting.

With the expansion of telehealth services, there is a need for evidence-based treatment adherence interventions that can be delivered remotely to people living with HIV. Evidence-based behavioral health counseling can be delivered via telephone, as well as in-office services. However, there is limited research on counseling delivery formats and their differential outcomes. The purpose of this study was to conduct a head-to-head comparison of behavioral self-regulation counseling delivered by telephone versus behavioral self-regulation counseling delivered by in-office sessions to improve HIV treatment outcomes. Patients (N = 251) deemed at risk for discontinuing care and treatment failure living in a rural area of the southeastern USA were referred by their care provider. The trial implemented a Wennberg Randomized Preferential Design to rigorously test: (a) patient preference and (b) comparative effects on patient retention in care and treatment adherence. There was a clear patient preference for telephone-delivered counseling (69%) over in-office-delivered counseling (31%) and participants who received telephone counseling completed a greater number of sessions. There were few differences between the two intervention delivery formats on clinical appointment attendance, antiretroviral adherence, and HIV viral load. Overall improvements in health outcomes were not observed across delivery formats. Telephone-delivered counseling did show somewhat greater benefit for improving depression symptoms, whereas in-office services demonstrated greater benefits for reducing alcohol use. These results encourage offering most patients the choice of telephone and in-office behavioral health counseling and suggest that more intensive interventions may be needed to improve clinical outcomes for people living with HIV who may be at risk for discontinuing care or experiencing HIV treatment failure.

Stigmatisation of alcohol use among people receiving antiretroviral therapy for HIV infection, Cape Town, South Africa.

Antiretroviral therapy (ART) effectively treats HIV infection, with improved longevity and quality of life among people living with HIV. Alcohol use, however, remains a robust barrier to ART. This study, for the first time, examined the effects of the stigmatisation of alcohol use on ART adherence. Patients receiving ART in Cape Town, South Africa who currently drink alcohol (N = 187) and those who do not drink alcohol (N = 106) completed measures of alcohol use, alcohol-ART adherence, and alcohol-ART stigma. Participants also provided permission to access their most recent HIV viral load from clinic medical records. Results of a mediation model demonstrated significant detrimental effects of alcohol use on ART adherence. In addition, the indirect effects of alcohol use on ART adherence through alcohol-ART stigma was also significant, indicating that alcohol-ART stigma at least in part mediates the association between alcohol use and ART adherence. The same pattern of results was observed in relation to HIV viral load obtained from medical records. Interventions designed to address alcohol use as a barrier to ART adherence should incorporate alcohol-ART stigma as a barrier to adherence as well as a barrier to participating in adherence interventions.

HIV Status Disclosure and Sexual Transmission Risks Among People Who Are Living With HIV and Receiving Treatment for Non-HIV Sexually Transmitted Infections, Cape Town, South Africa.

BACKGROUND: HIV status disclosure to sex partners potentially reduces the risk of sexually transmitting HIV. However, there is limited information on the associations between HIV status disclosure in types of sexual partnerships and ensuing sexual practices. METHODS: We examined HIV status disclosure to sex partners among 205 men and women living with HIV and receiving diagnostic and treatment services for a co-occurring sexually transmitted infection (STI) in Cape Town, South Africa. Participants completed partner-by-partner sexual behavior interviews and provided permission to extract recurrent STI clinic visits over the subsequent 12 months. RESULTS: Three groups were formed on the basis of HIV status disclosure to sex partners: (1) 22% reported only HIV same-status partners, (2) 26% had HIV-negative or unknown HIV status (HIV different status) sex partners to whom they had disclosed their HIV status, and (3) 52% had at least one HIV different-status partner to whom they had not disclosed. There were no associations between HIV status disclosure and demographic characteristics, sexual practices, or recurrent STI clinic visits. Undisclosed HIV status to at least one HIV different-status sex partner was associated with greater alcohol use and less likelihood of receiving antiretroviral therapy; participants who were least likely to disclose their HIV status to partners drank more alcohol and were less likely to be taking antiretroviral therapy. CONCLUSIONS: High prevalence of partner nondisclosure and lack of significant correlates to HIV status disclosure indicate a need for further research with an eye toward identifying disclosure processes and mechanisms that may ultimately lead to effective interventions.

Individual Social Capital and the HIV Continuum of Care in a Rural Setting of the Southeast United States.

