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BACKGROUND: Rural African people living with HIV face significant challenges in entering and remaining in HIV care. In rural Uganda, for example, there is a threefold higher prevalence of HIV compared to the national average and lower engagement throughout the HIV continuum of care. There is an urgent need for appropriate interventions to improve entry and retention in HIV care for rural Ugandans with HIV. Though many adults living with HIV in rural areas prioritize seeking care services from traditional healers over formal clinical services, healers have not been integrated into HIV care programs. The Omuyambi trial is investigating the effectiveness of psychosocial support delivered by traditional healers as an adjunct to standard HIV care versus standard clinic-based HIV care alone. Additionally, we are evaluating the implementation process and outcomes, following the Consolidated Framework for Implementation Research. METHODS: This cluster randomized hybrid type 1 effectiveness-implementation trial will be conducted among 44 traditional healers in two districts of southwestern Uganda. Healers were randomized 1:1 into study arms, where healers in the intervention arm will provide 12 months of psychosocial support to adults with unsuppressed HIV viral loads receiving care at their practices. A total of 650 adults with unsuppressed HIV viral loads will be recruited from healer clusters in the Mbarara and Rwampara districts. The primary study outcome is HIV viral load measured at 12 months after enrollment, which will be analyzed by intention-to-treat. Secondary clinical outcome measures include (re)initiation of HIV care, antiretroviral therapy adherence, and retention in care. The implementation outcomes of adoption, fidelity, appropriateness, and acceptability will be evaluated through key informant interviews and structured surveys at baseline, 3, 9, 12, and 24 months. Sustainability will be measured through HIV viral load measurements at 24 months following enrollment. DISCUSSION: The Omuyambi trial is evaluating an approach that could improve HIV outcomes by incorporating previously overlooked community lay supporters into the HIV cascade of care. These findings could provide effectiveness and implementation evidence to guide the development of policies and programs aimed at improving HIV outcomes in rural Uganda and other countries where healers play an essential role in community health. TRIAL REGISTRATION: ClinicalTrials.gov NCT05943548. Registered on July 5, 2023. The current protocol version is 4.0 (September 29, 2023).
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Infecciones por VIH , Ensayos Clínicos Controlados Aleatorios como Asunto , Carga Viral , Humanos , Infecciones por VIH/tratamiento farmacológico , Infecciones por VIH/diagnóstico , Uganda/epidemiología , Medicinas Tradicionales Africanas/métodos , Fármacos Anti-VIH/uso terapéutico , Resultado del Tratamiento , Servicios de Salud Rural , Adulto , Apoyo Social , Población Rural , Factores de Tiempo , Femenino , Masculino , Practicantes de la Medicina TradicionalRESUMEN
BACKGROUND: Social desirability can negatively affect the validity of self-reported measures, including underreporting of stigmatized behaviors like alcohol consumption. The Marlowe-Crowne Social Desirability Scale (SDS) is widely implemented and comprised of Denial and Attribution Domains (i.e., tendencies to deny undesirable traits or attribute socially desirable traits to oneself, respectively). Yet, limited psychometric research has been conducted in sub-Saharan Africa, where the prevalence of unhealthy alcohol consumption is high as well as religiosity and hierarchical social norms. To address this gap, we (a) conducted an exploratory study assessing certain psychometric properties of the 28-item SDS (Runyankole-translated) among persons with HIV (PWH) in Uganda, and (b) examined the relationship between social desirability and self-reported alcohol use. METHODS: We pooled baseline data (N = 1153) from three studies of PWH engaged in alcohol use from 2017 to 2021. We assessed the translated scale's construct validity (via confirmatory factor analysis), internal consistency, item performance, differential item functioning by gender, concurrent validity with the DUREL religiosity index domains, and the association between social desirability and self-reported alcohol use. RESULTS: Participants had a mean age of 40.42 years, 63% were men, and 91% had an undetectable HIV viral load. The 28-item SDS had satisfactory construct validity (Model fit indices: RMSEA = 0.07, CFI = 0.84, TLI = 0.82) and internal consistency (Denial Domain ΩTotal = 0.82, Attribution Domain ΩTotal = 0.69). We excluded Item 14 ("I never hesitate to help someone in trouble") from the Attribution Domain, which mitigated differential measurement error by gender and slightly improved the construct validity (Model fit indices: RMSEA = 0.06, CFI = 0.86, TLI = 0.85) and reliability (Attribution Domain ΩTotal = 0.72) of the 27-item modified SDS. Using the 27-item SDS, we found that social desirability was weakly correlated with religiosity and inversely associated with self-reported alcohol use after adjusting for biomarker-measured alcohol use and other confounders (ß = -0.05, 95% confidence interval: -0.09 to -0.01, p-value = 0.03). CONCLUSIONS: We detected and mitigated measurement error in the 28-item Runyankole-translated SDS, and found that the modified 27-item scale had satisfactory construct validity and internal consistency in our sample. Future studies should continue to evaluate the psychometric properties of the Runyankole-translated SDS, including retranslating Item 14 and reevaluating its performance.
