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Item Accuracy of nine-item Patient Health Questionnaire against psychiatric diagnosis for depression among people with HIV(Wolters Kluwer, 2024) Yotebieng, Marcel; Zotova, Natalia; Bernard, Charlotte; Goodrich, Suzanne; Rogers Awoh, Ajeh; Watnick, Dana; Nsonde, Dominique Mahambu; Tchiengang Moungang, Elodie Flore; Nguemo Noumedem, Julie Laure; Nko'o Mbongo'o, Guy Calvin; Minga, Albert; Seydi, Moussa; Gandou, Paul; Kwobah, Edith Kamaru; Atwoli, Lukoye; Jaquet, Antoine; Wools-Kaloustian, Kara; Anastos, Kathryn; IeDEA Consortium; Medicine, School of MedicineObjective: The aim of this study was to assess the performance of the nine-item Patient Health Questionnaire (PHQ-9) against psychiatrist diagnosis in people with HIV (PWH). Design: Cross-sectional analysis of data collected between January 2018 and July 2022 across five sites in Cameroon, Cote d'Ivoire, Kenya, Senegal, and the Republic of Congo. Participants were ≥18 years and receiving HIV care at the participating site. PHQ-9 was administered by study staff followed by a psychiatrist's evaluation within 3 days. Results: Overall, 778 participants with complete data were included: 297 (38.2%) in Cameroon, 132 (17.0%) in Congo, 148 (19.0%) in Cote d'Ivoire, 98 (12.6%) in Kenya, and 103 (13.2%) in Senegal. The area under the curve for PHQ-9 score was generally high ranging from 0.935 [95% confidence interval (CI): 0.893, 0.977] in Cote d'Ivoire to 0.768 (95% CI: 0.589, 0.947) in Congo. However, for the common cut-off score ≥10, sensitivity was low: 50% or lower in Cameroon, Congo and Senegal, 66.7% in Kenya and 70.6% in Cote d'Ivoire. But negative predictive values (NPV) were high: 98.9% (95% CI: 96.9%, 99.8%) in Cameroon, 96.1 (95% CI: 91.1, 98.7) in Cote d'Ivoire, 96.3% (95% CI: 89.7%, 99.2%) in Kenya, 95.7% (95% CI: 90.2%, 98.6%) in Congo, and 89.0% (95% CI: 81.2%, 94.4%) in Senegal. Interpretation: Across all countries, PHQ-9 score ≥10 performed very poorly (low sensitivity) as a tool to identify psychiatrist diagnosed depression. However, the observed high NPV suggests it can be used to rule out depression.Item Adaptation of the Client Diagnostic Questionnaire for East Africa(Public Library of Science, 2024-03-19) Kwobah, Edith Kamaru; Goodrich, Suzanne; Kulzer, Jayne Lewis; Kanyesigye, Michael; Obatsa, Sarah; Cheruiyot, Julius; Kiprono, Lorna; Kibet, Colma; Ochieng, Felix; Bukusi, Elizabeth A.; Ofner, Susan; Brown, Steven A.; Yiannoutsos, Constantin T.; Atwoli, Lukoye; Wools-Kaloustian, Kara; Medicine, School of MedicineResearch increasingly involves cross-cultural work with non-English-speaking populations, necessitating translation and cultural validation of research tools. This paper describes the process of translating and criterion validation of the Client Diagnostic Questionnaire (CDQ) for use in a multisite study in Kenya and Uganda. The English CDQ was translated into Swahili, Dholuo (Kenya) and Runyankole/Rukiga (Uganda) by expert translators. The translated documents underwent face validation by a bilingual committee, who resolved unclear statements, agreed on final translations and reviewed back translations to English. A diagnostic interview by a mental health specialist was used for criterion validation, and Kappa statistics assessed the strength of agreement between non-specialist scores and mental health professionals' diagnoses. Achieving semantic equivalence between translations was a challenge. Validation analysis was done with 30 participants at each site (median age 32.3 years (IQR = (26.5, 36.3)); 58 (64.4%) female). The sensitivity was 86.7%, specificity 64.4%, positive predictive value 70.9% and negative predictive value 82.9%. Diagnostic accuracy by the non-specialist was 75.6%. Agreement was substantial for major depressive episode and positive alcohol (past 6 months) and alcohol abuse (past 30 days). Agreement was moderate for other depressive disorders, panic disorder and psychosis screen; fair for generalized anxiety, drug abuse (past 6 months) and Post Traumatic Stress Disorder (PTSD); and poor for drug abuse (past 30 days). Variability of agreement between sites was seen for drug use (past 6 months) and PTSD. Our study successfully adapted the CDQ for use among people living with HIV in East Africa. We established that trained non-specialists can use the CDQ to screen for common mental health and substance use disorders with reasonable accuracy. Its use has the potential to increase case identification, improve linkage to mental healthcare, and improve outcomes. We recommend further studies to establish the psychometric