Factors that influence the satisfaction of people living with HIV with differentiated antiretroviral therapy delivery models in east Central Uganda: a cross-sectional study.

BACKGROUND: The World Health Organization (WHO) and the Uganda Ministry of Health recommend differentiated service delivery models (DSDMs) as patient-centered antiretroviral therapy (ART) mechanisms for people living with HIV/AIDS (PLHIV) with undetectable viral loads. We studied patient satisfaction with ART services, and its associated factors amongst PLHIV enrolled in DSDMs in Uganda. METHODS: This cross-sectional study involved a random sample of PLHIV accessing DSDM-related ART at nine facilities in East Central Uganda. Eligible patients were adult PLHIV (≥18 years), on ART, and enrolled for at least 12 months in one of three DSDMs: Community Client-Led ART Delivery (CCLAD), Community Drug Distribution Points (CDDP), or Fast-Track Drug Refill (FTDR). We collected data from June to July 2019. A validated tool measured satisfaction. General Estimating Equations with modified Poisson regression and exchangeable correlation structures accounted for clustering at health facilities and identified DSDM-related satisfaction factors. RESULTS: Of 842 participants enrolled, 530 (63.5%) accessed HIV care through CDDP, 166 (20.1%) through CCLAD, and 146 (16.3%) through FTDR; 541 (64.2%) were satisfied with DSDM services: 78.7% in CDDP, 42.8% in CCLAD, and 36.3% in FTDR. The delivery and treatment factors positively associated with satisfaction included: being enrolled on CDDP [adjusted prevalence ratio (aPR) = 1.51, 95% CI:1.47-1.56] or FTDR [aPR = 1.47, 95% CI:1.26-1.71] relative to CCLAD and being enrolled in a DSDM for more than 3 years [aPR = 1.28, 95% CI:1.11-1.48]. Poor ART adherence [aPR = 0.33, 95% CI:0.19-0.56] and having a baseline WHO HIV stage of 3 or 4 [aPR = 0.36, 95% CI:0.20-0.64] relative to stages 1 and 2 were negatively associated. Among socioeconomic factors, having lower transport costs (< $1.35) per clinic visit [aPR = 1.34, 95% CI:1.17-1.53], being employed [aPR = 1.61, 95% CI:1.38-1.87], and being single [aPR = 1.10, 95% CI:1.08-1.13] were positively associated with satisfaction; drinking alcohol at least once a week [aPR = 0.77, 95% CI:0.63-0.93] was negatively associated with patient satisfaction. CONCLUSIONS: Results showed that 64.2% of patients were satisfied with DSDM services. HIV service delivery and treatment factors (DSDM type, time in DSDM, WHO stage, ART adherence), plus social factors (employment and marital status, transport costs, alcohol consumption), were associated with patient satisfaction. DSDM implementers should tailor services to address these factors to improve patient satisfaction.

Late Presentation With HIV in Africa: Phenotypes, Risk, and Risk Stratification in the REALITY Trial.

Background: Severely immunocompromised human immunodeficiency virus (HIV)-infected individuals have high mortality shortly after starting antiretroviral therapy (ART). We investigated predictors of early mortality and "late presenter" phenotypes. Methods: The Reduction of EArly MortaLITY (REALITY) trial enrolled ART-naive adults and children ≥5 years of age with CD4 counts <100 cells/µL initiating ART in Uganda, Zimbabwe, Malawi, and Kenya. Baseline predictors of mortality through 48 weeks were identified using Cox regression with backwards elimination (exit P > .1). Results: Among 1711 included participants, 203 (12%) died. Mortality was independently higher with older age; lower CD4 count, albumin, hemoglobin, and grip strength; presence of World Health Organization stage 3/4 weight loss, fever, or vomiting; and problems with mobility or self-care at baseline (all P < .04). Receiving enhanced antimicrobial prophylaxis independently reduced mortality (P = .02). Of five late-presenter phenotypes, Group 1 (n = 355) had highest mortality (25%; median CD4 count, 28 cells/µL), with high symptom burden, weight loss, poor mobility, and low albumin and hemoglobin. Group 2 (n = 394; 11% mortality; 43 cells/µL) also had weight loss, with high white cell, platelet, and neutrophil counts suggesting underlying inflammation/infection. Group 3 (n = 218; 10% mortality) had low CD4 counts (27 cells/µL), but low symptom burden and maintained fat mass. The remaining groups had 4%-6% mortality. Conclusions: Clinical and laboratory features identified groups with highest mortality following ART initiation. A screening tool could identify patients with low CD4 counts for prioritizing same-day ART initiation, enhanced prophylaxis, and intensive follow-up. Clinical Trials Registration: ISRCTN43622374.

Improving Iron and Folic Acid Supplementation Among Pregnant Women: An Implementation Science Approach in East-Central Uganda.

