Impact of the COVID-19 pandemic on mental health and viral suppression among persons living with HIV in western Washington.

The COVID-19 pandemic and social distancing measures elevated stress levels globally, exacerbating mental health challenges for people with HIV (PWH). We examined the effect of COVID-19-related stress on mental health among PWH in western Washington, exploring whether social support and coping self-efficacy were protective. Data on COVID-19-related stress, mental health, social support, and coping self-efficacy were collected using online surveys during the pandemic. Pre-COVID-19 mental health data were available for a subset of participants and were linked with the survey data. In the total sample (N = 373), COVID-19-stress was associated with elevated depression (PHQ-8, ß = 0.21, 95%CI [0.10, 0.32]) and anxiety (GAD-7, ß = 0.28, 95%CI [0.17, 0.39]). Among the subset of respondents with pre-pandemic mental health data (N = 103), COVID-19-related stress was associated with elevated PHQ-8 scores (ß = 0.35, 95%CI [0.15, 0.56]) and GAD-7 scores (ß = 0.35, 95%CI [0.16, 0.54]), adjusted for baseline mental health and other confounders. Coping self-efficacy was negatively associated with GAD-7 scores (ß = -0.01, 95%CI [-0.01, 0.00]), while social support was negatively associated with PHQ-8 scores (ß = -0.06, 95%CI [-0.12, -0.01]). Viral suppression before and during the pandemic did not differ among participants with available data. While COVID-19-related stress predicted elevated depression and anxiety symptoms among PWH, social support and coping self-efficacy were protective.

Mobile solutions to Empower reproductive life planning for women living with HIV in Kenya (MWACh EMPOWER): Protocol for a cluster randomized controlled trial.

BACKGROUND: Women living with HIV (WLWH) face unique reproductive health (RH) barriers which increase their risks of unmet need for contraception, contraceptive failure, unintended pregnancy, and pregnancy-related morbidity and mortality and may prevent them from achieving their reproductive goals. Patient-centered counseling interventions that support health care workers (HCWs) in providing high-quality RH counseling, tailored to the needs of WLWH, may improve reproductive health outcomes. METHODS AND DESIGN: We are conducting a non-blinded cluster randomized controlled trial (cRCT) of a digital health intervention for WLWH (clinicaltrials.gov #NCT05285670). We will enroll 3,300 WLWH seeking care in 10 HIV care and treatment centers in Nairobi and Western Kenya. WLWH at intervention sites receive the Mobile WACh Empower intervention, a tablet-based RH decision-support counseling tool administered at baseline and SMS support during two years of follow-up. WLWH at control sites receive the standard of care FP counseling. The decision-support tool is a logic-based tool for family planning (FP) counseling that uses branching logic to guide RH questions based on participants' reproductive life plans, tailoring counseling based on the responses. Follow-up SMSs are based in the Information-Motivation-Behavioral (IMB) Skills model of behavioral change and are tailored to participant characteristics and reproductive needs through separate SMS "tracks". Follow-up visits are scheduled quarterly for 2 years to assess plans for pregnancy, pregnancy prevention, and contraceptive use. The primary outcome, FP discontinuation, will be compared using an intent-to-treat analysis. We will also assess the unmet need for FP, dual method use, viral load suppression at conception and unintended pregnancy. DISCUSSION: The Mobile WACh Empower intervention is innovative as it combines a patient-centered counseling tool to support initial reproductive life decisions with longitudinal SMS for continued RH support and may help provide RH care within the context of provision of HIV care.

Electronic Medical Record Data Missingness and Interruption in Antiretroviral Therapy Among Adults and Children Living With HIV in Haiti: Retrospective Longitudinal Study.

