Disengagement and re-engagement with antiretroviral therapy (ART) are common in South Africa, but routine monitoring is insufficient to inform policy development. To address this gap, Anova implemented the 2020 National Adherence Guidelines' re-engagement standard operating procedure (re-engagement SOP) and collected additional data to describe the characteristics of re-engagement visits to inform HIV programmes.

Between July and December 2022, we conducted a study at nine primary healthcare facilities in Johannesburg. Staff were trained on the re-engagement SOP and provided with job aides to support implementation. Administration clerks categorized visits based on the time elapsed since the missed appointment: ≤14days and >14 days, with the latter identified as re-engaging. For these clients, clinicians filled out "re-engagement clinical assessment forms" that included visit dates, both clinician-assessed and self-reported treatment interruptions, and clinical details. Data on missed appointments and previous viral loads were extracted from medical records. The information was entered into REDCap. We present data from three out of the nine facilities, selected for their comprehensive data collection and high coverage of all re-engaging clients.

A total of 2342 clients returned following a missed scheduled appointment. The majority, 1523 (65%), missed their appointments by ≤ 14 days, while 819 (35%) were >14 days late (re-engaging). Among those re-engaging, 635 (78%) re-engagement clinical assessment forms were completed. A missed appointment date was available for 623 with 25% (n = 161) returning 2-4 weeks late, 47% (n = 298) 4-12 weeks and 26% (n = 164) >12 weeks late. Self-reported ART interruption, available for 89% (567/635), indicated the majority (54%, n = 304) experienced no interruption. Clinical concerns were identified in 65 (10%) cases. A majority (79%, 504/635) had prior viral load results, with 73% (370/504) below 50 copies/ml.

Clients frequently return to care shortly after missed appointments. Despite missing scheduled ART refill dates, many report not interrupting treatment, either having treatment on hand or sourcing ART elsewhere. Most re-engaging clients were adherent prior to disengagement, and clinical concerns are rare. A differentiated service delivery approach, prioritizing flexibility and reduced healthcare burden, is required to support client's needs and preferences at re-engagement.

Objective measurement of antiretrovirals may aid clinical interventions for improving adherence to HIV prevention or treatment regimens. A point-of-care urine test could provide real-time information about recent adherence to regimens containing tenofovir disoproxil fumarate or tenofovir alafenamide. We developed a lateral flow immunoassay (LFA) and ELISA for urinary tenofovir.

The intensity of the LFA test line was quantified using an optical reader and visually scored 0-5 by two independent people, using a reference card. The sensitivity and specificity of both the ELISA and LFA were determined for two different tenofovir concentration cut-offs for tenofovir disoproxil fumarate and tenofovir alafenamide adherence-1500 and 150 ng/mL, respectively. To validate the assays, we measured 586 urine samples from 28 individuals collected as part of a study of tenofovir pharmacokinetics in adults, which were also measured by MS for reference.

Both the LFA signal and ELISA signal were each strongly correlated with drug concentrations (0.91 and 0.92, respectively). The LFA signal and ELISA were highly sensitive and specific at both thresholds (LFA sensitivity/specificity: tenofovir disoproxil fumarate, 89%/96%; and tenofovir alafenamide, 90%/96%) (ELISA sensitivity/specificity: tenofovir disoproxil fumarate, 94%/94%; and tenofovir alafenamide, 92%/84%). Visual scoring of the LFA was also highly sensitive and specific at both the tenofovir disoproxil fumarate threshold and the tenofovir alafenamide threshold (sensitivity/specificity: tenofovir disoproxil fumarate, 91%/94%; and tenofovir alafenamide, 87%/90%).

Our rapid semi-quantitative test can measure tenofovir concentrations relevant to both tenofovir alafenamide and tenofovir disoproxil fumarate adherence, which may support adherence-promoting interventions across a range of HIV care settings.

Older adults are susceptible to medication nonadherence, which may signify functional decline. Thus, performance-based proxies of medication-taking behavior may help diagnose dementia. We assessed the Medication Management Ability Assessment's (MMAA) clinical utility and ecological validity.

This was a retrospective chart review of 180 outpatients (age = 72 ± 8 years) who completed the MMAA during clinical evaluations. Forty-seven were cognitively normal (CN), 103 had mild cognitive impairment (MCI), and 30 had dementia. Most (136) were independent in medication management, whereas 28 were assisted and 16 were dependent. Kruskal-Wallis tests assessed whether MMAA scores differed by diagnosis and independence. Receiver operating characteristic (ROC) analyses identified diagnostic cut-offs. Classification accuracy estimates were derived.

