Adult AIDS Clinical Trials Group Research Articles

Depression and its role in adherence to anti-retroviral treatment in people living with HIV and AIDS in Chennai

ABSTRACT Context: The AIDS epidemic has drastically reduced in India since it was first identified in 1986, largely due to the widespread availability of anti-retroviral treatment (ART). Management of HIV is currently more focussed on long term morbidities, including mental health. Depression is the most common co-morbidity seen in people living with HIV. Depression is found to negatively affect patient adherence to ART. Poor adherence to ART leads to drug resistance and susceptibility to opportunistic infections. Aims: The purpose of this study is to find the prevalence of depression among people living with HIV and to study the correlation between depression and adherence to ART. Setting and Design: The study was conducted in the ART centre at Rajiv Gandhi Government General Hospital in Chennai, between August and October 2022. Methods and Materials: Patient health questionnaire-9 (PHQ-9) was used to identify depression, and the Adult AIDS clinical trials group (AACTG) questionnaire was used to identify adherence. Statistical Analysis Used: Data were entered in MS Excel and were analysed using Statistical Package for Social Science (SPSS) Version 16. The association between categorical data were analysed using Chi-square and Fisher exact test. The correlation between adherence and depression was done using the Spearman correlation. Results: The prevalence of depression was found to be 20.2%. A mild negative correlation was found between depression and adherence. Depression was found to have a significant correlation with women, unemployed, widowed, divorced individuals, and those with diabetes mellitus and tuberculosis. Conclusion: Depression is an important risk factor for adherence to ART. Though severe depression was not found in this study, mild and moderate depression was associated with reduced adherence to ART. Treating depression is likely to improve adherence and the overall wellbeing of patients with HIV and AIDS.

Determinants of Adherence to Option B+ Antiretroviral Therapy among HIV Positive Pregnant Women Attending Antenatal Clinics at Tertiary Health Institutions in Anambra State

Purpose: The study ascertained determinants of adherence to option B+ antiretroviral therapy (ART) among HIV positive pregnant women attending antenatal clinics at tertiary health institutions in Anambra state.
 Methodology: A cross-sectional descriptive design was adopted in conducting the study among HIV positive pregnant women attending antenatal clinics at tertiary health institutions in Anambra state. A sample size of one hundred and forty six (146) HIV positive pregnant women was selected by purposive and convenience sampling techniques. Adult AIDS Clinical Trial Group (AACTG) standardized questionnaire was used in data collection which were analyzed with IBM SPSS software database (version 25). Chi square was used for test of hypotheses at p < 0.05 level of significance.
 Findings: Results revealed that the women with parity less than 4 (105(89%) were more adherent to ART; the women with primary education as highest level of education (13(92.9%) were more adherent to ART; the women within the age range 15-25 years (32(97%) were adherent; the women working in the informal sector (31 (96.9%) were more adherent to ART. The study also showed that there is no significant relationship between the women’s level of education, parity, age and adherence to ART but there is significant relationship between the women’s occupation and adherence to ART. From the study, it was ascertained that the HIV positive pregnant woman’s parity, level of education and age are not determinants of adherence to Option B+ ART but occupation of the women is.
 Recommendations: Health care providers or mentor mothers in the health care facilities should give more attention to the HIV positive pregnant women working in the informal sector and unemployed than the women working in the formal sector in regards to their adherence to ART.

Determinants of Adherence to Option B+ Antiretroviral Therapy among HIV Positive Pregnant Women Attending Antenatal Clinics at Tertiary Health Institutions in Anambra State