Social capital is associated with the health of people living with HIV, and yet few studies have examined social capital in relation to the HIV continuum of care in the United States. The current study assessed individual social capital within social networks of 251 people living with HIV and residing in a rural area of the southeastern United States. Participants completed computerized self-administered measures that included markers of social capital and disclosure of HIV status to network members. We estimated individual social capital for each relationship identified in the social network interviews and tested regression models at three points along the HIV continuum of care: receiving ART, ART adherence, and HIV viral suppression. Results indicated that one in four participants had not disclosed their HIV status to at least one member of their social network and disclosure was not associated with social capital. Regression models showed that participants with larger social networks and less social capital were more likely to be receiving ART and more likely to have HIV suppressed viral loads. Alcohol use, not social capital, was related to ART non-adherence. Participant's depressive symptomatology was unrelated to any HIV care continuum metrics assessed in this study. We conclude that social capital is drawn upon at critical points along the HIV continuum of care. Interventions should focus on building social capital within social networks and provide support to key network members when patients are transitioning into care, initiating ART and experiencing HIV unsuppressed viral loads.

Cumulative Effects of Stigma Experiences on Retention in HIV Care Among Men and Women in the Rural Southeastern United States.

The stigmatization of HIV infection impedes every step along the HIV continuum of care, particularly care engagement and retention. The differential effects of various sources of stigma on retention in HIV care have been the subject of limited research. We examined the accumulation of HIV stigma experiences over 1 year in relationship to treatment retention among 251 men and women marginally engaged in HIV care in the southeastern United States. Results showed that cumulative stigma experiences predicted poorer retention in care, with greater stigma experiences related to less consistency in attending scheduled medical appointments. HIV stigma originating from family members and acts of overt discrimination were the most frequently experienced sources of stigma and were most closely associated with disengagement from HIV care. In addition, analyses by gender indicated that retention in care for men was impacted by stigma to a greater extent than among women. These findings reaffirm the importance of HIV stigma as a barrier to HIV care and provide new directions for interventions to mitigate the negative effects of stigma on patients who are not fully engaged in HIV care. Clinical trials registration NCT104180280.

Stigma management intervention to improve antiretroviral therapy adherence: Phase-I test of concept trial, Cape Town South Africa.

Combination antiretroviral therapy (cART) has transformed HIV infection from a universally fatal disease to a medically manageable chronic illness. We conducted a Phase-I test of concept intervention trial to examine feasibility and potential efficacy of behavioural self-regulation counselling designed to improve care retention and cART adherence. The intervention was culturally adapted from client-centered evidence-based interventions that are grounded in behavioural self-regulation theory and available in the US. The intervention adaptation included enhancements to directly address HIV stigma and alcohol-related sources of nonadherence. Fifty patients receiving cART in Cape Town, South Africa were randomised to receive either: (a) five weekly cellphone-delivered sessions of stigma and alcohol-enhanced behavioural self-regulation counselling or (b) a contact matched control condition. Participants were baseline assessed and followed for two weeks post-intervention, with 94% of participants retained throughout the study. Participants receiving the intervention significantly improved cART adherence from baseline-to-follow up and improvement was significantly greater than the control condition. Behaviours related to stigma and alcohol use that impede cART adherence were significantly reduced, and there was uptake of adherence improvement strategies. The current study supports the potential efficacy of relatively brief behavioural self-regulation counselling delivered by cellphone in a context of differentiated care in South Africa.

Treatment adherence in HIV stigmatized environments in South Africa: stigma avoidance and medication management.

Stigmatization of HIV infection undermines antiretroviral therapy (ART) adherence. The current study examined strategies that people living with HIV employ to manage their ART in stigmatized environments. We conducted an anonymous survey with 439 patients receiving ART at a community clinic in Cape Town, South Africa. Measures included demographic and health characteristics, ART adherence, stigma experiences, efforts to conceal ART to avoid stigma (stigma-medication management strategies), and beliefs that ART nonadherence itself is stigmatizing. One in four participants had forgone taking their ART in social settings to avoid stigmatization, a behavior associated with younger age, experiencing greater stigma, and poorer ART adherence. Regression models found stigma-medication management strategies significantly predicted ART nonadherence over and above age, gender, alcohol use, and HIV stigma experiences. We also found that a significant majority of participants believed that having unsuppressed HIV and ART nonadherence are irresponsible and should be reprimanded by clinicians. Results show that the behavioral effects of stigma directly impede ART adherence. The behaviors that patients may employ to avoid stigma are amenable to interventions to directly improve ART adherence while managing stigma concerns.