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Infecciones por VIH , Psicometría , Deseabilidad Social , Humanos , Masculino , Femenino , Infecciones por VIH/psicología , Adulto , Uganda , Persona de Mediana Edad , Autoinforme , Consumo de Bebidas Alcohólicas/psicología , Consumo de Bebidas Alcohólicas/epidemiología , Reproducibilidad de los Resultados , Encuestas y Cuestionarios/normasRESUMEN
BACKGROUND: Tenofovir/lamivudine/dolutegravir (TLD) is the preferred first-line antiretroviral therapy (ART) regimen for people with HIV (PWH), including those who were previously virologically suppressed on non-nucleoside reverse transcriptase inhibitors (NNRTIs). We sought to estimate the real-world effectiveness of the TLD transition in Ugandan public-sector clinics. METHODS: We conducted a prospective cohort study of PWH ≥18 years who were transitioned from NNRTI-based ART to TLD. Study visits were conducted on the day of TLD transition and 24- and 48- weeks later. The primary endpoint was viral suppression (<200â copies/mL) at 48-weeks. We collected blood for retrospective viral load (VL) assessment and conducted genotypic resistance tests for specimens with VL >500â copies/mL. RESULTS: We enrolled 500 participants (median age of 47 years; 41% women). At 48-weeks after TLD transition, 94% of participants were in care with a VL <200â copies/mL (n = 469/500); 2% (n = 11/500) were lost from care or died; and only 2% (n = 9/500) had a VL >500â copies/mL. No incident resistance to DTG was identified. Few participants (2%, n = 9/500) discontinued TLD due to adverse events. CONCLUSIONS: High rates of viral suppression, high tolerability, and lack of emergent drug resistance support use of TLD as the preferred first-line regimen in the region.
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We integrated safer conception care into a Ugandan HIV clinic. People with HIV (PWH), or partnered with a PWH, and desiring children were eligible for the Healthy Families Clinic Program. Clients completed quarterly safer conception counselling visits and questionnaires to provide information around method preferences and outcomes (partner pregnancy, partner seroconversion). We used clinic level data to evaluate longitudinal viral suppression among PWH. Between November 2016 and January 2020, 361 clients (53% men) accessed services. 75% were PWH (51% women, 96% men): 99% were on antiretroviral therapy (ART) and most reported HIV-sero-different partnerships (97%). Frequently selected safer conception methods included ART (86%), timed condomless sex (74%), and PrEP (40%) with important differences by HIV-serostatus and gender. 22.5% reported pregnancy. Most (97%) PWH were virally suppressed at enrolment and 81% of non-virally suppressed PWH were virally suppressed at 15 months. Two HIV-negative clients (2%) had HIV seroconversion. There is demand for safer conception care in a public sector HIV-clinic in Uganda. Men and women have unique safer conception care preferences. The majority of clients engaged in safer conception care had viral suppression at follow up.
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Infecciones por VIH , Población Rural , Humanos , Uganda , Femenino , Masculino , Infecciones por VIH/tratamiento farmacológico , Adulto , Embarazo , Fertilización , Adulto JovenRESUMEN
Economic incentives to promote health behavior change are highly efficacious for substance use disorders as well as increased medication adherence. Knowledge about participants' experiences with and perceptions of incentives is needed to understand their mechanisms of action and optimize future incentive-based interventions. The Drinkers' Intervention to Prevent Tuberculosis (DIPT) trial enrolled people with HIV (PWH) in Uganda with latent tuberculosis and unhealthy alcohol use in a 2x2 factorial trial that incentivized recent alcohol abstinence and isoniazid (INH) adherence on monthly urine testing while on INH preventive therapy. We interviewed 32 DIPT study participants across trial arms to explore their perspectives on this intervention. Participants described 1) satisfaction with incentives of sufficient size that allowed them to purchase items that improved their quality of life, 2) multiple ways in which incentives were motivating, from gamification of "winning" through support of pre-existing desire to improve health to suggesting variable effects of extrinsic and intrinsic motivation, and 3) finding value in learning results of increased clinical monitoring. To build effective incentive programs to support both reduced substance use and increased antimicrobial adherence, we recommend carefully selecting incentive magnitude as well as harnessing both intrinsic motivation to improve health and extrinsic reward of target behavior. In addition to these participant-described strengths, incorporating results of clinical monitoring related to the incentive program that provide participants more information about their health may also contribute to health-related empowerment.
