Reducing time to differentiated service delivery for newly-diagnosed people living with HIV in Kigali, Rwanda: a pilot, unblinded, randomized controlled trial.

BACKGROUND: Differentiated service delivery (DSD) programs for people living with HIV (PWH) limit eligibility to patients established on antiretroviral therapy (ART), yet uncertainty exists regarding the duration on ART necessary for newly-diagnosed PWH to be considered established. We aimed to determine the feasibility, acceptability, and preliminary impact of entry into DSD at six months after ART initiation for newly-diagnosed PWH. METHODS: We conducted a pilot randomized controlled trial in three health facilities in Rwanda. Participants were randomized to: (1) entry into DSD at six months after ART initiation after one suppressed viral load (DSD-1VL); (2) entry into DSD at six months after ART initiation after two consecutive suppressed viral loads (DSD-2VL); (3) treatment as usual (TAU). We examined feasibility by examining the proportion of participants assigned to intervention arms who entered DSD, assessed acceptability through patient surveys and by examining instances when clinical staff overrode the study assignment, and evaluated preliminary effectiveness by comparing study arms with respect to 12-month viral suppression. RESULTS: Among 90 participants, 31 were randomized to DSD-1VL, 31 to DSD-2VL, and 28 to TAU. Among 62 participants randomized to DSD-1VL or DSD-2VL, 37 (60%) entered DSD at 6 months while 21 (34%) did not enter DSD because they were not virally suppressed. Patient-level acceptability was high for both clinical (mean score: 3.8 out of 5) and non-clinical (mean score: 4.1) elements of care and did not differ significantly across study arms. Viral suppression at 12 months was 81%, 81% and 68% in DSD-1VL, DSD-2VL, and TAU, respectively (p = 0.41). CONCLUSIONS: The majority of participants randomized to intervention arms entered DSD and had similar rates of viral suppression compared to TAU. Results suggest that early DSD at six months after ART initiation is feasible for newly-diagnosed PWH, and support current WHO guidelines on DSD. TRIAL REGISTRATION: Clinicaltrials.gov NCT04567693; first registered on September 28, 2020.

Psychometrics of the Children's Report of Parental Behavior Inventory among caregivers and youth with HIV.

Parenting has been implicated in a range of youth health outcomes. Positive parenting during adolescence, a critical period of developmental change, may equip youth with the necessary tools for their transition into adulthood and, for youth living with HIV, their transition from pediatric HIV care into adult HIV care. Yet, because few studies have carefully assessed the psychometric properties of parenting instruments applied cross-culturally, the validity of parenting research derived in these contexts remains unclear. This study tested the factor structure of the Children's Report of Parenting Behavior Inventory (CRPBI) in a novel setting (e.g., Rwanda), context (e.g., youth with HIV), and considering multiple informants (caregivers and youth). Youth (N = 330) were on average 16.78 years of age; 51% self-identified as female. Caregivers (N = 330) were on average 44.40 years of age; 80% self-identified as female. The factor structures for youth and caregiver CRPBIs appeared to be indicative of two dimensions: (a) acceptance and positive involvement, and (b) hostile detachment and rejection. The CRPBI worked well for youth reports and showed predictive validity. The CRPBI worked less well for caregivers, necessitating the removal of 10 items, seven of which were related to hostile detachment and rejection. The reliability of both CRPBIs was supported. The CRPBI appears to function well for youth, but not as well for caregivers, in this novel context with this unique population of youth with HIV. The findings support careful assessment of instruments developed in high-resource settings and then used in resource-constrained contexts. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Association Between Clinical Encounter Frequency and HIV-Related Stigma Among Newly-Diagnosed People Living with HIV in Rwanda.

