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Background: This study evaluated the effectiveness and responsiveness of differentiated Human Immunodeficiency Virus (HIV)/Acquired Immuno-Deficiency Syndrome (AIDS) service delivery models (DSDMs) implemented to enhance antiretroviral therapy (ART) access and outcomes for patients while addressing Tuberculosis (TB)-HIV integration, focusing on four of the five DSDMs currently implemented in Uganda. Methodology: A descriptive cross-sectional survey was conducted in eight districts of central Uganda using Lot Quality Assurance Sampling approach from 7th to 23rd March 2023. We randomly sampled 2668 patients who have been on ART for at least 1 year in a Facility-Based Individual Management (FBIM) model or in a non-FBIM DSDM for at least one year. Data were collected through patient interviews and review of records in ART and DSDM registers as well as ART cards. We analyzed the data in proportions, comparing the selected ART outcome and responsiveness indicators between Community Client Led ART Distribution (CCLAD), Community Drugs Distribution Point (CDDP) and Fast-Track Drug Refill (FTDR) DSDMs with the standard care (FBIM) model. The ART outcome variables include patients retained in the 1st line of the ART regimen, patients in World Health Organization clinical stage 1 during the last facility visit, patients who had no CD4 request during the past 12 months, viral load suppression, ART adherence, and patients who reported that they did not experience HIV/AIDS-related symptoms in the past 6 months. The variables on TB care include screening for TB using the intensified case finding form and patients tested positive for TB. Responsiveness variables include the perceived; travel time for ART refill, travel distance for ART refill, convenience and flexibility during ART refill, cost of travel for ART refill, fear of being seen at ART refill point, waiting time before service, adequacy of service time, crowding and risk of infections, social support, ability to address ART treatment challenges, HIV status disclosure and barriers to access. Non-overlap in 95% confidence interval in indicator proportion between non-FBIM DSDM and FBIM means a statistically significant difference in proportion, or otherwise non-significant. Results: Higher proportions of ART patients in the CCLAD and CDDP DSDMs adhered to ART, had suppressed viral load, and a lower TB prevalence than those in FBIM model. Additionally, more CCLAD and CDDP clients reported shorter travel time and distance to access ART than their counterparts in the FBIM model. Compared to FBIM model, higher proportions of those in CCLAD and CDDP also reported flexibility in ART refill scheduling, reduced transport costs, fewer privacy concerns, less HIV/AIDS-related stigma, shorter waiting times, more efficient services, decreased congestion at ART pickup sites, enhanced peer support, improved problem-solving assistance, and increased HIV status disclosure. The FTDR model outperformed FBIM in proportions with fewer requests for CD4 testing, viral load suppression, as well as proportions of clients who reported; shorter travel time, lower transportation cost, decreased privacy concerns, shorter waiting time, and efficient service provision. Compared to both CDDP and FTDR, the FBIM had a higher proportion of clients remain on the first-line ART regimen. Conclusion: Community-based DSDMs show responsiveness to clients' needs without compromising the effectiveness of ART care for patients. Although FTDR also demonstrates high effectiveness and responsiveness for clients on ART, there is potential for further improvement. Planners and implementers of ART programs should consider both demand- and supply-side innovations to sustain the continuation of DSDMs. [ABSTRACT FROM AUTHOR]