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BACKGROUND: Smoking and alcohol use frequently co-occur and are the leading causes of preventable death in sub-Saharan Africa (SSA) and are common among people living with HIV (PLWH). While alcohol use has been shown to be associated with reduced adherence to antiretroviral treatment (ART), which may affect HIV viral suppression, the independent effect of smoking on HIV outcomes in SSA is unknown. We aimed to 1) describe the prevalence of current smoking and correlates of smoking; 2) assess the association of smoking with viral suppression, adjusting for level of alcohol use; 3) explore the relationship between smoking and CD4 cell count <350 cells/mm3, among participants who are virally suppressed. METHODS: We analyzed data from the Drinkers Intervention to Prevent Tuberculosis (DIPT) and the Alcohol Drinkers' Exposure to Preventive Therapy for TB (ADEPTT) studies conducted in Southwest Uganda. The studies enrolled PLWH who were on ART for at least 6 months and co-infected with latent tuberculosis and dominated with participants who had unhealthy alcohol use. Current smoking (prior 3 months) was assessed by self-report. Alcohol use was assessed using the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C, modified for prior 3 months) and phosphatidylethanol (PEth), an alcohol biomarker. We used logistic regression to estimate the cross-sectional association between smoking and lack of virological suppression (≥40 copies/ml), adjusting for level of alcohol use and other covariates, and to examine the association between smoking and CD4 cell counts among PLWH with viral suppression. RESULTS: Of the 955 participants enrolled from 2017 to 2021 who had viral load (VL) results, 63% were men, median age was 40 years (interquartile range [IQR] 32-47), 63% engaged in high/very high-risk alcohol use (AUDIT-C≥6 or PEth≥200 ng/mL), and 22% reported smoking in the prior 3 months. Among 865 participants (91%) with viral suppression and available CD4 count, 11% had a CD4 cell count <350 cells/mm3. In unadjusted and adjusted analyses, there was no evidence of an association between smoking and lack of virological suppression nor between smoking and CD4 count among those with viral suppression. CONCLUSIONS: The prevalence of smoking was high among a study sample of PLWH in HIV care with latent TB in Southwest Uganda in which the majority of persons engaged in alcohol use. Although there was no evidence of an association between smoking and lack of virological suppression, the co-occurrence of smoking among PLWH who use alcohol underscores the need for targeted and integrated approaches to reduce their co-existence and improve health.
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Alcoholismo , Fármacos Anti-VIH , Infecciones por VIH , Masculino , Humanos , Adulto , Femenino , Estudios Transversales , Alcoholismo/complicaciones , Fumar/epidemiología , Uganda/epidemiología , Infecciones por VIH/complicaciones , Infecciones por VIH/tratamiento farmacológico , Infecciones por VIH/epidemiología , Antirretrovirales/uso terapéutico , Recuento de Linfocito CD4 , Etanol/uso terapéutico , Carga Viral , Fármacos Anti-VIH/uso terapéuticoRESUMEN
Background: HIV is one of the leading causes of morbidity and mortality, with 39.0 million people living with HIV worldwide, 25.6 million of whom reside in the African region. Highly active anti-retroviral therapy (HAART) has improved survival and quality of life, yet some patients develop viral non-suppression. Dolutegravir (DTG) has been recommended since 2018 as a first-line treatment option in low- and middle-income countries owing to its effectiveness, low cost, and tolerability, but some studies have reported virological non-suppression with its use. This study aims to explore the prevalence and factors associated with virological non-suppression in adults taking DTG-based regimens in Mbarara Regional Referral Hospital. Methods: A retrospective cohort study was carried out among people living with HIV (PLWHIV) taking DTG-based HAART regimens by way of record review. SPSS was used for analysis, and both binary and multivariate logistic regression analyses were performed to test associated factors. Results: Among the 422 participants' records reviewed, 62.8% were female (median age 40 years, IQR=13). The prevalence of virological non-suppression was 4.2%. Poor adherence to HAART was significantly associated with virological non-suppression, with 100.3 increased adjusted odds (95% CI: 28.90-348.12, p<0.001) compared to those with a record of good adherence. The reasons for poor adherence included alcohol use, stigma, forgetting to take medication, transport problems, and irregular timing of swallowing. Conclusion: This study found poor adherence to be associated with a 4.2% prevalence of virological non-suppression among PLWHIV in a large public HIV care clinic. Despite the high suppression rates on DTG-based regimens, adherence counseling and viral load monitoring need to be emphasized at all HIV care centers to mark the trends of virological non-suppression.
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BACKGROUND: People with HIV (PWH) on integrase inhibitor-based regimens may be at risk of excess weight gain, but it is unclear if this risk is consistent across settings. We assessed weight change over 48âweeks among PWH who were transitioned to tenofovir disoproxil fumarate/lamivudine/dolutegravir (TLD). DESIGN: We conducted a prospective cohort study at public-sector HIV clinics in Uganda and South Africa. METHODS: Eligible participants were adults who were transitioned to TLD. Weight was measured at enrollment, 24-, and 48-weeks post TLD transition. Our outcomes were weight change, change in waist circumference, and clinically significant weight gain, defined as ≥10% increase in weight from baseline, over 48âweeks. We used linear mixed-effects regression models, adjusted for demographic factors, to estimate weight gain and identify risk factors. RESULTS: Weight data were available for 428 participants in Uganda and 367 in South Africa. The mean weight change was 0.6âkg [95% CI: 0.1-1.0] in Uganda and 2.9âkg [2.3-3.4] in South Africa ( P â<â0.001). The mean change in waist circumference was 0.8âcm [95% CI: 0.0-1.5]) in Uganda and 2.3âcm [95% CI: 1.4-3.2] in South Africa ( P â=â0.012). Clinically significant weight gain occurred in 9.8% [7.0-12.6] of participants in Uganda and 18.0% [14.1-21.9] in South Africa ( P â<â0.001). After adjustment, PWH gained significantly less weight in Uganda than in South Africa. CONCLUSIONS: PWH in South Africa experienced significantly greater weight gain and increases in waist circumference compared to Uganda. Strategies to address weight gain in PWH should be carefully considered and may vary by region.