INTRODUCTION: To address maternal iron-deficiency anemia and low uptake of iron and folic acid supplementation (IFAS) among antenatal care (ANC) clinic attendees in East-Central Uganda, the Anemia Implementation Science Initiative embedded enhanced quality improvement (QI) activities into an integrated health project utilizing QI methodologies. METHODS: To address 2 bottlenecks of stock-outs and inadequate health education for pregnant women during ANC, an enhanced QI intervention was implemented from July 2019 to September 2020 in 2 districts. We conducted a mixed-methods effectiveness quasi-experimental study to assess whether the intervention increased the availability of IFAS in the intervention districts. We used longitudinal facility-level data from 2 treatment districts and 1 comparison district for the quantitative results. Difference-in-difference estimation was used to measure the impact of the intervention on IFAS health education and IFA availability at the health facility. We used logistic regression modeling to control for factors associated with IFAS uptake and potential differences in baseline values. Researchers conducted exit interviews with ANC clients and in-depth interviews with providers and district managers for greater insights into the implementation process. RESULTS: The intervention increased the probability, at a statistically significant level, of pregnant women both receiving IFAS and receiving health education on IFAS during ANC. According to inter-viewees, the intervention approach improved stakeholder engagement and buy-in, which brought about change at all levels of the health system. DISCUSSION: The intervention successfully addressed the 2 main bottlenecks to availability of IFAS for pregnant women attending ANC-inadequate provision of IFAS education and a weak drug quantification process. Even without additional funds to purchase commodities, this approach improved district capacity to advocate for and manage IFAS commodities. It could also be used to strengthen overall ANC quality.

Effect of ready-to-use supplementary food on mortality in severely immunocompromised HIV-infected individuals in Africa initiating antiretroviral therapy (REALITY): an open-label, parallel-group, randomised controlled trial.

BACKGROUND: In sub-Saharan Africa, severely immunocompromised HIV-infected individuals have a high risk of mortality during the first few months after starting antiretroviral therapy (ART). We hypothesise that universally providing ready-to-use supplementary food (RUSF) would increase early weight gain, thereby reducing early mortality compared with current guidelines recommending ready-to-use therapeutic food (RUTF) for severely malnourished individuals only. METHODS: We did a 2 × 2 × 2 factorial, open-label, parallel-group trial at inpatient and outpatient facilities in eight urban or periurban regional hospitals in Kenya, Malawi, Uganda, and Zimbabwe. Eligible participants were ART-naive adults and children aged at least 5 years with confirmed HIV infection and a CD4 cell count of fewer than 100 cells per µL, who were initiating ART at the facilities. We randomly assigned participants (1:1) to initiate ART either with (RUSF) or without (no-RUSF) 12 weeks' of peanut-based RUSF containing 1000 kcal per day and micronutrients, given as two 92 g packets per day for adults and one packet (500 kcal per day) for children aged 5-12 years, regardless of nutritional status. In both groups, individuals received supplementation with RUTF only when severely malnourished (ie, body-mass index [BMI] <16-18 kg/m2 or BMI-for-age Z scores <-3 for children). We did the randomisation with computer-generated, sequentially numbered tables with different block sizes incorporated within an online database. Randomisation was stratified by centre, age, and two other factorial randomisations, to 12 week adjunctive raltegravir and enhanced anti-infection prophylaxis (reported elsewhere). Clinic visits were scheduled at weeks 2, 4, 8, 12, 18, 24, 36, and 48, and included nurse assessment of vital status and symptoms and dispensing of all medication including ART and RUSF. The primary outcome was mortality at week 24, analysed by intention to treat. Secondary outcomes included absolute changes in weight, BMI, and mid-upper-arm circumference (MUAC). Safety was analysed in all randomly assigned participants. Follow-up was 48 weeks. This trial is registered with ClinicalTrials.gov (NCT01825031) and the ISRCTN registry (43622374). FINDINGS: Between June 18, 2013, and April 10, 2015, we randomly assigned 1805 participants to treatment: 897 to RUSF and 908 to no-RUSF. 56 (3%) were lost-to-follow-up. 96 (10·9%, 95% CI 9·0-13·1) participants allocated to RUSF and 92 (10·3%, 8·5-12·5) to no-RUSF died within 24 weeks (hazard ratio 1·05, 95% CI 0·79-1·40; log-rank p=0·75), with no evidence of interaction with the other randomisations (both p>0·7). Through 48 weeks, adults and adolescents aged 13 years and older in the RUSF group had significantly greater gains in weight, BMI, and MUAC than the no-RUSF group (p=0·004, 0·004, and 0·03, respectively). The most common type of serious adverse event was specific infections, occurring in 90 (10%) of 897 participants assigned RUSF and 87 (10%) of 908 assigned no-RUSF. By week 48, 205 participants had serious adverse events in both groups (p=0·81), and 181 had grade 4 adverse events in the RUSF group compared with 172 in the non-RUSF group (p=0·45). INTERPRETATION: In severely immunocompromised HIV-infected individuals, providing RUSF universally at ART initiation, compared with providing RUTF to severely malnourished individuals only, improved short-term weight gain but not mortality. A change in policy to provide nutritional supplementation to all severely immunocompromised HIV-infected individuals starting ART is therefore not warranted at present. FUNDING: Joint Global Health Trials Scheme (UK Medical Research Council, UK Department for International Development, and Wellcome Trust).