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Background: Rates of perinatal depression (antenatal and postnatal depression) in South Asia are among the highest in the world. The delivery of effective psychological treatments for perinatal depression through existing health systems is a challenge due to a lack of human resources. This paper reports on a trial protocol that aims to evaluate the effectiveness and cost-effectiveness of the Thinking Healthy Programme delivered by peers (Thinking Healthy Programme Peer-delivered; THPP), for women with moderate to severe perinatal depression in rural and urban settings in Pakistan and India.Methods/design: THPP is evaluated with two randomised controlled trials: a cluster trial in Rawalpindi, Pakistan, and an individually randomised trial in Goa, India. Trial participants are pregnant women who are registered with the lady health workers in the study area in Pakistan and pregnant women attending outpatient antenatal clinics in India. They will be screened using the patient health questionnaire-9 (PHQ-9) for depression symptoms and will be eligible if their PHQ-9 is equal to or greater than 10 (PHQ-9 ≥ 10). The sample size will be 560 and 280 women in Pakistan and India, respectively. Women in the intervention arm (THPP) will be offered ten individual and four group sessions (Pakistan) or 6-14 individual sessions (India) delivered by a peer (defined as a mother from the same community who is trained and supervised in delivering the intervention). Women in the control arm (enhanced usual care) will receive health care as usual, enhanced by providing the gynaecologist or primary-health facilities with adapted WHO mhGAP guidelines for depression treatment, and providing the woman with her diagnosis and information on how to seek help for herself. The primary outcomes are remission and severity of depression symptoms at the 6-month postnatal follow-up. Secondary outcomes include remission and severity of depression symptoms at the 3-month postnatal follow-up, functional disability, perceived social support, breastfeeding rates, infant height and weight, and costs of health care at the 3- and 6-month postnatal follow-ups. The primary analysis will be intention-to-treat.Discussion: The trials have the potential to strengthen the evidence on the effectiveness and cost-effectiveness of an evidence-based psychological treatment recommended by the World Health Organisation and delivered by peers for perinatal depression. The trials have the unique opportunity to overcome the shortage of human resources in global mental health and may advance our understanding about the use of peers who work in partnership with the existing health systems in low-resource settings.Trial Registration: Pakistan Trial: ClinicalTrials.gov Identifier: NCT02111915 (9 April 2014) India Trial: ClinicalTrials.gov Identifier: NCT02104232 (1 April 2014). [ABSTRACT FROM AUTHOR]

Background Despite harmful drinking causing a significant burden on global health, there is a large treatment gap, especially in low- and middle-income countries. A major barrier to care is the lack of adequately skilled human resources to deliver contextually appropriate treatments. This paper describes the systematic process used to develop Counselling for Alcohol Problems ( CAP), a brief psychological treatment (PT) for delivery by lay counselors in routine primary care settings to men with harmful drinking in India. Methods CAP was developed using a methodology involving 3 sequential steps: (i) identifying potential treatment strategies; (ii) developing a theoretical framework for the treatment; and (iii) evaluating the acceptability and feasibility of the treatment. Results CAP is a 3-phase treatment delivered over 1 to 4 sessions based on a motivational interviewing ( MI) stance and involves the following strategies: assessment and personalized feedback, family engagement, drink refusal skills, skills to address drinking urges, problem-solving skills and handling difficult emotions, and relapse prevention and management. Data from a case series were used to inform several adaptations to enhance the acceptability of CAP to the recipients and feasibility of delivery by lay counselors of the treatment, for example expansion of the target group to include alcohol-dependent patients and the extension of the delivery settings to include home-based delivery. There was preliminary evidence of the effectiveness of CAP. Conclusions CAP is an acceptable brief PT for harmful drinking delivered by lay counselors in primary care whose effectiveness is currently being tested in a randomized controlled trial based in primary care in Goa, India. [ABSTRACT FROM AUTHOR]