Background: Children (aged 0-14 years) living with HIV often experience lower rates of HIV diagnosis, treatment, and viral load suppression. In Haiti, only 63% of children living with HIV know their HIV status (compared to 85% overall), 63% are on treatment (compared to 85% overall), and 48% are virally suppressed (compared to 73% overall). Electronic medical records (EMRs) can improve HIV care and patient outcomes, but these benefits are largely dependent on providers having access to quality and nonmissing data. Objective: We sought to understand the associations between EMR data missingness and interruption in antiretroviral therapy treatment by age group (pediatric vs adult). Methods: We assessed associations between patient intake record data missingness and interruption in treatment (IIT) status at 6 and 12 months post antiretroviral therapy initiation using patient-level data drawn from iSanté, the most widely used EMR in Haiti. Missingness was assessed for tuberculosis diagnosis, World Health Organization HIV stage, and weight using a composite score indicator (ie, the number of indicators of interest missing). Risk ratios were estimated using marginal parameters from multilevel modified Poisson models with robust error variances and random intercepts for the facility to account for clustering. Results: Data were drawn from 50 facilities and comprised 31,457 patient records from people living with HIV, of which 1306 (4.2%) were pediatric cases. Pediatric patients were more likely than adult patients to experience IIT (n=431, 33% vs n=7477, 23.4% at 6 months; P<.001). Additionally, pediatric patient records had higher data missingness, with 581 (44.5%) pediatric records missing at least 1 indicator of interest, compared to 7812 (25.9%) adult records (P<.001). Among pediatric patients, each additional indicator missing was associated with a 1.34 times greater likelihood of experiencing IIT at 6 months (95% CI 1.08-1.66; P=.008) and 1.24 times greater likelihood of experiencing IIT at 12 months (95% CI 1.05-1.46; P=.01). These relationships were not statistically significant for adult patients. Compared to pediatric patients with 0 missing indicators, pediatric patients with 1, 2, or 3 missing indicators were 1.59 (95% CI 1.26-2.01; P<.001), 1.74 (95% CI 1.02-2.97; P=.04), and 2.25 (95% CI 1.43-3.56; P=.001) times more likely to experience IIT at 6 months, respectively. Among adult patients, compared to patients with 0 indicators missing, having all 3 indicators missing was associated with being 1.32 times more likely to experience IIT at 6 months (95% CI 1.03-1.70; P=.03), while there was no association with IIT status for other levels of missingness. Conclusions: These findings suggest that both EMR data quality and quality of care are lower for children living with HIV in Haiti. This underscores the need for further research into the mechanisms by which EMR data quality impacts the quality of care and patient outcomes among this population. Efforts to improve both EMR data quality and quality of care should consider prioritizing pediatric patients.

Does HIV index testing bring patients into treatment at earlier stages of HIV disease? Results from a retrospective study in Ukraine.

BACKGROUND: Over one-third of people living with HIV (PLH) in Ukraine are not on treatment. Index testing services, which link potentially exposed partners (named partners) of known PLH (index patients) with testing and treatment services, are being scaled in Ukraine and could potentially close this gap. METHODS: This retrospective study included patient data from 14,554 adult PLH who initiated antiretroviral treatment (ART) between October 2018 and May 2021 at one of 35 facilities participating in an intervention to strengthen index testing services. Mixed effects modified Poisson models were used to assess differences between named partners and other ART initiators, and an interrupted time series (ITS) analysis was used to assess changes in ART initiation over time. RESULTS: Compared to other ART initiators, named partners were significantly less likely to have a confirmed TB diagnosis (aRR = 0.56, 95% CI = 0.40, 0.77, p < 0.001), a CD4 count less than 200 cells/mm3 (aRR = 0.84, 95% CI = 0.73, 0.97, p = 0.017), or be categorized as WHO HIV stage 4 (aRR = 0.68, 9% CI = 0.55, 0.83, p < 0.001) at the time of ART initiation, and were significantly more likely to initiate ART within seven days of testing for HIV (aRR = 1.36, 95% CI = 1.22, 1.50, p < 0.001). Our ITS analysis showed a modest 2.34% (95% CI = 0.26%, 4.38%; p = 0.028) month-on-month reduction in mean ART initiations comparing the post-intervention period to the pre-intervention period, although these results were likely confounded by the COVID epidemic. CONCLUSION: Our findings suggest that index testing services may be beneficial in bringing PLH into treatment at an earlier stage of HIV disease and decreasing delays between HIV testing and ART initiation, potentially improving patient outcomes and retention in the HIV care cascade.

