An mHealth Intervention to Address Depression and Improve Antiretroviral Therapy Adherence Among Youths Living With HIV in Uganda: Protocol for a Pilot Randomized Controlled Trial.

BACKGROUND: People living with HIV often struggle with mental health comorbidities that lower their antiretroviral therapy (ART) adherence. There is growing evidence that depression treatment may improve ART adherence and result in improved HIV outcomes. Given that mental health services are severely underequipped in low-resource settings, including in Uganda, new solutions to increase access to mental health care and close the treatment gap are urgently needed. This protocol paper presents the Suubi-Mhealth study, which proposed to develop a mobile health (mHealth) intervention for use among Ugandan youths (14-17 years) with comorbid HIV and depression, taking into account their unique contextual, cultural, and developmental needs. OBJECTIVE: The proposed study is guided by the following objectives: (1) to develop and iteratively refine an intervention protocol for Suubi-Mhealth based on formative work to understand the needs of youths living with HIV; (2) to explore the feasibility and acceptability of Suubi-Mhealth on a small scale to inform subsequent refinement; (3) to test the preliminary impact of Suubi-Mhealth versus a waitlist control group on youths' outcomes, including depression and treatment adherence; and (4) to examine barriers and facilitators for integrating Suubi-Mhealth into health care settings. METHODS: Youths will be eligible to participate in the study if they are (1) 14-17 years of age, (2) HIV-positive and aware of their status, (3) receiving care and ART from one of the participating clinics, and (4) living within a family. The study will be conducted in 2 phases. In phase 1, we will conduct focus group discussions with youths and health care providers, for feedback on the proposed intervention content and methods, and explore the feasibility and acceptability of the intervention. In phase II, we will pilot-test the preliminary impact of the intervention on reducing depression and improving ART adherence. Assessments will be conducted at baseline, 1-, 2-, and 6-months post intervention completion. RESULTS: Participant recruitment for phase 1 is completed. Youths and health care providers participated in focus group discussions to share their feedback on the proposed Suubi-Mhealth intervention content, methods, design, and format. Transcription and translation of focus group discussions have been completed. The team is currently developing Suubi-Mhealth content based on participants' feedback. CONCLUSIONS: This study will lay important groundwork for several initiatives at the intersection of digital therapeutics, HIV treatment, and mental health, especially among sub-Saharan African youths, as they transition through adolescence and into adult HIV care settings. TRIAL REGISTRATION: ClinicalTrials.gov NCT05965245; https://clinicaltrials.gov/study/NCT05965245. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/54635.

Preliminary Impact of Group-Based Interventions on Stigma, Mental Health, and Treatment Adherence Among Adolescents Living with Human Immunodeficiency Virus in Uganda.

OBJECTIVE: To examine the preliminary impact of group cognitive behavioral therapy and multiple family group-based family strengthening to address HIV stigma and improve the mental health functioning of adolescents living with HIV in Uganda. STUDY DESIGN: We analyzed data from the Suubi4Stigma study, a 2-year pilot randomized clinical trial that recruited adolescents living with HIV (10-14 years) and their caregivers (n = 89 dyads), from 9 health clinics. We fitted separate three-level mixed-effects linear regression models to test the effect of the interventions on adolescent outcomes at 3 and 6 months post intervention initiation. RESULTS: The average age was 12.2 years and 56% of participants were females. Participants in the multiple family group-based family strengthening intervention reported lower levels of internalized stigma (mean difference = -0.008, 95% CI = -0.015, -0.001, P = .025) and depressive symptoms at 3 months (mean difference = -0.34, 95% CI = -0.53, -0.14, P < .001), compared with usual care. On the other hand, participants in the group cognitive behavioral therapy intervention reported lower levels of anticipated stigma at 3 months (mean difference = -0.039, 95% CI = -0.072, -0.006), P = .013) and improved self-concept at 6 months follow-up (mean difference = 0.04, 95% CI = 0.01, 0.01, P = .025). CONCLUSION: Outcome trends from this pilot study provide compelling evidence to support testing the efficacy of these group-based interventions on a larger scale. TRIAL REGISTRATION: The study is registered in the Clinical trials.gov database (Identifier #: NCT04528732).

Feasibility and Acceptability of Group-Based Stigma Reduction Interventions for Adolescents Living with HIV and Their Caregivers: The Suubi4Stigma Randomized Clinical Trial (2020-2022).