properties of the translated tool.Item Compression Therapy for HIV-Associated Kaposi Sarcoma Leg Lymphedema: Results of the Kenyan Improvised Compression for Kaposi Sarcoma Randomized Controlled Trial(American Society of Clinical Oncology, 2022) Chang, Aileen Y.; Karwa, Rakhi; Odhiambo, Haji; Were, Phelix; Fletcher, Sara L.; Tonui, Edith C.; Kohn, Michael A.; Lee, Jeannette; Chang, Di; Lensing, Shelly; Namaemba, Diana Flora; Busakhala, Naftali; Kiprono, Samson K.; Maurer, Toby; Goodrich, Suzanne; Pastakia, Sonak D.; Dermatology, School of MedicinePurpose: Evaluate the effectiveness of compression while receiving chemotherapy compared with chemotherapy alone in the treatment of HIV-associated Kaposi sarcoma (KS) lymphedema. Methods: A randomized controlled trial was conducted in a single oncology clinic in western Kenya (NCT03404297). A computer-generated randomization schedule was used to allocate treatment arms. Randomized block design was used for stratification by lymphedema stage. Participants were HIV positive adults age ≥ 18 years on antiretroviral therapy with biopsy-proven KS associated with leg lymphedema and being initiated on chemotherapy. The intervention was 10 weeks of weekly clinic-based application of two-component paste compression bandages. The primary outcome was change in the Lower Extremity Lymphedema Index (LELI) score from week 0 to week 14. The secondary outcomes were change in the Lymphedema Quality of Life measure (LYMQOL) and change in the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 score from week 0 to week 14. Blinded outcome assessments were conducted. Results: Of 30 participants randomly assigned, 25 eligible patients (chemotherapy [control], n = 13; compression plus chemotherapy [intervention], n = 12) returned at week 14. Change in LELI, LYMQOL, and EORTC QLQ-C30 scores between week 14 and week 0 did not significantly differ by arm. The mean (standard deviation) change in LELI score was -25.9 (34.6) for the control arm compared with -13.3 (29.5) for the intervention arm, P = .340. The difference (95% CI) in the change in LELI score was -12.6 (-39.3 to 14.1). Conclusion: Future studies evaluating a 14-week change in LELI for KS lymphedema should assume a standard deviation of approximately 30. Lessons learned from this pilot trial should inform the development of a larger, multicenter trial to evaluate the effectiveness of compression for KS lymphedema.Item Development, Assessment, and Outcomes of a Community-Based Model of Antiretroviral Care in Western Kenya Through a Cluster-Randomized Control Trial(Wolters Kluwer, 2021-06-01) Goodrich, Suzanne; Siika, Abraham; Mwangi, Ann; Nyambura, Monicah; Naanyu, Violet; Yiannoutsos, Constantin; Spira, Thomas; Bateganya, Moses; Toroitich-Ruto, Cathy; Otieno-Nyunya, Boaz; Wools-Kaloustian, Kara; Medicine, School of MedicineObjective: To develop and assess an alternative care model using community-based groups for people living with HIV and facilitate by lay personnel. Methods: Geographic locations in the Academic Model Providing Access to Healthcare Kitale clinic catchment were randomized to standard of care versus a community-based care group (ART Co-op). Adults stable on antiretroviral therapy and virally suppressed were eligible. Research Assistant-led ART Co-ops met in the community every 3 months. Participants were seen in the HIV clinic only if referred. CD4 count and viral load were measured in clinic at enrollment and after 12 months. Retention, viral suppression, and clinic utilization were compared between groups using χ2, Fisher exact, and Wilcoxon rank sum tests. Results: At 12 months, there were no significant differences in mean CD4 count or viral load suppression. There was a significant difference in patient retention in assigned study group between the intervention and control group (81.6% vs 98.6%; P < 0.001), with a number of intervention patients withdrawing because of stigma, relocation, pregnancy, and work conflicts. All participants, however, were retained in an HIV care program for the study duration. The median number of clinic visits was lower for the intervention group than that for the control group (0 vs 3; P < 0.001). Conclusions: Individuals retained in a community-based HIV care model had clinical outcomes equivalent to those receiving clinic-based care. This innovative model of HIV care addresses the problems of insufficient health care personnel and patient retention barriers, including time, distance, and cost to attend clinic, and has the potential for wider implementation.Item Effects of Alcohol Use on Patient Retention in HIV Care in East