Impact of the COVID-19 Pandemic on Persons Living with HIV in Western Washington: Examining Lived Experiences of Social Distancing Stress, Personal Buffers, and Mental Health.

Pandemic-related stressors may disproportionately affect the mental health of people with HIV (PWH). Stratified, purposive sampling was used to recruit 24 PWH who participated in a quantitative survey on COVID-19 experiences for in-depth interviews (IDIs). IDIs were conducted by Zoom, audio recorded and transcribed. Thematic analysis was used to develop an adapted stress-coping model. Participants experienced acute stress following exposure events and symptoms compatible with COVID-19. Social isolation and job loss were longer-term stressors. While adaptive coping strategies helped promote mental health, participants who experienced multiple stressors simultaneously often felt overwhelmed and engaged in maladaptive coping behaviors. Healthcare providers were important sources of social support and provided continuity in care and referrals to mental health and social services. Understanding how PWH experienced stressors and coped during the COVID-19 pandemic can help healthcare providers connect with patients during future public health emergencies, address mental health needs and support adaptive coping strategies.

"Take services to the people": strategies to optimize uptake of PrEP and harm reduction services among people who inject drugs in Uganda.

BACKGROUND: People who inject drugs (PWID) are at increased risk of HIV acquisition and often encounter barriers to accessing healthcare services. Uganda has high HIV prevalence among PWID and lacks integrated pre-exposure prophylaxis (PrEP) and harm reduction services. Understanding PWID experiences accessing and using harm reduction services and PrEP will inform strategies to optimize integration that align with PWID needs and priorities. METHODS: Between May 2021 and March 2023, we conducted semi-structured interviews with PWID in Kampala, Uganda. We recruited participants with and without previous experience accessing harm reduction services and/or PrEP using purposive and snowball sampling. Interviews were audio recorded, translated, and transcribed. We used thematic analysis to characterize motivations for uptake of harm reduction and HIV prevention services, and strategies to optimize delivery of needle and syringe programs (NSP), medications for opioid use disorder (MOUD), and PrEP. RESULTS: We conducted interviews with 41 PWID. Most participants were relatively aware of their personal HIV risk and accurately identified situations that increased risk, including sharing needles and engaging in transactional sex. Despite risk awareness, participants described engaging in known HIV risk behaviors to satisfy immediate drug use needs. All reported knowledge of harm reduction services, especially distribution of sterile needles and syringes, and many reported having experience with MOUD. Participants who had accessed MOUD followed two primary trajectories; limited resources and relationships with other PWID caused them to discontinue treatment while desire to regain something they believed was lost to their drug use motivated them to continue. Overall, PrEP knowledge among participants was limited and few reported ever taking PrEP. However, participants supported integrating PrEP into harm reduction service delivery and advocated for changes in how these services are accessed. Stigma experienced in healthcare facilities and challenges acquiring money for transportation presented barriers to accessing current facility-based harm reduction and HIV prevention services. CONCLUSIONS: Meeting the HIV prevention needs of PWID in Uganda will require lowering barriers to access, including integrated delivery of PrEP and harm reduction services and bringing services directly to communities. Additional training in providing patient-centered care for healthcare providers may improve uptake of facility-based services.

Estimating the costs of adolescent HIV care visits and an intervention to facilitate transition to adult care in Kenya.