Background: HIV/AIDS continues to be a significant contributor to illness and death, particularly in sub-Saharan Africa. In this study, we conducted a qualitative assessment to understand Client and Healthcare Provider Perspectives on Differential Service Delivery Models in Uganda. The purpose was to establish strengths and weaknesses within the services delivery models, inform policy and decision-making, and to facilitate context specific solutions. Methods: Between February and April 2023, a qualitative cross-sectional study was utilised to gather insights from a targeted selection of individuals, including People Living with HIV (PLHIV), healthcare workers, HIV focal persons, community retail pharmacists, and various stakeholders. The data collection process included eleven in-depth interviews, nine key informant interviews, and eight focus group discussions carried out across eight districts in Central Uganda. The collected data was analyzed through inductive thematic analysis with the aid of Excel. Results: The various Differentiated Service Delivery Models (DSDMs), notably Community-Client-Led Drug Distribution (CCLAD), Community Drug Distribution Point (CDDP), Community Retail Pharmacy Drug Distribution Point (CRPDDP), and the facility-based Facility Based Individual Model (FBIM), were reported to have several positive impacts. These included improved treatment adherence, efficient management of antiretroviral (ARV) supplies, reduced exposure to infectious diseases, enhanced healthcare worker hospitality, minimized travel time for ART refills, stigma reduction, and decreased waiting times. Concern was raised about the lack of improvement in HIV status disclosure, opportunistic infection treatment, adherence to seasonal appointments, and sustainability due to the overreliance of the DSDMs on donor funding, suggesting potential discontinuation without funding. Doubts about health workers' commitment surfaced. Notably, the CCLAD model displayed self-sustainability, with clients financially supporting group members to collect medicines. Conclusion: Community-based DSDMs, such as CCLAD and CDDP, improve ART refill convenience, social support, and client experiences. These models reduce travel and waiting times, lowering infection risks. Addressing challenges and enhancing facility-based models is vital. In order to maintain funding after donor funding ends, sustainability measures like cross-subsidization can be used. If well implemented, the DSDMs have the potential to produce better or comparable ART outcomes compared to the FBIM model. [ABSTRACT FROM AUTHOR]

Introduction: Habits are a common strategy for successfully countering medication non‐adherence, yet existing interventions do not support participants during the long habit formation period, resulting in high attrition. We test a novel intervention combining text messages and incentives with anchoring to support antiretroviral therapy (ART) pill‐taking habits. Methods: In a randomized, parallel controlled trial, a sample of 155 participants 18 years and older who initiated ART within 3 months were recruited at Mildmay Uganda between October 2021 and April 2022. All participants were educated on the anchoring strategy and chose an anchor, that is existing routines, to pair with pill‐taking. Participants were randomized to either usual care (C = 49), daily text message reminders to follow their anchoring plan (Messages group; T1 = 49) or messages and incentives conditional on pill‐taking in line with their anchor (Incentives group; T2 = 57). Assessments occurred at baseline, month 3 (end of intervention) and month 9 (end of observation period). The primary outcomes are electronically measured mean adherence and pill‐taking consistent with participants' anchor time. Results: The primary outcome of pill‐taking in line with the anchoring plan was higher in the Incentives group during the 3‐month intervention (12.2 p.p. [95% CI: 2.2 22.2; p =.02]), and remained significantly higher after the incentives were withdrawn (months 4−6 (14.2 p.p. [95% CI 1.1 27.2; p =.03]); months 7−9 (14.1 p.p. [95% CI −0.2 28.5; p =.05])). Mean adherence was higher in both treatment groups relative to the control group during the intervention (T1 vs. C, p =.06; T2 vs. C, p =.06) but not post‐intervention. Conclusions: The promising approach of using incentives to support habit formation among ART treatment initiators needs to be evaluated in a fully powered study to further our understanding of the habit formation process and to evaluate its cost‐effectiveness. [ABSTRACT FROM AUTHOR]

