Barriers continue to limit access to viral load (VL) monitoring across sub-Saharan Africa adversely impacting control of the HIV epidemic. The objective of this study was to determine whether the systems and processes required to realize the potential of rapid molecular technology are available at a prototypical lower-level (i.e., level III) health center in rural Uganda. In this open-label pilot study, participants underwent parallel VL testing at both the central laboratory (i.e., standard of care) and on-site using the GeneXpert HIV-1 assay. The primary outcome was the number of VL tests completed each clinic day. Secondary outcomes included the number of days from sample collection to receipt of result at clinic and the number of days from sample collection to patient receipt of the result. From August 2020 to July 2021, we enrolled a total of 242 participants. The median number of daily tests performed on the Xpert platform was 4, (IQR = 2–7). Time from sample collection to result was 51 days (IQR = 45–62) for samples sent to the central laboratory and 0 days (IQR = 0–0.25) for the Xpert assay conducted at the health center. However, few participants elected to receive results by one of the expedited options, which contributed to similar time-to-patient between testing approaches (89 versus 84 days, p = 0.07). Implementation of a rapid, near point-of-care VL assay at a lower-level health center in rural Uganda appears feasible, but interventions to promote rapid clinical response and influence patient preferences about result receipt require further study. Trial registration: ClinicalTrials.gov Identifier: NCT04517825, Registered 18 August 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT04517825.

Background Antiretroviral therapy (ART) improves the health of people living with HIV (PLHIV) and reduces HIV transmission. While availability and efficacy of ART have improved in sub-Saharan Africa (SSA), access remains a challenge. Travel burden, measured as travel time, distance, and cost, has been posited as a potential barrier to ART. For example, a previous study at a large, urban referral center in Uganda showed GPS-measured distance was associated with clinic absenteeism. However, others suggest that PLHIV are willing to travel farther for HIV care because of stigma or for higher quality care. Less is known about the effect of travel burden in rural settings where transportation infrastructure is sparse, and there are few transportation options. Therefore, the objective of this study funded by the IDSA GERM Program was to explore potential associations between distance- and time-to-clinic in a highland area of rural western Uganda with HIV outcomes including viral suppression. Methods We enrolled 129 adult participants receiving care at the Bugoye ART clinic. Using a handheld GPS device, we mapped routes between participants’ home and clinic recording trip distance, time, and mode of transportation. We abstracted clinical outcomes from participant medical records. Modified Poisson regression with robust error variance was used to estimate risk ratios of associations between main exposures (e.g., distance to clinic, time to clinic) and primary outcomes (e.g., detectable viral load, missed an ART dose, and history of opportunistic infection [OI]). Results Distance and time to clinic were significantly and positively associated with probability of detectable viral load. In adjusted analyses, for every 10-km increase in distance, participants were almost twice as likely to have detectable viral loads (PR: 1.95 [95% CI 1.12, 3.41]). For every 10 additional minutes spent traveling, risk of viral non-suppression increased by almost 40% (PR=1.39 [95% CI 1.08, 1.78]). Neither distance nor time to clinic was associated with increased risk having missed an ART dose or history of OI. Conclusion These results suggest travel burden may adversely affect achievement of 90/90/90 goals, and novel, decentralized ART distribution mechanisms may be required. Disclosures All Authors: No reported disclosures.

This article details the study protocol for a double-blind, randomized placebo-controlled trial to determine the effectiveness of permethrin-treated baby wraps to prevent Plasmodium falciparum malaria infection in children 6–24 months of age. Participating mother-infant dyads will be randomized to receive either a permethrin-treated or a sham-treated wrap, known locally as a “lesu.” After a baseline home visit, during which time all participants will receive new long-lasting insecticidal nets, participants will attend scheduled clinic visits every two weeks for a period of 24 weeks. In the event of an acute febrile illness or other symptoms that may be consistent with malaria (e.g., poor feeding, headache, malaise), participants will be instructed to present to their respective study clinic for evaluation. The primary outcome of interest is the incidence of laboratory-confirmed, symptomatic malaria in participating children. Secondary outcomes of interest include: (1) change in children’s hemoglobin levels; (2) change in children’s growth parameters; (3) prevalence of asymptomatic parasitemia in children; (4) hospitalization for malaria in children; (5) change in the mother’s hemoglobin level; and (6) clinical malaria in the mother. Analyses will be conducted using a modified intent-to-treat approach, with woman-infant dyads who attend one or more clinic visits analyzed according to the arm to which they were randomly assigned. This is the first use of an insecticide-treated baby wrap for prevention of malaria in children. The study began recruitment in June 2022 and is ongoing. ClinicalTrials.gov Identifier: NCT05391230, Registered 25 May 2022.