Gender Moderates Results of a Randomized Clinical Trial for the Khanya Intervention for Substance Use and ART Adherence in HIV Care in South Africa.
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ABSTRACT:
SUBMITTER: Belus JM
PROVIDER: S-EPMC9550692 | biostudies-literature | 2022 Nov
REPOSITORIES: biostudies-literature
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Gender Moderates Results of a Randomized Clinical Trial for the Khanya Intervention for Substance Use and ART Adherence in HIV Care in South Africa.
Belus Jennifer M JM Joska John A JA Bronsteyn Yosef Y Rose Alexandra L AL Andersen Lena S LS Regenauer Kristen S KS Myers Bronwyn B Hahn Judith A JA Orrell Catherine C Safren Steve A SA Magidson Jessica F JF
AIDS and behavior 20220727 11
Little is known about gender effects of alcohol and drug use (AOD) among people living with HIV (PLWH) in resource-limited settings. Using multilevel models, we tested whether gender moderated the effect of Khanya, a cognitive-behavioral therapy-based intervention addressing antiretroviral (ART) adherence and AOD reduction. We enrolled 61 participants from HIV care and examined outcomes at 3- and 6-months compared to enhanced treatment as usual (ETAU). Gender significantly moderated the effect o ...[more]
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Project description:IntroductionSouth Africa (SA) has the highest number of people living with HIV (PLWH) globally, and a significant burden of alcohol and other drug use (AOD). Although integrating AOD treatment into HIV care may improve antiretroviral therapy (ART) adherence, this is not typically routine practice in SA or other low-resource settings. Identifying interventions that are feasible and acceptable for implementation is critical to improve HIV and AOD outcomes.MethodsA pilot randomized hybrid type 1 effectiveness-implementation trial (N = 61) was conducted to evaluate the feasibility and acceptability of Khanya, a task-shared, peer-delivered behavioral intervention to improve ART adherence and reduce AOD in HIV care in SA. Khanya was compared to enhanced treatment as usual (ETAU), a facilitated referral to on-site AOD treatment. Implementation outcomes, defined by Proctor's model, included feasibility, acceptability, appropriateness and fidelity. Primary pilot effectiveness outcomes were ART adherence at post-treatment (three months) measured via real-time electronic adherence monitoring, and AOD measured using biomarker and self-report assessments over six months. Data collection was conducted from August 2018 to April 2020.Results and discussionNinety-one percent of participants (n = 56) were retained at six months. The intervention was highly feasible, acceptable, appropriate and delivered with fidelity (>90% of components delivered as intended by the peer). There was a significant treatment-by-time interaction for ART adherence (estimate = -0.287 [95% CI = -0.507, -0.066]), revealing a 6.4 percentage point increase in ART adherence in Khanya, and a 22.3 percentage point decline in ETAU. Both groups evidenced significant reductions in alcohol use measured using phosphatidylethanol (PEth) (F(2,101) = 4.16, p = 0.01), significantly decreased likelihood of self-reported moderate or severe AOD (F(2,104) = 7.02, p = 0.001), and significant declines in alcohol use quantity on the timeline follow-back (F(2,102) = 21.53, p < 0.001). Among individuals using drugs and alcohol, there was a greater reduction in alcohol use quantity in Khanya compared to ETAU over six months (F(2,31) = 3.28, p = 0.05).ConclusionsResults of this pilot trial provide initial evidence of the feasibility and acceptability of the Khanya intervention for improving adherence in an underserved group at high risk for ongoing ART non-adherence and HIV transmission. Implementation results suggest that peers may be a potential strategy to extend task-sharing models for behavioral health in resource-limited, global settings.