Purpose: Adolescents living with HIV (ALHIV) are at high risk for adherence to antiretroviral (ART) treatment and poor health-seeking behaviors, both of which potentially compromise their quality of and satisfaction with life. This study, therefore, seeks to examine the relationship between physical health, pediatric quality of life, life satisfaction, and medication adherence among ALHIV in southwestern Uganda. Methods: Baseline data from the Suubi+Adherence study, 2012–2018, that recruited 702 adolescents, aged 10–16 years, living with HIV in Uganda were analyzed. To account for overdispersion, negative binomial regression analyses were used to examine the impact of physical health, pediatric quality of life, and life satisfaction on self-reported medication adherence. We controlled for participants' socio-demographic factors. Results: Results indicated that after adjusting for socio-demographic characteristics, adolescents' reported satisfaction with life was associated with a decrease in the reported number of days missed taking medication by 41.2% (IRR (incidence risk ratio) = 0.588; p (p value) = 0.014). On the other hand, the low level of pediatric quality of life was associated with a 5% increase in the reported number of days missed taking medication (IRR = 1.055, p = 0.044). Personal health was not statistically significant in the model. Conclusion: Our study findings indicated that quality of life and life satisfaction are significantly associated with antiretroviral (ART) medication among ALHIV. Hence, strengthening existing support systems and creating additional support for optimal ART adherence and treatment outcomes for ALHIV in low-resource communities might be beneficial. Moreover, with the increasing HIV prevalence rates among adolescents, effective and comprehensive efforts that are responsive to the special needs of ALHIV must be developed to ensure optimal adherence to ART medication as it leads to low vertical infection and superinfection rates. [ABSTRACT FROM AUTHOR]

Decision-making errors such as present bias (PB) can have important consequences for health behaviors, but have been largely studied in the financial domain. We conducted a mixed-method study on PB in the context of ART adherence among clinic-enrolled adults in Uganda (n = 39). Specifically, we quantified PB by asking about preferences between medication available sooner to minimize headaches versus available later to cure headaches. We describe demographic similarities among PB participants and qualitatively explored how participants reflected on their PB (or absence thereof) in the context of health. Participants reporting PB were predominantly male, single/unmarried, older, had higher levels of education and income and more advanced HIV progression. Three common reasons for more present-biased choices provided were: (1) wanting to avoid pain, (2) wanting to return to work, and (3) fear of one's health worsening if s/he did not address their illness immediately. While PB in the financial domain often suggests that poorer individuals are more likely to prefer immediate rewards over their wealthier counterparts, our results suggest poor health is potentially a driving factor of PB. Further research is needed to build on these finding and inform how programs can frame key messages regarding ART adherence to patients displaying PB. Trial registration: ClinicalTrials.gov identifier: NCT03494777. [ABSTRACT FROM AUTHOR]

Background: HIV stigma remains a formidable barrier to HIV treatment adherence among school-attending adolescents living with HIV, owing to high levels of HIV stigma within schools, rigid school structures and routines, lack of adherence support, and food insecurity. Thus, this protocol paper presents an evidence-informed multilevel intervention that will simultaneously address family- and school-related barriers to HIV treatment adherence and care engagement among adolescents living with HIV attending boarding schools in Uganda. Objective: The proposed intervention--Multilevel Suubi (MSuubi)--has the following objectives: examine the impact of M-Suubi on HIV viral suppression (primary outcome) and adherence to HIV treatment, including keeping appointments, pharmacy refills, pill counts, and retention in care; examine the effect of M-Suubi on HIV stigma (internalized, anticipated, and enacted), with secondary analyses to explore hypothesized mechanisms of change (eg, depression) and intervention mediation; assess the cost and cost-effectiveness of each intervention condition; and qualitatively examine participants' experiences with HIV stigma, HIV treatment adherence, and intervention and educators' attitudes toward adolescents living with HIV and experiences with group-based HIV stigma reduction for educators, and program or policy implementation after training. Methods: MSuubi is a 5-year multilevel mixed methods randomized controlled trial targeting adolescents living with HIV aged 10 to 17 years enrolled in a primary or secondary school with a boarding section. This longitudinal study will use a 3-arm cluster randomized design across 42 HIV clinics in southwestern Uganda. Participants will be randomized at the clinic level to 1 of the 3 study conditions (n=14 schools; n=280 students per study arm). These include the bolstered usual care (consisting of the literature on antiretroviral therapy adherence promotion and stigma reduction), multiple family groups for HIV stigma reduction plus family economic empowerment (MFG-HIVSR plus FEE), and Group-based HIV stigma reduction for educators (GED-HIVSR). Adolescents randomized to the GED-HIVSR treatment arm will also receive the MFG-HIVSR plus FEE treatment. MSuubi will be provided for 20 months, with assessments at baseline and 12, 24, and 36 months. Results: This study was funded in September 2021. Participant screening and recruitment began in April 2022, with 158 dyads enrolled as of May 2022. Dissemination of the main study findings is anticipated in 2025. Conclusions: MSuubi will assess the effects of a combined intervention (family-based economic empowerment, financial literacy education, and school-based HIV stigma) on HIV stigma among adolescents living with HIV in Uganda. The results will expand our understanding of effective intervention strategies for reducing stigma among HIV-infected and noninfected populations in Uganda and improving HIV treatment outcomes among adolescents living with HIV in sub-Saharan Africa. [ABSTRACT FROM AUTHOR]