MMAA performance differed across diagnosis as expected (p's < .001). Those who were independent in medication management outperformed assisted and dependent counterparts (p's < .001). Assisted and dependent cases were no different. At a cut-off = 23, the MMAA was good-to-strong in distinguishing dementia from CN cases (Sn = 0.96, Sp = 0.83), dementia from MCI (Sn = 0.70, Sp = 0.83), and dementia from functionally unimpaired cases (Sn = 0.78, Sp = 0.83). At a cut-off = 27, it had good sensitivity but weaker specificity when distinguishing both MCI and all cognitively impaired patients (MCI and dementia) from CN cases (Sn = 0.81, Sp = 0.66 and Sn = 0.81, Sp = 0.72, respectively).

The MMAA has ecological validity and clinical utility in identifying dementia. Its inclusion in neuropsychological practice may be especially useful when medication mismanagement is suspected.

In this report, we review the need for point-of-care (POC) or near real-time testing for antiretrovirals, progress in the field, evidence for guiding implementation of these tests globally, and future directions in objective antiretroviral therapy (ART) or pre-exposure prophylaxis (PrEP) adherence monitoring.

Two cornerstones to end the HIV/AIDS pandemic are ART, which provides individual clinical benefits and eliminates forward transmission, and PrEP, which prevents HIV acquisition with high effectiveness. Maximizing the individual and public health benefits of these powerful biomedical tools requires high and sustained antiretroviral adherence. Routine monitoring of medication adherence in individuals receiving ART and PrEP may be an important component in interpreting outcomes and supporting optimal adherence. Existing practices and subjective metrics for adherence monitoring are often inaccurate or unreliable and, therefore, are generally ineffective for improving adherence. Laboratory measures of antiretroviral concentrations using liquid chromatography tandem mass spectrometry have been utilized in research settings to assess medication adherence, although these are too costly and resource-intensive for routine use. Newer, less costly technologies such as antibody-based methods can provide objective drug-level measurement and may allow for POC or near-patient adherence monitoring in clinical settings. When coupled with timely and targeted counseling, POC drug-level measures can support adherence clinic-based interventions to ART or PrEP in near real time.

A critical feature of an adherence assessment tool is its ability to predict virologic failure in people living with HIV (PLHIV). We, therefore, aimed to compare the predictive performance of commonly used adherence measures. We systematically searched MEDLINE, Embase and LILACS up to February 2018, to identify relevant observational studies comparing the effects of any two of the following adherence measurements on virologic outcomes: electronic monitoring, pill count, pharmacy refill, self-report and physician assessment. We analyzed data by pairwise meta-analyzes with a random-effects model. The proportion of virologic failures among non-adherent participants in each adherence measure was used to calculate the odds ratio (OR), with 95% Confidence Intervals (95%CI). Heterogeneity was assessed, with potential causes identified by sensitivity and subgroup analysis. We included 38 studies with individual patient data for 18,010 patients. All possible comparisons between pairs of the five adherence measures were considered and a total of nine comparison groups could be established. Meta-analysis suggested that self-report was a better predictor of virologic failure than pill count when the recall period was within one week (OR: 2.35, 95%CI: 1.07-5.18, p = 0.03). Physician assessment had higher odds of predicting virologic failure than did either self-report (OR: 2.63, 95%CI: 1.37-5.26, p < 0.01) or pharmacy refill (OR: 3.57, 95%CI: 1.69-7.14, p < 0.001). There was no difference in the predictive performance between any of the other measures that we were able to compare (p > 0.05). The combination of multiple measures did not increase the predictive value when compared to any of the measures alone. Low-cost and simple adherence measures such as self-report predict virologic failure better than or equally well as objective measures. Our results suggest that there is no need to use expensive or time-consuming adherence measures when the objective is to identify PLHIV at risk of treatment failure.

Preexposure prophylaxis (PrEP) for HIV has the potential to reduce HIV incidence in highly affected areas. The Southeastern United States is disproportionately impacted by HIV, and 3 counties in South Florida have the highest incidence of new HIV infections in the United States. This study explored the feasibility, acceptability, and uptake of PrEP in South Florida. Focus groups consisting of providers, administrators, and case managers at HIV-servicing community health centers and federally qualified health centers in South Florida reported broad support but low implementation of PrEP. Generally, participants indicated that the centers were appropriate locations for implementation. However, practical concerns and perceived limitations due to financial, insurance, and immigration status of those who would potentially benefit from the intervention were widely reported. Addressing provider concerns appears necessary for successful expansion of PrEP implementation in highly impacted areas such as South Florida.