INTRODUCTION: Adolescents with HIV in sub-Saharan Africa face challenges transitioning to adult HIV care, which can affect long-term HIV care adherence and retention. An adolescent transition package (ATP) focused on transition tools can improve post-transition clinical outcomes, but its implementation costs are unknown. METHODS: We estimated the average cost per patient of an HIV care visit and ATP provision to adolescents. Data was collected from 13 HIV clinics involved in a randomized clinical trial evaluating ATP in western Kenya. We conducted a micro-costing and activity-driven time estimation to assess costs from the provider perspective. We developed a flow-map, conducted staff interviews, and completed time and motion observation. ATP costs were estimated as the difference in average cost for an HIV care transition visit in the intervention compared to control facilities. We assessed uncertainty in costing estimates via Monte Carlo simulations. RESULTS: The average cost of an adolescent HIV care visit was 29.8USD (95%CI 27.5, 33.4) in the standard of care arm and 32.9USD (95%CI 30.5, 36.8) in the ATP intervention arm, yielding an incremental cost of 3.1USD (95%CI 3.0, 3.4) for the ATP intervention. The majority of the intervention cost (2.8USD) was due ATP booklet discussion with the adolescent. CONCLUSION: The ATP can be feasibly implemented in HIV care clinics at a modest increase in overall clinic visit cost. Our cost estimates can be used to inform economic evaluations or budgetary planning of adolescent HIV care interventions in Kenya.

Adolescent experiences, perceptions, and preferences for the process of HIV status disclosure in Kenya.

Introduction: Disclosure of HIV status to adolescents living with HIV has been associated with improved treatment outcomes. However, there are limited data regarding the experiences of, perceptions of, and preferences for the process of disclosure of HIV status among adolescents and young adults living with HIV (AYLH), especially in sub-Saharan Africa. Methods: Young adults living with HIV from 20 HIV clinics in Kenya who participated in a clinical trial evaluating the effectiveness of a disclosure and transition package completed an anonymous survey in 2019. We described their experiences and preferences using counts and proportions and assessed factors associated with satisfaction with the disclosure process using linear regression, reporting age-adjusted mean differences (aMD), and 95% confidence intervals (95%CIs). Results: Of the 375 enrolled AYLH, 265 (71%) had perinatally acquired HIV, of whom 162 (61%) were female. The median age of the enrolled AYLH was 16 years (IQR: 14-19 years), and all of them were on antiretroviral therapy (ART). For over half (55%) of the participants, caregivers disclosed their HIV status, and 57% preferred that their caregivers disclose the status to them. Most (78%) of the participants preferred full disclosure by 12 years of age. The majority (69%) believed the disclosure was planned, and 11% suspected being HIV positive before the disclosure. Overall, 198 (75%) AYLH reported that they were ready for disclosure when it happened, and 86% were satisfied with the process. During both pre-disclosure (67 and 70%, respectively) and post-disclosure (>75% for each), AYLH felt supported by the clinic and caregivers. Factors associated with higher satisfaction with the disclosure process were pre-disclosure clinic support (aMD: 0.19 [95%CI: 0.05-0.33]) and pre-disclosure (aMD: 0.19 [0.06-0.31]) and post-disclosure (aMD: 0.17 [0.03-0.31]) caregiver support. AYLH who suspected they were HIV positive before they were disclosed to tended to have lower satisfaction when compared to those who never suspected (aMD: -0.37 [-0.74-(-0.01)]). Overall, they reported that disclosure positively influenced their ART adherence (78%), clinic attendance (45%), and communication with caregivers (20%), and 40% reported being happier after disclosure. Conclusion: Young adults living with HIV advocated for an appropriately timed disclosure process with the involvement of caregivers and healthcare workers (HCWs). Support from caregivers and HCWs before and during disclosure is key to improving their disclosure experience.

"Pharmacies are Everywhere, and You can get it at any Time": Experiences With Pharmacy-Based PrEP Delivery Among Adolescent Girls and Young Women in Kisumu, Kenya.

INTRODUCTION: Many Kenyan adolescent girls and young women (AGYW) with behaviors associated with HIV acquisition access contraception at retail pharmacies. Offering oral pre-exposure prophylaxis (PrEP) in pharmacies could help reach AGYW with PrEP services. METHODS: We piloted PrEP delivery at 3 retail pharmacies in Kisumu, Kenya. AGYW purchasing contraception were offered PrEP by nurses with remote prescriber oversight. AGYW who accepted were provided with a free 1-month supply. We conducted in-depth interviews with AGYW 30 days postobtaining PrEP. Transcripts were analyzed to explore experiences of AGYW accessing PrEP at pharmacies. RESULTS: We conducted 41 interviews. AGYW preferred pharmacies for accessing PrEP and they were willing to pay for PrEP even if available for free at clinics. Reasons for this preference included accessibility, lack of queues, and medication stockouts, privacy, anonymity, autonomy, and high-quality counseling from our study nurses. CONCLUSIONS: Pharmacies may be an important PrEP access option for this population.

