'I feel that I should decide on my own .': who should be involved in the decision-making process for adolescent involvement in HIV research?

INTRODUCTION: Efforts to improve health outcomes among adolescents and young adults living with HIV (ALHs) are hampered by limited adolescent engagement in HIV-related research. We sought to understand the views of adolescents, caregivers and healthcare workers (HCWs) about who should make decisions regarding ALHs' research participation. METHODS: We conducted focus group discussions (FGDs) and in-depth interviews (IDIs) with ALHs (aged 14-24 years), caregivers of ALHs and HCWs from six HIV care clinics in Western Kenya. We used semi-structured guides to explore ALHs' involvement in research decisions. Transcripts were analysed using thematic analysis; perspectives were triangulated between groups. RESULTS: We conducted 24 FGDs and 44 IDIs: 12 FGDs with ALHs, 12 with caregivers, and 44 IDIs with HCWs, involving 216 participants. HCWs often suggested that HIV research decision-making should involve caregivers and ALHs deciding together. In contrast, ALHs and parents generally thought decisions should be made individually, whether by HCWs/research teams (although this is likely ethically problematic), adolescents or caregivers. Caregiver and ALH preferences depended on ALHs' age, with younger ALHs requiring more support. A few caregivers felt that ALHs should consult with the research team/HCWs due to their greater knowledge of clinical care. ALHs emphasised that they should independently decide because they thought they had the right to do so and the capacity to consent. Poor communication and parental non-disclosure of HIV status influenced ALHs' views to exclude caregivers from decision-making. Regarding influences on research decision-making, ALHs were more willing to participate based on perceived contribution to science and less interested in participating in studies with potential risks, including loss of confidentiality. DISCUSSION: While research teams and HCWs felt that adolescents and caregivers should jointly make research decisions, ALHs and caregivers generally felt individuals should make decisions. As ALHs sometimes find caregiver support lacking, improving family dynamics might enhance research engagement.

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.

Effect of HIV stigma on depressive symptoms, treatment adherence, and viral suppression among youth with HIV.

OBJECTIVE: We estimated the effects of HIV stigma on mental health and treatment outcomes for youth with HIV (YWH). DESIGN: Secondary analysis of data for YWH ages 15-24 years in Western Kenya. METHODS: Participants completed a longitudinal survey (baseline, months 6 and 12) assessing socio-demographics, antiretroviral therapy (ART) adherence, depressive symptoms (PHQ-9), and HIV stigma (10-item Wright scale). First viral load (VL) after enrollment was abstracted from records. We estimated risk of depressive symptoms (score > 4), nonadherence (missing ≥2 days of ART in a month), and detectable VL (≥50 copies/ml) for each standard deviation (SD) increase in HIV stigma score, adjusted for age and sex (and regimen in VL model). The generalizing estimating equation models included measures for the three visits. RESULTS: Median age for the 1011 YWH was 18 years. At baseline, frequency of nonadherence, depressive symptoms and detectable VL was 21%, 21%, and 46%, respectively. Mean stigma score was 25 (SD = 7.0). Each SD stigma score increment was associated with higher risk of depressive symptoms {adjusted relative risk [aRR] 1.31 [95% confidence interval (CI): 1.20-1.44]}, nonadherence [aRR 1.16 (CI: 1.05-1.27)] and detectable VL [aRR 1.20 (CI: 1.08-1.32)]. Experienced and anticipated stigma were associated with detectable VL [aRR 1.16 (CI: 1.10-1.22) and aRR 1.23 (CI: 1.12-1.35), respectively]. Internalized and perceived community stigma were associated with depressive symptoms [aRR 1.31 (CI: 1.21-1.40) and aRR 1.24 (CI: 1.13-1.36), respectively]. CONCLUSIONS: Stigma was associated with depressive symptoms, nonadherence and detectable VL. Interventions to decrease stigma may improve virologic and mental health outcomes in YWH.

"[T]he laws need to change to reflect current society": Insights from stakeholders involved in development, review or implementation of policies about adolescent consent for HIV testing, care and research in Kenya.