Africa(Springer, 2024) Monroy, Alexa; Goodrich, Suzanne; Brown, Steven A.; Balanos, Theofanis; Bakoyannis, Giorgos; Diero, Lameck; Byakwaga, Helen; Muyindike, Winnie; Kanyesigye, Michael; Aluda, Maurice; Lewis‑Kulzer, Jayne; Yiannoutsos, Constantin; Wools‑Kaloustian, Kara; East Africa International Epidemiologic Databases to Evaluate AIDS (EA-IeDEA) Consortium; Medicine, School of MedicineWe sought to investigate the association between hazardous alcohol use and gaps in care for people living with HIV over a long-term follow-up period. Adults who had participated in our previously published Phase I study of hazardous alcohol use at HIV programs in Kenya and Uganda were eligible at their 42 to 48 month follow-up visit. Those who re-enrolled were followed for an additional ~ 12 months. Hazardous alcohol use behavior was measured using the Alcohol Use Disorders Identification Test (AUDIT) tool. Deidentified clinical data were used to assess gaps in care (defined as failure to return to clinic within 60 days after a missed visit). The proportion of patients experiencing a gap in care at a specific time point was based on a nonparametric moment-based estimator. A semiparametric Cox proportional hazard model was used to determine the association between hazardous alcohol use at enrollment in Phase I (AUDIT score ≥ 8) and gaps in care. Of the 731 study-eligible participants from Phase I, 5.5% had died, 10.1% were lost to follow-up, 39.5% transferred, 7.5% declined/not approached, and 37.3% were enrolled. Phase II participants were older, had less hazardous drinking and had a lower WHO clinical stage than those not re-enrolled. Hazardous drinking in the re-enrolled was associated with a Hazard Ratio (HR) of 1.88 [p-value = 0.016] for a gap in care. Thus, hazardous alcohol use at baseline was associated with an increased risk of experiencing a gap in care and presents an early target for intervention.Item Effects of the COVID-19 pandemic on late postpartum women living with HIV in Kenya(Public Library of Science, 2023-03-29) Humphrey, John M.; Alera, Marsha; Enane, Leslie A.; Kipchumba, Bett; Goodrich, Suzanne; Scanlon, Michael; Songok, Julia; Musick, Beverly; Diero, Lameck; Yiannoutsos, Constantin; Wools-Kaloustian, Kara; Medicine, School of MedicineAlthough an estimated 1.4 million women living with HIV (WHIV) are pregnant each year globally, data describing the effects of the COVID-19 pandemic on postpartum women in low- and middle-income countries (LMICs) are limited. To address this gap, we conducted phone surveys among 170 WHIV ≥18 years and 18-24 months postpartum enrolled in HIV care at the Academic Model Providing Access to Healthcare in western Kenya, and assessed the effects of the pandemic across health, social and economic domains. We found that 47% of WHIV experienced income loss and 71% experienced food insecurity during the pandemic. The majority (96%) of women reported having adequate access to antiretroviral treatment and only 3% reported difficulties refilling medications, suggesting that the program's strategies to maintain HIV service delivery during the early phase of the pandemic were effective. However, 21% of WHIV screened positive for depression and 8% for anxiety disorder, indicating the need for interventions to address the mental health needs of this population. Given the scale and duration of the pandemic, HIV programs in LMICs should work with governments and non-governmental organizations to provide targeted support to WHIV at highest risk of food and income insecurity and their associated adverse health outcomes.Item Integrated community-based HIV and non-communicable disease care within microfinance groups in Kenya: study protocol for the Harambee cluster randomised trial(BMJ, 2021-05-18) Genberg, Becky L.; Wachira, Juddy; Steingrimsson, Jon A.; Pastakia, Sonak; Tina Tran, Dan N.; Said, Jamil AbdulKadir; Braitstein, Paula; Hogan, Joseph W.; Vedanthan, Rajesh; Goodrich, Suzanne; Kafu, Catherine; Wilson-Barthes, Marta; Galárraga, Omar; Medicine, School of MedicineIntroduction: In Kenya, distance to health facilities, inefficient vertical care delivery and limited financial means are barriers to retention in HIV care. Furthermore, the increasing burden of non-communicable diseases (NCDs) among people living with HIV complicates chronic disease treatment and strains traditional care delivery models. Potential strategies for improving HIV/NCD treatment outcomes are differentiated care, community-based care and microfinance (MF). Methods and analysis: We will use a cluster randomised trial to evaluate integrated community-based (ICB) care incorporated