Purpose: The study ascertained determinants of adherence to option B+ antiretroviral therapy (ART) among HIV positive pregnant women attending antenatal clinics at tertiary health institutions in Anambra state.
 Methodology: A cross-sectional descriptive design was adopted in conducting the study among HIV positive pregnant women attending antenatal clinics at tertiary health institutions in Anambra state. A sample size of one hundred and forty six (146) HIV positive pregnant women was selected by purposive and convenience sampling techniques. Adult AIDS Clinical Trial Group (AACTG) standardized questionnaire was used in data collection which were analyzed with IBM SPSS software database (version 25). Chi square was used for test of hypotheses at p < 0.05 level of significance.
 Findings: Results revealed that the women with parity less than 4 (105(89%) were more adherent to ART; the women with primary education as highest level of education (13(92.9%) were more adherent to ART; the women within the age range 15-25 years (32(97%) were adherent; the women working in the informal sector (31 (96.9%) were more adherent to ART. The study also showed that there is no significant relationship between the women’s level of education, parity, age and adherence to ART but there is significant relationship between the women’s occupation and adherence to ART. From the study, it was ascertained that the HIV positive pregnant woman’s parity, level of education and age are not determinants of adherence to Option B+ ART but occupation of the women is.
 Recommendations: Health care providers or mentor mothers in the health care facilities should give more attention to the HIV positive pregnant women working in the informal sector and unemployed than the women working in the formal sector in regards to their adherence to ART.

HIV-Specific Patient-Reported Outcome Measures: A Systematic Review of Psychometric Properties.

The management of people living with HIV/AIDS (PLWHA) is multidimensional and complex. Using patient-reported outcome measures (PROMs) has been increasingly recognized to be the key factor for providing patient-centered healthcare to meet the lifelong needs of PLWHA from diagnosis to death. However, there is currently no consensus on a PROM recommended for healthcare providers and researchers to assess health outcomes in PLWHA. The purpose of this systematic review was to summarize and categorize the available validated HIV-specific PROMs in adult PLWHA and to assess these PROMs using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology. This systematic review followed the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines. Literature search of three recommended databases (PubMed, Embase, and PsychINFO) was conducted on January 15, 2021. Studies were included if they assessed any psychometric property of HIV-specific PROMs in adult PLWHA and met the eligibility criteria. The PROMs were assessed for nine psychometric properties, evaluated in each included study following the COSMIN methodology by assessing the following: (1) the methodological quality assessed using the COSMIN risk of bias checklist, (2) overall rating of results, (3) level of evidence assessed using the modified Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach, and (4) level of recommendation. A total of 88 PROMs classified into eight categories, assessing the psychometric properties of PROMs for adult PLWHA, were identified in 152 studies including 79213 PLWHA. The psychometric properties of the majority of the included PROMs were rated with insufficient evidence. The PROMs that received Class A recommendation were the Poz Quality of Life, HIV Symptom Index or Symptoms Distress Module of the ACTG, and the People Living with HIV Resilience Scale. In addition, because of lack of evidence, recommendations regarding use could not be made for most of the remaining assessed PROMs (received class B recommendation). This systematic review recommends three PROMs to assess health outcomes in adult PLWHA. However, all these PROMs have some shortcomings. In addition, most of the included PROMs do not have sufficient evidence for assessing their psychometric properties, and require a more comprehensive validation of the psychometric properties in the future to provide more scientific evidence. Thus our findings may provide a reference to the selection of high-quality HIV-specific PROMs by healthcare providers and researchers for clinical practice and research.

Bayesian analysis of multivariate linear mixed models with censored and intermittent missing responses.

Multivariate longitudinal data usually exhibit complex features such as the presence of censored responses due to detection limits of the assay and unavoidable missing values arising when participants make irregular visits that lead to intermittently recorded characteristics. A generalization of the multivariate linear mixed model constructed by taking into account impacts of censored and intermittent missing responses simultaneously, which is named as the MLMM-CM, has been recently proposed for more precisely analyzing such kinds of data. This paper aims at presenting a fully Bayesian sampling-based approach to the MLMM-CM for addressing the uncertainties of censored and missing responses as well as unknown parameters. Two widely accepted Bayesian computational techniques based on the Markov chain Monte Carlo and the inverse Bayes formulas coupled with the Gibbs (IBF-Gibbs) schemes are developed for carrying out posterior inference of the model. The proposed methodology is illustrated through a simulation study and a real-data example from the Adult AIDS Clinical Trials Group 388 study. Numerical results show empirically that the proposed Bayesian methodology performs satisfactorily and offers reliable posterior inference.