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Infecciones por VIH , Compuestos Heterocíclicos con 3 Anillos , Oxazinas , Piperazinas , Piridonas , Aumento de Peso , Humanos , Sudáfrica/epidemiología , Piridonas/uso terapéutico , Uganda/epidemiología , Masculino , Femenino , Infecciones por VIH/tratamiento farmacológico , Estudios Prospectivos , Adulto , Compuestos Heterocíclicos con 3 Anillos/uso terapéutico , Aumento de Peso/efectos de los fármacos , Oxazinas/uso terapéutico , Piperazinas/uso terapéutico , Persona de Mediana Edad , Inhibidores de Integrasa VIH/uso terapéutico , Fármacos Anti-VIH/uso terapéutico , Lamivudine/uso terapéutico , Tenofovir/uso terapéutico , Sustitución de Medicamentos , Adulto JovenRESUMEN
Globally, over one million people acquire curable sexually transmitted infections (STI) each day. Understanding how people think about STIs is key to building culturally appropriate STI prevention and treatment programs. We explored STI knowledge and perceptions in rural, southwestern Uganda to inform future interventions. From August 2020 to December 2020, we conducted individual in-depth interviews among adult men and women (≥18 years) with recent or current personal or partner pregnancy, a history of an STI diagnosis and treatment, and membership in an HIV-sero-different relationship. Interviews explored STI knowledge, perceptions, and barriers and facilitators to engaging in STI care. We used inductive and deductive approaches to generate a codebook guided by the healthcare literacy skills framework in a thematic analysis. Ten men with STI, five of their female partners, eighteen women with STI, and four of their male partners participated in individual in-depth interviews. The median age was 41 (range 27-50) for men and 29 (range 22-40) for women. Sixteen (43%) participants were with HIV. Significant themes include: 1) Participants obtained STI knowledge and information from the community (friends, family members, acquaintances) and medical professionals; 2) While participants knew STIs were transmitted sexually, they also believed transmission occurred via non-sexual mechanisms. 3) Participants associated different connotations and amounts of stigma with each STI, for example, participants reported that syphilis was passed down "genetically" from parent to child. 4) Participants reported uncertainty about whether STIs affected pregnancy outcomes and whether antenatal STI treatment was safe. The complicated nature of STIs has led to understandable confusion in settings without formal sexual healthcare education. Robust counseling and education prior to sexual debut will help allow men and women to understand the signs, symptoms, and treatments necessary for STI cure and to navigate often complicated and overburdened healthcare systems.
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In Uganda, four in ten women report experiencing intimate partner violence (IPV) in the past year. Salient drivers of IPV in sub-Saharan Africa include stress related to household finances, alcohol use, and partner infidelity. We conducted 42 interviews with participants (n = 32) in the Drinkers' Intervention to Prevent Tuberculosis (DIPT) study which included economic incentives, and their partners (n = 10) to understand how participating in DIPT during COVID-19 lockdown restrictions impacted relationship dynamics in intimate partnerships. Our findings highlight the need to develop policies to address root causes of IPV and to ensure continuity of IPV services in future pandemics. Policy and programming recommendations based on study results are presented.
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Alcohol use is an important factor in achieving and maintaining viral suppression and optimal mental health among persons with HIV (PWH), however, the effect of age at first regular drinking on viral suppression and depression remains poorly understood. Here, using secondary data from the Alcohol Drinkers' Exposure to Preventive Therapy for Tuberculosis (ADEPT-T) study, we used logistic regression analyses to explore whether there is an association between age at first regular drinking and viral suppression (< 40 copies/ml), or presence of depressive symptoms (Center for Epidemiologic Studies Depression, CES-D ≥ 16) among 262 PWH. The median age at first regular drinking was 20.5 years (IQR: 10), with high proportions starting under age 12 (12.2%) and as teens (13.4%). The majority had an undetectable viral load (91.7%) and 11% had symptoms of probable depression. We found no significant association between age at first regular drinking and viral suppression (i.e., child (aOR = 0.76 95%CI: 0.18, 3.26), adolescent (aOR = 0.74 95%CI: 0.18, 2.97) and young adult (aOR = 1.27 95%CI: 0.40, 3.97)) nor with depressive symptoms (i.e., child (aOR = 0.72 95%CI: 0.19, 2.83), adolescent (aOR = 0.59 95%CI: 0.14, 2.50) and young adult (aOR = 0.57 95%CI: 0.22, 1.53)). Age at first regular drinking among PWH did not appear to be associated with either viral suppression or the presence of depressive symptoms, suggesting interventions may best be focused on the harmful effects of current alcohol use.
