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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.

Background Despite Rwanda’s progress toward HIV epidemic control, 16.2% of HIV-positive individuals are unaware of their HIV positive status. Tailoring the public health strategy could help reach these individuals with new HIV infection and achieve epidemic control. Recency testing is primarily for surveillance, monitoring, and evaluation but it’s not for diagnostic purposes. However, it’s important to know what proportion of the newly diagnosed are recent infections so that HIV prevention can be tailored to the profile of people who are recently infected. We therefore used available national data to characterize individuals with recent HIV infection in Rwanda to inform the epidemic response. Methods We included all national-level data for recency testing reported from October 2018 to June 2020. Eligible participants were adults (aged ≥15 years) who had a new HIV diagnosis, who self-reported being antiretroviral therapy (ART) naïve, and who had consented to recency testing. Numbers and proportions of recent HIV infections were estimated, and precision around these estimates was calculated with 95% confidence intervals (CI). Logistic regression was used to assess factors associated with being recently (within 12 months) infected with HIV. Results Of 7,785 eligible individuals with a new HIV-positive diagnosis, 475 (6.1%) met the criteria for RITA recent infection. The proportion of RITA recent infections among individuals with newly identified HIV was high among those aged 15–24 years (9.6%) and in men aged ≥65 years (10.3%) compared to other age groups; and were higher among women (6.7%) than men (5.1%). Of all recent cases, 68.8% were women, and 72.2% were aged 15–34 years. The Northern province had the fewest individuals with newly diagnosed HIV but had the highest proportion of recent infections (10.0%) compared to other provinces. Recent infections decreased by 19.6% per unit change in time (measured in months). Patients aged ≥25 years were less likely to have recent infection than those aged 15–24 years with those aged 35–49 years being the least likely to have recent infection compared to those aged 15–24 years (adjusted odds ratio [aOR], 0.415 [95% CI: 0.316–0.544]). Conclusion Public health surveillance targeting the areas and the identified groups with high risk of recent infection could help improve outcomes.

Nearly a quarter of a million children have acquired HIV, prompting the implementation of new protocols-Option B and B+-for treating HIV+ pregnant women. While efficacy has been demonstrated in randomized trials, there is limited real-world evidence on the impact of these changes. Using longitudinal, routinely collected data we assessed the impact of the adoption of WHO Option B in Rwanda on mother to infant transmission.We used interrupted time series analysis to evaluate the impact of Option B on mother-to-child HIV transmission in Rwanda. Our primary outcome was the proportion of HIV tests in infants with positive results at six weeks of age. We included data for 20 months before and 22 months after the 2010 policy change.Of the 15,830 HIV tests conducted during our study period, 392 tested positive. We found a significant decrease in both the level (-2.08 positive tests per 100 tests conducted, 95% CI: -2.71 to -1.45, p < 0.001) and trend (-0.11 positive tests per 100 tests conducted per month, 95% CI: -0.16 to -0.07, p < 0.001) of test positivity. This represents an estimated 297 fewer children born without HIV in the post-policy period or a 46% reduction in HIV transmission from mother to child.The adoption of Option B in Rwanda contributed to an immediate decrease in the rate of HIV transmission from mother to child. This suggests other countries may benefit from adopting these WHO guidelines.

There are limited viral load (VL) data available from programs implementing "Option B+," lifelong antiretroviral treatment (ART) to all HIV-positive pregnant and postpartum women, in resource-limited settings. Extent of viral suppression from a prevention of mother-to-child transmission of HIV program in Rwanda was assessed among women enrolled in the Kigali Antiretroviral and Breastfeeding Assessment for the Elimination of HIV (Kabeho) Study. ARV drug resistance testing was conducted on women with VL>2000 copies/ml. In April 2013-January 2014, 608 pregnant or early postpartum HIV-positive women were enrolled in 14 facilities. Factors associated with detectable enrollment VL (>20 copies/ml) were examined using generalized estimating equations. The most common antiretroviral regimen (56.7%, 344/607) was tenofovir/lamivudine/efavirenz. Median ART duration was 13.5 months (IQR 3.0-48.8); 76.1% of women were on ART at first antenatal visit. Half of women (315/603) had undetectable RNA-PCR VL and 84.6% (510) had 36 months compared to those on ART 4-36 months (72/191, 37.7% versus 56/187, 29.9%), though the difference was not significant. The odds of having detectable enrollment VL decreased significantly as duration on ART at enrollment increased (AOR = 0.99, 95% CI: 0.9857, 0.9998, p = 0.043). There was a higher likelihood of detectable VL for women with lower gravidity (AOR = 0.90, 95% CI: 0.84, 0.97, p = 0.0039), no education (AOR = 2.25, (95% CI: 1.37, 3.70, p = 0.0004), nondisclosure to partner (AOR = 1.97, 95% CI: 1.21, 3.21, p = 0.0063) and side effects (AOR = 2.63, 95% CI: 1.72, 4.03, p 36 months with genotyping available. Most women were receiving ART at first antenatal visit, with relatively high viral suppression rates. Shorter ART duration was associated with higher VL, with a concerning increasing trend for higher viremia and drug resistance among women on ART for >3 years.