Assessment of adherence and factors contributing to non-adherence among patients on anti-retroviral therapy in a tertiary care hospital: A cross sectional study.

Background:For the successful treatment of human immunodeficiency virus (HIV), it is important that drugs should be taken regularly. Non-adherence not only increases chances of failure of treatment but also leads to the development of resistance to drugs and hence more focus has been given to adherence in the treatment protocol of HIV.Objectives:To determine the level of adherence, its determinants, and to ascertain reasons for non-adherence of antiretroviral therapy (ART) in patients with HIV/acquired immunodeficiency syndrome (AIDS).Methods:A cross-sectional study conducted at an adult ART clinic over a period of one year. The sample size was 320. A systematic random sampling technique was used. Semi-structured Adult AIDS Clinical Trials Group questionnaire was used. Beck Depression Inventory (BDI-II) for current depression and self-report of four days recall method and multi-method approach were used for adherence measurement.Results:The mean age of respondents was 37.26 ± 8.3 years. About 60.3% were males, 34.1% females, and 5.6% were transgenders (TGs). High adherence was found in 87.2% by self-report and 72.5% by multi-method approach. History of opportunistic infection and depression were found to be the best predictors of adherence. Reasons for short term non-adherence were found to be simply forgot to take medications, being away from home, busy with other things, and ran out of pills. Reasons for long-term non-adherence were financial difficulty, side-effects, and shift to alternate therapy.Conclusions:Significant non-adherence to ART necessitates addressing adherence issues in pre-ART counseling, the involvement of family and social support.

Circulating CD30+CD4+ T Cells Increase Before Human Immunodeficiency Virus Rebound After Analytical Antiretroviral Treatment Interruption.

Identification of nonviral markers of human immunodeficiency virus (HIV) infection that increase before viral rebound during analytical treatment interruption (ATI) may affect HIV persistence research. We previously showed that HIV ribonucleic acid (RNA) is enriched in CD30+CD4+ T cells in many individuals. Here, we studied CD30+CD4+ T-cell dynamics before ATI, during ATI (before detectable plasma RNA), and after HIV rebound. Peripheral blood mononuclear cells from 23 participants collected longitudinally from 5 Adult AIDS Clinical Trials Group studies incorporating ATI were included in this study. Flow cytometric characterization of expression of CD30 and markers of T-cell activation and exhaustion were performed along with HIV-1 RNA and deoxyribonucleic acid quantification and measurement of soluble plasma CD30 and CD30 ligand. The percentage of CD4+ T cells expressing CD30 significantly increased from pre-ATI to postinterruption time points before detectible viremia (1.65 mean relative increase, P = .005). Seventy-seven percent of participants experienced an increase in CD30+ cells before viral rebound. In contrast, there were no significant differences between pre-ATI and postinterruption pre-rebound time points in percentages of lymphocytes expressing CD69, CD38/HLA-DR, or PD-1 until after HIV recrudescence. CD30 may be a surrogate marker of early replication or viral transcriptional activity before detection by routine peripheral blood sampling.

Comparison of clinical and laboratory profile of Haart adherent and non-adherent HIV/AIDS patients in Calabar, Nigeria