Implementation determinants and strategies in integration of PrEP into maternal and child health and family planning services: experiences of frontline healthcare workers in Kenya.

Background: Delivery of PrEP to adolescent girls and young women (AGYW) and to pregnant women through maternal and child health (MCH) and family planning (FP) clinics is scaling up in Kenya. Evaluation of implementation challenges and strategies is critical to optimize delivery. Methods: We conducted focus group discussions (FGDs) with healthcare workers (HCWs) in MCH and FP clinics offering PrEP in a large implementation project in Kisumu, Kenya. Discussion guides were based on the Consolidated Framework for Implementation Research (CFIR). FGDs were audio recorded and transcribed. Directed content analysis was used to identify implementation challenges and strategies to overcome them. Results: Fifty HCWs from 26 facilities participated in 8 FGDs. HCWs believed PrEP integration was appropriate because it met the needs of AGYW and pregnant women by providing a female-controlled prevention strategy and aligned with policy priorities of elimination of vertical HIV transmission. They were universally accepting of PrEP provision, especially through MCH clinics, noting the relative advantage of this approach because it: (1) enabled high coverage, (2) harmonized PrEP and MCH visits, and (3) minimized stigma compared to PrEP offered through HIV care clinics. However, HCWs noted implementation challenges affecting feasibility and adoption including: (1) increased workload and documentation burden amid workforce shortages, (2) insufficient health care worker knowledge (3) multiple implementing partners with competing priorities (4) drug and documentation form stockouts. HCWs employed various implementation strategies to overcome challenges, including task shifting from nurses to HIV testing providers, patient flow modifications (e.g., fast-tracking PrEP clients to reduce wait times), PrEP demand generation and myth clarification during health talks, provider education, dedicated PrEP delivery rooms, and coordination with adolescent-friendly services. Additional suggested strategies to improve PrEP integration included community education to increase broader PrEP awareness and enable shorter counseling sessions, and task-shifting data entry and client risk assessments. Conclusions: HCWs were enthusiastic about the appropriateness and acceptability of integrating PrEP services into MCH and FP clinics but noted challenges to adoption and feasibility. Strategies to address challenges focused on improving provider time and space constraints, and increasing provider and client knowledge.

Characterizing provider-led adaptations to mobile phone delivery of the Adolescent Transition Package (ATP) in Kenya using the Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS): a mixed methods approach.

BACKGROUND: The COVID-19 pandemic resulted in disruptions to routine HIV services for youth living with HIV (YLH), provoking rapid adaptation to mitigate interruptions in care. The Adolescent Transition to Adult Care for HIV-infected adolescents (ATTACH) study (NCT03574129) was a hybrid I cluster randomized trial testing the effectiveness of a healthcare worker (HCW)-delivered disclosure and transition intervention - the Adolescent Transition Package (ATP). During the pandemic, HCWs leveraged phone delivery of the ATP and were supported to make adaptations. We characterized real-time, provider-driven adaptations made to support phone delivery of the ATP. METHODS: We conducted continuous quality improvement (CQI) meetings with HCWs involved in phone delivery of the ATP at 10 intervention sites. CQI meetings used plan-do-study-act (PDSA) cycles and were audio-recorded. Adaptations were coded by two-independent coders using the Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS). Adaptation testing outcomes (adopt, retest, or abandon) and provider experience implementing the adaptations were also recorded. We summarized adaptation characteristics, provider experience, and outcomes. RESULTS: We identified 72 adaptations, 32 were unique. Overall, adaptations included modification to context (53%, n = 38), content (49%, n = 35), and evaluation processes (13%, n = 9). Context adaptations primarily featured changes to personnel, format, and setting, while content and evaluation adaptations were frequently achieved by simple additions, repetition, and tailoring/refining of the phone delivery strategy. Nine adaptations involved abandoning, then returning to phone delivery. HCWs sought to increase reach, improve fidelity, and intervention fit within their context. Most adaptations (96%, n = 69) were perceived to increase the feasibility of phone delivery when compared to before the changes were introduced, and HCWs felt 83% (n = 60) of adaptations made phone delivery easier. Most adaptations were either incorporated into routine workflows (47%) or tested again (47%). CONCLUSION: Adaptation of phone delivery was a feasible and effective way of addressing challenges with continuity of care for YLH during the COVID-19 pandemic. Adaptations were primarily context adaptions. While FRAME-IS was apt for characterizing adaptations, more use cases are needed to explore the range of its utility. TRIAL REGISTRATION: Trial registered on ClinicalTrial.gov as NCT03574129.

