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The long-term effects of a family based economic empowerment intervention (Suubi+Adherence) on suppression of HIV viral loads among adolescents living with HIV in southern Uganda: Findings from 5-year cluster randomized trial.

ABSTRACT: BACKGROUND:The rapid scale-up of HIV therapy across Africa has failed to adequately engage adolescents living with HIV (ALWHIV). Retention and viral suppression for this group (ALWHIV) is 50% lower than for adults. Indeed, on the African continent, HIV remains the single leading cause of mortality among adolescents. Strategies tailored to the unqiue developmental and social vulnerabilities of this group are urgently needed to enhance successful treatment. METHODS:We carried out a five-year longitudinal cluster randomized trial (ClinicalTrials.gov ID: NCT01790373) with adolescents living with HIV (ALWHIV) ages 10 to 16 years clustered at health care clinics to test the effect of a family economic empowerment (EE) intervention on viral suppression in five districuts in Uganda. In total, 39 accredited health care clinics from study districts with existing procedures tailored to adolescent adherence were eligible to participate in the trial. We used data from 288 youth with detectable HIV viral loads (VL) at baseline (158 -intervention group from 20 clinics, 130 -non-intervention group from 19 clinics). The primary end point was undetectable plasma HIV RNA levels, defined as < 40 copies/ml. We used Kaplan-Meier (KM) analysis and Cox proportional hazard models to estimate intervention effects. FINDINGS:The Kaplan-Meier (KM) analysis indicated that an incidence of undetectable VL (0.254) was significantly higher in the intervention condition compared to 0.173 (in non-intervention arm) translated into incidence rate ratio of 1.468 (CI: 1.064-2.038), p = 0.008. Cox regression results showed that along with the family-based EE intervention (adj. HR = 1.446, CI: 1.073-1.949, p = 0.015), higher number of medications per day had significant positive effects on the viral suppression (adj.HR = 1.852, CI: 1.275-2.690, p = 0.001). INTERPRETATION:A family economic empowerment intervention improved treatment success for ALWHIV in Uganda. Analyses of cost effectiveness and scalability are needed to advance incorporation of this intervention into routine practice in low and middle-income countries.

SUBMITTER: Ssewamala FM

PROVIDER: S-EPMC7010288 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:IntroductionEvidence from low-resource settings indicates that economic insecurity is a major barrier to HIV treatment adherence. Economic empowerment (EE) interventions have the potential to improve adherence outcomes among adolescents living with HIV (ALWHIV) by mitigating the effects of poverty. This study aims to assess the efficacy and cost-effectiveness of a savings-led family-based EE intervention, Suubi + Adherence, aimed at improving antiretroviral therapy (ART) adherence outcomes ALWHIV in Uganda.MethodsAdolescents (mean age 12 years at enrolment; 56% female) receiving ART for HIV at 39 health centres were randomized to Suubi + Adherence intervention (n = 358) or bolstered standard of care (BSOC; n = 344). A difference-in-differences analysis was employed to assess the change in the proportion of virally suppressed adolescents (HIV RNA viral load <40 copies/mL) over 24 months. The cost-effectiveness analysis examined how much the intervention cost to virally suppress one additional adolescent relative to BSOC from the healthcare provider perspective.ResultsAt 24 months, the intervention was associated with an 8.85-percentage point [95% confidence interval (CI) 0.80 to 16.90 percentage points] increase in the proportion of virally suppressed adolescents between the study arms (p = 0.032). Per-participant costs were US$177 and US$263 for the BSOC and intervention groups respectively. The incremental cost of virally suppressing one additional adolescent was estimated at US$970 [95% CI, US$508 to 10,725] over two years.ConclusionsOur results support the integration of family-based EE interventions into adherence-support strategies as part of routine HIV care in low-resource settings to address the underlying economic drivers of poor ART adherence among ALWHIV. Moreover, per-participant costs to achieve viral suppression do not seem prohibitive compared to other community-based adherence interventions targeted at ALWHIV in low-resource settings. Further research on combination interventions at the nexus of economic security and HIV treatment and care is needed to inform the development of feasible and scalable HIV policies and programmes.

