Development and validation of a prediction tool to support engagement in HIV care among young people ages 10-24 years in Kenya.

INTRODUCTION: Loss to follow-up (LTFU) among adolescents and young adults living with HIV (AYALWH) is a barrier to optimal health and HIV services. We developed and validated a clinical prediction tool to identify AYALWH at risk of LTFU. METHODS: We used electronic medical records (EMR) of AYALWH ages 10 to 24 in HIV care at 6 facilities in Kenya and surveys from a subset of participants. Early LTFU was defined as >30 days late for a scheduled visit in the last 6 months, which accounts for clients with multi-month refills. We developed a tool combining surveys with EMR ('survey-plus-EMR tool'), and an 'EMR-alone' tool to predict high, medium, and low risk of LTFU. The survey-plus-EMR tool included candidate sociodemographics, partnership status, mental health, peer support, any unmet clinic needs, WHO stage, and time in care variables for tool development, while the EMR-alone included clinical and time in care variables only. Tools were developed in a 50% random sample of the data and internally validated using 10-fold cross-validation of the full sample. Tool performance was evaluated using Hazard Ratios (HR), 95% Confidence Intervals (CI), and area under the curve (AUC) ≥ 0.7 for good performance and ≥0.60 for modest performance. RESULTS: Data from 865 AYALWH were included in the survey-plus-EMR tool and early LTFU was (19.2%, 166/865). The survey-plus-EMR tool ranged from 0 to 4, including PHQ-9 ≥5, lack of peer support group attendance, and any unmet clinical need. High (3 or 4) and medium (2) prediction scores were associated with greater risk of LTFU (high, 29.0%, HR 2.16, 95%CI: 1.25-3.73; medium, 21.4%, HR 1.52, 95%CI: 0.93-2.49, global p-value = 0.02) in the validation dataset. The 10-fold cross validation AUC was 0.66 (95%CI: 0.63-0.72). Data from 2,696 AYALWH were included in the EMR-alone tool and early LTFU was 28.6% (770/2,696). In the validation dataset, high (score = 2, LTFU = 38.5%, HR 2.40, 95%CI: 1.17-4.96) and medium scores (1, 29.6%, HR 1.65, 95%CI: 1.00-2.72) predicted significantly higher LTFU than low-risk scores (0, 22.0%, global p-value = 0.03). Ten-fold cross-validation AUC was 0.61 (95%CI: 0.59-0.64). CONCLUSIONS: Clinical prediction of LTFU was modest using the surveys-plus-EMR tool and the EMR-alone tool, suggesting limited use in routine care. However, findings may inform future prediction tools and intervention targets to reduce LTFU among AYALWH.

Access to Oral Fluid-Based Human Immunodeficiency Virus Self-Tests Increases Testing Among Male Partners of Adolescent Girls in Kenya: A Randomized Controlled Trial.

PURPOSE: The risk of human immunodeficiency virus (HIV) among adolescent girls (AGs) may be reduced if they know the HIV status of their male partners. We assessed the ability of AGs in Siaya County, Kenya, to offer HIV self-tests to their partners to promote partner and couples testing. METHODS: Eligible AGs were 15-19 years old, self-tested HIV-negative, and had a male partner not tested in the past 6 months. Participants were randomly assigned to receive two oral fluid-based self-tests (intervention arm) or a referral coupon for facility-based testing (comparison arm). The intervention included counseling on ways to safely introduce self-tests to partners. Follow-up surveys were conducted within 3 months. RESULTS: Among 349 AGs enrolled, median age was 17 years (interquartile range 16-18), 88.3% of primary partners were noncohabiting boyfriends, and 37.5% were unaware if their partner had ever tested. At 3 months, 93.9% of the intervention arm and 73.9% of the comparison arm reported that partner testing occurred. Compared to the comparison arm, partner testing was more likely in the intervention arm (risk ratio = 1.27; 95% confidence interval 1.15-1.40; p < .001). Among participants whose partners got tested, 94.1% and 81.5% in the intervention and comparison arms, respectively, reported that couples testing occurred; couples testing was more likely in the intervention than comparison arm (risk ratio = 1.15; 95% confidence interval 1.15-1.27; p = .003). Five participants reported partner violence, one study-related. DISCUSSION: Provision of multiple self-tests to AGs for the purpose of promoting partner and couples testing should be considered in Kenya and other settings where AGs face a high risk of HIV acquisition.