The health and economic threats posed by the COVID-19 pandemic can be sources of great distress among people living with HIV, which in turn can impact the management of their HIV disease. We examined change in depression from pre- to post-lockdown restrictions and correlates of elevated depressive symptoms, including antiretroviral therapy (ART) adherence. Participants enrolled in a randomized controlled trial of an ART adherence intervention in Uganda. The month-12 follow-up assessment was fully administered just prior to the start of the pandemic-related lockdown in March 2020; at the conclusion of the lockdown three months later, we administered a mixed-methods phone-based assessment. ART adherence was electronically monitored throughout the study period, including during and after the lockdown. Depression was assessed with the 8-item Patient health questionnaire (PHQ-8), on which scores > 9 signify a positive screen for elevated depressive symptoms. A sample of 280 participants completed both the month-12 and post-lockdown assessments. Rates of elevated depressive symptoms nearly tripled from month 12 (n = 17, 6.1%) to the post-lockdown assessment (n = 50, 17.9%; McNemar test <.001). Elevated depressive symptoms at post-lockdown were associated with being female, indicators of economic struggles at month 12 (unemployment, low income, high food insecurity), and lower ART adherence during the 3-month lockdown period [mean of 71.9% (SD = 27.9) vs. 80.8% (SD = 24.1) among those not depressed; p =.041] in bivariate analysis. In multiple regression analysis, higher food insecurity [adj. OR (95% CI) = 4.64 (2.16–9.96)] and perception that the pandemic negatively impacted ART adherence [adj. OR (95% CI) = 1.96 (1.22–3.16)] remained associated with a greater likelihood of elevated depressive symptoms, when other correlates were controlled for. Qualitative data suggested that economic stressors (lack of food, work, and money) were key contributors to elevated depressive symptoms, and these stressors led to missed ART doses because of lack of food and stress induced forgetfulness. Elevated depressive symptoms significantly increased during the COVID-19 lockdown and was associated with food insecurity and reduced ART adherence. Mechanisms for identifying and treating depression and food insecurity are needed to help PLHIV cope with and mitigate the harmful effects of unexpected crises that may impede disease management and access to food. [ABSTRACT FROM AUTHOR]

Background: Youth living with HIV (YLHIV) in Sub-Saharan African (SSA) are less likely to adhere to antiretroviral therapy (ART) and other health-related regimens. As a consequence, YLHIV are not only at risk for health problems and mental health comorbidities, but are also at risk for cognitive deficits, including in areas of memory and executive functioning. The Suubi+Adherence study followed 702 adolescents (10-16 years of age) receiving bolstered standard of care and a family economic empowerment intervention comprising an incentivized youth financial savings account (YSA) augmented with financial literacy training (FLT) and peer mentorship. The study findings pointed to superior short-term viral suppression and positive adolescent health and mental health functioning among participants receiving the intervention. The original group of adolescents who received Suubi+Adherence are now transitioning into young adulthood. This paper presents a protocol for the follow-up phase titled Suubi+Adherence Round 2.Methods: The original cohort in Suubi+Adherence will be tracked for an additional five years (2020-2025). Specifically, the long term follow-up will allow to: 1) ascertain the extent to which the short term outcomes identified in the first 6 years of the intervention are maintained as the same group transitions through young adulthood; and 2) address new scientific questions regarding ART adherence; HIV care engagement; protective health behaviors; and the potential of FEE to mitigate the development of HIV-associated neurocognitive disorders in YLHIV. Additionally, the team examines the potential mechanisms through which the observed long-term outcomes happen. Moreover, the Suubi+Adherence-Round 2 adds a qualitative component and extends the cost effectiveness component.Discussion: Guided by asset and human development theories, Suubi+Adherence-R2 will build on the recently concluded Suubi+Adherence study to conduct one of the largest and longest running studies of YLHIV in SSA as they transition into young adulthood. The study will address new scientific questions regarding long-term ART adherence, HIV care engagement, protective health behaviors, and the potential of FEE to mitigate the development of HIV-associated neurocognitive disorders in YLHIV. The findings may inform efforts to improve HIV care among Uganda's YLHIV, with potential replicability in other low-resource countries.Trial Registration: ClinicalTrials.gov , ID: NCT01790373. [ABSTRACT FROM AUTHOR]