Project description:BackgroundGlobally, 1.8 million children<15 years are living with HIV. Sub-Saharan Africa (SSA), as a region, is heavily burdened by HIV, with 90% of new infections among children happening there. Within SSA, Uganda has an HIV prevalence of 7.2% among 15-49-year-olds, with high prevalence in Masaka region (12%). Uganda also reports unprecedented numbers of perinatally HIV-infected children, with close to 150,000 children (ages 0-14) living with HIV (CLHA). However adherence to antiretroviral therapy (ART) among children and youth is poor, and has been attributed to economic insecurity, including lack of finances for transportation to clinic appointments, inadequate meals to support medication consumption, and resource prioritization towards school expenses. Yet, few programs aimed at addressing ART adherence have applied combination interventions to address economic stability and ART Adherence within the traditional framework of health education and HIV care. This paper describes a study protocol for a 5-year, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) funded, cluster randomized-controlled trial to evaluate a combination intervention, titled Suubi + Adherence, aimed at improving ART adherence among HIV perinatally infected adolescents (ages 10-16 at study enrollment) in Uganda.MethodsSuubi + Adherence was evaluated via a two-arm cluster randomized-controlled trial design in 39 health clinics, with a total enrollment of 702 HIV + adolescents (ages 10-16 at enrollment). The study addresses two primary outcomes: 1) adherence to HIV treatment regimen and 2) HIV knowledge and attitudes. Secondary outcomes include family functioning, sexual risk-taking behavior, and financial savings behavior. For potential scale-up, cost effectiveness analysis was employed to compare the relative costs and outcomes associated with each study arm: family economic strengthening comprising matched savings accounts, financial management training and small business development, all intended for family economic security versus bolstered usual care (SOC) comprising enhanced adherence sessions to ensure more standardized and sufficient adherence counseling.DiscussionThis study aims to advance knowledge and inform the development of the next generation of programs aimed at increasing adherence to HIV treatment for HIV + adolescents in low-resource regions such as SSA. To our knowledge, the proposed study is the first to integrate and test family economic empowerment and stability-focused interventions for HIV + adolescents in Uganda (and much of SSA)-so families would have the necessary finances to manage HIV/AIDS as a chronic illness. The study would provide crucial evidence about the effects of an economic empowerment program on short and long-term impact, which is essential if such interventions are to be taken to scale.Trial registrationThis trial was registered with ClinicalTrials.gov (registration number: NCT01790373) on 13 February 2013.

Project description:Improving economic resources of impoverished youth may alter intentions to engage in sexual risk behaviors by motivating positive future planning to avoid HIV risk and by altering economic contexts contributing to HIV risk. Yet, few studies have examined the effect of economic-strengthening on economic and sexual behaviors of orphaned youth, despite high poverty and high HIV infection in this population. Hierarchal longitudinal regressions were used to examine the effect of a savings-led economic empowerment intervention, the Suubi-Maka Project, on changes in orphaned adolescents' cash savings and attitudes toward savings and HIV-preventive practices over time. We randomized 346 Ugandan adolescents, aged 10-17 years, to either the control group receiving usual orphan care plus mentoring (n?=?167) or the intervention group receiving usual orphan care plus mentoring, financial education, and matched savings accounts (n?=?179). Assessments were conducted at baseline, 12, and 24 months. Results indicated that intervention adolescents significantly increased their cash savings over time (b?=?$US12.32, ±1.12, p?<?.001) compared to adolescents in the control group. At 24 months post-baseline, 92% of intervention adolescents had accumulated savings compared to 43% in the control group (p?<?.001). The largest changes in savings goals were the proportion of intervention adolescents valuing saving for money to buy a home (?T1-T0?=?+14.9, p?<?.001), pursue vocational training (?T1-T0?=?+8.8, p?<?.01), and start a business (T1-T0?=?+6.7, p?<?.01). Intervention adolescents also had a significant relative increase over time in HIV-preventive attitudinal scores (b?=?+0.19, ±0.09, p?<?.05), most commonly toward perceived risk of HIV (95.8%, n?=?159), sexual abstinence or postponement (91.6%, n?=?152), and consistent condom use (93.4%, n?=?144). In addition, intervention adolescents had 2.017 significantly greater odds of a maximum HIV-prevention score (OR?=?2.017, 95%CI: 1.43-2.84). To minimize HIV risk throughout the adolescent and young adult periods, long-term strategies are needed to integrate youth economic development, including savings and income generation, with age-appropriate combination prevention interventions.

Project description:BackgroundYouth 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.MethodsThe 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.DiscussionGuided 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 registrationClinicalTrials.gov , ID: NCT01790373.

