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1. Assessment of weight gain in adult patients living with HIV receiving first‐line dolutegravir‐based or efavirenz‐based ART regimens in routine care clinics in Tshwane district, South Africa: An observational study.

Author

Sawry, Shobna, Ayalew, Kassahun, Maimela, Gloria, Briggs‐Hagen, Melissa, van Wyk‐Heath, Marelize, Mthethwa, Simangele, Shai, Sannie, Mngomezulu, Nkululeko N., Tlhowe, Lawrence, Achere‐Darko, Josephine, Bedford, Jason, Martin, Catherine E., Fairlie, Lee, and Imrie, John

Subjects
HIV integrase inhibitors, LAMIVUDINE, RISK assessment, ANTIRETROVIRAL agents, RESEARCH funding, BODY mass index, HIV-positive persons, TENOFOVIR, SCIENTIFIC observation, HIV infections, TREATMENT effectiveness, RETROSPECTIVE studies, DESCRIPTIVE statistics, LONGITUDINAL method, MEDICAL records, ACQUISITION of data, COMPARATIVE studies, WEIGHT gain, EFAVIRENZ, REGRESSION analysis, ADULTS
Abstract

Introduction: Although dolutegravir (DTG) is deemed stable, safe, cost‐effective, and clinically beneficial, it also carries the risk of side effects, including observed weight gain among patients on DTG‐based antiretroviral therapy (ART) regimens. We compared weight changes among adults (≥18 years) initiating tenofovir disoproxil fumarate, lamivudine, and dolutegravir (TLD) or tenofovir disoproxil fumarate, emtricitabine, and efavirenz (TEE) regimens and those switching from TEE to TLD (TEE‐to‐TLD switchers) in three large primary care facilities in South Africa Methods: We conducted a retrospective longitudinal record review using patient medical records, extracting relevant demographic and clinical data from October 2018 to June 2021 from randomly selected adults who initiated TLD or TEE (initiators) and adult TEE‐to‐TLD switchers. We assessed weight, body mass index (BMI), and percentage weight changes for both groups and fitted linear regression and generalized linear models to determine factors associated with weight and BMI change and percentage weight change ≥10%, respectively, among treatment initiators. We fitted linear mixed‐effect models among TEE‐to‐TLD switchers to consider repeated measures. Results: Of 860 initiators, 450 (52.3%) initiated on TEE and 410 (47.7%) on TLD, with median follow‐up of 1.4 years and 1.0 year, respectively. At initiation, 43.3% on TEE and 40.8% on TLD were overweight or obese. TLD initiators had an adjusted higher mean weight gain of 1.6 kg (p < 0.001) and mean BMI gain of 0.51 kg/m2 (p < 0.001) than TEE initiators. Independent risk factors for higher mean weight and BMI included age ≥50 years, male, on ART for >12 months, initial BMI of <18.5 kg/m2, and CD4 counts <200 cells/μL. Of 298 TEE‐to‐TLD switchers, 36.6% were overweight or obese at TEE initiation. Comparing before and after TLD switch, TEE‐to‐TLD switchers had an adjusted mean weight of 1.2 kg less while on TLD (p = 0.026). Being overweight and CD4 counts >350 cells/μL were independent risk factors for lower weight gain after TLD switch. Conclusions: We report more weight gain among TLD than among TEE initiators, although to a lesser extent than previously reported. TEE‐to‐TLD switchers experienced less weight gain after TLD switch; return to health before receiving TLD may be a contributory factor. The current findings are reassuring for those switching to a DTG‐based regimen [ABSTRACT FROM AUTHOR]

Published
2024
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2. Universal test and treat and the HIV epidemic in rural South Africa: a phase 4, open-label, community cluster randomised trial

