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

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 \u3c 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

Effects of a combination economic empowerment and family strengthening intervention on psychosocial well-being among Ugandan adolescent girls and young women: Analysis of a cluster randomized controlled trial (Suubi4Her)

PURPOSE: Economic empowerment and family strengthening interventions have shown promise for improving psychosocial well-being in a range of populations. This study investigates the effect of a combination economic and family strengthening intervention on psychosocial well-being among Ugandan adolescent girls and young women (AGYW). METHODS: We harnessed data from a three-arm cluster randomized controlled trial among AGYW aged 14-17 years in 47 Ugandan secondary schools. Schools were randomized to either a youth development account intervention (YDA) [N = 16 schools], YDA plus a multiple family group intervention (YDA + MFG) [N = 15 schools], or bolstered standard of care (BSOC) [N = 16 schools]. We estimated the effect of each intervention (BSOC = referent) on three measures of psychosocial well-being: hopelessness (Beck\u27s Hopelessness Scale), self-concept (Tennessee Self-Concept Scale), and self-esteem (Rosenberg Self-Esteem Scale) at 12 months following enrollment using multi-level linear mixed models for each outcome. RESULTS: A total of 1,260 AGYW (mean age, 15.4) were enrolled-471 assigned to YDA (37%), 381 to YDA + MFG (30%), and 408 to usual care (32%). Over the 12-month follow-up, participants assigned to the YDA + MFG group had significantly greater reductions in hopelessness and improvements in self-esteem outcomes compared to BSOC participants. Those enrolled in the YDA arm alone also had significantly greater reductions in hopelessness compared to BSOC participants. DISCUSSION: Combination interventions, combining economic empowerment (represented here by YDA), and family-strengthening (represented by MFG) can improve the psychosocial well-being of AGYW. The long-term effects of these interventions should be further tested for potential scale-up in an effort to address the persistent mental health treatment gap in resource-constrained settings

Self-Reported Adherence to Antiretroviral Therapy (ART) Among Women Engaged in Commercial Sex Work in Southern Uganda

We examined the correlates of self-reported adherence to antiretroviral therapy (ART) among women engaged in commercial sex work (WESW) in Uganda. We used baseline data from a longitudinal study, which recruited 542 WESW in Southern Uganda. We used nested regression models to determine the individual and family, and economic level correlates of self-reported adherence. Study findings show that older age (OR = 1.07, 95% CI = 1.013, 1.139), secondary education (OR = 2.01, 95% CI = 1.306, 3.084), large household size (OR = 1.08, 95% CI = 1.020, 1.136), high family cohesion (OR = 1.06, 95% CI = 1.052, 1.065), and high financial self-efficacy (OR = 1.07, 95% CI = 1.006, 1.130) were associated with good self-reported adherence to ART. Married women (OR=-0.39, 95% CI = 0.197, 0.774), depression (OR = 0.85, 95% CI = 0.744, 0.969), alcohol use (OR = 0.72, 95% CI = 0.548, 0.954), ever been arrested (OR = 0.58, 95% CI = 0.341, 0.997), and high household assets ownership (OR = 0.48, 95% CI = 0.313, 0.724) were associated with poor self-reported adherence to ART. Findings suggest a need to adopt a multi-level approach to address gaps in ART adherence among WESW

Factors Associated with Consistent Condom Use Among Women Engaged in Sex Work: Lessons From the Kyaterekera Study in Southwestern Uganda

We examined the factors associated with consistent condom use among women engaged in sex work in the Southern parts of Uganda. We used baseline data from a longitudinal study involving WESW from 19 hotspots in Southern Uganda. We conducted hierarchical models to determine the individual, economic, behavioral, and health-related factors associated with consistent condom use. We found that, alcohol use (b=-0.48, 95% CI=-0.77, -0.19), accepting money for condomless sex (b=-0.33, 95% CI=-0.38, -0.28), multiple customers (b=-0.01, 95% CI=-0.01, -0.005), being married (b = 0.50, 95% CI = 0.01, 0.99), owning more assets (b = 0.08, 95% CI = 0.05, 0.13), having another income earner in the household (b = 0.55, 95% CI = 0.27, 0.83), condom use self-efficacy (b = 0.11, 95% CI = 0.03, 0.19), condom use communication (b = 0.06, 95% CI = 0.001, 0.12), and being knowledgeable about HIV/STIs transmission (b = 0.08, 95% CI = 0.01, 0.15) were associated with consistent condom use. Additionally, 29% of the women were consistent condom users. Hence, there is need to implement interventions that promote consistent condom use among WESW

PrEP acceptability and initiation among women engaged in sex work in Uganda: Implications for HIV prevention

Background Women engaged in sex work (WESW) are disproportionately affected by HIV. In Uganda, HIV prevalence among WESW is estimated at 37%, accounting for 18% of all new infections in the country. WESW experience poverty, gender-based violence, and other issues that reduce their power and limit their ability to negotiate condom use. Female-controlled strategies, including pre-exposure prophylaxis (PrEP), may afford women more transmission protection, but barriers to access and use persist. This cross-sectional study examined baseline PrEP acceptability and initiation among WESW recently enrolled in a randomized clinical trial in Uganda to test the impact of a combination HIV risk reduction and economic empowerment intervention on sexual risk outcomes (clinicaltrials.gov, NCT03583541)

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

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 \u3c 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

A Multilevel Integrated Intervention to Reduce the Impact of HIV Stigma on HIV Treatment Outcomes Among Adolescents Living With HIV in Uganda: Protocol for a Randomized Controlled Trial

BackgroundHIV 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. ObjectiveThe 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. MethodsMSuubi 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. ResultsThis 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. ConclusionsMSuubi 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. Trial RegistrationClinicalTrials.gov NCT05307250; https://clinicaltrials.gov/ct2/show/NCT05307250 International Registered Report Identifier (IRRID)PRR1-10.2196/4010

Suubi + Adherence4Youth: a study protocol to optimize the Suubi Intervention for Adherence to HIV treatment for youth living with HIV in Uganda

Abstract Background Suubi 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. Methods A 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. Discussion The 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 Registration This project was registered at clinicaltrials.gov (NCT05600621) on October, 31, 2022. https://clinicaltrials.gov/ct2/show/NCT0560062

Suubi+Adherence-Round 2: A study protocol to examine the longitudinal HIV treatment adherence among youth living with HIV transitioning into young adulthood in Southern Uganda

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: NCT0179037