HIV-related stigma in healthcare settings remains a key barrier to engaging people living with HIV (PLHIV) in care. This study investigated the association between clinical encounter frequency and HIV-related anticipated, enacted, and internalized stigma among newly-diagnosed PLHIV in Rwanda. From October 2020 to May 2022, we collected data from adult PLHIV on antiretroviral therapy (ART) in Kigali, Rwanda who were participating in a randomized, controlled trial testing early entry into differentiated care at 6 months after ART initiation. We measured anticipated HIV stigma with five-point Likert HIV Stigma Framework measures, enacted stigma with the four-point Likert HIV/AIDS Stigma Instrument, and internalized stigma with the four-point Likert HIV/AIDS Stigma Instrument. We used multivariable linear regression to test the associations between clinical encounter frequency (average inter-visit interval ≥ 50 days vs. < 50 days) and change in mean anticipated, enacted and internalized HIV stigma over the first 12 months in care. Among 93 individuals enrolled, 76 had complete data on encounter frequency and stigma measurements and were included in the present analysis. Mean internalized stigma scores of all participants decreased over the first 12 months in care. Anticipated and enacted stigma scores were low and did not change significantly over time. There was no association between encounter frequency and change in internalized stigma. In this pilot study of newly-diagnosed Rwandan PLHIV with relatively low levels of HIV-related stigma, clinical encounter frequency was not associated with change in stigma. Additional research in diverse settings and with larger samples is necessary to further explore this relationship.

Experiences of stigma and HIV care engagement in the context of Treat All in Rwanda: a qualitative study.

BACKGROUND: 'Treat All' policies recommending immediate antiretroviral therapy (ART) soon after HIV diagnosis for all people living with HIV (PLHIV) are now ubiquitous in sub-Saharan Africa. While early ART initiation and retention is effective at curtailing disease progression and transmission, evidence suggests that stigma may act as a barrier to engagement in care. This study sought to understand the relationships between HIV stigma and engagement in care for PLHIV in Rwanda in the context of Treat All. METHODS: Between September 2018 and March 2019, we conducted semi-structured, qualitative interviews with adult PLHIV receiving care at two health centers in Kigali, Rwanda. We used a grounded theory approach to data analysis to develop conceptual framework describing how stigma influences HIV care engagement in the context of early Treat All policy implementation in Rwanda. RESULTS: Among 37 participants, 27 (73%) were women and the median age was 31 years. Participants described how care engagement under Treat All, including taking medications and attending appointments, increased their visibility as PLHIV. This served to normalize HIV and use of ART but also led to high levels of anticipated stigma in the health center and community at early stages of treatment. Enacted stigma from family and community members and resultant internalized stigma acted as additional barriers to care engagement. Nonetheless, participants described how psychosocial support from care providers and family members helped them cope with stigma and promoted continued engagement in care. CONCLUSIONS: Treat All policy in Rwanda has heightened the visibility of HIV at the individual and social levels, which has influenced HIV stigma, normalization, psychosocial support and care engagement in complex ways. Leveraging the individual and community support described by PLHIV to deliver evidence-based, peer or provider-delivered stigma reduction interventions may aid in attaining Treat All goals.

Results of the Kigali Imbereheza Project: A 2-Arm Individually Randomized Trial of TI-CBT Enhanced to Address ART Adherence and Mental Health for Rwandan Youth Living With HIV.

BACKGROUND: Adolescents living with HIV have elevated mental distress and suboptimal antiretroviral therapy (ART) adherence. SETTING: Two urban clinics in Kigali, Rwanda. METHODS: A 2-arm individual randomized controlled trial compared Trauma-Informed Cognitive Behavioral Therapy enhanced to address HIV (TI-CBTe) with usual care (time-matched, long-standing, unstructured support groups) with 356 12- to 21-year-old (M = 16.78) Rwandans living with HIV. TI-CBTe included 6 group-based 2-hour sessions led by trained and supervised 21- to 25-year-old Rwandans living with HIV. Participants reported their ART adherence, depression/anxiety, and Post-Traumatic Stress Disorder symptoms at baseline, 6, 12, and 18 months. RESULTS: ART adherence was relatively high at baseline, and youth reported elevated rates of depression/anxiety and trauma symptoms. There were no differential treatment effects on adherence, but depression/anxiety improved over time. Youth with lower depression/anxiety at baseline seemed to benefit more from TI-CBTe than usual care, whereas women with high baseline distress seemed to benefit more from usual care. Youth were less likely to score in high Post-Traumatic Stress Disorder symptom categories at the follow-up, with no differential treatment effects. CONCLUSIONS: TI-CBTe did not outperform usual care on ART adherence, possibly reflecting relatively high adherence at baseline, simplified medication regimens over time, a strong comparison condition, or because youth assigned to TI-CBTe returned to their support groups after the intervention. TI-CBTe was more effective for youth with lower depression/anxiety symptoms, whereas youth with high distress benefitted more from the support groups. TI-CBTe was feasible and acceptable, and young adults living with HIV were able to deliver a mental health intervention with fidelity. The powerful nature of the comparison group, ongoing support groups, points to the potential value of locally crafted interventions in low-resource settings.