Project description:BackgroundSuubi is an evidenced based multi-component intervention that targets psychosocial and economic hardships to improve ART adherence, viral suppression, mental health, family financial stability, and family cohesion for adolescents living with HIV (ALHIV) in Uganda. Suubi was originally tested as a combined package of four components: 1) Financial Literacy Training; 2) incentivized matched Youth Savings Accounts with income-generating activities; 3) a manualized and visual-based intervention for ART adherence and stigma reduction; and 4) engagement with HIV treatment-experienced role models. However, it is unknown if each component in Suubi had a positive effect, how the components interacted, or if fewer components could have produced equivalent effects. Hence, the overall goal of this new study is to identify the most impactful and sustainable economic and psychosocial components across 48 health clinics in Uganda.MethodsA total of 576 ALHIV (aged 11-17 years at enrollment) will be recruited from 48 clinics and each clinic will be randomized to one of 16 study conditions. Each condition represents every possible combination of the 4 components noted above. Assessments will be conducted at baseline, 12, 24, 36 and 48- months post-intervention initiation. Using the multi-phase optimization strategy (MOST), we will identify the optimal combination of components and associated costs for viral suppression, as well as test key mediators and moderators of the component-viral suppression relationship.DiscussionThe study is a shift in the paradigm of research to use new thinking to build/un-pack highly efficacious interventions that lead to new scientific knowledge in terms of understanding what drives an intervention's success and how to iterate on them in ways that are more efficient, affordable and scalable. The study advances intervention science for HIV care outcomes globally.Trial registrationThis project was registered at clinicaltrials.gov (NCT05600621) on October, 31, 2022. https://clinicaltrials.gov/ct2/show/NCT05600621.

Project description:IntroductionAchieving optimal adherence to antiretroviral therapy (ART) among adolescents living with HIV (ALWHIV) is challenging, especially in low-resource settings. To help accurately determine who is at risk of poor adherence, we developed and internally validated models comprising multi-level factors that can help to predict the individualized risk of poor adherence among ALWHIV in a resource-limited setting such as Uganda.MethodsWe used data from a sample of 637 ALWHIV in Uganda who participated in a longitudinal study, "Suubi+Adherence" (2012 to 2018). The model was developed using the Least Absolute Shrinkage and Selection Operator (LASSO) penalized regression to select the best subset of multi-level predictors (individual, household, community or economic-related factors) of poor adherence in one year's time using 10-fold cross-validation. Seventeen potential predictors included in the model were assessed at 36 months of follow-up, whereas adherence was assessed at 48 months of follow-up. Model performance was evaluated using discrimination and calibration measures.ResultsFor the model predicting poor adherence, five of the 17 predictors (adherence history, adherence self-efficacy, family cohesion, child poverty and group assignment) were retained. Its ability to discriminate between individuals with and without poor adherence was acceptable; area under the curve (AUC) = 69.9; 95% CI: 62.7, 72.8. There was no evidence of possible areas of miscalibration (test statistic = 1.20; p = 0.273). The overall performance of the model was good.ConclusionsOur findings support prediction modelling as a useful tool that can be leveraged to improve outcomes across the HIV care continuum. Utilizing information from multiple sources, the risk prediction score tool applied here can be refined further with the ultimate goal of being used in a screening tool by practitioners working with ALWHIV. Specifically, the tool could help identify and provide early interventions to adolescents at the highest risk of poor adherence and/or viral non-suppression. However, further fine-tuning and external validation may be required before wide-scale implementation.

Project description:BACKGROUND:An undetectable serum HIV-1 load is key to effectiveness of antiretroviral (ARV) therapy, which depends on adherence to treatment. We evaluated factors possibly associated with ARV adherence and virologic response in HIV-infected heterosexual individuals. METHODS:A cross-sectional study was conducted in 200 HIV-1 serodiscordant couples and 100 unpartnered individuals receiving ARV treatment at a tertiary hospital in southern Brazil. All subjects provided written informed consent, answered demographic/behavioral questionnaires through audio computer-assisted self-interviews (ACASI), and collected blood and vaginal samples for biological markers and assessment of sexually transmitted infections (STIs). HIV-negative partners were counseled and tested for HIV-1. RESULTS:The study population mean age was 39.9 years, 53.6% were female, 62.5% were Caucasian, 52.6% had incomplete or complete elementary education, 63.1% resided in Porto Alegre. Demographic, behavioral and biological marker characteristics were similar between couples and single individuals. There was an association between adherence reported on ACASI and an undetectable serum viral load (P<0.0001). Logistic regression analysis demonstrated that single-tablet ARV-regimens were independently associated with adherence (OR = 2.3; 95CI%: 1.2-4.4; P = 0.011) after controlling for age, gender, education, marital status, personal income, ARV regimen, and median time of ARV use. A positive correlation between genital secretion PCR results and serum viral load was significant in the presence of STIs (r = 0.359; P = 0.017). Although HIV PCR detection in vaginal secretions was more frequent in women with detectable viremia (9/51, 17.6%), it was also present in 7 of 157 women with undetectable serum viral loads (4.5%), p = 0.005. CONCLUSIONS:ARV single tablet regimens are associated with adherence. Detectable HIV-1 may be present in the genital secretions of women with undetectable viremia which means there is potential for HIV transmission in adherent individuals with serologic suppression.

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The long-term effects of a family based economic empowerment intervention (Suubi+Adherence) on suppression of HIV viral loads among adolescents living with HIV in southern Uganda: Findings from 5-year cluster randomized trial.

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