Mortality and Loss to Follow-Up Among Adolescents and Young Adults Attending HIV Care Programs in Kenya.

Mortality and loss to follow-up (LTFU) among adolescents and youth living with HIV (AYLHIV) remain high. We evaluated mortality and LTFU during the test and treat era. We abstracted medical records of AYLHIV for 10-24 years between January 2016 and December 2017 in 87 HIV clinics in Kenya. Using competing risk survival analysis, we compared incidence rates and determined correlates of mortality and LTFU among newly enrolled [<2 years since antiretroviral therapy (ART) initiation] and AYLHIV on ART for ≥2 years. Among 4201 AYLHIV, 1452 (35%) and 2749 (65%) were new enrollments and on ART for ≥2 years, respectively. AYLHIV on antiretroviral therapy (ART) for ≥2 years were younger and more likely to have perinatally acquired HIV (p < 0.001). Incidence of mortality and LTFU per 100 person-years were 2.32 [95% confidence interval (CI): 1.64-3.28] and 37.8 (95% CI: 34.7-41.3), respectively, among new enrollments and 1.22 (95% CI: 0.94-1.59) and 10.2 (95% CI: 9.3-11.1), respectively, among those on ART for ≥2 years. New enrollments had almost twice higher risk of mortality [subdistribution hazard ratio (sHR) 1.92 (1.30, 2.84), p = 0.001] and sevenfold higher risk of LTFU [sHR 7.71 (6.76, 8.79), p < 0.001] than those on ART for ≥2 years. Among new enrollments, mortality was higher in males and those with World Health Organization (WHO) stage III/IV disease at enrollment, and LTFU was associated with pregnancy, older age, and nonperinatal acquisition. Female sex and WHO stage (I/II) were associated with LTFU among those on ART for ≥2 years. During the study period from January 1, 2016, to December 31, 2017, the mortality incidence observed did not demonstrate improvement from earlier studies despite universal test and treat and better ART regimens. This trial was registered with ClinicalTrials.gov, NCT03574129.

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.

Correction: A Text Messaging-Based Support Intervention to Enhance Pre-exposure Prophylaxis for HIV Prevention Adherence During Pregnancy and Breastfeeding: Protocol for a Randomized Controlled Trial.

[This corrects the article DOI: 10.2196/41170.].

Addressing the Know-Do Gap in Adolescent HIV: Framing and Measuring Implementation Determinants, Outcomes, and Strategies in the AHISA Network.

Implementation science (IS) uses systematic methods to close gaps between research and practice by identifying and addressing barriers to implementation of evidence-based interventions (EBIs). To reach UNAIDS HIV targets, IS can support programs to reach vulnerable populations and achieve sustainability. We studied the application of IS methods in 36 study protocols that were part of the Adolescent HIV Prevention and Treatment Implementation Science Alliance (AHISA). Protocols focused on youth, caregivers, or healthcare workers in high HIV-burden African countries and evaluated medication, clinical and behavioral/social EBIs. All studies measured clinical outcomes and implementation science outcomes; most focused on early implementation outcomes of acceptability (81%), reach (47%), and feasibility (44%). Only 53% used an implementation science framework/theory. Most studies (72%) evaluated implementation strategies. Some developed and tested strategies, while others adapted an EBI/strategy. Harmonizing IS approaches allows cross study learning and optimization of delivery of EBIs and could support attainment of HIV goals.