This study examined the feasibility and acceptability of two group-based interventions: group-cognitive behavioral therapy (G-CBT) and a family-strengthening intervention delivered via multiple family group (MFG-FS), to address HIV stigma among adolescents living with HIV (ALHIV) and their caregivers. A total of 147 adolescent -caregiver dyads from 9 health clinics situated within 7 political districts in Uganda were screened for eligibility. Of these, 89 dyads met the inclusion criteria and provided consent to participate in the study. Participants were randomized, at the clinic level, to one of three study conditions: Usual care, G-CBT or MFG-FS. The interventions were delivered over a 3-month period. While both adolescents and their caregivers attended the MFG-FS sessions, G-CBT sessions were only attended by adolescents. Data were collected at baseline, 3 and 6-months post intervention initiation. The retention rate was 94% over the study period. Across groups, intervention session attendance ranged between 85 and 92%, for all sessions. Fidelity of the intervention was between 85 and 100%, and both children and caregivers rated highly their satisfaction with the intervention sessions. ALHIV in Uganda, and most of sub-Saharan Africa, are still underrepresented in stigma reduction interventions. The Suubi4Stigma study was feasible and acceptable to adolescents and their caregivers -supporting testing the efficacy of the interventions in a larger trial.

The relationship between life satisfaction, personal health, quality of life, and medication adherence among adolescents living with HIV in southwestern Uganda.

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.

Assessing the Feasibility of Economic Approaches to Prevent Substance Abuse Among Adolescents: Protocol for a Mixed Methods Study.

BACKGROUND: Adolescent alcohol and drug use (ADU) is a significant public health challenge. Uganda, one of the poorest countries in Sub-Saharan Africa (SSA), has the second-highest rate of per capita alcohol consumption in SSA, and over one-third of Ugandan adolescents have used alcohol in their lifetime (over 50% of them engage in heavy episodic drinking). These estimates further increase in fishing villages, a key HIV-vulnerable population, where ADU is normative. However, few studies have assessed ADU among adolescents and youths living with HIV despite their increased risk for ADU and its impact on engagement in HIV care. Moreover, data on risk and resilience factors for ADU are scarce as only few studies evaluating ADU interventions in SSA have reported positive outcomes. The majority have been implemented in school settings, potentially excluding adolescents in fishing communities with high school dropout rates, and none have targeted risk factors including poverty and mental health, which are rampant among adolescents and youths living with HIV and their families, undermine their coping skills and resources, and have been associated with increased risk for ADU among them. OBJECTIVE: We propose a mixed methods study with a sample of 200 adolescents and youths living with HIV (aged 18-24 years) seen at 6 HIV clinics in southwestern Uganda's fishing communities to (1) examine the prevalence and consequences of ADU and identify the multilevel risk and resilience factors associated with ADU among them and (2) explore the feasibility and short-term effects of an economic empowerment intervention on ADU among them. METHODS: This study comprises four components: (1) focus group discussions (FGDs) with adolescents and youths living with HIV (n=20) and in-depth qualitative interviews with health providers (n=10) from 2 randomly selected clinics; (2) a cross-sectional survey with 200 adolescents and youths living with HIV; (3) a randomized controlled trial with a subgroup of adolescents and youths living with HIV (n=100); and (4) 2 postintervention FGD with adolescents and youths living with HIV (n=10 per group). RESULTS: Participant recruitment for the first qualitative phase has completed. As of May 4, 2023, ten health providers from 6 clinics have been recruited, provided written consent to participate, and participated in in-depth qualitative interviews. Two FGDs was conducted with 20 adolescents and youths living with HIV from 2 clinics. Data transcription, translation, and analysis of qualitative data has commenced. The cross-sectional survey will commence shortly after and dissemination of the main study findings is targeted for 2024. CONCLUSIONS: Our findings will advance our understanding of ADU among adolescents and youths living with HIV and inform the design of future interventions to address ADU among them. TRIAL REGISTRATION: ClinicalTrials.gov NCT05597865; https://clinicaltrials.gov/ct2/show/NCT05597865. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/46486.

Bridges-Round 2: A study protocol to examine the longitudinal HIV risk prevention and care continuum outcomes among orphaned youth transitioning to young adulthood.