| S-EPMC8222840 | biostudies-literature
Project description:BackgroundSubstance use is prevalent in South Africa and associated with poor HIV treatment outcomes, yet, it is largely unaddressed in HIV care. Implementing an evidence-based, task-shared intervention for antiretroviral therapy (ART) adherence and substance use integrated into HIV care may be a feasible and effective way to improve HIV treatment outcomes and reduce substance use in this population.MethodsGuided by the RE-AIM framework, a randomized, hybrid type 1 effectiveness-implementation trial (n = 60) is being used to evaluate a peer-delivered intervention that integrates evidence-based intervention components, including Life-Steps (problem solving and motivational skills for HIV medication adherence), behavioral activation to increase alternative, substance-free rewarding activities in one's environment, and relapse prevention skills, including mindfulness. The comparison condition is enhanced standard of care, which includes facilitating a referral to a local substance use treatment clinic (Matrix). Participants are followed for a period of 6 months. Implementation outcomes are defined by Proctor's model for implementation and include mixed methods evaluations of feasibility, acceptability, and fidelity, and barriers and facilitators to implementation. Primary patient-level effectiveness outcomes are ART adherence (Wisepill) and substance use (WHO-ASSIST and urinalysis); viral load is an exploratory outcome.DiscussionResults of this trial will provide important evidence as to whether peer delivery of an integrated intervention for ART adherence and substance use is feasible, acceptable, and effective. Implementation outcomes will provide important insight into using peers as an implementation strategy to extend task sharing models for behavioral health in resource-limited settings globally.Trial registrationClinicalTrials.gov identifier: NCT03529409. Trial registered on May 18, 2018.
| S-EPMC7326344 | biostudies-literature
Project description:IntroductionAntiretroviral treatment (ART) adherence rates are lower among adolescents living with HIV (ALHIV) than among adults and children, but more evidence is needed on long-term sustained ART adherence among ALHIV. This study assesses rates of sustained ART adherence in a cohort of adolescents in South Africa.MethodsA prospective cohort of adolescents (10-19 years) living with HIV (baseline sample N = 1 046, 55% female, mean age 13.6) in the Eastern Cape Province in South Africa were interviewed at baseline (2014-15) and followed-up twice (2015-16, 2017-18). All adolescents ever initiated on treatment in 52 government health facilities were traced (with 90% uptake, 94% retention at Wave 2, and 97% retention at Wave 3, 3.4% mortality) and their clinic records were extracted where available. We investigate sustained ART adherence among adolescents interviewed at all three waves of data collection (N = 933). To quantify adherence at each study wave, we used self-reported past-week adherence (including weekdays and weekends). Self-reported adherence was validated using HIV-1 RNA viral load (>50 copies/mL cut-off) reported in clinic records, in a random-intercept logistic regression.Results and discussionAt baseline, approximately 66% (N = 615) of adolescents reported past-week ART adherence, and of these 45.3% reported adherence at both baseline and follow-up. Only 37.1% of the sample reported sustained past-week ART adherence over the three waves of the study. Most adolescents (N = 587, 62.9%) report inconsistent adherence across time (including 6.4% disengaged from care). Older (P = 0.007) and adolescents with horizontally acquired HIV (P = 0.002) were more likely to report inconsistent adherence across time. Controlling for socio-demographic characteristics, past-week adherence was associated with non-detectable viral load (aOR 1.72, 95%CI 1.14-2.59, P = 0.009). Overall, of the adolescents with viral load measurements at study Wave 1 and Wave 2, 50.6% maintained undetectable viral load for the preceding year.ConclusionsAdolescents living with HIV reported very low rates of sustained ART adherence. Adherence reported at a single time may mask high rates of variability in adherence over time. These findings highlight the urgent need for enhanced and effective interventions to assist ALHIV with ART adherence through the challenging years of adolescence.
