To describe associations of high-risk human papillomavirus (HR-HPV) with high-grade cervical intraepithelial neoplasia (CIN2+) in women living with HIV (WLHIV) in Burkina Faso (BF) and South Africa ...(SA).
Prospective cohort of WLHIV attending HIV outpatient clinics and treatment centres. Recruitment was stratified by ART status. Cervical HPV genotyping using INNO-LiPA and histological assessment of 4-quadrant cervical biopsies at enrolment and 16 months later.
Among women with CIN2+ at baseline, the prevalence of any HR-HPV genotypes included in the bi/quadrivalent (HPV16/18) or nonavalent (HPV16/18/31/35/45/52/58) HPV vaccines ranged from 37% to 90%. HPV58 was most strongly associated with CIN2+ (aOR = 5.40, 95%CI: 2.77-10.53). At 16-months follow-up, persistence of any HR-HPV was strongly associated with incident CIN2+ (aOR = 7.90, 95%CI: 3.11-20.07), as was persistence of HPV16/18 (aOR = 5.25, 95%CI: 2.14-12.91) and the additional HR types in the nonavalent vaccine (aOR = 3.23, 95%CI: 1.23-8.54).
HR-HPV persistence is very common among African WLHIV and is linked to incident CIN2+. HPV vaccines could prevent between 37-90% of CIN2+ among African WLHIV.
Summary Background Although structured psychological treatments are recommended as first-line interventions for depression, only a small fraction of people globally receive these treatments because ...of poor access in routine primary care. We assessed the effectiveness and cost-effectiveness of a brief psychological treatment (Healthy Activity Program HAP) for delivery by lay counsellors to patients with moderately severe to severe depression in primary health-care settings. Methods In this randomised controlled trial, we recruited participants aged 18–65 years scoring more than 14 on the Patient Health Questionnaire 9 (PHQ-9) indicating moderately severe to severe depression from ten primary health centres in Goa, India. Pregnant women or patients who needed urgent medical attention or were unable to communicate clearly were not eligible. Participants were randomly allocated (1:1) to enhanced usual care (EUC) alone or EUC combined with HAP in randomly sized blocks (block size four to six two to four for men), stratified by primary health centre and sex, and allocation was concealed with use of sequential numbered opaque envelopes. Physicians providing EUC were masked. Primary outcomes were depression symptom severity on the Beck Depression Inventory version II and remission from depression (PHQ-9 score of <10) at 3 months in the intention-to-treat population, assessed by masked field researchers. Secondary outcomes were disability, days unable to work, behavioural activation, suicidal thoughts or attempts, intimate partner violence, and resource use and costs of illness. We assessed serious adverse events in the per-protocol population. This trial is registered with the ISRCTN registry, number ISRCTN95149997. Findings Between Oct 28, 2013, and July 29, 2015, we enrolled and randomly allocated 495 participants (247 50% to the EUC plus HAP group two of whom were subsequently excluded because of protocol violations and 248 50% to the EUC alone group), of whom 466 (95%) completed the 3 month primary outcome assessment (230 49% in the EUC plus HAP group and 236 51% in the EUC alone group). Participants in the EUC plus HAP group had significantly lower symptom severity (Beck Depression Inventory version II in EUC plus HAP group 19·99 SD 15·70 vs 27·52 13·26 in EUC alone group; adjusted mean difference −7·57 95% CI −10·27 to −4·86; p<0·0001) and higher remission (147 64% of 230 had a PHQ-9 score of <10 in the HAP plus EUC group vs 91 39% of 236 in the EUC alone group; adjusted prevalence ratio 1·61 1·34–1·93) than did those in the EUC alone group. EUC plus HAP showed better results than did EUC alone for the secondary outcomes of disability (adjusted mean difference −2·73 –4·39 to −1·06; p=0·001), days out of work (−2·29 –3·84 to −0·73; p=0·004), intimate partner physical violence in women (0·53 0·29–0·96; p=0·04), behavioural activation (2·17 1·34–3·00; p<0·0001), and suicidal thoughts or attempts (0·61 0·45–0·83; p=0·001). The incremental cost per quality-adjusted life-year gained was $9333 (95% CI 3862–28 169; 2015 international dollars), with an 87% chance of being cost-effective in the study setting. Serious adverse events were infrequent and similar between groups (nine 4% in the EUC plus HAP group vs ten 4% in the EUC alone group; p=1·00). Interpretation HAP delivered by lay counsellors plus EUC was better than EUC alone was for patients with moderately severe to severe depression in routine primary care in Goa, India. HAP was readily accepted by this previously untreated population and was cost-effective in this setting. HAP could be a key strategy to reduce the treatment gap for depressive disorders, the leading mental health disorder worldwide. Funding Wellcome Trust.