Nutrition‐sensitive agriculture (NSA) interventions offer a means to improve the dietary quality of rural, undernourished populations. Their effectiveness could be further increased by understanding how household dynamics enable or inhibit the uptake of NSA behaviours. We used a convergent parallel mixed‐methods design to describe the links between household dynamics—specifically intrahousehold power inequalities and intrahousehold cooperation—and dietary quality and to explore whether household dynamics mediated or modified the effects of NSA interventions tested in a cluster‐randomized trial, Upscaling Participatory Action and Videos for Agriculture and Nutrition (UPAVAN). We use quantitative data from cross‐sectional surveys in 148 village clusters at UPAVAN's baseline and 32 months afterwards (endline), and qualitative data from family case studies and focus group discussions with intervention participants and facilitators. We found that households cooperated to grow and buy nutritious foods, and gendered power inequalities were associated with women's dietary quality, but cooperation and women's use of power was inhibited by several interlinked factors. UPAVAN interventions were more successful in more supportive, cooperative households, and in some cases, the interventions increased women's decision‐making power. However, women's decisions to enter into negotiations with family members depended on whether women deemed the practices promoted by UPAVAN interventions to be feasible, as well as women's confidence and previous cultivation success. We conclude that interventions may be more effective if they can elicit cooperation from the whole household. This will require a move towards more family‐centric intervention models that empower women while involving other family members and accounting for the varied ways that families cooperate and negotiate. Key messages: Household cooperation and intrahousehold power inequalities may influence children's and mothers' dietary diversity in rural OdishaThese factors partly determine the effects of nutrition‐sensitive agriculture (NSA) interventions tested in Upscaling Participatory Action and Videos for Agriculture and Nutrition, indicating that NSA interventions may be more effective if they include multiple family members.There is wide heterogeneity in household dynamics and the constraints that families face. Further research is needed to identify how interventions can respond to this heterogeneity so that NSA interventions are effective in an inclusive and empowering way. [ABSTRACT FROM AUTHOR]

Objective: The objective of this study was to assess the effectiveness of a comprehensive hospital-based sickle cell disease (SCD) model involving improvements of proven interventions in a tribal area of Gujarat, India. Methods: This was a quasi-experimental study involving five primary health centers each in the intervention and control groups. This study was conducted from June 2016 to May 2018 in three tribal areas of Gujarat, India. The intervention was a hospital-based comprehensive care model for SCD patients. We included all SCD patients between the ages of 5 and 40 years in the study area. We measured outcomes at baseline and end line by household survey. The analysis was done using a difference-in-difference method. Results: A total of 84 and 101 patients were recruited in the intervention and control groups, respectively. The baseline characteristics were comparable in both the groups. At end line, there was a significant difference in coverage of proven interventions including pneumococcal vaccination- odds ratio (OR) 21.3 (95% CI 9.7–46.8, P value 0.002), folic acid - OR 4.1 (CI 2.2–7.8, P <0.001), chloroquine –OR 4.9 (CI 2.4–10.2, P <0.001), and hydroxyurea for severe SCD patients - OR7.1 (CI 1.8–28.6, P < 0.001) in the intervention group compared to the control group. The improvement for the clinical outcome indicators including pain crisis rate (mean difference [MD]: −0.18 [−1.17–0.812]), hospitalization rate (MD: −0.08 [−0.375–0.210]), and blood transfusion rate (MD: −0.60 [−0.532–0.412]) in the intervention group in comparison with the control group was nonsignificant. Conclusion: This study shows that the comprehensive hospital-based SCD model has great potential to improve the coverage of proven interventions for SCD. Further investigation is needed to assess the impact on clinical outcomes. [ABSTRACT FROM AUTHOR]

Importance: Mental health comorbidities are increasing worldwide and worsen outcomes for people with diabetes, especially when care is fragmented.Objective: To assess whether collaborative care vs usual care lowers depressive symptoms and improves cardiometabolic indices among adults with diabetes and depression.Design, Setting, and Participants: Parallel, open-label, pragmatic randomized clinical trial conducted at 4 socioeconomically diverse clinics in India that recruited patients with type 2 diabetes; a Patient Health Questionnaire-9 score of at least 10 (range, 0-27); and hemoglobin A1c (HbA1c) of at least 8%, systolic blood pressure (SBP) of at least 140 mm Hg, or low-density lipoprotein (LDL) cholesterol of at least 130 mg/dL. The first patient was enrolled on March 9, 2015, and the last was enrolled on May 31, 2016; the final follow-up visit was July 14, 2018.Interventions: Patients randomized to the intervention group (n = 196) received 12 months of self-management support from nonphysician care coordinators, decision support electronic health records facilitating physician treatment adjustments, and specialist case reviews; they were followed up for an additional 12 months without intervention. Patients in the control group (n = 208) received usual care over 24 months.Main Outcomes and Measures: The primary outcome was the between-group difference in the percentage of patients at 24 months who had at least a 50% reduction in Symptom Checklist Depression Scale (SCL-20) scores (range, 0-4; higher scores indicate worse symptoms) and a reduction of at least 0.5 percentage points in HbA1c, 5 mm Hg in SBP, or 10 mg/dL in LDL cholesterol. Prespecified secondary outcomes were percentage of patients at 12 and 24 months who met treatment targets (HbA1c <7.0%, SBP <130 mm Hg, LDL cholesterol <100 mg/dL [<70 mg/dL if prior cardiovascular disease]) or had improvements in individual outcomes (≥50% reduction in SCL-20 score, ≥0.5-percentage point reduction in HbA1c, ≥5-mm Hg reduction in SBP, ≥10-mg/dL reduction in LDL cholesterol); percentage of patients who met all HbA1c, SBP, and LDL cholesterol targets; and mean reductions in SCL-20 score, Patient Health Questionnaire-9 score, HbA1c, SBP, and LDL cholesterol.Results: Among 404 patients randomized (mean [SD] age, 53 [8.6] years; 165 [40.8%] men), 378 (93.5%) completed the trial. A significantly greater percentage of patients in the intervention group vs the usual care group met the primary outcome (71.6% vs 57.4%; risk difference, 16.9% [95% CI, 8.5%-25.2%]). Of 16 prespecified secondary outcomes, there were no statistically significant between-group differences in improvements in 10 outcomes at 12 months and in 13 outcomes at 24 months. Serious adverse events in the intervention and usual care groups included cardiovascular events or hospitalizations (4 [2.0%] vs 7 [3.4%]), stroke (0 vs 3 [1.4%]), death (2 [1.0%] vs 7 [3.4%]), and severe hypoglycemia (8 [4.1%] vs 0).Conclusions and Relevance: Among patients with diabetes and depression in India, a 12-month collaborative care intervention, compared with usual care, resulted in statistically significant improvements in a composite measure of depressive symptoms and cardiometabolic indices at 24 months. Further research is needed to understand the generalizability of the findings to other low- and middle-income health care settings.Trial Registration: ClinicalTrials.gov Identifier: NCT02022111. [ABSTRACT FROM AUTHOR]