Background: The burden of HIV/AIDS has reduced following sustained interventions especially with introduction of highly active antiretroviral therapy (HAART). HIV/AIDS has become a chronic condition for which adherence to therapy is of public health relevance. This study was aimed at assessing the relationship between adherence to HAART and clinical and laboratory outcomes in a tertiary centre. Methodology: This was a cross-sectional descriptive study of three hundred and forty eight (348) respondents on HAART. Adherence was measured using an adapted adult AIDS clinical trial group (AACTG) with optimal adherence set at ≥95%. Clinical stage, anthropometry, CD4, total lymphocyte and haemoglobin were used to monitor clinical, immunological and haematological outcome of adherence. Result: The mean (SD) age of respondents was 34.8 (5.3) years, ranging from 18 - 68 years, with male: female ratio of 1:1.7. Adherence to HAART was 89.1%. Non-adherent compared with adherent respondents, had marginally significantly higher proportion of WHO AIDS Stage 3 disease (44.7% vs. 26.4%, p=0.05). Comparing baseline with current values, change in mean CD4 cell counts was significantly higher among adherent compared with non-adherent respondents (187 vs. 125, p=0.00). Also, change in mean total lymphocyte counts was significantly higher among adherent compared with non-adherent respondents (508 vs. 314, p=0.00). Change in CD4 cell count significantly correlated with adherence (t=0.15, p<0.05). Conclusion: Self-reported optimal adherence significantly correlated with immunological recovery, which is a key determinant of good clinical outcome in HIV patients. Measures aimed at sustaining adherence to HAART, and regular assessment of CD4 count should be strengthened.

Sociodemographic profile and predictors of outpatient clinic attendance among HIV-positive patients initiating antiretroviral therapy in Selangor, Malaysia.

BackgroundInconsistent literature evidence suggests that sociodemographic, economic, and system- and patient-related factors are associated with clinic attendance among the HIV-positive population receiving antiretroviral therapy (ART) around the world. We examined the factors that predict outpatient clinic attendance among a cohort of HIV-positive patients initiating ART in Selangor, Malaysia.Patients and methodsThis cross-sectional study analyzed secondary data on outpatient clinic attendance and sociodemographic, economic, psychosocial, and patient-related factors among 242 adult Malaysian patients initiating ART in Selangor, Malaysia. Study cohort was enrolled in a parent randomized controlled trial (RCT) in Hospital Sungai Buloh Malaysia between January and December 2014, during which peer counseling, medication, and clinic appointment reminders were provided to the intervention group through short message service (SMS) and telephone calls for 24 consecutive weeks. Data on outpatient clinic attendance were extracted from the hospital electronic medical records system, while other patient-level data were extracted from pre-validated Adult AIDS Clinical Trial Group (AACTG) adherence questionnaires in which primary data were collected. Outpatient clinic attendance was categorized into binary outcome – regular attendee and defaulter categories – based on the number of missed scheduled outpatient clinic appointments within a 6-month period. Multivariate regression models were fitted to examine predictors of outpatient clinic attendance using SPSS version 22 and R software.ResultsA total of 224 (93%) patients who completed 6-month assessment were included in the model. Out of those, 42 (18.7%) defaulted scheduled clinic attendance at least once. Missed appointments were significantly more prevalent among females (n=10, 37.0%), rural residents (n=10, 38.5%), and bisexual respondents (n=8, 47.1%). Multivariate binary logistic regression analysis showed that Indian ethnicity (adjusted odds ratio [AOR] =0.235; 95% CI [0.063–0.869]; P=0.030) and heterosexual orientation (AOR =4.199; 95% CI [1.040–16.957]; P=0.044) were significant predictors of outpatient clinic attendance among HIV-positive patients receiving ART in Malaysia.ConclusionEthnicity and sexual orientation of Malaysian patients may play a significant role in their level of adherence to scheduled clinic appointments. These factors should be considered during collaborative adherence strategy planning at ART initiation.

Mobile phone reminders and peer counseling improve adherence and treatment outcomes of patients on ART in Malaysia: A randomized clinical trial.