Contrasting Comprehension of HIV Research by Adolescents, Young Adults, and Caregivers in Western Kenya: A Cross-sectional Analysis.

ABSTRACT: Adolescent participation in research is critical to inform interventions that improve outcomes for this group. Adolescents and young adults living with HIV often present to care without caregivers, yet caregiver permission is typically required for those younger than 18 years. We evaluated whether understanding of key consent information differed between adolescents ( n = 1,393) and caregiver adults ( n = 169). Compared with caregivers, adolescents aged 10-14 years showed significantly lower understanding, whereas understanding for older adults living with HIV did not differ significantly from caregivers. Risks were the least understood consent information for all age groups. Our findings suggest that for low-risk research, waiving caregiver permission requirements will not compromise the ethical need to ensure understanding of research before enrollment and may allow adolescents greater access to potential research benefits.

Health and Economic Outcomes Associated With COVID-19 in Women at High Risk of HIV Infection in Rural Kenya.

Importance: COVID-19 lockdowns may affect economic and health outcomes, but evidence from low- and middle-income countries remains limited. Objective: To assess the economic security, food security, health, and sexual behavior of women at high risk of HIV infection in rural Kenya during the COVID-19 pandemic. Design, Setting, and Participants: This survey study of women enrolled in a randomized trial in a rural county in Kenya combined results from phone interviews, conducted while social distancing measures were in effect between May 13 and June 29, 2020, with longitudinal, in-person surveys administered between September 1, 2019, and March 25, 2020. Enrolled participants were HIV-negative and had 2 or more sexual partners within the past month. Surveys collected information on economic conditions, food security, health status, and sexual behavior. Subgroup analyses compared outcomes by reliance on transactional sex for income and by educational attainment. Data were analyzed between May 2020 and April 2021. Main Outcomes and Measures: Self-reported income, employment hours, numbers of sexual partners and transactional sex partners, food security, and COVID-19 prevention behaviors. Results: A total of 1725 women participated, with a mean (SD) age of 29.3 (6.8) years and 1170 (68.0%) reporting sex work as an income source before the COVID-19 pandemic. During the pandemic, participants reported experiencing a 52% decline in mean (SD) weekly income, from $11.25 (13.46) to $5.38 (12.51) (difference, -$5.86; 95% CI, -$6.91 to -$4.82; P < .001). In all, 1385 participants (80.3%) reported difficulty obtaining food in the past month, and 1500 (87.0%) worried about having enough to eat at least once. Reported numbers of sexual partners declined from a mean (SD) total of 1.8 (1.2) partners before COVID-19 to 1.1 (1.0) during (difference, -0.75 partners; 95% CI, -0.84 to -0.67 partners; P < .001), and transactional sex partners declined from 1.0 (1.1) to 0.5 (0.8) (difference, -0.57 partners; 95% CI, -0.64 to -0.50 partners; P < .001). In subgroup analyses, women reliant on transactional sex for income were 18.3% (95% CI, 11.4% to 25.2%) more likely to report being sometimes or often worried that their household would have enough food than women not reliant on transactional sex (P < .001), and their reported decline in employment was 4.6 hours (95% CI, -7.9 to -1.2 hours) greater than women not reliant on transactional sex (P = .008). Conclusions and Relevance: In this survey study, COVID-19 was associated with large reductions in economic security among women at high risk of HIV infection in Kenya. However, shifts in sexual behavior may have temporarily decreased their risk of HIV infection.