BACKGROUND: Youth orphaned by HIV in sub-Saharan Africa experience immense hardships including social disadvantage, adverse childhood events and limited economic prospects. These adversities disrupt the normative developmental milestones and can gravely compromise their health and emotional wellbeing. The Bridges to the Future study (2012-2018) prospectively followed 1,383 adolescents, between 10-16 years, to evaluate the efficacy and cost-effectiveness of a family-based economic empowerment intervention comprising of child development accounts, financial literacy training, family income generating activities and peer mentorship. Study findings show efficacy of this contextually-driven intervention significantly improving mental health, school retention and performance and sexual health. However, critical questions, such as those related to the longitudinal impact of economic empowerment on HIV prevention and engagement in care remain. This paper presents a protocol for the follow-up phase titled, Bridges Round 2. METHODS: The Original Bridges study participants will be tracked for an additional four years (2022-2026) to examine the longitudinal developmental and behavioral health outcomes and potential mechanisms of the effect of protective health behaviors of the Bridges cohort. The study will include a new qualitative component to examine participants' experiences with the intervention, the use of biomedical data to provide the most precise results of the highly relevant, but currently unknown sexual health outcomes among study participants, as well as a cost-benefit analysis to inform policy and scale-up. DISCUSSION: Study findings may contribute to the scientific knowledge for low-resource communities on the potential value of providing modest economic resources to vulnerable boys and girls during childhood and early adolescence and how these resources may offer long-term protection against known HIV risks, poor mental health functioning and improve treatment among the HIV treatment care continuum.

Correlates of Intimate Partner Violence Among Young Women Engaged in Sex Work in Southern Uganda.

Intimate partner violence (IPV) is a significant global public health problem that results in high social and economic costs to individuals and communities. Compared to women in the general population, women engaged in sex work (WESW) are more likely to experience physical, emotional, and sexual IPV. This study examines the correlates of IPV among young WESW with their intimate partners in Southern Uganda. We used baseline data from the Kyaterekera project, a 5 year NIH-funded longitudinal study aimed at reducing HIV risks among 542 WESW in Southern Uganda. To examine the factors associated with IPV, we fitted three separate multi-level Poisson regression models for physical, emotional, and sexual IPV, respectively. Average age was 31.4 years, and 54% of the women reported being victims of at least one form of IPV from their intimate partners. Model one assessed correlates of sexual IPV. Being married women (ß = .71, 95% CI [0.24, 1.17]), divorced/separated/widowed (ß = .52, [0.02, 1.02]), depressed (ß = .04, [0.02, 0.05]), and having any sexually transmitted infections (STIs) (ß = .58, [0.14, 1.01]) were associated with sexual IPV. Model two assessed correlates of physical IPV. Experience of childhood sexual abuse (ß = .12, [0.04, 0.19]) was associated with an increase in physical IPV, and increasing age reduced its occurrence (ß = -.02, [-0.04, -0.001]). Finally, model three assessed emotional IPV. Women with higher education (ß = .49, [0.14, 0.85]) and symptoms of depression (ß = .02, [0.001, 0.04]) had higher risks for emotional IPV. For WESW, IPV presents an additional potential pathway for HIV and STIs acquisition and transmission through a lack of negotiating power for safe sex. Efforts to reduce violence against WESW should be prioritized as a strategy for enhancing the well-being of WESW.

The Relationship Between Family Cohesion and Depression Among School-Going Children With Elevated Symptoms of Behavioral Challenges in Southern Uganda.

PURPOSE: Depression is among the leading causes of disability and contributes significantly to the overall disease burden affecting children. Family cohesion has been identified as a protective factor against depression. Examining this relationship is necessary in sub-Saharan Africa, specifically in Uganda-a country characterized by a high prevalence of HIV/AIDS, and high rates of chronic poverty, all of which stress family functioning and elevate child behavioral challenges. This study examined the relationship between family cohesion and depression among school-going children with elevated symptoms of behavioral challenges in southern Uganda. METHODS: At baseline, 2089 children were enrolled in the National Institutes of Health-funded Strengthening Mental Health and Research Training Africa study in Southwestern Uganda. This article analyzed data from 626 children aged 8-13 years with elevated behavioral challenges. We conducted multilevel mixed-effects Poisson regression to determine the association between family cohesion and depression. We controlled for sociodemographic and household characteristics. RESULTS: The mean age was 10.3 years. The overall mean depression score was 3.2 (standard deviation = 2.7, range = 0-15). Family cohesion (ß = -0.03, 95% confidence interval [CI]: -0.04, -0.02, p < .001) and owning essential items by the child (ß = -0.13, 95% CI: -0.23, -0.04, p = .005) were protective against depression among children. Additionally, we observed being a single orphan (ß = -0.44, 95% CI: -0.03, -0.86, p = .036) and having both parents (ß = -0.43, 95% CI: -0.06, -0.81, p = .023) were associated with depression among children. DISCUSSION: Findings from this study reveal that family cohesion was protective against depression. Therefore, it is vital to strengthen family support systems by developing programs aimed at strengthening family relationships as a catalyst for addressing depression among children.