| S-EPMC8552454 | biostudies-literature
Project description:BackgroundHIV is a leading cause of morbidity and mortality in South Africa that can be managed using antiretroviral therapy (ART). Adherence clubs are interventions that have been introduced to decentralize ART to improve ART adherence and provide social support for club members. However, ART adherence can be suboptimal even among adherence club members.AimThis study aimed to determine the factors affecting ART adherence among people living with HIV/AIDS (PLWHA) attending adherence clubs in Ekurhuleni Metropolitan Municipality.MethodsA cross-sectional study was conducted. Ordinal logistic regression was used in univariable and multivariable analyses to determine factors significantly associated with adherence scores. Factors included in the final model were age, comorbidity, ART regimen and club membership duration.ResultsThe records of 730 participants were analysed. After adjusting for age, participants with comorbidities were half as likely to report high ART adherence scores compared to participants without comorbidities (AOR = 0.5, 95% CI: 0.3-0.8, p = 0.005). The adjusted odds of reporting high levels of adherence among participants on cART were 1.8 times those on a single tablet regimen (AOR = 1.8, 95% CI: 1.0-3.2; p = 0.033). There was a 20% reduction in the adjusted odds of reporting high ART adherence for each additional year of adherence club membership (AOR = 0.8, 95% CI: 0.8-0.9, p<0.001).ConclusionIncreasing years spent as adherence club members, single tablet ART regimens and the presence of comorbidities were all significantly associated with low ART adherence among study participants. Regular assessment of the quality of counselling sessions for ART adherence club members and questionnaires for early screening of treatment fatigue have been suggested as tools for improved adherence in ART adherence club settings.
| S-EPMC9624407 | biostudies-literature
Project description:IntroductionMental health problems are prevalent in adolescents living with HIV (ALHIV), often remain untreated, and may negatively affect antiretroviral therapy (ART) adherence and viral suppression. We implemented routine mental health screening at a paediatric ART clinic to improve the identification and management of mental health problems in ALHIV. In this report, we examine screening outcomes, associated patient characteristics and the odds of unsuppressed viral load in ALHIV screening positive for mental disorders.MethodsAdolescents aged 10 to 19 years attending Rahima Moosa Hospital in Johannesburg, South Africa between February 1, 2018, and January 1, 2020, were offered mental health screening at each routine HIV care visit. The screening included four pre-screening questions followed by full screening (conditional on positive pre-screening) for depression (Patient Health Questionnaire-9 [PHQ-9]), suicide (Adolescent Innovations Project [AIP]-handbook), anxiety (Generalized Anxiety Disorder-7 [GAD-7]), post-traumatic stress disorder (PTSD) (Primary Care PTSD Screen [PC-PTSD-5]) and substance use (CAGE Adapted to Include Drugs [CAGE-AID]). We assessed screening outcomes and calculated adjusted odds ratios for associations between positive screening tests at the first screen and unsuppressed viral load (>400 copies/mL) at the measurement taken closest to the date of screening, within hundred days before and one day after screening.ResultsOut of 1203 adolescents who attended the clinic, 1088 (90.4%) were pre-screened of whom 381 (35.0%) underwent full screening, 48 (4.4%) screened positive for depression (PHQ-9 ≥10), 29 (2.8%) for suicidal concern, 24 (2.2%) for anxiety (GAD-7 ≥10), 38 (3.2%) for PTSD (PC-PTSD-5 ≥3), 18 (1.7%) for substance use (CAGE-AID ≥2) and 97 (8.9%) for any of these conditions. Positive screening for depression (aOR 2.39, 95% CI 1.02 to 5.62), PTSD (aOR 3.18, 95% CI 1.11 to 9.07), substance use (aOR 7.13, 95% CI 1.60 to 31.86), or any condition (aOR 2.17, 95% CI 1.17 to 4.02) were strongly associated with unsuppressed viral load.ConclusionsALHIV affected by mental health problems have increased rates of unsuppressed viral load and need specific clinical attention. The integration of routine mental health screening in paediatric ART programmes is a feasible approach for identifying and referring adolescents with mental health and adherence problems to counselling and psychosocial support services and if needed to psychiatric care.
| S-EPMC7720277 | biostudies-literature
Project description:We followed adolescents and adults living with HIV aged older than 15 years who enrolled in a South African private-sector HIV programme to examine adherence and viral non-suppression (viral load > 400 copies/mL) of participants with (20,743, 38%) and without (33,635, 62%) mental health diagnoses. Mental health diagnoses were associated with unfavourable adherence patterns. The risk of viral non-suppression was higher among patients with organic mental disorders [adjusted risk ratio (aRR) 1.55, 95% confidence interval (CI) 1.22-1.96], substance use disorders (aRR 1.53, 95% CI 1.19-1.97), serious mental disorders (aRR 1.30, 95% CI 1.09-1.54), and depression (aRR 1.19, 95% CI 1.10-1.28) when compared with patients without mental health diagnoses. The risk of viral non-suppression was also higher among males, adolescents (15-19 years), and young adults (20-24 years). Our study highlights the need for psychosocial interventions to improve HIV treatment outcomes-particularly of adolescents and young adults-and supports strengthening mental health services in HIV treatment programmes.