BackgroundAdherence to treatment remains the cornerstone of long term viral suppression and successful treatment outcomes among patients receiving Antiretroviral Therapy (ART).Objective(s)Evaluate the effectiveness of mobile phone reminders and peer counseling in improving adherence and treatment outcomes among HIV positive patients on ART in Malaysia.MethodsA single-blind, parallel group RCT conducted in Hospital Sungai Buloh, Malaysia in which 242 adult Malaysian patients were randomized to intervention or control groups. Intervention consisted of a reminder module delivered through SMS and telephone call reminders by trained research assistants for 24 consecutive weeks (starting from date of ART initiation), in addition to adherence counseling at every clinic visit. The length of intended follow up for each patient was 6 months. Data on adherence behavior of patients was collected using specialized, pre-validated Adult AIDS Clinical Trial Group (AACTG) adherence questionnaires. Data on weight, clinical symptoms, CD4 count and viral load tests were also collected. Data was analyzed using SPSS version 22 and R software. Repeated measures ANOVA, Friedman’s ANOVA and Multivariate regression models were used to evaluate efficacy of the intervention.ResultsThe response rate after 6 months follow up was 93%. There were no significant differences at baseline in gender, employment status, income distribution and residential location of respondents between the intervention and control group. After 6 months follow up, the mean adherence was significantly higher in the intervention group (95.7; 95% CI: 94.39–96.97) as compared to the control group (87.5; 95% CI: 86.14–88.81). The proportion of respondents who had Good (>95%) adherence was significantly higher in the intervention group (92.2%) compared to the control group (54.6%). A significantly lower frequency in missed appointments (14.0% vs 35.5%) (p = 0.001), lower viral load (p = 0.001), higher rise in CD4 count (p = 0.017), lower incidence of tuberculosis (p = 0.001) and OIs (p = 0.001) at 6 months follow up, was observed among patients in the intervention group.ConclusionMobile phone reminders (SMS and telephone call reminders) and peer counseling are effective in improving adherence and treatment outcomes among HIV positive patients on ART in Malaysia. These findings may be of potential benefit for collaborative adherence planning between patients and health care providers at ART commencement.

Influence of Spirituality and Religion on Adherence to Highly Active Antiretroviral Therapy in Adult HIV/AIDS Patients in Calabar, Nigeria

The emergence of a chronic medical illness such as Human Immune Deficiency Virus and Acquired Immunodeficiency Syndrome (HIV/AIDS) may be the time when people turn to the Sacred through spirituality and religion. HIV is a chronic illness that requires strict adherence to medication regimens that may be influenced by spirituality/religion. This study was aimed at finding the association between spirituality/religion and adherence to highly active antiretroviral therapy (HAART) in adult HIV/AIDS patients. This is a cross-sectional descriptive study of 370 patients. Adherence was measured using an adapted adult AIDS clinical trial group (AACTG) and visual analogue scale (VAS) tools. Spirituality was assessed using Functional Assessment of Chronic Illness Therapy-Spirituality Expanded (FACIT-Sp-Ex) scale, religiosity with Duke University Religion index (DUREL), and religious coping with Brief Religious Coping (RCOPE) scale. Adherence rates were 86.2 and 43.8% using AACTG and VAS tools, respectively. Statistical significant correlation was found between spirituality and adherence to HAART (r = 0.265; p = 0.00). Also, significant correlation was found between positive religious coping and adherence (r = 0.15, p = 0.003). Odds ratio indicated that female respondents were 1.6 times more likely to be adherent, compared with males. Similarly, every unit rise in spirituality score yielded a 1.3 times increased likelihood of adherence to HAART on multiple logistic regression of adherence to HAART with relevant predictors. Both spirituality and positive religious coping have positive influence on optimal adherence. Therefore, the training of health care personnel to assess and provide spiritual care and involvement of chaplains/religious leaders is advocated for improved adherence.