School environments affect health and academic outcomes. With increasing secondary school retention in low-income and middle-income countries, promoting quality school social environments could offer ...a scalable opportunity to improve adolescent health and wellbeing.
We did a cluster-randomised trial to assess the effectiveness of a multi-component whole-school health promotion intervention (SEHER) with integrated economic and process evaluations in grade 9 students (aged 13–14 years) at government-run secondary schools in the Nalanda district of Bihar state, India. Schools were randomly assigned (1:1:1) to three groups: the SEHER intervention delivered by a lay counsellor (the SEHER Mitra SM group), the SEHER intervention delivered by a teacher (teacher as SEHER Mitra TSM group), and a control group in which only the standard government-run classroom-based life-skills Adolescence Education Program was implemented. The primary outcome was school climate measured with the Beyond Blue School Climate Questionnaire (BBSCQ). Students were assessed at the start of the academic year (June, 2015) and again 8 months later at the end of the academic year (March, 2016) via self-completed questionnaires. This study is registered with ClinicalTrials.gov, number NCT02484014.
Of the 112 eligible schools in the Nalanda district, 75 were randomly selected to participate in the trial. We randomly assigned 25 schools to each of the three groups. One school subsequently dropped out of the TSM group, leaving 24 schools in this group. The baseline survey included a total of 13 035 participants, and the endpoint survey included 14 414 participants. Participants in the SM-delivered intervention schools had substantially higher school climate scores at endpoint survey than those in the control group (BBSCQ baseline-adjusted mean difference aMD 7·57 95% CI 6·11–9·03; effect size 1·88 95% CI 1·44–2·32, p<0·0001) and the TSM-delivered intervention (aMD 7·57 95% CI 6·06–9·08; effect size 1·88 95% CI 1·43–2·34, p<0·0001). There was no effect of the TSM-delivered intervention compared with control (aMD −0·009 95% CI −1·53 to 1·51, effect size 0·00 95% CI −0·45 to 0·44, p=0·99). Compared with the control group, participants in the SM-delivered intervention schools had moderate to large improvements in the secondary outcomes of depression (aMD −1·23 95% CI −1·89 to −0·57), bullying (aMD −0·91 95% CI −1·15 to −0·66), violence victimisation (odds ratio OR 0·62 95% CI 0·46–0·84), violence perpetration (OR 0·68 95% CI 0·48–0·96), attitude towards gender equity (aMD 0·41 95% CI 0·21–0·61), and knowledge of reproductive and sexual health (aMD 0·29 95% CI 0·06–0·53). Similar results for these secondary outcomes were noted for the comparison between SM-delivered intervention schools and TSM-delivered intervention schools (depression: aMD −1·23 95% CI −1·91 to −0·55; bullying: aMD −0·83 95% CI −1·08 to −0·57; violence victimisation: OR 0·49 95% CI 0·35–0·67; violence perpetration: OR 0·49 95% CI 0·34–0·71; attitude towards gender equity: aMD 0·23 95% CI 0·02–0·44; and knowledge of reproductive and sexual health: aMD 0·22 95% CI −0·02 to 0·47). However, no effects on these secondary outcomes were observed for the TSM-delivered intervention schools compared with the control group (depression: aMD −0·03 95% CI −0·70 to 0·65; bullying: aMD −0·08 95% CI −0·34 to 0·18; violence victimisation: OR 1·27 95% CI 0·93–1·73; violence perpetration: OR 1·37 95% CI 0·95–1·95; attitude towards gender equity: aMD 0·17 95% CI −0·09 to 0·38; and knowledge of reproductive and sexual health: aMD 0·06 95% CI −0·18 to 0·32).
The multi-component whole-school SEHER health promotion intervention had substantial beneficial effects on school climate and health-related outcomes when delivered by lay counsellors, but no effects when delivered by teachers. Future research should focus on the evaluation of the scaling up of the SEHER intervention in diverse contexts and delivery agents.
John D. and Catherine T. MacArthur Foundation, USA and the United Nations Population Fund India Office.
To carry out an economic evaluation of a task-shifting intervention for the treatment of depressive and anxiety disorders in primary-care settings in Goa, India.