| S-EPMC10149479 | biostudies-literature
Project description:ObjectivesResearch on migration and HIV has largely focused on male migration, often failing to measure HIV risks associated with migration for women. We aimed to establish whether associations between migration and HIV infection differ for women and men, and identify possible mechanisms by which women's migration contributes to their high infection risk.DesignData on socio-demographic characteristics, patterns of migration, sexual behavior and HIV infection status were obtained for a population of 11,677 women aged 15-49 and men aged 15-54, resident members of households within a demographic surveillance area participating in HIV surveillance in 2003-04.MethodsLogistic regression was conducted to examine whether sex and migration were independently associated with HIV infection in three additive effects models, using measures of recent migration, household presence and migration frequency. Multiplicative effects models were fitted to explore whether the risk of HIV associated with migration differed for males and females. Further modeling and simulations explored whether composition or behavioral differences accounted for observed associations.ResultsRelative to non-migrant males, non-migrant females had higher odds of being HIV-positive (adjusted odds ratio [aOR] = 1.72; 95% confidence interval [1.49-1.99]), but odds were higher for female migrants (aOR = 2.55 [2.07-3.13]). Female migrants also had higher odds of infection relative to female non-migrants (aOR = 1.48 [1.23-1.77]). The association between number of sexual partners over the lifetime and HIV infection was modified by both sex and migrant status: For male non-migrants, each additional partner was associated with 3% higher odds of HIV infection (aOR = 1.03 [1.02-1.05]); for male migrants the association between number of partners and HIV infection was non-significant. Each additional partner increased odds of HIV infection by 22% for female non-migrants (aOR = 1.22 [1.12-1.32]) and 46% for female migrants (aOR = 1.46 [1.25-1.69]).ConclusionsHigher risk sexual behavior in the context of migration increased women's likelihood of HIV infection.
| S-EPMC2902532 | biostudies-literature
Project description:IntroductionPeople with HIV (PWH) are at increased risk for atherosclerotic cardiovascular disease (CVD). Screening for CVD risk factors is recommended but not routine in South African HIV clinics. We sought to describe the prevalence of CVD risk factors among antiretroviral treatment (ART)-experienced patients in South Africa.MethodsWe performed a prospective, observational cross-sectional study of PWH (>21 years, excluding pregnant women) on ART in South Africa. We interviewed patients regarding CVD risk factors, and obtained two blood pressure (BP) measurements and random/fasting glucose via a point-of-care glucometer. Standardized chart reviews provided individuals' HIV-specific data. We defined hypertension as: self-reported use of antihypertensives or mean systolic BP (SBP) ≥140 mmHg or diastolic BP (DBP) ≥90 mmHg (Stage 1) or SBP ≥160 mmHg or DBP ≥100 mmHg (Stage 2). We defined diabetes as self-reported use of insulin/oral hypoglycaemics or fasting (random) glucose ≥7.0 (≥11.1) mmol. We obtained risk ratios (RR) for hypertension from a multivariable log-binomial regression model, adjusting for age, sex and diabetes.ResultsFrom March 2015 to February 2016, 458 participants enrolled with median age 38 years (interquartile range (IQR) 33 to 44 years) and median CD4 466/μL (IQR 317 to 638/μL); 78% were women. Participants were on ART for a median of four years, with 33% on ART ≥6 years. Almost a quarter (106/458) met the study definition for hypertension, of whom 45/106 (42%) were previously diagnosed, 23/45 (51%) were on medication and 4/23 (17%) were controlled. Eight participants had asymptomatic hypertensive urgency (BP≥180/110 mmHg). Of the 458 participants, 26 (6%) met the study definition for diabetes, half of whom (13/26) were already diagnosed; 11/13 (85%) were on treatment, of whom 4/11 (36%) had normal glucose. Age was the only significant predictor of hypertension (RR, 1.04; 95% CI, 1.03 to 1.06, p < 0.0001) in the multivariable model.ConclusionsHypertension and diabetes were prevalent among PWH prescribed ART in South Africa with less than half diagnosed, and still fewer treated and controlled. Hypertension was independently associated with age but not with HIV-specific factors. Screening for and treatment of CVD risk factors could decrease future morbidity and mortality, especially as this population ages.