Rwanda's National PMTCT program aims to achieve elimination of new HIV infections in children by 2015. In November 2010, Rwanda adopted the WHO 2010 ARV guidelines for PMTCT recommending Option B (HAART) for all HIV-positive pregnant women extended throughout breastfeeding and discontinued (short course-HAART) only for those not eligible for life treatment. The current study aims to assess the cost-effectiveness of this policy choice.Based on a cohort of HIV-infected pregnant women in Rwanda, we modelled the cost-effectiveness of six regimens: dual ARV prophylaxis with either 12 months breastfeeding or replacement feeding; short course HAART (Sc-HAART) prophylaxis with either 6 months breastfeeding, 12 months breastfeeding, or 18 months breastfeeding; and Sc-HAART prophylaxis with replacement feeding. Direct costs were modelled based on all inputs in each scenario and related unit costs. Effectiveness was evaluated by measuring HIV-free survival at 18 months. Savings correspond to the lifetime costs of HIV treatment and care avoided as a result of all vertical HIV infections averted.All PMTCT scenarios considered are cost saving compared to "no intervention." Sc-HAART with 12 months breastfeeding or 6 months breastfeeding dominate all other scenarios. Sc-HAART with 12 months breastfeeding allows for more children to be alive and HIV-uninfected by 18 months than Sc-HAART with 6 months breastfeeding for an incremental cost per child alive and uninfected of 11,882 USD. This conclusion is sensitive to changes in the relative risk of mortality by 18 months for exposed HIV-uninfected children on replacement feeding from birth and those who were breastfed for only 6 months compared to those breastfeeding for 12 months or more.Our findings support the earlier decision by Rwanda to adopt WHO Option B and could inform alternatives for breastfeeding duration. Local contexts and existing care delivery models should be part of national policy decisions.

INTRODUCTION: We sought to compare risk of death among children aged under-2 years born to HIV positive mother (HIV-exposed) and to HIV negative mother (HIV non-exposed), and identify determinants of under-2 mortality among the two groups in Rwanda. METHODS: In a stratified, two-stage cluster sampling design, we selected mother-child pairs using national Antenatal Care (ANC) registers. Household interview with each mother was conducted to capture socio-demographic data and information related to pregnancy, delivery and post-partum. Data were censored at the date of child death. Using Cox proportional hazard model, we compared the hazard of death among HIV-exposed children and HIV non-exposed children. RESULTS: Of 1,455 HIV-exposed children, 29 (2.0%; 95% CI: 1.3%-2.7%) died by 6 months compared to 18 children of the 1,565 HIV non-exposed children (1.2%; 95% CI: 0.6%-1.7%). By 9 months, cumulative risks of death were 3.0% (95%; CI: 2.2%-3.9%) and 1.3% (96%; CI: 0.7%-1.8%) among HIV-exposed and HIV non-exposed children, respectively. By 2 years, the hazard of death among HIV-exposed children was more than 3 times higher (aHR:3.5; 95% CI: 1.8-6.9) among HIV-exposed versus non-exposed children. Risk of death by 9-24 months of age was 50% lower among mothers who attended 4 or more antenatal care (ANC) visits (aHR: 0.5, 95% CI: 0.3-0.9), and 26% lower among families who had more assets (aHR: 0.7, 95% CI: 0.5-1.0). CONCLUSION: Infant mortality was independent of perinatal HIV exposure among children by 6 months of age. However, HIV-exposed children were 3.5 times more likely to die by 2 years,. Fewer antenatal visits, lower household assets and maternal HIV seropositive status were associated with increased mortality by 9-24 months.