Prevalence of probable mental, neurological and substance use conditions and case detection at primary healthcare facilities across three districts in Ghana: findings from a cross-sectional health facility survey.

BACKGROUND: Few studies have examined the prevalence of mental, neurological and substance use (MNS) conditions, case detection and treatment in primary healthcare in rural settings in Africa. We assessed prevalence and case detection at primary healthcare facilities in low-resource rural settings in Ghana. METHODS: A cross-sectional survey was conducted at the health facility level in three demonstration districts situated in Bongo (Upper East Region), Asunafo North (Ahafo Region) and Anloga (Volta Region) in Ghana. The study participants were resident adult (> 17 years) out-patients seeking healthcare at primary care facilities in each of the three demonstration districts. Data were collected on five priority MNS conditions: depression, psychosis, suicidal behaviour, epilepsy and alcohol use disorders. RESULTS: Nine hundred and nine (909) people participated in the survey. The prevalence of probable depression was 15.6% (142/909), probable psychotic symptoms was 12% (109/909), probable suicidal behaviour was 11.8% (107/909), probable epilepsy was 13.1% (119/909) and probable alcohol use disorders was 7.8% (71/909). The proportion of missed detection for cases of depression, self-reported psychotic symptoms, epilepsy and alcohol use disorders (AUD) ranged from 94.4 to 99.2%, and was similar across study districts. Depression was associated with self-reported psychotic symptoms (RR: 1.68; 95% CI: 1.12-1.54). For self-reported psychotic symptoms, a reduced risk was noted for being married (RR: 0.62; 95% CI: 0.39-0.98) and having a tertiary level education (RR: 0.12; 95% CI: 0.02-0.84). Increased risk of suicidal behaviour was observed for those attending a health facility in Asunafo (RR: 2.31; 95% CI: 1.27-4.19) and Anloga districts (RR: 3.32; 95% CI: 1.93-5.71). Age group of 35 to 44 years (RR: 0.43; 95% CI: 0.20-0.90) was associated with reduced risk of epilepsy. Being female (RR: 0.19; 95% CI: 0.12-0.31) and having a tertiary education (RR: 0.27; 95% CI: 0.08-0.92) were associated with reduced risk of AUD. CONCLUSIONS: Our study found a relatively high prevalence of probable MNS conditions, and very low detection and treatment rates in rural primary care settings in Ghana. There is a need to improve the capacity of primary care health workers to detect and manage MNS conditions.

Temporal pathways of change in two randomized controlled trials for depression and harmful drinking in Goa, India.

BACKGROUND: The current study explored the temporal pathways of change within two treatments, the Healthy Activity Program (HAP) for depression and the Counselling for Alcohol Problems (CAP) Program for harmful drinking. METHODS: The study took place in the context of two parallel randomized controlled trials in Goa, India. N = 50 random participants who met a priori criteria were selected from each treatment trial and examined for potential direct and mediational pathways. In HAP, we examined the predictive roles of therapy quality and patient-reported activation, assessing whether activation mediated the effects of therapy quality on depression (Patient Health Questionnaire-9) outcomes. In CAP, we examined the predictive roles of therapy quality and patient change- and counter-change-talk, assessing whether change- or counter-change-talk mediated the effects of therapy quality on daily alcohol consumption. RESULTS: In HAP, therapy quality (both general and treatment-specific skills) was associated with patient activation; patient activation but not therapy quality significantly predicted depression outcomes, and patient activation mediated the effects of higher general skills on subsequent clinical outcomes [a × b = -2.555, 95% confidence interval (CI) -5.811 to -0.142]. In CAP, higher treatment-specific skills, but not general skills, were directly associated with drinking outcomes, and reduced levels of counter-change talk both independently predicted, and mediated the effects of higher general skills on, reduced alcohol consumption (a × b = -24.515, 95% CI -41.190 to -11.060). Change talk did not predict alcohol consumption and was not correlated with counter-change talk. CONCLUSION: These findings suggest that therapy quality in early sessions operated through increased patient activation and reduced counter-change talk to reduce depression and harmful drinking respectively.

Psychological treatments for depression among women experiencing intimate partner violence: findings from a randomized controlled trial for behavioral activation in Goa, India.