"Sign Me Up": a qualitative study of video observed therapy (VOT) for patients receiving expedited methadone take-homes during the COVID-19 pandemic.

BACKGROUND: Federal and state regulations require frequent direct observation of methadone ingestion at an Opioid Treatment Program (OTP)-a requirement that creates barriers to patient access. Video observed therapy (VOT) may help to address public health and safety concerns of providing take-home medications while simultaneously reducing barriers to treatment access and long-term retention. Evaluating user experiences with VOT is important for understanding the acceptability of this strategy. METHODS: We conducted a qualitative evaluation of a clinical pilot program of VOT via smartphone that was rapidly implemented between April and August 2020 during the COVID-19 pandemic within three opioid treatment programs. In the program, selected patients submitted video recordings of themselves ingesting methadone take-home doses, which were asynchronously reviewed by their counselor. We recruited participating patients and counselors for semi-structured, individual interviews to explore their VOT experiences after program completion. Interviews were audio recorded and transcribed. Transcripts were analyzed using thematic analysis to identify key factors influencing acceptability and the effect of VOT on the treatment experience. RESULTS: We interviewed 12 of the 60 patients who participated in the clinical pilot and 3 of the 5 counselors. Overall, patients were enthusiastic about VOT, noting multiple benefits over traditional treatment experiences, including avoiding frequent travel to the clinic. Some noted how this allowed them to better meet recovery goals by avoiding a potentially triggering environment. Most appreciated having increased time to devote to other life priorities, including maintaining consistent employment. Participants described how VOT increased their autonomy, allowed them to keep treatment private, and normalized treatment to align with other medications that do not require in-person dosing. Participants did not describe major usability issues or privacy concerns with submitting videos. Some participants reported feeling disconnected from counselors while others felt more connected. Counselors felt some discomfort in their new role confirming medication ingestion but saw VOT as a useful tool for select patients. CONCLUSIONS: VOT may be an acceptable tool to achieve equipoise between lowering barriers to treatment with methadone and protecting the health and safety of patients and their communities.

Considering Risks to Researchers and Staff in Low-Resource Settings during Public Health Crises: A Proposed Conceptual Model.

Human subjects research protections have historically focused on mitigating risk of harm and promoting benefits for research participants. In many low-resource settings (LRS), complex and often severe challenges in daily living, poverty, geopolitical uprisings, sociopolitical, economic, and climate crises increase the burdens of even minimal risk research. While there has been important work to explore the scope of ethical responsibilities of researchers and research teams to respond to these wider challenges and hidden burdens in global health research, less attention has been given to the ethical dilemmas and risk experienced by frontline researcher staff as they perform research-related activities in LRS. Risks such as job insecurity, moral distress, infection, or physical harm can be exacerbated during public health crises, as recently highlighted by the COVID-19 pandemic. We highlight the layers of risk research staff face in LRS and present a conceptual model to characterize drivers of this risk, with particular attention to public health crises. A framework by which funders, institutions, principal investigators, and/or research team leaders can systematically consider these additional layers of risk to researchers and frontline staff is an important and needed addition to routine research proposals and protocol review.

Tuberculosis Preventative Therapy Initiation and Completion Among Adolescents and Young Adults Living With HIV in Kenya.