We tested an intervention that aimed to increase retention in antiretroviral therapy (ART) among HIV-positive pregnant and postpartum women, a population shown to be vulnerable to poor ART outcomes. 133 pregnant women initiating ART at 2 hospitals in Uganda used real time-enabled wireless pill monitors (WPM) for 1 month, and were then randomized to receive text message reminders (triggered by late dose-taking) and data-informed counseling through 3 months postpartum or standard care. We assessed "full retention" (proportion attending all monthly clinic visits and delivering at a study facility; "visit retention" (proportion of clinic visits attended); and "postpartum retention" (proportion retained at 3 months postpartum). Intention-to-treat and per protocol analyses found that retention was relatively low and similar between groups, with no significant differences. Retention declined significantly post-delivery. The intervention was unsuccessful in this population, which experiences suboptimal ART retention and is in urgent need of effective interventions. [ABSTRACT FROM AUTHOR]

Studies have documented how levels and change in depression correspond to ART non-adherence. However, few studies have examined how levels of and change in adherence may relate to levels of and change in depression, although one might expect mental health to be related to physical health and how successful one is in managing disease. To assess the bidirectional nature of the association between these two constructs, we examined data from a prospective trial of an ART adherence intervention in Uganda that followed 143 participants over 20 months. Adherence was measured using electronic monitoring caps; non-adherence was defined as missing > 10% of prescribed doses; self-reported depression was measured using the Patient Health Questionnaire (PHQ-9), and PHQ-9 > 4 defined the presence of at least minor depression. Adjusted linear and logistic regression models were used to examine the longitudinal relationships between depression and non-adherence. At baseline, 40.6% had at least minor depression and 37.1% were non-adherent. Time varying change in the classification of depression (e.g., becoming depressed) predicted change in non-adherence status (e.g., becoming non-adherent), and this association remained when examining continuous measures of the constructs. Similarly, time varying measures of increases in non-adherence predicted increases in depression, regardless of whether continuous or binary classification measures were used. A temporal trend of increased non-adherence over time was observed, and this was accelerated by an increase in depression. Furthermore, those who had at least minor depression at baseline were more likely to be non-adherent at follow-up. These findings support the potential benefits of depression care and adherence support for improving adherence and mental health, respectively, and call for further research to examine such benefits. The trial has been registered with ClinicalTrials.gov (NCT02503072). [ABSTRACT FROM AUTHOR]

Ugandan fishing communities are dually burdened with high rates of HIV and alcohol use. This qualitative study explores context and motivation of alcohol consumption, and alcohol's effect on antiretroviral treatment (ART) adherence, among male fisherfolk living with HIV in Wakiso District, Uganda. We conducted in-depth semi-structured interviews with 30 men in HIV care and on ART, and used a thematic analysis approach for analysis. Alcohol use was identified as a major barrier to ART adherence through cognitive impairment and the intentional skipping of doses when drinking. Men reportedly reduced their drinking since HIV diagnosis -- motivated by counseling received from providers and a newfound desire to live a healthy lifestyle. However, social, occupational, and stress-related influences that make alcohol reduction difficult were identified. Our findings suggest alcohol use may pose a challenge to ART adherence for fishermen living with HIV -- and has implications for the tailoring of screening and brief intervention for alcohol reduction in HIV care for this population. [ABSTRACT FROM AUTHOR]

