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Item 1270. HIV Drug Resistance and Viral Outcomes after 2nd-line Antiretroviral Failure in Kenya(Oxford University Press, 2022) Ali, Shamim M.; Humphrey, John; Novitsky, Vladimir; Sang, Edwin; DeLong, Allison; Jawed, Bilal; Kemboi, Emmanuel; Goodrich, Suzanne; Gardner, Adrian; Hogan, Joseph W.; Kantor, Rami; Medicine, School of MedicineBackground: Program data on HIV drug resistance and clinical outcomes after 2nd-line antiretroviral therapy (ART) failure in resource-limited settings are limited, yet can inform care, particularly with better ART access and options. Methods: We examined resistance upon 2nd-line failure and subsequent viral outcomes at the Academic Model Providing Access to Healthcare (AMPATH) in Kenya. Charts of people with genotypes upon 2nd-line failure up to 6/2021 were reviewed; and associations with viral suppression (< 1000 copies/mL) closest to 12 months post-genotyping were determined using bi- and multivariate analyses, adjusting for age, sex, time on ART, switch to 3rd-line (darunavir-, dolutegravir-, and/or raltegravir-based ART), and any resistance to regimens upon viral load (VL) testing. Results: Of 194 participants (53% female; median age 41 years; median 3.3 and 4.1 years on 1st- and 2nd-line), 60% were on lopinavir/ritonavir and 40% on atazanavir/ritonavir-based regimens. Overall, 178 (92%) had any resistance: 19% mono-, 40% dual-, 41% triple-class; 79% to NRTIs; 81% NNRTIs; and 43% PIs - 33% of those on lopinavir/ritonavir; 58% on atazanavir/ritonavir (p< 0.001); 24% with intermediate-high predicted resistance to darunavir/ritonavir (12 upon LPV/ritonavir, and 8 upon atazanavir/ritonavir failure; p=0.98). Of 140/194 people with post-genotype VLs, 55% stayed on 2nd-line, and 45% switched to 3rd-line. Of those 140, 72% virally suppressed (89% who switched to 3rd-line; 58% who didn't), and 75% had any resistance to their regimen at post-genotype VL (90% who switched to 3rd-line; 62% who didn't). In bivariate analysis, suppression was associated with switching to 3rd-line, and with resistance upon VL testing (Table). In multivariate analysis, suppression remained more likely among those who switched to 3rd-line, and association with resistance was less pronounced. Conclusion: In a large Kenyan HIV program, high resistance upon 2nd-line failure, high failure rates, and suppression association with 3rd-line switch suggest the need for dedicated management of this vulnerable population. Potential association between resistance and better viral outcomes, similar to reports upon 1st-line failure, needs further data and suggests significance of inadequate adherence.Item Accuracy of Alternative PHQ-9 Scoring Algorithms to Screen for Depression in People Living With HIV in Sub-Saharan Africa(Wolters Kluwer, 2025) Bernard, Charlotte; Font, Hélène; Zotova, Natalia; Wools-Kaloustian, Kara; Goodrich, Suzanne; Kamaru Kwobah, Edith; Rogers Awoh, Ajeh; Nko'o Mbongo'o, Guy Calvin; Nsonde, Dominique Mahambu; Gandou, Paul; Minga, Albert; Tine, Judicaël Malick; Ndiaye, Ibrahima; Dabis, François; Seydi, Moussa; de Rekeneire, Nathalie; Yotebieng, Marcel; Jaquet, Antoine; IeDEA Cohort Collaboration; Medicine, School of MedicineBackground: Screening for depression remains a priority for people living with HIV (PLWH) accessing care. The 9-item Patient Health Questionnaire (PHQ-9) is a widely used depression screening tool, but has limited accuracy when applied across various cultural contexts. We aimed to evaluate the performance of alternative PHQ-9 scoring algorithms in sub-Saharan African PLWH. Setting: Five HIV programs in Cameroon, Côte d'Ivoire, Kenya, Senegal, and the Republic of Congo. Methods: Adult PLWH were screened for depression during the 2018-2022 period. Diagnosis confirmation was done by psychiatrist blinded clinical evaluation (gold standard). Diagnostic performances, including sensitivity and area under the curve (AUC) of the traditional PHQ-9 scoring (positive screening - score ≥ 10), were compared to alternative scoring algorithms including (1) the presence of ≥1 mood symptom (PHQ-9 items 1 and 2) combined with ≥2 other symptoms listed in the PHQ-9, and (2) a simplified recoding of each 4-response item into 2 categories (absence/presence). Results: A total of 735 participants were included [54% women, median age 42 years (interquartile range 34-50)]. Depression was diagnosed by a psychiatrist in 95 (13%) participants. Alternative scoring sensitivities (0.59-0.74) were higher than that of the traditional score's (0.39). Compared to traditional scoring, AUC was significantly higher for PHQ-9 alternative scoring. Across settings, alternative scoring algorithms increased sensitivity and reduced variability. Conclusions: As a primary screening test, new scoring algorithms seemed to improve the PHQ-9 sensitivity in identifying depression and reducing heterogeneity across settings. This alternative might be considered to identify PLWH in need of referral for further diagnostic evaluations.