To test the efficacy of an intervention to reduce tobacco use among youth (10-19 years old) in slum communities in Delhi, India. This community- based cluster-randomized trial included 14 slums composed of purposely built resettlement colonies and adjacent inhabitant-built Jhuggi Jhopris. Youth in the intervention received a 2 year multiple-component intervention: (a) youth and adult leader training; (b) peer-led interactive activities and outreach; (c) tobacco cessation camps; and (d) enforcement of India's Tobacco Control Law (smoke-free environments and youth access). Overall, no differences between the intervention and control conditions were observed over time; self-reported tobacco use declined in both groups. However, when stratified by type of residence, a significant decrease was observed among youth in the resettlement colonies in the intervention group for overall tobacco use (slope=-0.69) and cigarette and bidi smoking (slope=-0.66), compared to an increase in the control group (slope=0.24 and 0.12, respectively) (P<0.001). No differences in smokeless tobacco (SLT) use were observed for either group. Comprehensive community-based interventions that engage youth can be effective in reducing smoking among disadvantaged youth in India. More intensive interventions, like tax increases or large-scale media campaigns, appear warranted for the most marginalized in this context and for SLT products. [ABSTRACT FROM AUTHOR]

Mobile phone induced electromagnetic field (MPEMF) as well as chanting of Vedic mantra ‘OM’ has been shown to affect cognition and brain haemodynamics, but findings are still inconclusive. Twenty right-handed healthy teenagers (eight males and 12 females) in the age range of 18.25 ± 0.44 years were randomly divided into four groups: (1) MPONOM (mobile phone ‘ON’ followed by ‘OM’ chanting); (2) MPOFOM (mobile phone ‘OFF’ followed by ‘OM’ chanting); (3) MPONSS (mobile phone ‘ON’ followed by ‘SS’ chanting); and (4) MPOFSS (mobile phone ‘OFF’ followed by ‘SS’ chanting). Brain haemodynamics during Stroop task were recorded using a 64-channel fNIRS device at three points of time: (1) baseline, (2) after 30 min of MPON/OF exposure, and (3) after 5 min of OM/SS chanting. RM-ANOVA was applied to perform within- and between-group comparisons, respectively. Between-group analysis revealed that total scores on incongruent Stroop task were significantly better after OM as compared to SS chanting (MPOFOM vs MPOFSS), pre-frontal activation was significantly lesser after OM as compared to SS chanting in channel 13. There was no significant difference between MPON and MPOF conditions for Stroop performance, as well as brain haemodynamics. These findings need confirmation through a larger trial in future. [ABSTRACT FROM PUBLISHER]

In health education and behavior change interventions, process tracking monitors the delivery of an intervention and its receipt to the intended audience. A randomized controlled trial in the state of Bihar, India was conducted to help school teachers become tobacco free through appropriately designed intervention program and delivery system. We describe the results from process tracking of this intervention delivery. The intervention program was centred on six topics delivered in each school through 12 sessions over 6 successive months. The program deliverers recorded the process measures as total number of sessions and program-components implemented (fidelity); time spent conducting sessions (dose) and proportion of teachers attending at least one session (reach). The outcome measures (teachers' exposure to intervention messages and tobacco policy adoption) were assessed post-intervention. All 12 sessions were delivered in 33 out of 36 schools. Thirty-one schools implemented all six program components. In 18 schools, ≥95% of the teachers participated in one or more sessions. Thirty-three schools received 12 or more hours of dose. In 29 schools, 100% teachers reported exposure to all program messages. Tobacco policy was adopted by all schools. Thus, the intervention was generally delivered as planned and it had a positive impact on teachers and schools. [ABSTRACT FROM AUTHOR]