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Infecciones por VIH , Niño , Adulto Joven , Adolescente , Humanos , Infecciones por VIH/complicaciones , Infecciones por VIH/epidemiología , Infecciones por VIH/psicología , Uganda/epidemiología , Depresión/epidemiología , Depresión/psicología , Carga Viral , Consumo de Bebidas Alcohólicas/epidemiología , Consumo de Bebidas Alcohólicas/psicologíaRESUMEN
OBJECTIVES: Evidence on the acceptability of urine-based assays for tuberculosis (TB) diagnosis among patients remains limited. We sought to describe patients' experiences and perceptions of urine sampling for TB testing at point of care. SETTING: Study sites in Kenya, Uganda, Mozambique and South Africa. PARTICIPANTS: Adult ambulatory HIV patients enrolled in a TB diagnostic study were selected purposively. INTERVENTION: For this qualitative descriptive study, audiorecorded individual interviews conducted with consenting participants were translated, transcribed and analysed using content analysis. Ethical agreement was obtained from relevant ethical review committees. RESULTS: Fifty-eight participants were interviewed. Three domains were identified. Overall, participants described urine sampling as easy, rapid and painless, with the main challenge being lacking the urge. Urine was preferred to sputum sampling in terms of simplicity, comfort, stigma reduction, convenience and practicality. While perceptions regarding its trustworthiness for TB diagnosis differed, urine sampling was viewed as an additional mean to detect TB and beneficial for early diagnosis. Participants were willing to wait for several hours for same-day results to allay the emotional, physical and financial burden of having to return to collect results, and would rather not pay for the test. Facilitators of urine sampling included cleanliness and perceived privacy of sampling environments, comprehensive sampling instructions and test information, as well as supplies such as toilet paper and envelopes ensuring confort and privacy when producing and returning samples. Participants motivation for accepting urine-based TB testing stemmed from their perceived susceptibility to TB, the value they attributed to their health, especially when experiencing symptoms, and their positive interactions with the medical team. CONCLUSIONS: This study suggests that urine sampling is well accepted as a TB diagnostic method and provides insights on how to promote patients' uptake of urine-based testing and improve their sampling experiences. These results encourage the future broad use of urine-based assays at point of care.
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Infecciones por VIH , Tuberculosis , Adulto , Humanos , Infecciones por VIH/diagnóstico , Tuberculosis/diagnóstico , Sistemas de Atención de Punto , Esputo , SudáfricaRESUMEN
BACKGROUND: Alcohol use is common among people with HIV and is a risk factor for tuberculosis disease and non-adherence to isoniazid preventive therapy (IPT). Few interventions exist to reduce alcohol use and increase IPT adherence in sub-Saharan Africa. The aim of this study was to test the hypothesis that financial incentives conditional on point-of-care negative urine alcohol biomarker testing and positive urine isoniazid testing would reduce alcohol use and increase isoniazid adherence, respectively, in people with HIV who have latent tuberculosis infection and hazardous alcohol use. METHODS: We conducted an open-label, 2×2 factorial randomised controlled trial in Uganda. Eligible for the study were non-pregnant HIV-positive adults (aged ≥18 years) prescribed antiretroviral therapy for at least 6 months, with current heavy alcohol use confirmed by urine ethyl glucuronide (biomarker of recent alcohol use) and a positive Alcohol Use Disorders Identification Test-Consumption (AUDIT-C; ≥3 for women, ≥4 for men) for the past 3 months' drinking, no history of active tuberculosis, tuberculosis treatment, or tuberculosis preventive therapy, and a positive tuberculin skin test. We randomly assigned participants (1:1:1:1) initiating 6 months of IPT to: no incentives (group 1); or incentives for recent alcohol abstinence (group 2), isoniazid adherence (group 3), or both (group 4). Escalating incentives were contingent on monthly point-of-care urine tests negative for ethyl glucuronide (groups 2 and 4), or positive on IsoScreen (biomarker of recent isoniazid use; groups 3 and 4). The primary alcohol outcome was non-hazardous use by self-report (AUDIT-C <3 for women, <4 for men) and phosphatidylethanol (PEth; past-month alcohol biomarker) <35 ng/mL at 3 months and 6 months. The primary isoniazid adherence outcome was more than 90% bottle opening of days prescribed. We performed intention-to-treat analyses. This trial is registered with ClinicalTrials.gov (NCT03492216), and is complete. FINDINGS: From April 16, 2018, to Aug 2, 2021, 5508 people were screened, of whom 680 were randomly assigned: 169 to group 1, 169 to group 2, 170 to group 3, and 172 to group 4. The median age of participants was 39 years (IQR 32-47), 470 (69%) were male, 598 (90%) of 663 had HIV RNA viral loads of less than 40 copies per mL, median AUDIT-C score was 6 (IQR 4-8), and median PEth was 252 ng/mL (IQR 87-579). Among 636 participants who completed the trial with alcohol use endpoint measures (group 1: 152, group 2: 159, group 3: 161, group 4: 164), non-hazardous alcohol use was more likely in the groups with incentives for alcohol abstinence (groups 2 and 4) versus no alcohol incentives (groups 1 and 3): 57 (17·6%) of 323 versus 31 (9·9%) of 313, respectively; adjusted risk difference (aRD) 7·6% (95% CI 2·7 to 12·5, p=0·0025). Among 656 participants who completed the trial with isoniazid adherence endpoint measures (group 1: 158, group 2: 163, group 3: 168, group 4: 167), incentives for isoniazid adherence did not increase adherence: 244 (72·8%) of 335 in the isoniazid incentive groups (groups 3 and 4) versus 234 (72·9%) of 321 in the no isoniazid incentive groups (groups 1 and 2); aRD -0·2% (95% CI -7·0 to 6·5, p=0·94). Overall, 53 (8%) of 680 participants discontinued isoniazid due to grade 3 or higher adverse events. There was no significant association between randomisation group and hepatotoxicity resulting in isoniazid discontinuation, after adjusting for sex and site. INTERPRETATION: Escalating financial incentives contingent on recent alcohol abstinence led to significantly lower biomarker-confirmed alcohol use versus control, but incentives for recent isoniazid adherence did not lead to changes in adherence. The alcohol intervention was efficacious despite less intensive frequency of incentives and clinic visits than traditional programmes for substance use, suggesting that pragmatic modifications of contingency management for resource-limited settings can have efficacy and that further evaluation of implementation is merited. FUNDING: National Institute on Alcohol Abuse and Alcoholism. TRANSLATION: For the Runyankole translation of the abstract see Supplementary Materials section.