Author

Bärnighausen, Till, Herbst, Kobus, Iwuji, Collins, Makowa, Thembisa, Naidu, Kevi, Newell, Marie-Louise, Okesola, Nonhlanhla, de Oliveira, Tulio, Pillay, Deenan, Rochat, Tamsen, Tanser, Frank, Viljoen, Johannes, Zuma, Thembelihle, McGrath, Nuala, Balestre, Eric, Dabis, François, Karcher, Sophie, Orne-Gliemann, Joanna, Plazy, Melanie, Prague, Mélanie, Thiébaut, Rodolphe, Tiendrebeogo, Thierry, Boyer, Sylvie, Donfouet, Hermann, Gosset, Andrea, March, Laura, Protopopescu, Camelia, Spire, Bruno, Calmy, Alexandra, Larmarange, Joseph, Inghels, Maxime, Diallo, Hassimiou, Calvez, Vincent, Derache, Anne, Marcelin, Anne-Geneviève, Dray-Spira, Rosemary, Lert, France, El Farouki, Kamal, Lessells, Richard, Freedberg, Kenneth, Imrie, John, Chaix, Marie-Laure, Newell, Colin, Hontelez, Jan, Bazin, Brigitte, Rekacewicz, Claire, Iwuji, Collins C, Thiebaut, Rodolphe, Dreyer, Jaco, and De Oliveira, Tulio

Published
2018
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4. Improving the effectiveness of HIV prevention : a randomised controlled trial of a small group behavioural intervention for 'high-risk' gay men attending genitourinary medicine clinics

Author

Imrie, John Chisholm Gray

Subjects
616.979205
Abstract

Gay men are one group that is seriously affected by HIV in the UK. Prevention interventions have been widely implemented, but few have been rigorously evaluated for their effectiveness. This thesis describes the first randomised controlled trial (RCT) of a small group behavioural intervention for 'high-risk' gay men attending genitourinary medicine (GUM) clinics to use incident sexually transmitted infections (STI) as the primary endpoint and examines its impact on local prevention policy and practice. At total of 343 gay men GUM clinic attenders were randomised to either standard management (brief session with a counsellor) or standard management plus a brief small group behavioural intervention delivered by trained co-facilitators. Follow up was by questionnaire at 6 and 12 months for self-reported behavioural outcomes and record review of the clinic databases for new STI diagnoses and treatment. The participation rate was 72.3%. Of those randomised to the intervention, 70.9% attended. Questionnaire follow up was 80.5% at 6 months and 71.1% at 12 months. In total, 89.8% of men returned one or both follow up questionnaires or had an STI screen (with results available) during the follow up. At baseline, 36.6% of intervention participants vs. 30.1% of controls reported unprotected anal intercourse (UAI) in the last month. At 12 months, these proportions were 27.2% and 31.5% respectively (adjusted /7-value = 0.32). However, 30.8% of intervention participants vs. 20.8% of controls had at least one STI diagnosed at the clinic during follow up (Odds Ratio = 1.692; 95% Confidence Interval: 1.033-2.772). Although intervention participants were slightly more likely to have an STI screen during the follow up period (52.9% vs. 48.2%), they were also more likely to screen positive for a new STI (Adjusted odds ratio = 1.841; 95% Confidence Interval 0.996-3.40). Process evaluation and secondary analysis identified 3 possible explanations for these unanticipated results. These were: 1) inappropriate choice and use of behavioural change theories in determining the intervention content; 2) a mis-match between intervention facilitators? and participants? expectations and perceptions of the intervention; and 3) an unintended intervention effect of the trial?s retention and follow up procedures. The study concluded that the intervention did not reduce risk of acquiring an STI and demonstrated that even carefully conceived interventions should be rigorously evaluated. The trial results did not result in immediate changes in clinic practice or local HIV prevention policy. The thesis concludes that provision of rigorous research evidence alone cannot bring about changes in either HIV prevention policy or prevention practice.