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 Accuracy of PHQ-9 Against Psychiatric Diagnosis for Depression Among People Living with HIV: A Mixed-Method Study in Cameroon, Kenya, and the Republic of Congo(Elsevier, 2022-05-13) Yotebieng, Marcel; Zotova, Natalia; Watnick, Dana; Goodrich, Suzanne; Rogers Awoh, Ajeh; Mahambu Nsonde, Dominique; Tchiengang Moungang, Elodie Flore; Nguemo Noumedem, Julie Laure; Mbongo'o Nko'o, Guy Calvin; Gandou, Paul; Kamaru Kwobah, Edith; Atwoli, Lukoye; Wools-Kaloustian, Kara; Anastos, Kathryn; Medicine, School of MedicineBackground: Depression is highly prevalent among people living with HIV (PLWH) and is known to negatively impact HIV care and HIV clinical outcomes. Integration of depression management into HIV care is challenging because of the difficulties identifying depression. The aim of this study was to assess the performance of the 9-item Patient Health questionnaire (PHQ-9) as a diagnostic instrument against psychiatrist diagnosis in PLWH. Methods: Data were collected between January 2018 and June 2021 across three sites in Cameroon, Kenya, and the Republic of Congo. Participants were ≥18 years, diagnosed with HIV between 3-24 months prior to enrollment. PHQ-9 was administered by study staff followed by a psychiatrist’s evaluation within 3 days. In Cameroon, in-depth qualitative and cognitive interviews were conducted with a sub-sample of participants. Results: Overall, 530 participants with complete data were included: 300 (56.6%) in Cameroon, 132 (24·9%) in Congo, and 98 (18·5%) in Kenya. PHQ-9 was highly accurate in excluding current depression, with areas under the curve for the continuous PHQ-9 score from 0·888 (95% CI: 0·784, 0·992) in Cameroon, 0·802 (95% CI: 0·603, 1·00) in Kenya, to 0·768 (95% CI: 0·589, 0·947) in Congo and negative predictive values (NPV) of 98·9% (95% CI: 96·9%, 99·8%) in Cameroon, 95·7% (95% CI: 90·2%, 98·6%) in Congo, and 96·3% (95% CI: 89·7%, 99·2%) in Kenya for a score >9. However, its sensitivity and positive predictive value (PPV) were generally low, ranging respectively, from 50·0% (95% CI: 11·8%, 88·2%) and 17·7% (3·8%, 43·3%) in Cameroon, 50·0% (95% CI: 18·7%, 81·3%) and 29·4% (95% CI: 10·3%, 56·0%) in Congo, to 66·7% (95% CI: 29·9%, 92·5%) and 37·5% (95% CI: 15·2%, 64·6%) in Kenya for scores >9. Cognitive interviews identified challenges in understanding some questions as well as processing response categories. Interpretation: PHQ-9 performed very poorly (low sensitivity and PPV) as a tool to identify psychiatrist diagnosed depression and caution must be exercised before using it as the only guide to initiating PLWH on pharmacological treatment. However, the observed high NPV suggests it can be used to rule out depression or to identify those to be referred for further evaluation.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 Comorbidities and HIV-related factors associated with mental health symptoms and unhealthy substance use among older adults living with HIV in low- and middle-income countries: a cross-sectional study(Wiley, 2025) Ross, Jeremy L.; Rupasinghe, Dhanushi; Chanyachukul, Thida; Crabtree Ramírez, Brenda; Murenzi, Gad; Kwobah, Edith; Mureithi, Fiona; Minga, Albert; Marbaniang, Ivan; Perazzo, Hugo; Parcesepe, Angela; Goodrich, Suzanne; Chimbetete, Cleophas; Mensah, Ephrem; Maruri, Fernanda; Nguyen, Dung Thi Hoai; López-Iñiguez, Alvaro; Lancaster, Kathryn; Byakwaga, Helen; Tlali, Mpho; Plaisy, Marie K.; Nimkar, Smita; Moreira, Rodrigo; Anastos, Kathryn; Semeere, Aggrey; Wandeler, Gilles; Jaquet, Antoine; Sohn, Annette; Sentinel Research Network of the International epidemiology Databases to Evaluate AIDS; Medicine, School of MedicineIntroduction: People with HIV (PWH) are vulnerable to mental health and substance use disorders (MSDs), but the extent to which these are associated with other non-communicable diseases in ageing PWH populations remains poorly documented. We assessed comorbidities associated with symptoms of MSD among PWH ≥40 years in the Sentinel Research Network (SRN) of the International epidemiology Database to Evaluate AIDS (IeDEA). Methods: Baseline data collected between June 