| S-EPMC6466898 | biostudies-literature
Project description:IntroductionRapid diagnostic tests (RDTs) are the primary diagnostic tools for HIV used in resource-constrained settings. Without a proper confirmation algorithm, there is concern that false-positive (FP) RDTs could result in misdiagnosis of HIV infection and inappropriate antiretroviral treatment (ART) initiation, but programmatic data on FP are few.MethodsWe examined the accuracy of RDT diagnosis among HIV-infected pregnant women attending public sector antenatal services in Cape Town, South Africa. We describe the proportion of women found to have started on ART erroneously due to FP RDT results based on pre-ART viral load (VL) testing and enzyme-linked immunosorbent assay (ELISA).ResultsWe analysed 952 consecutively enrolled pregnant women diagnosed as HIV infected based on two RDTs per local guideline and found 4.5% (43/952) of pre-ART VL results to be <50 copies/ml. After excluding 6 women who had detectable virus on subsequent VL measurements, ELISA was performed on the 37 remaining women. Of these, 3/952 (0.3%) HIV RDT diagnoses were found to be FP. We estimate that using ELISA to confirm all positive RDTs would cost $1110 (uncertainty interval $381-$5382) to identify one patient erroneously initiated on ART, while it costs $3912 for a lifetime of antiretrovirals with VL monitoring for one person.ConclusionsCompared to the cost of confirming the RDT-based diagnoses, the cost of HIV misdiagnosis is high. While testing programmes based on RDT should strive for constant quality improvement, where resources permit, laboratory confirmation algorithms can play an important role in strengthening the quality of HIV diagnosis in the era of universal ART.
| S-EPMC5625589 | biostudies-literature
Project description:BackgroundIn South Africa, persistence of the HIV epidemic and associated gender and racial disparities is a major concern after more than 20 years of democratic dispensation and efforts to create a more healthy and equal society. This paper profiles HIV prevalence and related factors among Black African men and women compared to other race groups in South Africa using the 2012 population-based national household HIV survey.MethodsThis secondary data analysis was based on the 2012 population-based nationally representative multi-stage stratified cluster random household sample. Bivariate and multiple logistic regression analysis were used to assess the relationship between HIV prevalence and associated factors by gender and racial profile.ResultsOverall HIV prevalence was significantly higher (p < 0.001) among both Black African males (16.6%; 95% CI: 15.0-18.4) and females (24.1%; 95% CI: 22.4-26.0) compared to their counterparts from other races. Among Black African males, increased risk of HIV was significantly associated with age group 25-49 years and those 50 years and older compared with young males 15-25 years. Among all males, reported condom use at last sex was significantly associated with increased risk of HIV. High socio-economic status (SES) and perceived risk of HIV were associated with a decreased risk of HIV. Among female condom use at last sex and ever testing for HIV was associated with increased prevalence of HIV only among Black African females. Lower prevalence of HIV was associated with marriage, tertiary education, high SES, having a partner five years younger, perceived risk of HIV, and awareness of HIV status among Black African females.ConclusionGender and racial disparities rooted in structural and contextual inequalities remain important factors for the maintenance of the generalized HIV epidemic in the country. HIV prevention interventions need to cut across all strata of society but also target risk factors salient for specific groups. Alleviating vulnerability to HIV along gender and racial lines should also be viewed as part of a broader public health strategy.
| S-EPMC6821038 | biostudies-literature