into MF groups in medium and high HIV prevalence areas in western Kenya. We will conduct baseline assessments with n=900 HIV positive members of 40 existing MF groups. Group clusters will be randomised to receive either (1) ICB or (2) standard of care (SOC). The ICB intervention will include: (1) clinical care visits during MF group meetings inclusive of medical consultations, NCD management, distribution of antiretroviral therapy (ART) and NCD medications, and point-of-care laboratory testing; (2) peer support for ART adherence and (3) facility referrals as needed. MF groups randomised to SOC will receive regularly scheduled care at a health facility. Findings from the two trial arms will be compared with follow-up data from n=300 matched controls. The primary outcome will be VS at 18 months. Secondary outcomes will be retention in care, absolute mean change in systolic blood pressure and absolute mean change in HbA1c level at 18 months. We will use mediation analysis to evaluate mechanisms through which MF and ICB care impact outcomes and analyse incremental cost-effectiveness of the intervention in terms of cost per HIV suppressed person-time, cost per patient retained in care and cost per disability-adjusted life-year saved. Ethics and dissemination: The Moi University Institutional Research and Ethics Committee approved this study (IREC#0003054). We will share data via the Brown University Digital Repository and disseminate findings via publication.Item Lower rates of ART initiation and decreased retention among ART-naïve patients who consume alcohol enrolling in HIV care and treatment programs in Kenya and Uganda(Public Library of Science, 2020-10-23) Patsis, Ioannis; Goodrich, Suzanne; Yiannoutsos, Constantin T.; Brown, Steven A.; Musick, Beverly S.; Diero, Lameck; Kulzer, Jayne L.; Bwana, Mwembesa Bosco; Oyaro, Patrick; Wools-Kaloustian, Kara K.; Biostatistics, School of Public HealthObjectives Almost 13 million people are estimated to be on antiretroviral therapy in Eastern and Southern Africa, and their disease course and program effectiveness could be significantly affected by the concurrent use of alcohol. Screening for alcohol use may be important to assess the prevalence of alcohol consumption and its impact on patient and programmatic outcomes. Methods As part of this observational study, data on patient characteristics and alcohol consumption were collected on a cohort of 765 adult patients enrolling in HIV care in East Africa. Alcohol consumption was assessed with the AUDIT questionnaire at enrollment. Subjects were classified as consuming any alcohol (AUDIT score >0), hazardous drinkers (AUDIT score ≥8) and hyper drinkers (AUDIT score ≥16). The effects of alcohol consumption on retention in care, death and delays in antiretroviral therapy (ART) initiation were assessed through competing risk (Fine & Gray) models. Results Of all study participants, 41.6% consumed alcohol, 26.7% were classified as hazardous drinkers, and 16.0% as hyper drinkers. Depending on alcohol consumption classification, men were 3–4 times more likely to consume alcohol compared to women. Hazardous drinkers (median age 32.8 years) and hyper drinkers (32.7 years) were slightly older compared to non-hazardous drinkers (30.7 years) and non-hyper drinkers (30.8 years), (p-values = 0.014 and 0.053 respectively). Median CD4 at enrollment was 330 cells/μl and 16% were classified World Health Organization (WHO) stage 3 or 4. There was no association between alcohol consumption and CD4 count or WHO stage at enrollment. Alcohol consumption was associated with significantly lower probability of ART initiation (adjusted sub-distribution hazard ratio aSHR = 0.77 between alcohol consumers versus non-consumers; p-value = 0.008), and higher patient non-retention in care (aSHR = 1.77, p-value = 0.023). Discussion Alcohol consumption is associated with significant delays in ART initiation and reduced retention in care for patients enrolling in HIV care and treatment programs in East Africa. Consequently, interventions that target alcohol consumption may have a significant impact on the HIV care cascade.Item Post-intervention perceptions on the antiretroviral therapy community group model in Trans Nzoia County, Kenya(PAMJ, 2024-03-08) Naanyu, Violet; Koros, Hillary; Goodrich, Suzanne; Siika, Abraham; Toroitich-Ruto, Cathy; Bateganya, Moses; Wools-Kaloustian, Kara; Medicine, School of MedicineIntroduction: the increasing number of people receiving antiretroviral therapy (ART) in sub-Saharan Africa has stressed already overburdened health systems. A care model utilizing community-based