Cost-utility and cost-effectiveness ...analyses based on generalized linear models were performed within a trial set in 24 public and private primary-care facilities. Subjects were randomly assigned to an intervention or a control arm. Eligible subjects in the intervention arm were given psycho-education, case management, interpersonal psychotherapy and/or antidepressants by lay health workers. Subjects in the control arm were treated by physicians. The use of health-care resources, the disability of each subject and degree of psychiatric morbidity, as measured by the Revised Clinical Interview Schedule, were determined at 2, 6 and 12 months.
Complete data, from all three follow-ups, were collected from 1243 (75.4%) and 938 (81.7%) of the subjects enrolled in the study facilities from the public and private sectors, respectively. Within the public facilities, subjects in the intervention arm showed greater improvement in all the health outcomes investigated than those in the control arm. Time costs were also significantly lower in the intervention arm than in the control arm, whereas health system costs in the two arms were similar. Within the private facilities, however, the effectiveness and costs recorded in the two arms were similar.
Within public primary-care facilities in Goa, the use of lay health workers in the care of subjects with common mental disorders was not only cost-effective but also cost-saving.
Strengthening Evidence base on scHool-based intErventions for pRomoting adolescent health (SEHER) is a multicomponent, whole-school health promotion intervention delivered by a lay counsellor or a ...teacher in government-run secondary schools in Bihar, India. The objective of this study is to examine the effects of the intervention after two years of follow-up and to evaluate the consistency of the findings observed over time.
We conducted a cluster randomised trial in which 75 schools were randomised (1:1:1) to receive the SEHER intervention delivered by a lay counsellor (SEHER Mitra SM) or a teacher (Teacher as SEHER Mitra TSM), respectively, alongside a standardised, classroom-based life skills Adolescence Education Program (AEP), compared to AEP alone (control group). The trial design was a repeat cross-sectional study. Students enrolled in grade 9 (aged 13-15 years) in the 2015-2016 academic year were exposed to the intervention for two years and the outcome assessment was conducted at three time points─at baseline in June 2015; 8-months follow-up in March 2016, when the students were still in grade 9; and endpoint at 17-months follow-up in December 2016 (when the students were in grade 10), the results of which are presented in this paper. The primary outcome, school climate, was measured with the Beyond Blue School Climate Questionnaire (BBSCQ). Intervention effects were estimated using mixed-effects linear or logistic regression, including a random effect to adjust for within-school clustering, minimisation variables, baseline cluster-level score of the outcome, and sociodemographic characteristics. In total, 15,232 students participated in the 17-month survey. Compared with the control group, the participants in the SM intervention group reported improvements in school climate (adjusted mean difference aMD = 7.33; 95% CI: 6.60-8.06; p < 0.001) and most secondary outcomes (depression: aMD = -4.64; 95% CI: -5.83-3.45; p < 0.001; attitude towards gender equity: aMD = 1.02; 95% CI: 0.65-1.40; p < 0.001; frequency of bullying: aMD = -2.77; 95% CI: -3.40 to -2.14; p < 0.001; violence victimisation: odds ratio OR = 0.08; 95% CI: 0.04-0.14; p < 0.001; and violence perpetration: OR = 0.16; 95% CI: 0.09-0.29; p < 0.001). There was no evidence of an intervention effect in the TSM group compared with control group. The effects of the lay counsellor-delivered intervention were larger for most outcomes at 17-months follow-up compared with those at 8 months: school climate (effect size ES; 95% CI = 2.23 1.97-2.50 versus 1.88 1.44-2.32, p < 0.001); depression (ES 95% CI = -1.19 -1.56 to -0.82 versus -0.27 -0.44 to -0.11, p < 0.001); attitude towards gender equity (ES 95% CI = 0.53 0.27-0.79 versus 0.23 0.10-0.36, p < 0.001); bullying (ES 95% CI = -2.22 -2.84 to -1.60 versus -0.47 -0.61 to -0.33, p < 0.001); violence victimisation (OR 95% CI = 0.08 0.04-0.14 versus 0.62 0.46-0.84, p < 0.001); and violence perpetration (OR 95% CI = 0.16 0.09-0.29 versus 0.68 0.48-0.96, p < 0.001), suggesting incremental benefits with an extended intervention. A limitation of the study is that 27% of baseline participants did not complete the 17-month outcome assessment.
The trial showed that the second-year outcomes were similar to the first-year outcomes, with no effect of the teacher-led intervention and larger benefits on school climate and adolescent health accruing from extending lay counsellor-delivered intervention.