Background: Polypharmacy has not been investigated in patients living with HIV in developing countries. The aims of this study were to determine the prevalence of polypharmacy, the factors associated with polypharmacy and whether polypharmacy was associated with adverse effects among older adults on anti-retroviral therapy (ART).Methods: Cross-sectional study in older adults aged 50 and over on ART attending an outpatient HIV/AIDS care centre in Uganda. Demographic and clinical data collected on number and type of medications plus supplements, possible medication related side-effects, comorbidity, frailty, cognitive impairment, current CD4 count and viral load.Results: Of 411 participants, 63 (15.3, 95% C.I. 11.9, 18.8) had polypharmacy (≥ 4 non- HIV medications). In multivariate analyses, polypharmacy was associated with one or more hospitalisations in the last year (Prevalence Ratio PR = 1.8, 95% C.I. 1.1, 3.1, p = 0.02), prescription by an internist (PR = 3.6, 95% C.I. 1.3, 10.5, p = 0.02) and frailty index scores of 5 to 6 (PR = 10.6, 95% C.I. 1.4, 78, p = 0.02), and 7 or more (PR = 17.4, 95% C.I. 2.4, 126.5, p = 0.005). Polypharmacy was not associated with frequency and severity of possible medication related side effects and falls.Conclusion: Polypharmacy is common among older HIV infected patients in sub-Saharan Africa. It's more prevalent among frail people, who have been in hospital in the last year and who have been seen by an internist. We found no evidence that polypharmacy results in any harm but this is worth exploring further. [ABSTRACT FROM AUTHOR]

Objectives. To assess the effectiveness of Short Message Service (SMS) reminder messages on antiretroviral and cotrimoxazole prophylaxis adherence among HIV-positive youths as well as the relative effectiveness of SMS with and without a response option. Methods. Eligible HIV-positive patients aged 15 to 22 years at 2 HIV clinics in Kampala, Uganda, participated in a year-long parallel individual-randomized controlled trial and were assigned in a 1-to-1-to-1 ratio to a weekly SMS message group, weekly SMS message with response option group, or a usual-care control group. Results. We enrolled 332 participants. Electronically measured mean adherence was 67% in the control group, 64% in the 1-way SMS group (95% confidence interval [CI] = 0.77, 1.14), and 61% in the 2-way SMS group (95% CI = 0.75, 1.12) in an intent-to-treat analysis. Results for secondary outcomes and complete-case analysis were similarly statistically insignificant across groups. Conclusions. Despite previous evidence that interventions using SMS reminders can promote antiretroviral therapy adherence, this study shows that they are not always effective in achieving behavior change. More research is needed to find out for whom, and under what conditions, they can be beneficial. [ABSTRACT FROM AUTHOR]

With depression known to impede HIV care adherence and retention, we examined whether depression alleviation improves these disease management behaviors. A sample of 1028 depressed HIV clients in Uganda enrolled in a cluster randomized controlled trial of two depression care models, and were surveyed over 12 months. Serial regression analyses examined whether depression alleviation was associated with self-reported antiretroviral therapy (ART) adherence and clinic attendance at month 12, and whether these relationships were mediated by self-efficacy and motivation. Among those with major depression, depression alleviation was associated with better ART adherence and clinic attendance at month 12; these relationships were fully mediated by self-efficacy at month 12, while adherence motivation partially mediated the relationship between depression alleviation and ART adherence. When both mediators were entered simultaneously, only self-efficacy was a significant predictor and still fully mediated the relationship between depression alleviation and adherence. These findings suggest that depression alleviation benefits both ART adherence and clinic attendance, in large part through improved confidence and motivation to engage in these disease management behaviors. [ABSTRACT FROM AUTHOR]