How early is too early? Challenges in ART initiation and engaging in HIV care under Treat All in Rwanda-A qualitative study.

INTRODUCTION: HIV treatment guidelines recommend that all people living with HIV (PLWH) initiate antiretroviral therapy (ART) as soon as possible after diagnosis (Treat All). As Treat All is more widely implemented, an increasing proportion of PLWH are likely to initiate ART when they are asymptomatic, and they may view the relative benefits and risks of ART differently than those initiating at more advanced disease stages. To date, patient perspectives of initiating care under Treat All in sub-Saharan Africa have not been well described. METHODS: From September 2018 to March 2019, we conducted individual, semi-structured, qualitative interviews with 37 patients receiving HIV care in two health centers in Kigali, Rwanda. Data were analyzed using a mixed deductive and inductive thematic analysis approach to describe perceived barriers to, facilitators of and acceptability of initiating and adhering to ART rapidly under Treat All. RESULTS: Of 37 participants, 27 were women and the median age was 31 years. Participants described feeling traumatized and overwhelmed by their HIV diagnosis, resulting in difficulty accepting their HIV status. Most were prescribed ART soon after diagnosis, yet fear of lifelong medication and severe side effects in the immediate period after initiating ART led to challenges adhering to therapy. Moreover, because many PLWH initiated ART while healthy, taking medications and attending appointments were visible signals of HIV status and highly stigmatizing. Nonetheless, many participants expressed enthusiasm for Treat All as a program that improved health as well as health equity. CONCLUSION: For newly-diagnosed PLWH in Rwanda, initiating ART rapidly under Treat All presents logistical and emotional challenges despite the perceived benefits. Our findings suggest that optimizing early engagement in HIV care under Treat All requires early and ongoing intervention to reduce trauma and stigma, and promote both individual and community benefits of ART.

Reducing time to differentiated service delivery for newly diagnosed people living with HIV in Kigali, Rwanda: study protocol for a pilot, unblinded, randomised controlled study.

INTRODUCTION: Current HIV guidelines recommend differentiated service delivery (DSD) models that allow for fewer health centre visits for clinically stable people living with HIV (PLHIV). Newly diagnosed PLHIV may require more intensive care early in their treatment course, yet frequent appointments can be burdensome to patients and health systems. Determining the optimal parameters for defining clinical stability and transitioning to less frequent appointments could decrease patient burden and health system costs. The objectives of this pilot study are to explore the feasibility and acceptability of (1) reducing the time to DSD from 12 to 6 months after antiretroviral therapy (ART) initiation,and (2) reducing the number of suppressed viral loads required to enter DSD from two to one. METHODS AND ANALYSES: The present study is a pilot, unblinded trial taking place in three health facilities in Kigali, Rwanda. Current Rwandan guidelines require PLHIV to be on ART for ≥12 months with two consecutive suppressed viral loads in order to transition to less frequent appointments. We will randomise 90 participants to one of three arms: entry into DSD at 6 months after one suppressed viral load (n=30), entry into DSD at 6 months after two suppressed viral loads (n=30) or current standard of care (n=30). We will measure feasibility and acceptability of this intervention; clinical outcomes include viral suppression at 12 months (primary outcome) and appointment attendance (secondary outcome). ETHICS AND DISSEMINATION: This clinical trial was approved by the institutional review board of Albert Einstein College of Medicine and by the Rwanda National Ethics Committee. Findings will be disseminated through conferences and peer-reviewed publications, as well as meetings with stakeholders. TRIAL REGISTRATION NUMBER: NCT04567693.