BACKGROUND: Tuberculosis is the leading cause of death among adolescents and young adults living with HIV (YWHIV) and their heightened risk warrants deeper understanding of utilization of tuberculosis-prevention measures within HIV care. SETTING: Retrospective study using clinic surveys and medical record data from 86 Kenyan HIV clinics. METHODS: Clinic surveys obtained information on tuberculosis preventive therapy (TPT) services. Medical records of YWHIV were abstracted. Bivariate and multivariate analyses used generalized linear models to determine individual-level and clinic-level cofactors of TPT initiation and completion. RESULTS: Among 10,328 eligible YWHIV, 4337 (42.0%) initiated TPT. Of 3295 with ≥6 months follow-up, 1774 (53.8%) completed TPT. A lower patient-to-staff ratio was a clinic-level cofactor of TPT initiation ( P = 0.044) and completion ( P = 0.004); designated adolescent areas were associated with TPT initiation {prevalence ratio 2.05 [95% confidence interval (CI): 1.46 to -2.88]}. Individual cofactors of TPT initiation included younger age at HIV-care enrollment [relative risk (RR) 0.85 (95% CI: 0.80 to 0.90)] and antiretroviral therapy (ART) duration [1-2 vs. <1 year RR 1.31 (95% CI: 1.18 to 1.45)]. TPT completion was associated with younger age [RR 0.91 (95% CI: 0.85 to 0.98)] and ART duration [2-5 vs. <1 year RR 1.27 (95% CI: 1.03 to 1.57)]. In multivariate models, TPT initiation was associated with younger age and ART duration [1-2 vs. 1 year; adjusted RR 1.30 (95% CI: 1.16 to 1.46)] and TPT completion with ART duration [2-5 vs. 1 year adjusted RR 1.23 (95% CI: 0.99 to 1.52)]. CONCLUSION: Over half of YWHIV did not initiate and >40% did not complete TPT, with distinct clinic-level and individual-level cofactors. Approaches to enhance adolescent-friendly infrastructure and support older YWHIV are necessary to improve TPT use.

"[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.

A Text Messaging-Based Support Intervention to Enhance Pre-exposure Prophylaxis for HIV Prevention Adherence During Pregnancy and Breastfeeding: Protocol for a Randomized Controlled Trial.

BACKGROUND: Cisgender women in Kenya are at elevated risk of HIV acquisition during pregnancy and post partum. Acute HIV infection during pregnancy and breastfeeding accounts for approximately one-third of all vertical HIV transmissions. The World Health Organization recommends offering oral tenofovir-based pre-exposure prophylaxis (PrEP) to pregnant and postpartum women who are HIV negative but at substantial and ongoing risk for HIV acquisition. PrEP delivery for pregnant and postpartum women is expanding within routine maternal child health clinics in Kenya. However, approximately half of pregnant women discontinue PrEP within 30 days of initiation. Therefore, it is crucial to develop PrEP adherence strategies that enhance support for adherence when peripartum events and health issues pose challenges to sustaining PrEP adherence. OBJECTIVE: We are conducting a randomized controlled trial to determine the effect of a bidirectional communication platform named Mobile Solutions for Women's and Children's Health (mWACh), which utilizes two-way SMS text messaging between patients and remote nurses to support PrEP adherence and address maternal health concerns in real time during the peripartum period. METHODS: The mWACh-PrEP study is a randomized trial designed to support PrEP adherence during the peripartum period by comparing mWACh-PrEP to the standard of care (ie, in-clinic adherence counseling) among women who are HIV negative and initiating PrEP. Purposive sampling was used to select 5 facilities offering PrEP in antenatal clinics in Kisumu and Siaya Counties, and block randomization will be used to divide participants into groups. Participants in the intervention arm will receive a customized messaging curriculum via SMS text messages targeted toward their particular perinatal stage. The primary outcome, PrEP adherence at 6 months post partum, will be evaluated using a log-binomial regression model, adjusting for imbalanced baseline characteristics. Based on a previous study of directly observed dosing conditions, we will use a hair tenofovir concentration cutoff of 0.038 ng/mg (corresponding to 7 doses/week) as the primary adherence outcome measured at 6 months post partum (binary outcome). Qualitative interviews and cost-effective analyses will be conducted to understand the feasibility, acceptability, and economic impact of the intervention. RESULTS: Enrollment began in March 2022 and is projected to continue until July 2023, with follow-up through March 2024. The study results are expected to be reported in 2025. CONCLUSIONS: This trial will provide insights into using mobile health to enhance PrEP adherence among pregnant and postpartum mothers. Additionally, the findings will have implications for the use of mobile health technology to improve adherence to other daily medications during the peripartum period. TRIAL REGISTRATION: ClinicalTrials.gov NCT04472884; https://clinicaltrials.gov/ct2/show/NCT04472884. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/41170.