Failure to adhere to anti-retroviral therapy (ART) can lead to a range of unfavourable consequences impacting upon people living with HIV (PLH) and society. It is, therefore, paramount that ART adherence is measured in a reliable manner and factors associated with adherence are identified. Lack of such data from West Bengal necessitated undertaking the current study.

Participants were included during August-October, 2011 from three Drop-In-Centres (DICs) from the three districts of West Bengal, India. ART-adherence was calculated by using formula based on pill-count and records collected from ART-card in possession of each of the 128 consenting adult PLH. Information on self-reported adherence, socio-demography, and adherence influencing issues was also collected through interviewer-administered questionnaire.

Of the 128 PLH, 99 (77%) and 93 (73%) PLH had ≥90 per cent and ≥95 per cent adherence, respectively to ART. Conversely, subjective reporting captured much higher proportion of PLH as 'well adherent'; a finding having implications for ongoing ART programme. Factors, independently associated with poor adherence (<90%), were '7 th to 12 th month period of ART intake' (adjusted OR=9.5; 90% CI 1.9 - 47.3; p0 =0.02) and 'non-disclosure of HIV status to family members' (adjusted OR=4; 90% CI 1.3 - 13; P=0.05. Results at 95 per cent adherence cut-off were similar.

Enabling environment, which would encourage people to disclose their HIV status and in turn seek adherence partners from families and beyond and ongoing adherence-counselling appear to be important issues in the programme. Relevance of these study findings in wider context is conceivable.

An estimated 50% of people living with HIV (PLHIV) globally are unaware of their status. Among those who know their HIV status, many do not receive antiretroviral therapy (ART) in a timely manner, fail to remain engaged in care, or do not achieve sustained viral suppression. Barriers across the HIV care continuum prevent PLHIV from achieving the therapeutic and preventive effects of ART.

A systematic literature search was conducted, and 6132 articles, including randomized controlled trials, observational studies with or without comparators, cross-sectional studies, and descriptive documents, met the inclusion criteria. Of these, 1047 articles were used to generate 36 recommendations to optimize the HIV care continuum for adults and adolescents.

Recommendations are provided for interventions to optimize the HIV care environment; increase HIV testing and linkage to care, treatment coverage, retention in care, and viral suppression; and monitor the HIV care continuum.

Optimal adherence to antiretroviral therapy (ART) is key to viral suppression, but may be impeded by psychosocial consequences of HIV-infection such as stigma and depression. Measures of adherence in India have been examined in clinic populations, but little is known about the performance of these measures outside clinical settings. We conducted a cross-sectional study of 151 Tamil-speaking people living with HIV/AIDS (PLHA) in India recruited through HIV support networks and compared single item measures from the Adult AIDS Clinical Trial Group (AACTG) scale, a visual analog scale (VAS), and a question on timing of last missed dose. Depression was measured using the Major Depression Inventory (MDI) and HIV-related stigma was measured using an adaptation of the Berger Stigma Scale. Mean age was 35.6 years (SD ± 5.9); 55.6% were male; mean MDI score was 11.9 (SD ± 9.1); and mean stigma score was 67.3 (SD ± 12.0). Self-reported perfect adherence (no missed doses) was 93.3% using the AACTG item, 87.1% using last missed dose, and 83.8% using the VAS. The measures had moderate agreement with each other (kappa 0.45-0.57). Depression was associated with lower adherence irrespective of adherence measure used, and remained significantly associated in multivariable analyses adjusting for age and marital status. Stigma was not associated with adherence irrespective of the measure used. The VAS captured the greatest number of potentially non-adherent individuals and may be useful for identifying PLHA in need of adherence support. Given the consistent and strong association between poorer adherence and depression, programs that jointly address adherence and mental health for PLHA in India may be more effective than programs targeting only one.