ClinicalTrials.gov NCT02907125.
The 2014-2016 Ebola epidemic in West Africa was the largest Ebola epidemic to date. Contact tracing was a core surveillance activity. Challenges with paper-based contact tracing systems include ...incomplete identification of contacts, delays in communication and response, loss of contact lists, inadequate data collection and transcription errors. The aim of this study was to design and evaluate an electronic system for tracing contacts of Ebola cases in Port Loko District, Sierra Leone, and to compare this with the existing paper-based system. The electronic system featured data capture using a smartphone application, linked to an alert system to notify the District Ebola Response Centre of symptomatic contacts.
The intervention was a customised three-tier smartphone application developed using Dimagi's CommCare platform known as the Ebola Contact Tracing application (ECT app). Eligible study participants were all 26 Contact Tracing Coordinators (CTCs) and 86 Contact Tracers (CTs) working in the 11 Chiefdoms of Port Loko District during the study period (April-August 2015). Case detection was from 13th April to 17th July 2015. The CTCs and their CTs were provided with smartphones installed with the ECT app which was used to conduct contact tracing activities. Completeness and timeliness of contact tracing using the app were compared with data from April 13th-June 7th 2015, when the standard paper-based system was used.
For 25 laboratory-confirmed cases for whom paper-based contact tracing was conducted, data for only 39% of 408 contacts were returned to the District, and data were often incomplete. For 16 cases for whom app-based contact tracing was conducted, 63% of 556 contacts were recorded as having been visited on the app, and the median recorded duration from case confirmation to first contact visit was 70 h.
There were considerable challenges to conducting high-quality contact tracing in this setting using either the paper-based or the app-based system. However, the study demonstrated that it was possible to implement mobile health (mHealth) in this emergency setting. The app had the benefits of improved data completeness, storage and accuracy, but the challenges of using an app in this setting and epidemic context were substantial.
Summary Background Depression and anxiety disorders are common mental disorders worldwide. The MANAS trial aimed to test the effectiveness of an intervention led by lay health counsellors in primary ...care settings to improve outcomes of people with these disorders. Methods In this cluster randomised trial, primary care facilities in Goa, India, were assigned (1:1) by computer-generated randomised sequence to intervention or control (enhanced usual care) groups. All adults who screened positive for common mental disorders were eligible. The collaborative stepped-care intervention offered case management and psychosocial interventions, provided by a trained lay health counsellor, supplemented by antidepressant drugs by the primary care physician and supervision by a mental health specialist. The research assessor was masked. The primary outcome was recovery from common mental disorders as defined by the International Statistical Classification of Diseases and Related Health Problems—10th revision (ICD-10) at 6 months. This study is registered with ClinicalTrials.gov , number NCT00446407. Findings 24 study clusters, with an equal proportion of public and private facilities, were randomised equally between groups. 1160 of 1360 (85%) patients in the intervention group and 1269 of 1436 (88%) in the control group completed the outcome assessment. Patients with ICD-10-confirmed common mental disorders in the intervention group were more likely to have recovered at 6 months than were those in the control group (n=620 65·0% vs 553 52·9%; risk ratio 1·22, 95% CI 1·00–1·47; risk difference=12·1%, 95% CI 1·6%–22·5%). The intervention had strong evidence of an effect in public facility attenders (369 65·9% vs 267 42·5%, risk ratio 1·55, 95% CI 1·02–2·35) but no evidence for an effect in private facility attenders (251 64·1% vs 286 65·9%, risk ratio 0·95, 0·74–1·22). There were three deaths and four suicide attempts in the collaborative stepped-care group and six deaths and six suicide attempts in the enhanced usual care group. None of the deaths were from suicide. Interpretation A trained lay counsellor-led collaborative care intervention can lead to an improvement in recovery from CMD among patients attending public primary care facilities. Funding The Wellcome Trust.
To evaluate associations of DNA methylation of the human tumour suppressor gene EPB41L3 with high-grade cervical intraepithelial neoplasia (CIN2+) and HIV-related factors among women living with ...HIV-1 (WLHIV) in Burkina Faso and South Africa.
Case-control study of WLHIV aged 25-50 with histology-determined CIN2+ (cases, N = 152) and ≤CIN1 (controls, N = 210).
EPB41L3 methylation was measured by pyrosequencing of bisulphite converted DNA from exfoliated cervical specimens at baseline and 16 months later. Median methylation levels were compared across CIN grades using the Mann-Whitney test and Cuzick test for trend. EPB41L3 methylation levels were dichotomized into 'high' and 'low' using the 66.7 percentile point of the distribution in the controls. Associations of EPB41L3 methylation with HIV-related factors were estimated by logistic regression.