A scoping review: Facilitators and barriers of cervical cancer screening and early diagnosis of breast cancer in Sub-Saharan African health settings.

To address gaps in access to cervical cancer screening and early diagnosis of breast cancer services in Sub-Saharan African (SSA), this scoping review was conducted to explore facilitators and barriers that exist on the patient-, provider-, and system-level. An extensive literature search was conducted in accordance with scoping review methodology and the Cochrane guidelines. Our search criteria were limited to original research studies conducted in community or clinical settings in SSA within the last 10 years (2010-2020). Themes found from this review included patient knowledge and provider education, access to screening services, trust, health-related behaviors, attitudes, values, and practices, community and social values, health infrastructure, resource allocation, and political will. Identified barriers included lack of knowledge about cervical and breast cancer among patients, gaps in education and training among providers, and lack of resources and health infrastructure at the facility level and within the overall health system. Facilitators included perceived risk of cancer, support and encouragement of the provider, and utilization of novel approaches in low-resource settings by health systems. To better address individual-, provider-, and health system and facility-based facilitators and barriers to care, there is a need for political and financial investment and further research on the health service delivery in specific national health systems, especially in the context of the global campaign to eliminate cervical cancer as a public health problem.

Applying the Exploration Preparation Implementation Sustainment (EPIS) Framework to the Kigali Imbereheza Project for Rwandan Adolescents Living With HIV.

BACKGROUND: Sub-Saharan African adolescents living with HIV face challenges to antiretroviral therapy (ART) adherence. Poor mental health drives nonadherence but can be improved with cognitive behavioral therapy (CBT). CBT delivered by peers may strengthen effects while building capacity for sustainment in low-income countries. This case study retrospectively applied the Exploration Preparation Implementation Sustainment framework to characterize the execution of the Kigali Imbereheza Project, a 2-arm individually randomized group controlled trial of Trauma-Informed Adherence-Enhanced CBT (TI-CBTe) delivered by Rwandan youth leaders (YLs) to adolescents living with HIV. METHODS: YL (n = 14, 43% female, M = 22.71 years) had confirmed HIV and self-reported ART adherence >95%. Participants (n = 356, 51% female, M = 16.78 years) living with HIV were randomized to TI-CBTe or usual care. Two YLs co-led TI-CBTe sessions over 2 months for a total of 12 hours, while other YL observed and rated fidelity. Participants reported on YL competence. Additional data evaluated feasibility, acceptability, uptake, and fidelity. RESULTS: In the Exploration phase, focus groups, stakeholder meetings, and individual interviews revealed strong consensus for delivering TI-CBT to reduce adolescent depression and trauma and improve ART adherence. In the Preparation phase, curriculum revisions were made, YLs were successfully trained, and a cascading supervision model was established. In the Implementation phase, YL delivered TI-CBTe with close monitoring and supervision. Findings revealed strong feasibility, acceptability, uptake, and fidelity, increasing the likelihood of Sustainment. CONCLUSIONS: Exploration Preparation Implementation Sustainment can guide implementation planning and delivery and evaluate implementation outcomes.

HIV Status Disclosure through Family-Based Intervention Supports Parenting and Child Mental Health in Rwanda.