INTRODUCTION: Engaging adolescents in HIV care and research promotes the development of interventions tailored to their unique needs. Guidelines generally require parental permission for adolescents to receive HIV care/testing or participate in research, with exceptions. Nevertheless, parental permission requirements can restrict adolescent involvement in care and research. To better appreciate prospects for policy reform, we sought to understand the perspectives of stakeholders involved in the development, review and implementation of policies related to adolescents living with HIV. METHODS: Semi-structured individual interviews (IDIs) were conducted from October 2019 to March 2020 with 18 stakeholders with expertise in the (1) development of policy through membership in the Law Society of Kenya or work as a health policy official; (2) review of policy through ethics review committee service; or (3) implementation of policy through involvement in adolescent education. IDIs were conducted in English by Kenyan social scientists, audio-recorded and transcribed verbatim. We used thematic analysis to identify themes around how policies can be reformed to improve adolescent engagement in HIV care and research. RESULTS: Our analysis identified three major themes. First, policies should be flexible rather than setting an age of consent. Stakeholders noted that adolescents' capacity for engagement in HIV care and research depended on context, perceived risks and benefits, and "maturity"-and that age was a poor proxy for the ability to understand. Second, policies should evolve with changing societal views about adolescent autonomy. Participants recognized a generational shift in how adolescents learn and mature, suggesting the need for a more frequent review of HIV care and research guidelines. Third, adults should empower adolescent decision-making. Stakeholders felt that caregivers can gradually involve adolescents in decision-making to equip them to gain ownership over their health and lives, improving their confidence and capacity. CONCLUSIONS: Revising relevant laws to consider context, alternative measures of maturity, and evolving societal views about adolescence, along with supporting caregivers to assist in developing adolescent autonomy may promote more equitable and representative participation of adolescents in HIV care and research. Additional research should explore how to support caregivers and other adults to empower adolescents and improve stakeholder engagement in a more routine process of policy reform.

Individual-, Interpersonal- and Institutional-Level Factors Associated with HIV Stigma Among Youth in Kenya.

HIV stigma remains a barrier in achieving optimal HIV treatment. We studied the prevalence and predictors of HIV stigma among adolescents and youth with HIV (AYWHIV) ages 15-24 years in Western Kenya. Of 1011 AYWHIV, 69% were female with a median age of 18 years. Most (59%) attended adolescent clinic days, and 40% attended support groups. One-quarter (27%) had experienced physical, 18% emotional, and 7% sexual violence. The majority of AYWHIV (88%) reported disclosure concerns, 48% reported perceived community stigma, 36% experienced, and 24% internalized stigma. Compared to AYWHIV attending adolescent clinics, those in general/adult clinics had higher internalized stigma. Similarly, having dropped out of school was associated with higher internalized stigma. AYWHIV in sexual relationships had higher experienced stigma and disclosure concerns. Lastly, exposure to violence was associated with higher experienced, internalized, perceived community stigma and disclosure concerns. These risk factors can be targeted when developing stigma-prevention interventions.

Data-informed stepped care to improve youth engagement in HIV care in Kenya: a protocol for a cluster randomised trial of a health service intervention.

INTRODUCTION: Adolescents and youth living with HIV (AYLHIV) have lower retention in care, adherence to treatment, and viral suppression compared with adults. Stepped care is a process by which clients are assigned to increasingly intensive services or 'steps' according to level of need. Differentiated care, in which stable clients access less frequent services, can be combined with stepped care to align needs and preferences of youth to promote optimal engagement in care. METHODS AND ANALYSIS: This hybrid type I effectiveness implementation cluster randomised trial aims to evaluate a data-informed stepped care (DiSC) intervention for AYLHIV. AYLHIV ages 10-24 receiving care at 24 HIV treatment facilities in Kisumu, Homabay and Migori counties in Kenya will be enrolled. Twelve facilities will be randomised to the DiSC intervention, and 12 will provide standard care. A clinical assignment tool developed by the study team will be used at intervention sites to assign AYLHIV to one of four steps based on risk for loss to follow-up: differentiated care, standard care, counselling services or intensive support services. The primary clinical outcome is retention in care, specifically missed visits (failure to return within 30 days for any visit) and 12-month loss to follow-up. Implementation outcomes are based on the Reach, Effectiveness, Adoption, Implementation and Maintenance framework. Proportions of missed visits will be compared using mixed effect models clustered by facility and participant. ETHICS AND DISSEMINATION: This study has been approved by the University of Washington Institutional Review Board (STUDY00011096), Maseno University Ethical Review Committee (MUERC/00917/20) and the Kenya National Commission for Science, Technology and Innovation (444824). AYLHIV provide written informed consent when legally permitted, or assent with caregiver permission for minors. Study staff will work with a Community Advisory Board, including youth members, to disseminate results via discussions, presentations, journal publications and local or international conferences. TRIAL REGISTRATION NUMBER: NCT05007717.