The objective of this observational cohort study was to compare adherence to protease inhibitor (PI)-based regimens or non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimens. HIV-seropositive, antiretroviral-naïve patients initiating therapy between 1998 and 2006 were identified using Veterans Health Administration databases. First-year adherence ratios were calculated as proportion of days covered (PDC). Multivariable regressions were run with an indicator for PDC >95, 90, 85, and 80 % as the dependent variable and an indicator for a PI-based regimen as the key independent variable. We controlled for residual unmeasured confounding by indication using an instrumental variable technique, using the physician's prescribing preference as the instrument. Out of 929 veterans on PI-based and 747 on NNRTI-based regimens, only 19.7 % of PI patients had PDC >80 %, compared to 35.1 % of NNRTI patients. In multivariable analysis, starting a PI regimen was significantly associated with poor adherence for all 4 adherence thresholds using conventional regressions and instrumental variable methods.

This pilot study assessed the determinants of engagement in HIV care among Zambian patients new to antiretroviral (ARV) therapy, and the effect of an intervention to increase medication adherence. Participants (n = 160) were randomized to a 3-month group or individual intervention utilizing a crossover design. Psychophysiological (depression, cognitive functioning, health status), social (social support, disclosure, stigma), structural factors (health care access, patient-provider communication), and treatment engagement (adherence to clinic visits and medication) were assessed. Participants initially receiving the group intervention improved their adherence, but gains were not maintained following crossover to the individual intervention. Increased social support and patient-provider communication and decreased concern about HIV medications predicted increased clinic attendance across both arms. Results suggest that early participation in a group intervention may promote increased adherence among patients new to ARV therapy, but long-term engagement in care may be sustained by both one-on-one and group interventions by health care staff.

This pilot study evaluated an intervention designed to enhance adherence among those new to antiretroviral therapy.

Participants (n = 80) were recruited from a hospital clinic in Chandigarh, India, and randomized to a 3-month group intervention or individual enhanced standard of care followed by crossover of condition and assessed over 6 months. Adherence was measured by prescription refill, pill count, and self-report.

At baseline, 56% of group condition (immediate intervention) and 54% of individual condition (delayed intervention) participants were nonadherent by pill count and 23% of group and 26% of individual condition participants self-reported skipping medication at least once over the last 3 months. From the postintervention to long-term follow-up, adherence in the group condition (immediate intervention) improved in comparison with adherence in the individual condition (delayed intervention; χ(2) = 5.67, P = .02).

Results support the use of interventions early in treatment to provide information and social support to establish long-term healthy adherence behaviors.

To assess adherence rates to nucleos(t)ide analogues (NUCs) therapy in patients with chronic hepatitis B virus infection and determine factors associated with adherence.

The questionnaire study was conducted in the liver clinics at Concord Repatriation General Hospital. All patients who were currently taking one or more NUCs were asked to complete a structured, self-administered 32-item questionnaire. Adherence was measured using visual analogue scales. The patient's treating clinician was also asked to assess their patient's adherence via a structured questionnaire.

A total of 80 patients completed the questionnaire. Sixty six percent of the patients (n = 49) reported optimal adherence whilst 25 (33.8%) graded their adherence to NUCs as suboptimal. Thirty four (43%) patients reported to have omitted taking their NUCs sometime in the past. Recent non-adherence was uncommon. Amongst the patients who reported skipping medications, the most common reason cited was "forgetfulness" (n = 27, 56.25%). Other common reasons included: ran out of medications (n = 5, 10.42%), being too busy (n = 4, 8.33%) and due to a change in daily routine (n = 5, 10.42%). Patients who reported low adherence to other prescription pills were also more likely to miss taking NUCs (P = 0.04). Patients who were under the care of a language-discordant clinician were also more likely to report suboptimal adherence to NUCs (P = 0.04).

Adherence rates were much less than that expected by the physician and has potential adverse affect on long term outcome. Communication and education appear central and strategies need to be implemented to improve ongoing adherence.

HIV has now become a manageable chronic disease. However, the treatment outcomes may get hampered by suboptimal adherence to ART. Adherence optimization is a concrete reality in the wake of 'universal access' and it is imperative to learn lessons from various studies and programmes. This review examines current literature on ART scale up, treatment outcomes of the large scale programmes and the role of adherence therein. Social, behavioural, biological and programme related factors arise in the context of ART adherence optimization. While emphasis is laid on adherence, retention of patients under the care umbrella emerges as a major challenge. An in-depth understanding of patients' health seeking behaviour and health care delivery system may be useful in improving adherence and retention of patients in care continuum and programme. A theoretical framework to address the barriers and facilitators has been articulated to identify problematic areas in order to intervene with specific strategies. Empirically tested objective adherence measurement tools and approaches to assess adherence in clinical/ programme settings are required. Strengthening of ART programmes would include appropriate policies for manpower and task sharing, integrating traditional health sector, innovations in counselling and community support. Implications for the use of theoretical model to guide research, clinical practice, community involvement and policy as part of a human rights approach to HIV disease is suggested.