PIN30 - Quality of Life of Hiv-Infected Patients Attending to A University Infectious Diseases Clinic In Venezuela

The aim of this study was to describe health-related quality of life (HRQoL) of HIV-infected patients attending to a university infectious diseases clinic in Venezuela. A sample of 82 HIV-infected HIV patients attending an infectious diseases clinic at the Central University of Venezuela was interviewed by the investigator for 20 to 25 minutes. The interview was guided by a structured questionnaire that included questions on sociodemographic and clinical characteristics, HRQoL, medication use, symptoms, and health behaviors. HRQoL was assessed using Spanish versions of EQ-5D descriptive system and EQ visual analogue scale (EQ-VAS). HIV-symptoms were assessed using the Adult AIDS Clinical Trials Group (AACTG) symptom scale. Data concerning CD4-cell count and viral load was extracted from the medical records. All data analyses were performed using SSPS for Windows Version 19.0. Of 82 participants, 50 (61%) were male and 32 (49%) were female. The mean age was 43.33 years (Range 18-73, SD= 10.378). Concerning the EQ-5D, none subject reported problems with self-care. Three subjects (3.7%) reported some problems with mobility. Six subjects (7.3%) reported some problems with usual activity. Twenty nine subjects (35.4%) reported some problems with pain/discomfort and 28 subjects (34.1%) with anxiety/depression. Mean rate of own health on EQ-VAS was 84.77 (SD 15.927). The mean reported symptoms was 38.84 (SD = 13.08; range 21-80). The mean CD4-cell count was 534.42 (SD = 264.02; range 75-1237). Fifty-two subjects (71.2%) had an undetectable viral load. Subjects were taking an average of 3.97 antiretroviral doses per day (SD = 1.81; range = 1-8). Study limitations include the sample size and the use of a convenient sample. Overall, this exploratory study demonstrates that quality of life among this group of HIV-infected patients in Venezuela was good.

Strengthening adherence to Anti Retroviral Therapy (ART) monitoring and support: operation research to identify barriers and facilitators in Nepal.

BackgroundAnti Retroviral Therapy (ART) is the cornerstone for comprehensive health sector response to Human Immunodeficiency Virus (HIV) treatment, care and support. Adherence of at least 95% is needed to keep HIV under control, as per World Health Organization (WHO) guidelines. This study was aimed at identifying the overall adherence level of, and barriers and facilitators to adherence for patients taking ART in different clinics in all five development regions of Nepal.MethodsA descriptive cross-sectional study was conducted among ART clients receiving free ART from Government of Nepal ART clinics. A total of 435 clients taking ART from twelve ART clinics in different regions of Nepal, aged fifteen years and above were interviewed on one-and-one basis using questionnaires developed in reference to Adult AIDS Clinical Trial Group (AACTG) toolkit among them data from 404 were analyzed after cleaning. Data was entered and analyzed using Statistical Package for Social Sciences (SPSS) software where the P value of < 0.05 was accepted as being statistically significant.ResultsThe overall adherence in the last month (missed less than three pills total) was 94.8% (383 out of 404). The main barrier to ART adherence was the fear of side effects (among 61.9% of the non adherent population) which included dizziness (18.1%) and headaches (15.4%). The standard wristwatch (39%) was found to be the most useful aid in enabling timely consumption of medication. Educational status (P = 0.018), drug using habits (P = 0.039) and the conducive environment at ART clinics (P = 0.004) were significantly associated with ART adherence.ConclusionImproving better adherence may require a more holistic approach to treatment regimen and adapting it to patient daily routines. This study identifies issues such as pill count for assessing adherence, better access to health care facilities by clients, better access to medication, as well as improved nutritional support issues for better adherence by the population in the future.Electronic supplementary materialThe online version of this article (doi:10.1186/s12913-015-0846-8) contains supplementary material, which is available to authorized users.

Educational Intervention to Improve Adherence to Anti Retro-viral Therapy (ART) among People Living with Human Immunodeficiency Virus (PLHIV) - A Randomized Controlled Trial