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.

The Psychosocial Effects of the COVID-19 Pandemic on Youth Living with HIV in Western Kenya.

The objective of this study was to assess psychosocial effects of COVID-19 among adolescents living with HIV (ALHIV) in Kenya and to assess the feasibility of conducting behavioral surveys by phone. We adapted our protocol to administer telephone rather than in-person follow-up surveys and included questions about COVID-19. The majority of participants (99%) reported having heard of COVID-19; 23% reported no longer being able to go outside, 17% reported that they could no longer go to their regular clinic for medical care, and 3% reported that they could no longer get medication refills. PHQ-9 screening identified 9% (n = 45) with mild depression symptoms, and 1% (n = 3) with moderate-to-severe depression symptoms. Young adults 20-24 years old had more mild to severe depressive symptoms than the younger age groups (p < 0.001). Offering remote peer-support or mental health care, continuing to offer differentiated care services, and considering financial support will support the health and well-being of ALHIV.

Factors Associated with Preference for Early Infant Male Circumcision Among a Representative Sample of Parents in Homa Bay County, Western Kenya.

Several countries scaling-up adult medical male circumcision (MMC) for HIV prevention intend to introduce early infant male circumcision (EIMC). To assess preference for EIMC in a community with a mature adult MMC program, we conducted a cross-sectional survey of a representative sample of mothers (n = 613) and fathers (n = 430) of baby boys ("index son") at 16 health facilities in western Kenya. Most (59 %) were for EIMC, generally. Just 29 % were for circumcising the index son. Pain and protection from HIV were the most frequently cited barrier and facilitator to EIMC, respectively. In multivariable logistic regression, ever talking with the partner about EIMC and positive serostatus were associated with preference for EIMC for the index son. Attitudes towards EIMC are favorable. Willingness to circumcise an infant son is modest. To facilitate EIMC uptake, education about EIMC pain management and encouraging discussion between parents about EIMC during pregnancy should be integrated into programs.

Safety of over twelve hundred infant male circumcisions using the Mogen clamp in Kenya.

BACKGROUND: Several sub-Saharan African countries plan to scale-up infant male circumcision (IMC) for cost-efficient HIV prevention. Little data exist about the safety of IMC in East and southern Africa. We calculated adverse event (AE) rate and risks for AEs associated with introduction of IMC services at five government health facilities in western Kenya. METHODS: AE data were analyzed for IMC procedures performed between September, 2009 and November, 2011. Healthy infants aged ≤ 2 months and weighing ≥ 2.5 kg were eligible for IMC. Following parental consent, trained clinicians provided IMC services free of charge under local anesthesia using the Mogen clamp. Odds ratios and 95% confidence intervals were used to explore AE risk factors. FINDINGS: A total of 1,239 IMC procedures were performed. Median age of infants was 4 days (IQR=1, 16). The overall AE rate among infants reviewed post-operatively was 2.7% (18/678; 95%CI: 1.4, 3.9). There was one severe AE involving excision of a small piece of the lateral aspect of the glans penis. Other AEs were mild or moderate and were treated conservatively. Babies one month of age or older were more likely to have an AE (OR 3.20; 95%CI: 1.23, 8.36). AE rate did not differ by nurse versus clinical officer or number of previous procedures performed. CONCLUSION: IMC services provided in Kenyan Government hospitals in the context of routine IMC programming have AE rates comparable to those in developed countries. The optimal time for IMC is within the first month of life.