Improving treatment adherence in patients with diabetes remains an important objective of behavioral science research. However, progress is often limited by the heterogeneity in methods used to measure treatment adherence and difficulties in generalizing across methodologies. Various measurement methods are often used with little attention paid to questions regarding validity. Doubts about validity of adherence measurement often lead investigators to measure distal clinical outcomes instead, such as glycemic control, resulting in a loss of information. This article provides an overview of the literature on diabetes medication adherence, with a focus on measurement issues. We also consider work conducted in other chronic illnesses, particularly HIV/AIDS, that may have value in guiding future directions of diabetes medication adherence research. We highlight the need for focused investigation on how characteristics of self-report methodologies affect the validity of patient responses and conclude with practical recommendations based on the current state of the science.

Simple questions are the most commonly used measures of antiretroviral treatment (ART) adherence in sub-Saharan Africa (SSA), but rarely validated. We administered five adherence questions in a public-sector primary care clinic in rural South Africa: 7-day recall of missed doses, 7-day recall of late doses, a six-level Likert item, a 30-day visual analogue scale of the proportion of doses missed, and recall of the time when an ART dose was last missed. We estimated question sensitivity and specificity in detecting immunologic (or virologic) failure assessed within 45 days of the adherence question date. Of 165 individuals, 7% had immunologic failure; 137 individuals had viral loads with 9% failure detected. The Likert item performed best for immunologic failure with sensitivity/specificity of 100%/5% (when defining nonadherence as self-reported adherence less than "excellent"), 42%/55% (less than "very good"), and 25%/95% (less than "good"). The remaining questions had sensitivities ≤17%, even when the least strict cutoffs defined nonadherence. When we stratified the analysis by gender, age, or education, question performance was not substantially better in any of the subsamples in comparison to the total sample. Five commonly used adherence questions performed poorly in identifying patients with treatment failure in a public-sector ART program in SSA. Valid adherence measurement instruments are urgently required to identify patients needing treatment support and those most at risk of treatment failure. Available estimates of ART adherence in SSA are mostly based on studies using adherence questions. It is thus unlikely that our understanding of ART adherence in the region is correct.

No it is not. Not yet. But looking at blood level variation might – in the near future - indeed become the de-facto gold standard for assessment of nonadherence in the transplant setting. If it does, this measurement method could lead to important discoveries not only for the transplant field but for adherence and outcomes research in other areas of medicine as well. Since nonadherence accounts for a majority of late rejections in pediatric solid organ transplant recipients (–3), the discovery of a useful measure of adherence could be of great clinical importance in the provision of posttransplant care.

In light of the increasing availability of generic highly active antiretroviral therapy (HAART) in India, further data are needed to examine variables associated with HAART nonadherence among HIV-infected Indians in clinical care. We conducted a cross-sectional analysis of 198 HIV-infected South Indian men and women between January and April 2008 receiving first-line non-nucleoside reverse transcriptase inhibitor (NNRTI)-based HAART. Nonadherence was defined as taking less than 95% of HAART doses in the last 1 month, and was examined using multivariable logistic regression models. Half of the participants reported less than 95% adherence to HAART, and 50% had been on HAART for more than 24 months. The median CD4 cell count was 435 cells per microliter. An increased odds of nonadherence was found for participants with current CD4 cell counts greater than 500 cells per microliter (adjusted odds ratio [AOR]: 2.22 [95% confidence interval {CI}: 1.04-4.75]; p = 0.038), who were on HAART for more than 24 months (AOR: 3.07 [95% CI: 1.35-7.01]; p = 0.007), who reported alcohol use (AOR: 5.68 [95%CI: 2.10-15.32]; p = 0.001), who had low general health perceptions (AOR: 3.58 [95%CI: 1.20-10.66]; p = 0.021), and who had high distress (AOR: 3.32 [95%CI: 1.19-9.26]; p = 0.022). This study documents several modifiable risk factors for nonadherence in a clinic population of HIV-infected Indians with substantial HAART experience. Further targeted culturally specific interventions are needed that address barriers to optimal adherence.