Among 94 WLHIV in Burkina Faso and 268 in South Africa, median methylation levels at baseline for EPB41L3 increased with increasing CIN grade in both countries (P-trend <0.001).'High' methylation was more frequent among women with a longer time since HIV diagnosis in Burkina Faso >5 years vs. ≤5 years; adjusted odds ratio (aOR) = 4.15, 95% CI 1.09-15.83, adjusted for age, CD4 count, high-risk HPV and CIN status, with low CD4 count in both countries (CD4 ≤200 vs. ≥350 cells/μl: aOR = 7.14, 95% CI 1.44-35.37 in Burkina Faso; aOR = 2.55, 95% CI 1.07-6.07 in South Africa), and with prolonged ART use in South Africa (ART >2 years vs. ART-naïve: aOR = 2.40, 95% CI: 1.23-4.69).
Methylation of EPB41L3 DNA is elevated among WLHIV with CIN2+ and independently associated with lower CD4 count and ART use.
Depression, alcohol use disorders (AUD), and neurocognitive disorders are the 3 most prevalent mental, neurological, and substance use disorders in people living with HIV infection in low- and ...middle-income countries (LMICs). Importantly, they have an impact on everyday functions and on HIV outcomes. Many LMICs have validated tools to screen for and diagnose depression and AUD in the general population that can be used among people living with HIV infection. Current screening and diagnostic methods for HIV-associated neurocognitive disorders in the era of antiretroviral therapy are suboptimal and require further research. In our view, 2 research priorities are most critical. One is the development of an integrated screening approach for depression, AUD, and neurocognitive disorders that can be used by nonspecialists in LMICs. Second, research is needed on interventions for depression and AUD that also target behavior change, as these could impact on adherence to antiretroviral therapy and improve mental symptoms. Mentorship and fellowship schemes at an individual and institutional level need to be further supported to build capacity and provide platforms for research on HIV and mental, neurological, and substance use disorders in LMICs.
Depression and anxiety are common mental disorders globally but are rarely recognized or treated in low-income settings. Task-shifting of mental health care to lay health workers (LHWs) might ...decrease the treatment gap.
To evaluate the effectiveness of a culturally adapted psychological intervention for common mental disorders delivered by LHWs in primary care.
Cluster randomized clinical trial with 6 months' follow-up conducted from September 1, 2014, to May 25, 2015, in Harare, Zimbabwe. Twenty-four clinics were randomized 1:1 to the intervention or enhanced usual care (control). Participants were clinic attenders 18 years or older who screened positive for common mental disorders on the locally validated Shona Symptom Questionnaire (SSQ-14).
The Friendship Bench intervention comprised 6 sessions of individual problem-solving therapy delivered by trained, supervised LHWs plus an optional 6-session peer support program. The control group received standard care plus information, education, and support on common mental disorders.
Primary outcome was common mental disorder measured at 6 months as a continuous variable via the SSQ-14 score, with a range of 0 (best) to 14 and a cutpoint of 9. The secondary outcome was depression symptoms measured as a binary variable via the 9-item Patient Health Questionnaire, with a range of 0 (best) to 27 and a cutpoint of 11. Outcomes were analyzed by modified intention-to-treat.
Among 573 randomized patients (286 in the intervention group and 287 in the control group), 495 (86.4%) were women, median age was 33 years (interquartile range, 27-41 years), 238 (41.7%) were human immunodeficiency virus positive, and 521 (90.9%) completed follow-up at 6 months. Intervention group participants had fewer symptoms than control group participants on the SSQ-14 (3.81; 95% CI, 3.28 to 4.34 vs 8.90; 95% CI, 8.33 to 9.47; adjusted mean difference, -4.86; 95% CI, -5.63 to -4.10; P < .001; adjusted risk ratio ARR, 0.21; 95% CI, 0.15 to 0.29; P < .001). Intervention group participants also had lower risk of symptoms of depression (13.7% vs 49.9%; ARR, 0.28; 95% CI, 0.22 to 0.34; P < .001).
Among individuals screening positive for common mental disorders in Zimbabwe, LHW-administered, primary care-based problem-solving therapy with education and support compared with standard care plus education and support resulted in improved symptoms at 6 months. Scaled-up primary care integration of this intervention should be evaluated.
pactr.org Identifier: PACTR201410000876178.
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