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Suubi+Adherence study protocol: A family economic empowerment intervention addressing HIV treatment adherence for perinatally infected adolescents.

ABSTRACT: Background:Globally, 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. Methods:Suubi + 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. Discussion:This 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 registration:This trial was registered with ClinicalTrials.gov (registration number: NCT01790373) on 13 February 2013.

SUBMITTER: Ssewamala FM

PROVIDER: S-EPMC6915750 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Suubi+Adherence study protocol: A family economic empowerment intervention addressing HIV treatment adherence for perinatally infected adolescents.

Ssewamala Fred M FM Byansi William W Bahar Ozge Sensoy OS Nabunya Proscovia P Neilands Torsten B TB Mellins Claude C McKay Mary M Namuwonge Flavia F Mukasa Miriam M Makumbi Fredrick Edward FE Nakigozi Gertrude G

Contemporary clinical trials communications 20191020

<h4>Background</h4>Globally, 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 antiretro ...[more]

PMID: 31872152

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Project description:BackgroundThe 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.MethodsWe 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.FindingsThe 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).InterpretationA 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.

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:BackgroundExisting studies have suggested decreased adherence and rebound in mortality in perinatally HIV-infected adolescents receiving antiretroviral therapy (ART) as compared to adults and young children.MethodsWe used both quantitative and qualitative approaches to identify factors influencing adherence among perinatally infected adolescents in Thailand. We analyzed data from 568 pairs of perinatally infected adolescents (aged 12-19) and their primary caregivers in the Teens Living With Antiretrovirals (TEEWA) study, a cross-sectional survey conducted in 2010-2012. We also conducted 12 in-depth interviews in 2014 with infected adolescents or their primary caregivers to elicit experiences of living with long-term ART.ResultsFrom the quantitative analysis, a total of 275 (48.4%) adolescents had evidence of suboptimal adherence based on this composite outcome: adolescents self-reported missing doses in the past 7 days, caregiver rating of overall adherence as suboptimal, or latest HIV-RNA viral load ≥1000 copies/ml. In multivariate logistic regression analysis, younger age, having grandparents or extended family members as the primary caregiver, caregiver-assessed poor intellectual ability, having a boy/girlfriend, frequent online chatting, self-reported unhappiness and easiness in asking doctors questions were significantly associated with suboptimal adherence. From the in-depth interviews, tensed relationships with caregivers, forgetfulness due to busy schedules, and fear of disclosing HIV status to others, especially boy/girlfriends, were important contributors to suboptimal adherence. Social and emotional support and counseling from peer group was consistently reported as a strong adherence-promoting factor.ConclusionOur findings highlight unique barriers of ART adherence among the perinatally infected adolescents. Future interventions should be targeted at helping adolescents to improve interpersonal relationships and build adaptive skills in recognizing and addressing challenging situations related to ART taking.

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: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:BackgroundChildren who have lost a parent to HIV/AIDS, known as AIDS orphans, face multiple stressors affecting their health and development. Family economic empowerment (FEE) interventions have the potential to improve these outcomes and mitigate the risks they face. We present efficacy and cost-effectiveness analyses of the Bridges study, a savings-led FEE intervention among AIDS-orphaned adolescents in Uganda at four-year follow-up.MethodsIntent-to-treat analyses using multilevel models compared the effects of two savings-led treatment arms: Bridges (1:1 matched incentive) and BridgesPLUS (2:1 matched incentive) to a usual care control group on the following outcomes: self-rated health, sexual health, and mental health functioning. Total per-participant costs for each arm were calculated using the treatment-on-the-treated sample. Intervention effects and per-participant costs were used to calculate incremental cost-effectiveness ratios (ICERs).FindingsAmong 1,383 participants, 55% were female, 20% were double orphans. Mean age was 12 years at baseline. At 48-months, BridgesPLUS significantly improved self-rated health, (0.25, 95% CI 0.06, 0.43), HIV knowledge (0.21, 95% CI 0.01, 0.41), self-concept (0.26, 95% CI 0.09, 0.44), and self-efficacy (0.26, 95% CI 0.09, 0.43) and lowered hopelessness (-0.28, 95% CI -0.43, -0.12); whereas Bridges improved self-rated health (0.26, 95% CI 0.08, 0.43) and HIV knowledge (0.22, 95% CI 0.05, 0.39). ICERs ranged from $224 for hopelessness to $298 for HIV knowledge per 0.2 standard deviation change.ConclusionsMost intervention effects were sustained in both treatment arms at two years post-intervention. Higher matching incentives yielded a significant and lasting effect on a greater number of outcomes among adolescents compared to lower matching incentives at a similar incremental cost per unit effect. These findings contribute to the evidence supporting the incorporation of FEE interventions within national social protection frameworks.

Dataset Information

Suubi+Adherence study protocol: A family economic empowerment intervention addressing HIV treatment adherence for perinatally infected adolescents.

Publications

Suubi+Adherence study protocol: A family economic empowerment intervention addressing HIV treatment adherence for perinatally infected adolescents.

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