Published
2005

10. Temporal trends of population viral suppression in the context of Universal Test and Treat: the ANRS 12249 TasP trial in rural South Africa

Author

Larmarange, Joseph, Diallo, Mamadou H., Mcgrath, Nuala, Iwuji, Collins, Plazy, Mélanie, Thiébaut, Rodolphe, Tanser, Frank, Bärnighausen, Till, Orne?Gliemann, Joanna, Pillay, Deenan, Dabis, François, Barnighausen, Till, Herbst, Kobus, Makowa, Thembisa, Naidu, Kevi, Okesola, Nonhlanhla, Oliveira, Tulio, Rochat, Tamsen, Viljoen, Johannes, Zuma, Thembelihle, Balestre, Eric, Dabis, Francois, Karcher, Sophie, Plazy, Melanie, Prague, Melanie, Thiebaut, Rodolphe, Tiendrebeogo, Thierry, Boyer, Sylvie, Donfouet, Hermann, Gosset, Andrea, March, Laura, Protopopescu, Camelia, Spire, Bruno, Calvez, Vincent, Derache, Anne, Marcelin, Anne?Genevieve, Dray?Spira, Rosemary, Lert, France, Farouki, Kamal El, Chaix, Marie?Laure, Bazin, Brigitte, Rekacewicz, Claire, Imrie, John, Lessells, Richard, Newell, Colin, Newell, Marie?Louise, Calmy, Alexandra, Freedberg, Kenneth, and Hontelez, Jan

Subjects
Time trends (Statistics) -- Analysis, Antiviral agents -- Dosage and administration, Immunosuppression -- Patient outcomes, HIV infection -- Risk factors -- Prevention, Health
Abstract

: Introduction: The universal test‐and‐treat (UTT) strategy aims to maximize population viral suppression (PVS), that is, the proportion of all people living with HIV (PLHIV) on antiretroviral treatment (ART) and virally suppressed, with the goal of reducing HIV transmission at the population level. This article explores the extent to which temporal changes in PVS explain the observed lack of association between universal treatment and cumulative HIV incidence seen in the ANRS 12249 TasP trial conducted in rural South Africa. Methods: The TasP cluster‐randomized trial (2012 to 2016) implemented six‐monthly repeat home‐based HIV counselling and testing (RHBCT) and referral of PLHIV to local HIV clinics in 2 × 11 clusters opened sequentially. ART was initiated according to national guidelines in control clusters and regardless of CD4 count in intervention clusters. We measured residency status, HIV status, and HIV care status for each participant on a daily basis. PVS was computed per cluster among all resident PLHIV (≥16, including those not in care) at cluster opening and daily thereafter. We used a mixed linear model to explore time patterns in PVS, adjusting for sociodemographic changes at the cluster level. Results: 8563 PLHIV were followed. During the course of the trial, PVS increased significantly in both arms (23.5% to 46.2% in intervention, +22.8, p < 0.001; 26.0% to 44.6% in control, +18.6, p < 0.001). That increase was similar in both arms (p = 0.514). In the final adjusted model, PVS increase was most associated with increased RHBCT and the implementation of local trial clinics (measured by time since cluster opening). Contextual changes (measured by calendar time) also contributed slightly. The effect of universal ART (trial arm) was positive but limited. Conclusions: PVS was improved significantly but similarly in both trial arms, explaining partly the null effect observed in terms of cumulative HIV incidence between arms. The PVS gains due to changes in ART‐initiation guidelines alone are relatively small compared to gains obtained by strategies to maximize testing and linkage to care. The achievement of the 90‐90‐90 targets will not be met if the operational and implementational challenges limiting access to care and treatment, often context‐specific, are not properly addressed. Clinical trial number: NCT01509508 (clinicalTrials.gov)/DOH‐27‐0512‐3974 (South African National Clinical Trials Register)., Introduction Antiretroviral treatment (ART), when taken early has several benefits, both in terms of morbidity and mortality and in terms of reduction in HIV sexual transmission. Mathematical modelling work suggested [...]