2020 and September 2022, from 10 HIV clinics in Asia, Latin America and Africa contributing to the SRN, were analysed. Symptoms of MSDs and comorbidities were assessed using standardized questionnaires, anthropometric and laboratory tests, including weight, height, blood pressure, glucose, lipids, chronic viral hepatitis and liver transient elastography. HIV viral load, CD4 count and additional routine clinical data were accessed from participant interview or medical records. HIV and non-HIV clinical associations of mental illness symptoms and unhealthy substance use were analysed using logistic regression. Mental illness symptoms were defined as moderate-to-severe depressive symptoms (PHQ-9 score >9), moderate-to-severe anxiety symptoms (GAD-7 >9) or probable post-traumatic stress disorder (PCL-5 >32). Unhealthy substance use was defined as ASSIST score >3, or AUDIT ≥7 for women (≥8 for men). Results: Of 2614 participants assessed at baseline study visits, 57% were female, median age was 50 years, median CD4 was 548 cells/mm3 and 86% had HIV viral load <1000 copies/ml. Overall, 19% had mental illness symptoms, 15% unhealthy substance use, 49% BMI >25 kg/m2, 38% hypertension, 15% type 2 diabetes, 35% dyslipidaemia, 34% liver disease and 23% history of tuberculosis. BMI >25 and dyslipidaemia were found in 54% and 40% of those with mental illness symptoms compared to 49% and 34% of those without. Mental illness symptoms were not significantly associated with the clinical factors assessed. Unhealthy substance use was more likely among those with dyslipidaemia (OR 1.55, CI 1.16-2.09, p = 0.003), and less likely in those with BMI >25 (OR 0.48, CI 0.30-0.77, p = 0.009). Conclusions: Improved integration of MSD and comorbidity services in HIV clinical settings, and further research on the association between MSD and comorbidities, and care integration among older PWH in low-middle-income countries, are required.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 Delivery of HIV care during the 2007 post-election crisis in Kenya: a case study analyzing the response of the Academic Model Providing Access to Healthcare (AMPATH) program(Springer Nature, 2013-12-01) Goodrich, Suzanne; Ndege, Samson; Kimaiyo, Sylvester; Some, Hosea; Wachira, Juddy; Braitstein, Paula; Sidle, John E.; Sitienei, Jackline; Owino, Regina; Chesoli, Cleophas; Gichunge, Catherine; Komen, Fanice; Ojwang, Claris; Sang, Edwin; Siika, Abraham; Wools-Kaloustian, Kara; Medicine, School of MedicineBackground: Widespread violence followed the 2007 presidential elections in Kenya resulting in the deaths of a reported 1,133 people and the displacement of approximately 660,000 others. At the time of the crisis the United States Agency for International Development-Academic Model Providing Access to Healthcare (USAID-AMPATH) Partnership was operating 17 primary HIV clinics in western Kenya and treating 59,437 HIV positive patients (23,437 on antiretroviral therapy (ART)). Methods: This case study examines AMPATH's provision of care and maintenance of patients on ART throughout the period of disruption. This was accomplished by implementing immediate interventions including rapid information dissemination through the media, emergency hotlines and community liaisons; organization of a Crisis Response leadership team; the prompt assembly of multidisciplinary teams to address patient care, including psychological support staff (in clinics and in camps for internally displaced persons (IDP)); and the use of the AMPATH Medical Records System to identify patients on ART who had missed clinic appointments. Results: These interventions resulted in the opening of all AMPATH clinics within five days of their scheduled post-holiday opening dates, 23,949 patient visits in January 2008 (23,259 previously scheduled), uninterrupted availability of antiretrovirals at all clinics, treatment of 1,420 HIV patients in IDP camps, distribution of basic provisions, mobilization of outreach services to locate missing AMPATH patients and delivery of psychosocial support to 300 staff members and 632 patients in IDP camps. Conclusion: Key lessons learned in maintaining the delivery of HIV care in a crisis situation include the importance of advance planning to develop programs that can function during a crisis, an emphasis on a rapid programmatic response, the ability of clinics to function autonomously, patient knowledge of their disease, the use of community and patient networks, addressing staff needs and developing effective patient tracking systems.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.