Patterns of and Factors Associated With Mental Health Service Utilization Among School-Going Adolescent Girls in Southwestern Uganda: A Latent Class Analysis.

PURPOSE: The study aimed to improve understanding of patterns of multiple family group intervention engagement and associated factors among adolescent girls in a low-resource country, Uganda. METHODS: The data used in this analysis were part of a larger cluster randomized controlled trial consisting of 1260 adolescent girls across 47 public secondary schools. The sample in the current study consisted of 317 adolescent girls (ages 14-17 at enrollment) recruited from senior one and senior two classes across 12 secondary schools in the southwestern region of Uganda. Participants in this study participated in the multiple family group intervention-a 16-week manualized intervention. Attendance data from 16 sessions were used to identify the heterogeneity of intervention engagement using latent class analysis modeling. Logistic regression analysis was conducted to assess the association between predisposing, enabling, need factors, and mental health utilization patterns. RESULTS: On average, participants attended 10 sessions (standard deviation = 5.90), 34.38% (N = 109) completed all 16 sessions, and 13.56% (N = 43) did not attend any of the sessions. Two attendance groups were identified: low and high attendants using latent class analysis. In addition, two family-level factors, the number of adults and the number of children in the family, were associated with an increase in the utilization of mental health services. DISCUSSION: Findings suggest that enhancing family support systems may be useful in promoting mental health utilization among adolescent girls with the potential to improve self-esteem, reduce feelings of inadequacy, and ultimately achieve better mental health outcomes.

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's 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.

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

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/NCT05600621.

Economic Abuse and Care-seeking Practices for HIV and Financial Support Services in Women Employed by Sex Work: A Cross-Sectional Baseline Assessment of a Clinical Trial Cohort in Uganda.

Economic hardship is a driver of entry into sex work, which is associated with high HIV risk. Yet, little is known about economic abuse in women employed by sex work (WESW) and its relationship to uptake of HIV prevention and financial support services. This study used cross-sectional baseline data from a multisite, longitudinal clinical trial that tests the efficacy of adding economic empowerment to traditional HIV risk reduction education on HIV incidence in 542 WESW. Mixed effects logistic and linear regressions were used to examine associations in reported economic abuse by demographic characteristics, sexual behaviors, HIV care-seeking, and financial care-seeking. Mean age was 31.4 years. Most WESW were unmarried (74%) and had less than primary school education (64%). 48% had savings, and 72% had debt. 93% reported at least one economic abuse incident. Common incidents included being forced to ask for money (80%), having financial information kept from them (61%), and being forced to disclose how money was spent (56%). WESW also reported partners/relatives spending money needed for bills (45%), not paying bills (38%), threatening them to quit their job(s) (38%), and using physical violence when earning income (24%). Married/partnered WESW (OR = 2.68, 95% CI:1.60-4.48), those with debt (OR = 1.70, 95% CI:1.04-2.77), and those with sex-work bosses (OR = 1.90, 95% CI:1.07-3.38) had higher economic abuse. Condomless sex (ß = +4.43, p < .05) was higher among WESW experiencing economic abuse, who also had lower odds of initiating PrEP (OR = .39, 95% CI:.17-.89). WESW experiencing economic abuse were also more likely to ask for cash among relatives (OR = 2.36, 95% CI:1.13-4.94) or banks (OR = 2.12, 95% CI:1.11-4.03). The high prevalence of HIV and economic abuse in WESW underscores the importance of integrating financial empowerment in HIV risk reduction interventions for WESW, including education about economic abuse and strategies to address it. Programs focusing on violence against women should also consider economic barriers to accessing HIV prevention services.

Suubi4StrongerFamilies: A study protocol for a clustered randomized clinical trial addressing child behavioral health by strengthening financial stability and parenting among families in Uganda.