Traditional recruitment methods for microbicide efficacy trials are labor intensive and may fail to reach high-risk hard-to-reach populations. We report duration of recruitment and lessons learned from a two-stage process to recruit female sex workers (FSWs) into a placebo microbicide trial, and examined characteristics associated with successful recruitment of peers who screened for and enrolled in the trial. FSWs were first recruited via respondent-driven sampling (RDS) to complete a survey and subsequently invited to screen for enrollment into a placebo microbicide trial taking place at a local clinic. It took 6 months to enroll 267 participants into the trial. Successful recruiters of peers who enrolled were more likely to have enrolled themselves (AOR 2.0, CI 1.3-2.9) and less likely to visit Nellore city (AOR 0.5, CI 0.3-0.9). Recruitment of FSWs via a two-stage recruitment strategy with RDS can be a good option for future clinical trials. [ABSTRACT FROM AUTHOR]

Body composition in HIV-infected individuals is subject to many influences. We conducted a pilot 6-month randomized trial of 68 women living with AIDS (WLA) from rural India. High protein intervention combined with education and supportive care delivered by HIV-trained village women (activated social health activist [Asha] life [AL]) was compared to standard protein with usual care delivered by village community assistants (usual care [UC]). Measurements included CD4 counts, ART adherence, socio-demographics, disease characteristics (questionnaires); and anthropometry (bioimpedance analyzer). Repeated measures analysis of variance modeled associations. AL significantly gained in BMI, muscle mass, fat mass, ART adherence, and CD4 counts compared to UC, with higher weight and muscle mass gains among ART adherent (≥66 %) participants who had healthier immunity (CD4 ≥450). BMI of WLA improved through high protein supplementation combined with education and supportive care. Future research is needed to determine which intervention aspect was most responsible. [ABSTRACT FROM AUTHOR]

In both a laboratory experiment (in Australia) using university as the basis of group membership, and a scenario experiment (in India) using religion as the basis of group membership, we observe more favourable respect and fairness ratings in response to an in-group authority than an out-group authority who administers non-instrumental voice. Moreover, we observe in our second experiment that reported likelihood of protest (herein called 'social-change voice') was relatively high following non-instrumental voice from an out-group authority, but relatively low following non-instrumental voice from an in-group authority. Our findings are consistent with relational models of procedural justice, and extend the work by examining likely use of alternative forms of voice as well as highlighting the relative importance of instrumentality. [ABSTRACT FROM AUTHOR]

ABSTRACT Aims This study evaluated the effectiveness of a brief intervention (BI) for illicit drugs (cannabis, cocaine, amphetamine-type stimulants and opioids) linked to the World Health Organization (WHO) Alcohol, Smoking and Substance Involvement Screening Test (ASSIST). The ASSIST screens for problem or risky use of 10 psychoactive substances, producing a score for each substance that falls into either a low-, moderate- or high-risk category. Design Prospective, randomized controlled trial in which participants were either assigned to a 3-month waiting-list control condition or received brief motivational counselling lasting an average of 13.8 minutes for the drug receiving the highest ASSIST score. Setting Primary health-care settings in four countries: Australia, Brazil, India and the United States. Participants A total of 731 males and females scoring within the moderate-risk range of the ASSIST for cannabis, cocaine, amphetamine-type stimulants or opioids. Measurements ASSIST-specific substance involvement scores for cannabis, stimulants or opioids and ASSIST total illicit substance involvement score at baseline and 3 months post-randomization. Findings Omnibus analyses indicated that those receiving the BI had significantly reduced scores for all measures, compared with control participants. Country-specific analyses showed that, with the exception of the site in the United States, BI participants had significantly lower ASSIST total illicit substance involvement scores at follow-up compared with the control participants. The sites in India and Brazil demonstrated a very strong brief intervention effect for cannabis scores ( P < 0.005 for both sites), as did the sites in Australia ( P < 0.005) and Brazil ( P < 0.01) for stimulant scores and the Indian site for opioid scores ( P < 0.01). Conclusions The Alcohol, Smoking and Substance Involvement Screening Test-linked brief intervention aimed at reducing illicit substance use and related risks is effective, at least in the short term, and the effect generalizes across countries. [ABSTRACT FROM AUTHOR]