INTRODUCTION: Few evidence-based interventions exist to support parenting and child mental health during the process of caregiver HIV status disclosure in sub-Saharan Africa. A secondary analysis of a randomized-controlled trial was conducted to examine the role of family-based intervention versus usual social work care (care as usual) in supporting HIV status disclosure within families in Rwanda. METHOD: Approximately 40 households were randomized to family-based intervention and 40 households to care as usual. Parenting, family unity, and child mental health during the process of disclosure were studied using quantitative and qualitative research methods. RESULTS: Many of the families had at least one caregiver who had not disclosed their HIV status at baseline. Immediately post-intervention, children reported lower parenting and family unity scores compared with those in the usual-care group. These changes resolved at 3-month follow-up. Qualitative reports from clinical counselor intervention sessions described supported parenting during disclosure. Overall findings suggest adjustments in parenting, family unity, and trust surrounding the disclosure process. CONCLUSION: Family-based intervention may support parenting and promote child mental health during adjustment to caregiver HIV status disclosure. Further investigation is required to examine the role of family-based intervention in supporting parenting and promoting child mental health in HIV status disclosure.

Family-based prevention of mental health problems in children affected by HIV and AIDS: an open trial.

OBJECTIVE: The objective of this study is to assess the feasibility and acceptability of an intervention to reduce mental health problems and bolster resilience among children living in households affected by caregiver HIV in Rwanda. DESIGN: Pre-post design, including 6-month follow-up. METHODS: The Family Strengthening Intervention (FSI) aims to reduce mental health problems among HIV-affected children through improved child-caregiver relationships, family communication and parenting skills, HIV psychoeducation and connections to resources. Twenty families (N = 39 children) with at least one HIV-positive caregiver and one child 7-17 years old were enrolled in the FSI. Children and caregivers were administered locally adapted and validated measures of child mental health problems, as well as measures of protective processes and parenting. Assessments were administered at pre and postintervention, and 6-month follow-up. Multilevel models accounting for clustering by family tested changes in outcomes of interest. Qualitative interviews were completed to understand acceptability, feasibility and satisfaction with the FSI. RESULTS: Families reported high satisfaction with the FSI. Caregiver-reported improvements in family connectedness, good parenting, social support and children's pro-social behaviour (P < 0.05) were sustained and strengthened from postintervention to 6-month follow-up. Additional improvements in caregiver-reported child perseverance/self-esteem, depression, anxiety and irritability were seen at follow-up (P < .05). Significant decreases in child-reported harsh punishment were observed at postintervention and follow-up, and decreases in caregiver reported harsh punishment were also recorded on follow-up (P < 0.05). CONCLUSION: The FSI is a feasible and acceptable intervention that shows promise for improving mental health symptoms and strengthening protective factors among children and families affected by HIV in low-resource settings.

Using Mixed-Methods Research to Adapt and Evaluate a Family Strengthening Intervention in Rwanda.

INTRODUCTION: Research in several international settings indicates that children and adolescents affected by HIV and other compounded adversities are at increased risk for a range of mental health problems including depression, anxiety, and social withdrawal. More intervention research is needed to develop valid measurement and intervention tools to address child mental health in such settings. OBJECTIVE: This article presents a collaborative mixed-methods approach to designing and evaluating a mental health intervention to assist families facing multiple adversities in Rwanda. METHODS: Qualitative methods were used to gain knowledge of culturally-relevant mental health problems in children and adolescents, individual, family and community resources, and contextual dynamics among HIV-affected families. This data was used to guide the selection and adaptation of mental health measures to assess intervention outcomes. Measures were subjected to a quantitative validation exercise. Qualitative data and community advisory board input also informed the selection and adaptation of a family-based preventive intervention to reduce the risk for mental health problems among children in families affected by HIV.. Community-based participatory methods were used to ensure that the intervention targeted relevant problems manifest in Rwandan children and families and built on local strengths. RESULTS: Qualitative data on culturally-appropriate practices for building resilience in vulnerable families has enriched the development of a Family-Strengthening Intervention (FSI). Input from community partners has also contributed to creating a feasible and culturally-relevant intervention. Mental health measures demonstrate strong performance in this population. CONCLUSION: The mixed-methods model discussed represents a refined, multi-phase protocol for incorporating qualitative data and community input in the development and evaluation of feasible, culturally-sound quantitative assessments and intervention models. The mixed-methods approach may be applied to research in other parts of sub-Saharan Africa and beyond.