Background: Children in Sub-Saharan Africa are burdened by significant unmet mental health needs. Across the region, high rates of poverty, HIV/AIDS, food insecurity, stigma, and an inadequate health safety net system exacerbate serious child behavioral health needs and impede an effective response. Disruptive behavioral disorders are particularly concerning as they persist through adolescence and adulthood. Hence, addressing the context-specific social influences on child behavioral health is critical given that children in the region comprise more than half of the total regional population. Against this backdrop, this study protocol describes a randomized clinical trial that will examine the mechanisms by which economic empowerment and family strengthening interventions targeting social, familial, and context-specific drivers affect the mental health of children in Uganda. Methods: The study uses an experimental, longitudinal design across 30 cluster-randomized primary schools to compare single and combination intervention options; influences of economic empowerment and family strengthening on economic, perceptual, and functioning mediators; and context-specific moderators. The study will be conducted with 900 Ugandan children in mid-upper primary school (10-14 years). The three study conditions (n = 300 each) are: (1) economic empowerment only (EE only), (2) multiple family group-based family strengthening only (MFG-based FS only), and (3) combined EE + MFG-based FS. The interventions will be provided for 12 months; and assessments will occur at baseline, 12, 24, and 36 months. Conclusion: Children in Sub-Saharan Africa are burdened by significant unmet mental health needs, including disruptive behavior disorders that persist through adolescence and adulthood if left untreated. The proposed study will examine the mechanisms by which economic empowerment and family strengthening interventions targeting social, familial and context-specific drivers affect the mental health of children in mid-upper primary schools in Uganda. Findings from this study can inform group, community, and population approaches that are needed for scalable solutions to address the social drivers negatively impacting child behavioral health in low-resource settings, including in Sub-Saharan Africa. Clinical trial registration: [https://clinicaltrials.gov/], identifier [NCT053 68714].

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.

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. TRIAL REGISTRATION: ClinicalTrials.gov NCT05307250; https://clinicaltrials.gov/ct2/show/NCT05307250. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/40101.

Monitoring adherence to antiretroviral therapy among adolescents in Southern Uganda: comparing Wisepill to Self-report in predicting viral suppression in a cluster-randomized trial.

INTRODUCTION: Optimal antiretroviral therapy (ART) adherence is crucial for improved patient outcomes; however, ART adherence among adolescents living with HIV (ALHIV) is low. Also, the performance of various adherence measures among ALHIV is under contention. We monitored ART adherence and compared Self-report (SR) and Wisepill electronic monitoring (EM) performance in measuring ART adherence and predicting HIV viral suppression among ALHIV. METHODS: Between January 2014 and December 2015, we recruited 702 ALHIV aged 10-16 years into our cluster-randomized controlled trial (2012-2018) in 39 clinics in Uganda. The intervention included a long-term savings child development account, four micro-enterprise workshops and 12 mentorship sessions. Using the entire sample, we performed multilevel logistic regression to predict monthly ART adherence trends for the first year of follow-up. Since it is possible that the intervention had different effects on SR and EM adherence, we used participants in the control arm only to compare adherence using SR and EM and to calculate their sensitivity and specificity in predicting viral suppression. RESULTS: There was a significant decline in adherence for each month throughout the entire follow-up period regardless of the group assigned. Good ART adherence was measured at 79.2% (75.2-82.6%) and 97.0% (95.4-98.1%) using EM and SR, respectively. Overall, 64.3% (60.6-67.9%) had suppressed viral loads. The specificities for EM and SR in predicting viral non-suppression were 80.4% (73.6-85.7%) and 96.7% (93.3-98.4%), while the sensitivities were 22.9% (15.0-33.3%) and 1.8% (0.4-6.9%), respectively. The area under the curve was low for both EM and SR, at 53.6% (45.7-61.5%) and 56.2% (53.2-59.3%), respectively. There was high agreement (78%) between SR and EM in monitoring adherence. CONCLUSIONS: Our findings highlighted the need for strategies for sustained optimal adherence. SR and EM measure adherence with a considerable agreement; however, neither is an accurate predictor of virological outcome. There is still a need for an acceptable, feasible and affordable method that predicts viral suppression among ALHIV.

Prevalence and predictors of HIV and sexually transmitted infections among vulnerable women engaged in sex work: Findings from the Kyaterekera Project in Southern Uganda.