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Alcoholismo , Infecciones por VIH , Tuberculosis , Adulto , Humanos , Masculino , Femenino , Adolescente , Persona de Mediana Edad , Isoniazida/uso terapéutico , Isoniazida/efectos adversos , Motivación , Uganda , Resultado del Tratamiento , Tuberculosis/prevención & control , Infecciones por VIH/complicaciones , Infecciones por VIH/tratamiento farmacológico , Etanol , BiomarcadoresRESUMEN
Many adolescents and young adults with HIV (AYWH) struggle with antiretroviral therapy (ART) adherence and experience poorer outcomes than adults. Relevant factors include forgetfulness and poor self-efficacy related to their evolving neurobiology. We qualitatively explored experiences of AYWH-caregivers dyads using real-time ART adherence monitors and associated reminder functions in the home setting. As part of an implementation science-oriented study, AYWH used the Wisepill adherence monitor for 3 months. AYWH could also opt for short message service (SMS) self-reminders, a self-selected social supporter for delayed or missed doses, or an alarm reminder. We conducted in-depth interviews with randomly selected AYWH-caregiver dyads regarding their experience using the monitor. Qualitative data were analyzed using inductive content analysis. We completed 15 AYWH-caregiver dyad interviews. Of the AYWH, 67% were female, mean age was 16 years, 56% lived with their biological mother, and 86% were virologically suppressed. AYWH and their caregivers generally found the adherence monitors acceptable, though some had privacy concerns. AYWH felt the monitors helped them take charge of their medication, largely through the real-time alarm and SMS reminders; this took the burden of adherence reminders away from the caregivers, improving strained AYWH-caregiver relationships. Two adolescents reported rebound poor adherence after monitor withdrawal. ART adherence monitors and associated tools were largely acceptable to AYWH and their caregivers in home settings. The intervention helped improve AYWH self-efficacy and alleviated burden from some AYWH-caregiver relationships. Rebound poor adherence suggests the need for on-going support and/or other means to achieve intrinsic mechanisms for sustained adherence. Clinical Trial Registration number: NCT03825952.
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Infecciones por VIH , VIH , Humanos , Adolescente , Femenino , Adulto Joven , Masculino , Cuidadores , Infecciones por VIH/tratamiento farmacológico , Uganda/epidemiología , Autoeficacia , Cumplimiento de la Medicación , Antirretrovirales/uso terapéutico , ElectrónicaRESUMEN
INTRODUCTION: In Uganda, COVID-19 lockdown policies curbed the spread of SARS-CoV-2, but their effect on HIV care is poorly understood. OBJECTIVES: We examined the effects of COVID-19 lockdown policies on ART initiation, missed visits, and viral suppression in Uganda. METHODS: We conducted a time series analysis using data from a dynamic cohort of persons with HIV enrolled between March 2017 and September 2021 at HIV clinics in Masaka and Mbarara Regional Referral Hospitals in Southwestern Uganda. Poisson and fractional probit regression were used to predict expected monthly antiretroviral therapy initiations, missed visits, and viral suppression based on pre-lockdown trends. Observed and expected trends were compared across three policy periods: April 2020-September 2021 (overall), April-May 2020 (1st lockdown), and June-August 2021 (2nd lockdown). RESULTS: We enrolled 7071 Persons living with HIV (PWH) (nMasaka = 4150; nMbarara = 2921). Average ART duration was 34 and 30 months in Masaka and Mbarara, respectively. During the 18-month post-lockdown period, monthly ART initiations were lower than expected in both Masaka (51 versus 63 visits; a decrease of 12 [95% CI: -2, 31] visits) and Mbarara (42 versus 55 visits; a decrase of 13 [95% CI: 0, 27] visits). Proportion of missed visits was moderately higher than expected post-lockdown in Masaka (10% versus 7%; 4% [95% CI: 1%, 7%] absolute increase), but not in Mbarara (13% versus 13%; 0% [95% CI: -4%, 6%] absolute decrease). Viral suppression rates were moderate-to-high in Masaka (64.7%) and Mbarara (92.5%) pre-lockdown and remained steady throughout the post-lockdown period. CONCLUSION: The COVID-19 lockdown in Uganda was associated with reductions in ART initiation, with minimal effects on retention and viral suppression, indicating a resilient HIV care system.