Published
2019
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19. Reducing Sexually Transmitted Infections Among Gay Men

Author

Noar, Seth M., Zimmerman, Rick S., Bonell, Chris, Strange, Vicki, Imrie, John, Stephenson, Judith M., Cowan, Frances M., Wanigaratne, Sahmil, Billington, Andrew J. P., Copas, Andrew J., French, Lesley, French, Patrick D., and Johnson, Anne M.

Published
2001

35. The United Kingdom

Author

Imrie, John, primary, Dougan, Sarah, additional, Gray, Kimberly, additional, Adler, Michael W, additional, Johnson, Anne M, additional, Evans, Barry G, additional, and Peters, Barry S, additional

Published
2007
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45. J Int AIDS Soc

Author

Larmarange, Joseph, Diallo, Mamadou, McGrath, Nuala, Iwuji, Collins, PLAZY, Mélanie, Thiébaut, Rodolphe, Tanser, Frank, Bärrnighausen, Till, Orne‐Gliemann, Joanna, Pillay, Deenan, Dabis, Francois, Herbst, Kobus, Makowa, Thembisa, Naidu, Kevi, Okesola, Nonhlanhla, Rochat, Tamsen, Viljoen, Johannes, Zuma, Thembelihle, Oliveira, Tulio, Karcher, Sophie, Prague, Mélanie, Tiendrebeogo, Thierry, Boyer, Sylvie, Donfouet, Hermann, Gosset, Andréa, March, Laura, Protopopescu, Camelia, Spire, Bruno, Calvez, Vincent, Derache, Anne, Marcelin, Anne‐Genevieve, Dray‐Spira, Rosemary, Lert, France, El Farouki, Kamal, Chaix, Marie‐Laure, Bazin, Brigitte, Rekacewicz, Claire, Imrie, John, Lessells, Richard, Newell, Colin, Newell, Marie‐Louise, Calmy, Alexandra, Freedberg, Kenneth, Hontelez, Jan, Centre population et développement (CEPED - UMR_D 196), Institut de Recherche pour le Développement (IRD)-Université de Paris (UP), London School of Hygiene and Tropical Medicine (LSHTM), Brighton and Sussex Medical School (BSMS), Institut de Santé Publique, d'Epidémiologie et de Développement (ISPED), Université Bordeaux Segalen - Bordeaux 2, Africa Health Research Institute [Durban/Mtubatuba] (AHRI), Harvard School of Public Health, University College of London [London] (UCL), Africa Centre for Health and Population Studies, University of KwaZulu-Natal (UKZN)-Medical Research Council of South Africa, Pathogénèse et contrôle des infections chroniques (PCCI), Centre Hospitalier Universitaire de Montpellier (CHU Montpellier )-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Epidémiologie et Biostatistique [Bordeaux], Université Bordeaux Segalen - Bordeaux 2-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), Sciences Economiques et Sociales de la Santé & Traitement de l'Information Médicale (SESSTIM - U912 INSERM - Aix Marseille Univ - IRD), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Sciences Economiques et Sociales de la Santé & Traitement de l'Information Médicale (SESSTIM - U1252 INSERM - Aix Marseille Univ - UMR 259 IRD), Sexual Health Unit, Institut National de la Santé et de la Recherche Médicale (Inserm)-Université de Bordeaux-Institut National de la Santé et de la Recherche Médicale (Inserm)-Université de Bordeaux, Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre de recherche en épidémiologie et santé des populations (CESP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Sud - Paris 11 (UP11)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse, Agence Nationale de Recherches sur le Sida et les Hépatites Virales (ANRS), HIV Unit, Geneva University Hospital, Massachusetts General Hospital [Boston], International Initiative for Impact EvaluationDeutsche Gesellschaft für Internationale Zusammenarbeit. Grant Number: 81151938Wellcome TrustAgence Nationale de Recherches sur le Sida et les Hepatites Virales. Grant Number: 2011‐375Bill and Melinda Gates Foundation, Bordeaux population health (BPH), Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Université de Bordeaux (UB), Statistics In System biology and Translational Medicine (SISTM), Inria Bordeaux - Sud-Ouest, Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria)-Epidémiologie et Biostatistique [Bordeaux], Université Bordeaux Segalen - Bordeaux 2-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Bordeaux Segalen - Bordeaux 2-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), Agence Nationale de Recherches sur le Sida et les Hépatites Virales, Institut de Recherche pour le Développement (IRD)-Université Paris Descartes - Paris 5 (UPD5), Santé, vulnérabilités et relations de genre au sud (SAGESUD - ERL Inserm U1244), Institut de Recherche pour le Développement (IRD)-Université Paris Descartes - Paris 5 (UPD5)-Institut de Recherche pour le Développement (IRD)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut de Recherche pour le Développement (IRD)-Université Paris Cité (UPCité), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre population et développement (CEPED - UMR_D 196), Institut de Recherche pour le Développement (IRD)-Université Paris Cité (UPCité)-Institut de Recherche pour le Développement (IRD)-Université Paris Cité (UPCité), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria)- Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre Hospitalier Universitaire de Montpellier (CHU Montpellier )-Université de Montpellier (UM), Epidémiologie, Systèmes d'Information, Modélisation, Université Pierre et Marie Curie - Paris 6 (UPMC)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Mode de vie, génétique et santé : études intégratives et transgénérationnelles (U1018 (Équipe 9)), Institut Gustave Roussy (IGR)-Centre de recherche en épidémiologie et santé des populations (CESP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris-Sud - Paris 11 (UP11)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris-Sud - Paris 11 (UP11)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris-Sud - Paris 11 (UP11)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), University of Southampton, Hôpital Universitaire de Genève, Heidelberg University, Public Health, HAL AMU, Administrateur, and Institut de Recherche pour le Développement (IRD)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Aix Marseille Université (AMU)

