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.

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.

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.