Intimate partner violence (IPV) strongly predicts depression, but it is unknown if women experiencing IPV can benefit from depression treatments in contexts where depression and IPV are prevalent. This study explored whether women experiencing IPV in Goa, India, can benefit from the Healthy Activity Program (HAP), a culturally adapted behavioral activation treatment, compared with enhanced usual care (EUC). Cross-sectional and longitudinal analyses were performed on data from a clinical trial. Measures assessed at baseline and 3 and 12 months included depressive symptoms. Measures assessed at 3 and 12 months included activation and IPV. Independent t tests were conducted to assess if participants experiencing IPV had higher depressive symptoms and lower activation at 3 and 12 months; hierarchical linear regression was conducted to determine if 3-month IPV predicted 12-month depressive symptoms across trial arms (Hypothesis 1). Hierarchical linear regression was then conducted to examine if the relationship between 3-month activation and 12-month depressive symptoms was moderated by 3-month IPV within each trial arm (Hypothesis 2). As expected, participants experiencing IPV had significantly lower activation levels and higher depressive symptoms compared with participants who did not experience IPV at 3 and 12 months in cross-sectional analyses. Similarly, IPV endorsed at 3 months significantly predicted depressive symptoms at 12 months. However, activation was significantly associated with less severe depressive symptoms at 12 months, irrespective of IPV endorsement among HAP participants. For EUC participants, IPV remained the only significant predictor of depressive symptoms at 12 months. Results suggest that women experiencing IPV can still benefit from behavioral activation.

The Healthy Activity Program (HAP), a lay counsellor-delivered brief psychological treatment for severe depression, in primary care in India: a randomised controlled trial.

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.

Counselling for Alcohol Problems (CAP), a lay counsellor-delivered brief psychological treatment for harmful drinking in men, in primary care in India: a randomised controlled trial.

BACKGROUND: Although structured psychological treatments are recommended as first-line interventions for harmful drinking, 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 Counselling for Alcohol Problems (CAP), a brief psychological treatment delivered by lay counsellors to patients with harmful drinking attending routine primary health-care settings. METHODS: In this randomised controlled trial, we recruited male harmful drinkers defined by an Alcohol Use Disorders Identification Test (AUDIT) score of 12-19 who were aged 18-65 years from ten primary health centres in Goa, India. We excluded patients who needed emergency medical treatment or inpatient admission, who were unable to communicate clearly, and who were intoxicated at the time of screening. Participants were randomly allocated (1:1) by trained health assistants based at the primary health centres to enhanced usual care (EUC) alone or EUC combined with CAP, in randomly sized blocks of four to six, stratified by primary health centre, and allocation was concealed with use of sequential numbered opaque envelopes. Physicians providing EUC and those assessing outcomes were masked. Primary outcomes were remission (AUDIT score of <8) and mean daily alcohol consumed in the past 14 days, at 3 months. Secondary outcomes were the effect of drinking, disability score, days unable to work, suicide attempts, intimate partner violence, and resource use and costs of illness. Analyses were on an intention-to-treat basis. We used logistic regression analysis for remission and zero-inflated negative binomial regression analysis for alcohol consumption. We assessed serious adverse events in the per-protocol population. This trial is registered with the ISCRTN registry, number ISRCTN76465238. FINDINGS: Between Oct 28, 2013, and July 29, 2015, we enrolled and randomly allocated 377 participants (188 [50%] to the EUC plus CAP group and 190 [50%] to the EUC alone group [one of whom was subsequently excluded because of a protocol violation]), of whom 336 (89%) completed the 3 month primary outcome assessment (164 [87%] in the EUC plus CAP group and 172 [91%] in the EUC alone group). The proportion with remission (59 [36%] of 164 in the EUC plus CAP group vs 44 [26%] of 172 in the EUC alone group; adjusted prevalence ratio 1·50 [95% CI 1·09-2·07]; p=0·01) and the proportion abstinent in the past 14 days (68 [42%] vs 31 [18%]; adjusted odds ratio 3·00 [1·76-5·13]; p<0·0001) were significantly higher in the EUC plus CAP group than in the EUC alone group, but we noted no effect on mean daily alcohol consumed in the past 14 days among those who reported drinking in this period (37·0 g [SD 44·2] vs 31·0 g [27·8]; count ratio 1·08 [0·79-1·49]; p=0·62). We noted an effect on the percentage of days abstinent in the past 14 days (adjusted mean difference [AMD] 16·0% [8·1-24·1]; p<0·0001), but no effect on the percentage of days of heavy drinking (AMD -0·4% [-5·7 to 4·9]; p=0·88), the effect of drinking (Short Inventory of Problems score AMD-0·03 [-1·93 to 1·86]; p=0.97), disability score (WHO Disability Assessment Schedule score AMD 0·62 [-0·62 to 1·87]; p=0·32), days unable to work (no days unable to work adjusted odds ratio 1·02 [0·61-1·69]; p=0.95), suicide attempts (adjusted prevalence ratio 1·8 [-2·4 to 6·0]; p=0·25), and intimate partner violence (adjusted prevalence ratio 3·0 [-10·4 to 4·4]; p=0·57). The incremental cost per additional remission was $217 (95% CI 50-1073), with an 85% chance of being cost-effective in the study setting. We noted no significant difference in the number of serious adverse events between the two groups (six [4%] in the EUC plus CAP group vs 13 [8%] in the EUC alone group; p=0·11). INTERPRETATION: CAP delivered by lay counsellors plus EUC was better than EUC alone was for harmful drinkers in routine primary health-care settings, and might be cost-effective. CAP could be a key strategy to reduce the treatment gap for alcohol use disorders, one of the leading causes of the global burden among men worldwide. FUNDING: Wellcome Trust.