Subjects
Counseling, Male, Rural Population, Impact evaluation, Human immunodeficiency virus (HIV), HIV Infections, medicine.disease_cause, South Africa, 0302 clinical medicine, Mass Screening, 030212 general & internal medicine, Viral suppression, 050207 economics, Referral and Consultation, Research Articles, Randomized Controlled Trials as Topic, education.field_of_study, retention in care, 050208 finance, Incidence, 05 social sciences, 3. Good health, SISTM, Infectious Diseases, Female, 0305 other medical science, Research Article, Adult, medicine.medical_specialty, Referral, Anti-HIV Agents, Population, antiretroviral therapy, Context (language use), Population health, IDLIC, 03 medical and health sciences, Acquired immunodeficiency syndrome (AIDS), 0502 economics and business, medicine, Humans, sustained viral suppression, education, Research ethics, 030505 public health, business.industry, Public Health, Environmental and Occupational Health, HIV, medicine.disease, CD4 Lymphocyte Count, Clinical trial, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, Family medicine, Test and treat, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, business, Delivery of Health Care, population health, Demography
Abstract

Background: The universal test-and-treat strategy (UTT) aims to maximize population viral suppression (PVS), i.e. the proportion of all people living with HIV (PLHIV) on antiretroviral treatment (ART) and virally suppressed in a community. We investigated whether PVS improved during the course of the ANRS 12249 TasP trial conducted in rural South Africa and investigating UTT impact on HIV incidence. Methods: The TasP cluster-randomized trial (2012-2016) implemented six-monthly repeat home-based HIV counselling and testing (RHBCT) and referral of PLHIV to local HIV clinics in 2×11 clusters opened sequentially. ART was initiated according to national guidelines in control clusters and regardless of CD 4 count in intervention clusters. We measured residency status, HIV status and HIV care status for each participant. PVS was computed per cluster among all resident PLHIV (≥16, including those not in care) at cluster opening and daily thereafter. We used a mixed linear model to explore time patterns in PVS, adjusting for sociodemographic changes at cluster level. Findings: 8 563 PLHIV were followed. Between cluster opening and January 1, 2016, PVS increased significantly in both arms (intervention: 23·5% to 46·2%, +22·8, p

Published
2019

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