INTRODUCTION: Women engaged in sex work (WESW) have an elevated risk of the human immunodeficiency virus (HIV) and sexually transmitted infections (STI). Estimates are three times higher than the general population. Understanding the predictors of HIV and STI among WESW is crucial in developing more focused HIV and STI prevention interventions among this population. The study examined the prevalence and predictors of HIV and STI among WESW in the Southern part of Uganda. METHODOLOGY: Baseline data from the Kyaterekera study involving 542 WESW (ages 18-55) recruited from 19 HIV hotspots in the greater Masaka region in Uganda was utilized. HIV and STI prevalence was estimated using blood and vaginal fluid samples bioassay. Hierarchical regression models were used to determine the predictors of HIV and STI among WESW. RESULTS: Of the total sample, 41% (n = 220) were found to be HIV positive; and 10.5% (n = 57) tested positive for at least one of the three STI (Neisseria gonorrhoeae, Chlamydia trachomatis and Trichomonas vaginalis) regardless of their HIV status. Older age (b = 0.09, 95%CI = 0.06, 0.13, p≤0.001), lower levels of education (b = -0.79, 95%CI = -1.46, -0.11, p≤0.05), fewer numbers of children in the household (b = -0.18, 95%CI = -0.36, -0.01), p≤0.05), location (i.e., fishing village (b = 0.51, 95%CI = 0.16, 0.85, p≤0.01) or small town (b = -0.60, 95%CI = -0.92, -0.28, p≤0.001)), drug use (b = 0.58, 95%CI = 0.076, 1.08, p≤0.05) and financial self-efficacy (b = 0.05, 95%CI = -0.10, 0.00, p≤0.05), were associated with the risk of HIV infections among WESW. Domestic violence attitudes (b = -0.24, 95%CI = -0.42, -0.07, p≤0.01) and financial distress (b = -0.07, 95%CI = -0.14, -0.004, p≤0.05) were associated with the risk of STI infection among WESW. CONCLUSION: Study findings show a high prevalence of HIV among WESW compared to the general women population. Individual and family level, behavioural and economic factors were associated with increased HIV and STI infection among WESW. Therefore, there is a need for WESW focused HIV and STI risk reduction and economic empowerment interventions to reduce these burdens.

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). METHODS: A total of 542 WESW from 19 high HIV-prevalent geographical areas were enrolled in the Kyaterekera study between June 2019 and March 2020. Women were eligible for the study if they: (1) were age 18 or over; (2) reported engagement in transactional sex (a sex act in exchange for pay) in the past 30 days; and (3) reported engagement in one or more episodes of unprotected sex in the past 30 days. Women completed a baseline assessment, were tested for HIV and other sexually transmitted infections (STIs) at enrollment, and were connected with antiretroviral therapy (ART), STI treatment, or PrEP, based on need and interest. Descriptive statistics examined baseline data on PrEP acceptability and initiation. Independent variables (i.e. years in sex work, recent sexual coercion, perceived HIV and sex work stigmas, harmful alcohol use, barriers to medical care, and social support) were derived from the empirical literature and women's self-report. Bivariate analysis was performed to test associations between main effects of these variables. Using binomial logistic regression, predictive models were evaluated for two distinct outcomes-PrEP acceptability and PrEP initiation/uptake. FINDINGS: At baseline, 59% of women (n = 322) tested HIV negative. Among WESW testing negative, 11% (n = 36) were already PrEP enrolled. Most women reported willingness to use PrEP (n = 317; 91%). Slightly over half of WESW not already on PrEP agreed to initiate PrEP (n = 158; 55%). Logistic regression models demonstrate that acceptability of or willingness to use PrEP was significantly associated with fewer years engaged in sex work (AOR= ·18, 95% CI 0·05-·66, p<·01) and greater perceived social support from family (AOR= 1·39, 95% CI 1·03 -1.88, p<·05). PrEP initiation was negatively associated with greater perceived social support from friends (AOR=·81, 95% CI ·68-0·97, p<·05) and positively associated with higher perceived stigma due to sex work among family members (AOR=2·20, 95% CI 1·15-4·22, p<·05). INTERPRETATION: Despite endorsing PrEP use, many WESW remain reluctant to use it. This gap in prevention practice highlights the heart of a failing PrEP prevention cascade. Findings point to the important role family and friend support may play in destigmatizing sex work and PrEP use for women. Social and structural-level efforts are needed to improve educational messaging and to integrate positive messaging into health promotion campaigns for women and their families, while also working toward decriminalizing sex work. FUNDING: This paper was made possible with funding from United States National Institute of Mental Health (Grant number: R01MH116768).