Background: Anti-retro-viral therapy (ART) has changed human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) from fatal disease to chronic illness, it does however requires almost perfect adherence for the medication to be therapeutically effective. Methodology: A study will be conducted among people living with Human Immunodeficiency Virus (PLHIV) aged 18 years and above, who are on ART at the ART center of Kasturba Medical College Hospital (KMCH), Attavar, Mangalore, India. Study consists of two phases: Phase I cross sectional study: A cross sectional study (n=409), has already been done to find out the level of adherence to ART using Adult AIDS Clinical Trials Group adherence follow-up questionnaire and the pre-testing for HIV related knowledge of the participants was done using HIV Knowledge Questionnaire. We observed the prevalence of non-adherence to be 27.1% (n=121) and HIV related knowledge was high among 127 (31.1%) and low among 282 (68.9%) PLHIV. Among the 121 non-adherents, 110 PLHIV will be included in the 2nd phase of the study using block randomization. Phase II randomized controlled trial (RCT): A sample size of 110 will be included in this study, which was calculated based on the statistical formula. Randomization of the participants will be done using block randomization method into intervention and control groups. HIV educational intervention will be provided for six months to the intervention group along with the standard patient care available at the hospital, whereas the control group will receive only the standard patient care available at the hospital for duration of six months. This will be followed by conduction of the first post-test at the end of 6th months among both the groups. The participants will be followed up for next 6 months and second post-test will be done at the end of 12th month for the assessment of study outcomes.

Antiretroviral therapy adherence measurement in non-clinical settings in South India

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.

Improving Diagnostic Capability for HPV Disease Internationally Within the NIH-NIAID Division of AIDS Clinical Trial Networks

To evaluate an external quality assurance (EQA) program for the laboratory diagnosis of human papillomavirus (HPV) disease that was established to improve international research capability within the Division of AIDS at the National Institute of Allergy and Infectious Disease-supported Adult AIDS Clinical Trials Group network. A three-component EQA scheme was devised comprising assessments of diagnostic accuracy of cytotechnologists and pathologists using available EQA panels, review of quality and accuracy of clinical slides from local sites by an outside expert, and HPV DNA detection using a commercially available HPV test kit. Seven laboratories and 17 pathologists in Africa, India, and South America participated. EQA scores were suboptimal for EQA proficiency testing panels in three of seven laboratories. There was good agreement between the local laboratory and the central reader 70% of the time (90% confidence interval, 42%-98%). Performance on the College of American Pathologists' HPV DNA testing panel was successful in all laboratories tested. The prequalifying EQA round identified correctable issues that will improve the laboratory diagnosis of HPV-related cervical disease at the participating international study sites and will provide a mechanism for ongoing education and continuous quality improvement.

Multiple self-report measures of antiretroviral adherence correlated in Sierra Leone, but did they agree?

In resource-poor settings, studies validating multiple self-report measures of adherence are limited and do not include data from West Africa. We prospectively assessed the associations between multiple self-report measures of adherence in 58 patients receiving antiretroviral therapy. Self-report measures included a 30-day visual analog scale, 30-day qualitative single-item measure, Adult AIDS Clinical Trial Group 4-day recall, and 3-level categorical 7-day qualitative measure. Unannounced pill count was the objective measure. Spearman's rho correlation coefficients, Bland-Altman plots, and receiver operator curve analyses were performed. Median and mean adherence by pill count were 81.8% and 78.6%, respectively. All self-report measures had either intermediate or high correlation with the pill count, and the 7-day measure had the highest level of correlation with pill count (r = 0.72). All self-report measures demonstrated good agreement when mean pill count adherence was greater than 90%. All but the 7-day measure posed challenges to patient understanding and administration of the measure. In this sample of participants that displayed largely suboptimal adherence, the 7-day measure was preferable, but all self-report measures demonstrated relatively good agreement with the objective criterion pill count measure and are adequate for clinical use in settings such as Sierra Leone.