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COVID-19 , Infecciones por VIH , Humanos , Uganda/epidemiología , Factores de Tiempo , COVID-19/epidemiología , SARS-CoV-2 , Control de Enfermedades Transmisibles , Infecciones por VIH/tratamiento farmacológico , Infecciones por VIH/epidemiología , Continuidad de la Atención al PacienteRESUMEN
Background: Brief alcohol reduction interventions for people living with HIV (PLWH) have resulted in mixed findings with some studies showing null or limited treatment effects. To better understand factors that may contribute to their success or failure, this qualitative study sought to explore participants' experiences in a randomized trial (RCT) of a brief counseling-based alcohol reduction intervention, including challenges that may have impeded alcohol reduction. Methods: We conducted in-depth semi-structured interviews with 24 PLWH engaging in unhealthy alcohol use, who were enrolled in an RCT to reduce alcohol consumption conducted in southwestern Uganda in 2019-2020 (NCT03928418). We used a collaborative thematic approach to analyze data from transcribed and translated audio recordings. Results: Perceived benefits of the intervention included increased awareness of alcohol use and its impact on personal finances, the relationship between alcohol use and violence, and a commitment to drinking reduction. Participants experienced several barriers to decreasing their alcohol use, including: prevailing social norms about alcohol use, lack of social support, and economic and social consequences of the COVID-19 pandemic. Conclusion: Factors in the immediate contexts of PLWH in low-income settings, including social norms influencing alcohol consumption and lack of social support, may impede the impact of alcohol reduction interventions, especially during times of stress such as the COVID-19 pandemic.
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COVID-19 , Infecciones por VIH , Humanos , Etanol , VIH , Infecciones por VIH/prevención & control , Infecciones por VIH/epidemiología , Pandemias , Uganda , Investigación CualitativaRESUMEN
BACKGROUND: Antiretroviral treatment improves health related quality of life (HRQoL) of people with human immunodeficiency virus (PWH). However, one third initiating first-line treatment experience virological failure and the determinants of HRQoL in this key population are unknown. Our study aims to identify determinants of among PWH failing antiretroviral treatment in sub-Saharan Africa. METHODS: We analysed data from a cohort of PWH having virological failure (> 1,000 copies/mL) on first-line ART in South Africa and Uganda. We measured HRQoL using the EuroQOL EQ-5D-3L and used a two-part regression model to obtain by-country analyses for South Africa and Uganda. The first part identifies risk factors that were associated with the likelihood of participants reporting perfect health (utility = 1) versus non-perfect health (utility < 1). The second part identifies risk factors that were associated with the EQ-5 L-3L utility scores for participants reporting non-perfect health. We performed sensitivity analyses to compare the results between the two-part model using tobit models and ordinary least squares regression. RESULTS: In both countries, males were more likely to report perfect health and participants with at least one comorbidity were less likely to report perfect health. In South Africa, participants with side effects and in Uganda those with opportunistic infections were also less likely to report perfect health. In Uganda, participants with 100% ART adherence were more likely to report perfect health. In South Africa, high HIV viral load, experiencing ART side effects, and the presence of opportunistic infections were each associated with lower HRQoL, whereas participants with 100% ART adherence reported higher HRQoL. In Uganda participants with lower CD4 count had lower HRQoL. CONCLUSION: Markers of advanced disease (opportunistic infection, high viral load, low CD4), side effects, comorbidities and lack of ART adherence negatively impacted HRQoL for PWH experiencing virological failure. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02787499.
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Infecciones por VIH , Infecciones Oportunistas , Masculino , Humanos , VIH , Calidad de Vida , Sudáfrica/epidemiología , Antirretrovirales , Infecciones por VIH/tratamiento farmacológico , Infecciones por VIH/epidemiologíaRESUMEN
ABSTRACT: Most sexually transmitted infections (STIs) are acquired in resource-limited settings (RLSs) where laboratory diagnostic access is limited. Advancements in point-of-care testing (POC) technology have the potential to bring STI testing to many RLSs. We define POC as performed near the patient and with results readily available to inform clinical practice. The World Health Organization Special Programme for Research and Training in Tropical Diseases further outlines desirable POC characteristics with the REASSURED criteria.Despite advantages related to immediate test-and-treat care, integrating POC into RLS health care systems can present challenges that preclude reliance on these tests. In 2018, we incorporated molecular near-POC for chlamydia, gonorrhea, and trichomoniasis and SDBioline treponemal immunochromatographic testing confirmed by rapid plasma reagin for syphilis diagnosis at the Mbarara University of Science and Technology Research Laboratory in rural southwestern Uganda. We describe our experiences with STI POC as a case example to guide a narrative review of the field using the Consolidated Framework for Implementation Research as a conceptual framework.Although POC and near-POC are described as easy to use, the challenges of limited person-power, health care processes, limited infrastructure/resources, high costs, and quality control obstacles can impede the impact of these tests. Increased investment in operators, training, and infrastructure, restructuring health care systems to accommodate increased POC access, and optimizing costs are all crucial to the successful implementation of STI POC in RLS. Expanded STI POC in RLS will increase access to accurate diagnoses, appropriate treatment, and engagement in partner notification, treatment, and prevention efforts.