The longitudinal impact of an evidence-based multiple family group intervention (Amaka Amasanyufu) on oppositional defiant disorder and impaired functioning among children in Uganda: analysis of a cluster randomized trial from the SMART Africa-Uganda scale-up study (2016-2022).

BACKGROUND: Oppositional Defiant Disorders (ODDs) and other Disruptive Behavior Disorders (DBDs) are common among children and adolescents in poverty-impacted communities in sub-Saharan Africa. Without early intervention, its progression into adulthood can result in dire consequences. We examined the impact of a manualized family strengthening intervention called Amaka Amasanyufu designed to reduce ODDs and other DBDs among school-going children residing in low-resource communities in Uganda. METHODS: We used longitudinal data from the SMART Africa-Uganda study (2016-2022). Public primary schools were randomized to: (1) Control condition (receiving usual care comprising generalized psychosocial functioning literature), 10 schools; (2) intervention delivered via parent peers (Amaka-parents), 8 schools or; (3) intervention delivered via community healthcare workers (Amaka-community), 8 schools. All the participants were blinded. At baseline, 8- and 16-weeks postintervention initiation, caregivers completed the Iowa Conners Scale, which measured Oppositional Defiant Disorder (ODD) and Impairment Rating Scale to evaluate children's overall impairment and impaired functioning with peers, siblings, and parents; impaired academic progress, self-esteem, and family functioning. Three-level linear mixed-effects models were fitted to each outcome. Pairwise comparisons of postbaseline group means within each time point were performed using Sidak's adjustment for multiple comparisons. Only children positive for ODD and other DBDs were analyzed. RESULTS: Six hundred and thirty-six children screened positive for ODDs and other DBDs (Controls: n = 243; Amaka-parents: n = 194; Amaka-community: n = 199). At 8 weeks, Amaka-parents' children had significantly lower mean scores for overall impairment compared to controls, (mean difference: -0.71, p = .001), while Amaka-community children performed better on ODD (mean difference: -0.84, p = .016). At 16 weeks, children in both groups were performing better on ODD and IRS than controls, and there were no significant differences between the two intervention groups. CONCLUSIONS: The Amaka Amasanyufu intervention was efficacious in reducing ODD and impaired functioning relative to usual care. Hence, the Amaka Amasanyufu intervention delivered either by Amaka-community or Amaka-parents has the potential to reduce negative behavioral health outcomes among young people in resource-limited settings and improve family functioning. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03081195. Registered on 16 March 2017.

Working with economically vulnerable women engaged in sex work: Collaborating with community stakeholders in Southern Uganda.

CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03583541.

Family-level correlates of disruptive behavior challenges among children in Southwestern Uganda.

Introduction: This exploratory study sought to examine the extent to which family-level factors are associated with disruptive behavioral disorder (DBD) symptoms, including oppositional defiant disorder (ODD) and conduct disorder (CD) among school children in Uganda, a low-resource country in SSA. The examination of key influences within the SSA context is important to guide needed investments in mental health care and family-level support. Importantly, identifying families at higher risk can inform the development of contextualized family interventions that reinforce positive parenting practices. Method: We analyzed baseline data (N = 2110) from the NIH-funded Strengthening Mental health And Research Training in Africa (SMART Africa) scale-up study in Southwestern Uganda. Children aged 8-13 and their caregivers were recruited from 30 public primary schools. DBDs were examined using the DBD rating scale, Iowa Conners, and Impairment scales. Logistic regression analysis using cluster adjusted robust standard errors to adjust for within-school clustering was conducted to assess the association between DBD symptoms and family-level factors, including parenting practices, marital status, and family size. Results: Results indicate that poor parental supervision (OR = 1.17; CI: 1.13, 1.21; P <.001), divorced families (OR = 1.33; CI: 1.03, 1.72; P <.05), and widowed families (OR = 1.48; CI: 1.10, 2.00; P <.01) were associated with higher DBD symptoms among children. On the other hand, caregiver age (OR = 0.99; CI: 0.98, 0.99; P <.01) was associated with lower DBD symptoms among children. Moreover, caregiver employment and parental education were not statistically significant in the model. Conclusion: Findings from the study reveal an association between family-level factors and behavioral difficulties among children in Uganda suggesting that divorced and widowed families may benefit from additional support in caring for children. Moreover, caregivers may also benefit from programs that provide tools for effective parental supervision.