Factors associated with suboptimal adherence to antiretroviral therapy in Viet Nam: a cross-sectional study using audio computer-assisted self-interview (ACASI)

BackgroundOptimal adherence to antiretroviral therapy (ART) is necessary for people living with HIV/AIDS (PLHIV). There have been relatively few systematic analyses of factors that promote or inhibit adherence to antiretroviral therapy among PLHIV in Asia. This study assessed ART adherence and examined factors associated with suboptimal adherence in northern Viet Nam.MethodsData from 615 PLHIV on ART in two urban and three rural outpatient clinics were collected by medical record extraction and from patient interviews using audio computer-assisted self-interview (ACASI).ResultsThe prevalence of suboptimal adherence was estimated to be 24.9% via a visual analogue scale (VAS) of past-month dose-missing and 29.1% using a modified Adult AIDS Clinical Trial Group scale for on-time dose-taking in the past 4 days. Factors significantly associated with the more conservative VAS score were: depression (p < 0.001), side-effect experiences (p < 0.001), heavy alcohol use (p = 0.001), chance health locus of control (p = 0.003), low perceived quality of information from care providers (p = 0.04) and low social connectedness (p = 0.03). Illicit drug use alone was not significantly associated with suboptimal adherence, but interacted with heavy alcohol use to reduce adherence (p < 0.001).ConclusionsThis is the largest survey of ART adherence yet reported from Asia and the first in a developing country to use the ACASI method in this context. The evidence strongly indicates that ART services in Viet Nam should include screening and treatment for depression, linkage with alcohol and/or drug dependence treatment, and counselling to address the belief that chance or luck determines health outcomes.

Efficacy of a lay health worker led group antiretroviral medication adherence training among non-adherent HIV-positive patients in KwaZulu-Natal, South Africa: Results from a randomized trial

There is a lack of theory-based randomized controlled trials to examine the effect of antiretroviral adherence in sub-Saharan Africa. We assessed the effectiveness of a lay health worker lead structured group intervention to improve adherence to antiretroviral therapy (ART) in a cohort of HIV-infected adults. This two-arm randomized controlled trial was undertaken at an HIV clinic in a district hospital in South Africa. A total of 152 adult patients on ART and with adherence problems were randomized 1:1 to one of two conditions, a standard adherence intervention package plus a structured three session group intervention or to a standard adherence intervention package alone. Self-reported adherence was measured using the Adult AIDS Clinical Trials Group adherence instrument prior to, post intervention and at follow-up. Baseline characteristics were similar for both conditions. At post-intervention, adherence information knowledge increased significantly in the intervention condition in comparison to the standard of care, while adherence motivation and skills did not significantly change among the conditions over time. There was a significant improvement in ART adherence and CD4 count and a significant reduction of depression scores over time in both conditions, however, no significant intervention effect between conditions was found. Lay health workers may be a useful adjunct to treatment to enhance the adherence information component of the medication adherence intervention, but knowledge may be necessary but not sufficient to increase adherence in this sample. Psychosocial informational interventions may require more advanced skill training in lay health workers to achieve superior adherence outcomes in comparison standard care in this resource-constrained setting.

Factors Influencing Adherence to ART

Adherence to therapy is central to the success of antiretroviral treatment (ART). With the availability of free ART under the national program in India, cost of ART is no longer the primary determinant of adherence. This study evaluated the adherence and factors influencing it among patients receiving free ART in a public health ART center in India. The adherence and its influences among 250 HIV-positive patients on first line ART for at least 3 months from the ART Center of Maulana Azad Medical College and Lok Nayak Hospital, New Delhi, India were analyzed. The adherence was assessed by patients' self report using the adult AIDS Clinical Trial Group (ACTG) questionnaire and counter checked with pharmacy records. The association of various parameters affecting adherence levels was analyzed by using SPSS package and Epiinfo software. Of the 250 patients, 242 (96.8%) had optimum adherence (>95%) and 8 (3.2%) were "non-adherent." CD4 counts (P = 0.05), high level of belief among patients, patients' knowledge about importance of adherence (P = 0.04), and sound mental health were positively influencing adherence. The main barriers to adherence were poor mental health and negative psychological states in the patients (0.001). The presence of adverse reactions to ART also resulted in poorer adherence. The modifiable factors most strongly associated with good adherence rates were higher current CD4 counts, patients' beliefs in ART, and positive mental health. These factors can be targeted by simple, practical interventions to improve and maintain high adherence levels.