peer-groups (ART Co-ops) facilitated by community health workers (CHW) was implemented (2016-2018) to address these challenges. In 2018, a post-intervention study assessed perceptions of the intervention. Methods: forty participants were engaged in focus group discussions consisting of ART Co-op clients, study staff, and health care providers from Kitale HIV clinic. Data were analyzed thematically for content on the intervention, challenges, and recommendations for improvement. Results: all participants liked the intervention. However, some reported traveling long distances to attend ART Co-op meetings and experiencing stigma with ART Co-ops participation. The ART Co-op inclusion criteria were considered appropriate; however, additional outreach to deliberately include spouses living with HIV, the disabled, the poor, and HIV pregnant women was recommended. Participants liked CHW-directed quarterly group meetings which included ART distribution, adherence review, and illness identification. The inability of the CHW to provide full clinical care, inconvenient meeting venues, poor timekeeping, and non-attendance behaviors were noted as issues. Participants indicated that program continuation, regular CHW training, rotating meetings at group members´ homes, training ART Co-ops leaders to assume CHW tasks, use of pill diaries to check adherence, nutritional support, and economically empowering members through income generation projects would be beneficial. Conclusion: the intervention was viewed positively by both clinic staff and clients. They identified specific challenges and generated actionable key considerations to improve access and acceptability of the community-based model of care.Item Prevalence and co-occurrence of symptoms of mental and substance use disorders among people with HIV age 40 and older in low- and middle-income countries: a cross-sectional study(Wiley, 2024) Parcesepe, Angela M.; Stockton, Melissa; Bernard, Charlotte; Kanguya, Tukiya; Kwobah, Edith Kamaru; Lopez, Alvaro; Murenzi, Gad; Ross, Jeremy; Minga, Albert; Maruri, Fernanda; Tlali, Mpho; Goodrich, Suzanne; Perazzo, Hugo; Musabyimana, Françoise; Nimkar, Smita; Lancaster, Kathryn; IeDEA Consortium; Medicine, School of MedicineIntroduction: Due to the increased effectiveness of and access to antiretroviral therapy (ART), people with HIV (PWH) are living longer. As a result, the population of older PWH has increased. Mental and substance use disorders (MSDs) are common and frequently co-occurring among PWH and are associated with poor HIV care outcomes. Research into the prevalence and co-occurrence of MSDs among ageing PWH remains limited, particularly in low- and middle-income countries (LMICs). Methods: We analysed data collected between 2020 and 2022 from the International epidemiology Databases to Evaluate AIDS (IeDEA) Sentinel Research Network cohort of PWH aged 40 years or older on ART at 11 HIV clinics in Brazil, Côte d'Ivoire, India, Kenya, Mexico, Uganda, Rwanda, Togo, Vietnam, Zambia and Zimbabwe. We estimated the prevalence and co-occurrence of unhealthy alcohol use (AUDIT-C ≥3 for women, ≥4 for men), unhealthy drug use (ASSIST >3 for cannabis, cocaine, amphetamines, inhalants, sedatives, hallucinogens and/or opioids), and moderate to severe symptoms of depression (PHQ-9 ≥10), anxiety (GAD-7 ≥10) and post-traumatic stress disorder (PTSD) (PCL-5 ≥33). Psychiatric multimorbidity was defined as having symptoms of two or more disorders assessed. Log binomial models assessed the association between socio-demographic and HIV care characteristics and symptoms of anxiety, depression, PTSD or unhealthy substance use. Results: Of 2821 participants, the prevalence of unhealthy alcohol and drug use was 21% and 5%, respectively. The prevalence of moderate to severe symptoms of depression, anxiety and PTSD was 14%, 9% and 6%, respectively. Overall, the prevalence of psychiatric multimorbidity was 11%. Among those with symptoms of at least one mental health or substance use outcome assessed (n = 1036), the prevalence of psychiatric multimorbidity was 31%. In binomial models, the prevalence of symptoms of depression and anxiety was higher, while the prevalence of unhealthy alcohol and drug use was lower among women than men. Conclusions: Unhealthy alcohol use and symptoms of depression were most commonly reported, among this cohort of PWH aged 40 or older across 11 LMICs. Integration of MSD screening and treatment into HIV care should be prioritized. The effectiveness and implementation of transdiagnostic or multi-focus mental health treatment approaches in HIV care settings should be examined.