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Infecciones por Chlamydia , Gonorrea , Infecciones por VIH , Enfermedades de Transmisión Sexual , Sífilis , Humanos , Uganda , Enfermedades de Transmisión Sexual/diagnóstico , Enfermedades de Transmisión Sexual/prevención & control , Pruebas en el Punto de Atención , Gonorrea/diagnóstico , Gonorrea/prevención & control , Sífilis/diagnóstico , Sífilis/prevención & control , Sistemas de Atención de Punto , Infecciones por Chlamydia/diagnóstico , Infecciones por VIH/diagnósticoRESUMEN
BACKGROUND: Half of people living with HIV (PLWH) in sub-Saharan Africa default from care within two years. In Uganda, and across sub-Saharan Africa, traditional healers (TH) are ubiquitous and often serve as the first line of health care. We hypothesized that with lay support training, TH could support relinkage to HIV care and ART adherence among rural Ugandan PLWH who have defaulted from HIV care. METHODS: Following the ADAPT-ITT framework, we adapted an evidence-based layperson HIV support program from South Africa for delivery by Ugandan TH. The ADAPT-ITT framework consists of (1) Assessment of needs; (2) Deciding which evidence-based interventions to adapt; (3) Adaptation of interventions; (4) Production of drafted adapted interventions; (5) Topical expert feedback; (6) Integration of expert feedback; (7) Training personnel; and (8) Testing the adapted intervention. The Testing phase was completed via a pilot mixed methods prospective cohort study. The study population included 12 TH practicing in Mbarara Township and 20 adult PLWH with suboptimal ART adherence (CASE adherence index score < 10) who received care from a participating TH and who resided in Mbarara Township. Primary outcome was re-linkage to HIV care within 14 days. Secondary outcomes were ART re-initiation, ART adherence, retention in care after 9 months, and implementation measures. Qualitative interviews were conducted with all participants. RESULTS: Data from the Assessment phase indicated that logistical challenges played an important role in disengagement from care among PLWH who receive care from TH, notably geographical distance to clinics and transportation costs. Additionally, HIV-related stigma and lack of social support were identified as barriers to entering and remaining in HIV care. Two core elements of the intervention were identified during the Production phase: (1) TH facilitating rapid re-linkage to HIV care and (2) TH provision of psychosocial support. In the pilot study phase, baseline median CASE adherence score was 3; only 5% of PLWH were adherent to ART via 4-day recall. The TH-delivered support achieved 100% linkage and ART initiation within 14 days, 95% ART adherence, and 100% of PLWH were retained in HIV care after 9 months. CONCLUSIONS: The ADAPT-ITT framework successfully guided the adaption of a community health worker-delivered intervention for delivery by TH. TH successfully facilitated re-linkage to HIV care, support ART adherence, and retention in care for PLWH when trained as part of a lay support person program. Future studies are needed to evaluate scale-up and long-term impact.
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OBJECTIVE: Isoniazid (INH) preventive therapy is recommended to prevent tuberculosis (TB) disease for persons with HIV (PWH), except for those with regular and heavy alcohol consumption, due to hepatotoxicity concerns. We aimed to quantify the incidence of severe INH-related toxicity among PWH with and without recent alcohol consumption. DESIGN: A prospective study of PWH receiving INH. METHODS: We included PWH in southwest Uganda with recent (prior 3 months) ( n â=â200) or no (prior year) self-reported alcohol consumption ( n â=â101), on antiretroviral therapy, TB infected (≥5âmm on tuberculin skin test), and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 2× or less the upper limit of normal (ULN). Grade 3+ INH-related toxicity was ALT or AST at least 5× the ULN or severe symptoms; we stopped IPT upon detection. Grade 2 INH-related toxicity was ALT or AST 2-5× the ULN or moderate symptoms. RESULTS: The cumulative incidence of Grade 3+ INH-related toxicity was 8.3% [95% confidence interval (95% CI) 5.4-12.0]; all resolved after INH cessation. Incidence was 6.0% (95% CI 3.1-10.2) among those reporting recent alcohol use and 12.9% (95% CI 7.0-21.0) among those reporting no prior year alcohol use. We found no differences by baseline phosphatidylethanol-confirmed alcohol severity. The cumulative incidence of Grade 2 toxicities (without Grade 3+) was 21.7% (95% CI 17.0-27.1); 25.0% (95% CI 19.0-31.8) among those with recent alcohol use and 14.8% (95% CI 8.1-23.9) among those with no prior year alcohol use. CONCLUSION: Alcohol use does not appear to increase risk for serious INH-related toxicity among PWH without significant liver enzyme elevations at baseline (≤2x ULN).