Sustained effectiveness and cost-effectiveness of Counselling for Alcohol Problems, a brief psychological treatment for harmful drinking in men, delivered by lay counsellors in primary care: 12-month follow-up of a randomised controlled trial.

BACKGROUND: Counselling for Alcohol Problems (CAP), a brief intervention delivered by lay counsellors, enhanced remission and abstinence over 3 months among male primary care attendees with harmful drinking in a setting in India. We evaluated the sustainability of the effects after treatment termination, the cost-effectiveness of CAP over 12 months, and the effects of the hypothesized mediator 'readiness to change' on clinical outcomes. METHODS AND FINDINGS: Male primary care attendees aged 18-65 years screening with harmful drinking on the Alcohol Use Disorders Identification Test (AUDIT) were randomised to either CAP plus enhanced usual care (EUC) (n = 188) or EUC alone (n = 189), of whom 89% completed assessments at 3 months, and 84% at 12 months. Primary outcomes were remission and mean standard ethanol consumed in the past 14 days, and the proposed mediating variable was readiness to change at 3 months. CAP participants maintained the gains they showed at the end of treatment through the 12-month follow-up, with the proportion with remission (AUDIT score < 8: 54.3% versus 31.9%; adjusted prevalence ratio [aPR] 1.71 [95% CI 1.32, 2.22]; p < 0.001) and abstinence in the past 14 days (45.1% versus 26.4%; adjusted odds ratio 1.92 [95% CI 1.19, 3.10]; p = 0.008) being significantly higher in the CAP plus EUC arm than in the EUC alone arm. CAP participants also fared better on secondary outcomes including recovery (AUDIT score < 8 at 3 and 12 months: 27.4% versus 15.1%; aPR 1.90 [95% CI 1.21, 3.00]; p = 0.006) and percent of days abstinent (mean percent [SD] 71.0% [38.2] versus 55.0% [39.8]; adjusted mean difference 16.1 [95% CI 7.1, 25.0]; p = 0.001). The intervention effect for remission was higher at 12 months than at 3 months (aPR 1.50 [95% CI 1.09, 2.07]). There was no evidence of an intervention effect on Patient Health Questionnaire 9 score, suicidal behaviour, percentage of days of heavy drinking, Short Inventory of Problems score, WHO Disability Assessment Schedule 2.0 score, days unable to work, or perpetration of intimate partner violence. Economic analyses indicated that CAP plus EUC was dominant over EUC alone, with lower costs and better outcomes; uncertainty analysis showed a 99% chance of CAP being cost-effective per remission achieved from a health system perspective, using a willingness to pay threshold equivalent to 1 month's wages for an unskilled manual worker in Goa. Readiness to change level at 3 months mediated the effect of CAP on mean standard ethanol consumption at 12 months (indirect effect -6.014 [95% CI -13.99, -0.046]). Serious adverse events were infrequent, and prevalence was similar by arm. The methodological limitations of this trial are the susceptibility of self-reported drinking to social desirability bias, the modest participation rates of eligible patients, and the examination of mediation effects of only 1 mediator and in only half of our sample. CONCLUSIONS: CAP's superiority over EUC at the end of treatment was largely stable over time and was mediated by readiness to change. CAP provides better outcomes at lower costs from a societal perspective. TRIAL REGISTRATION: ISRCTN registry ISRCTN76465238.

Sustained effectiveness and cost-effectiveness of the Healthy Activity Programme, a brief psychological treatment for depression delivered by lay counsellors in primary care: 12-month follow-up of a randomised controlled trial.

BACKGROUND: The Healthy Activity Programme (HAP), a brief behavioural intervention delivered by lay counsellors, enhanced remission over 3 months among primary care attendees with depression in peri-urban and rural settings in India. We evaluated the sustainability of the effects after treatment termination, the cost-effectiveness of HAP over 12 months, and the effects of the hypothesized mediator of activation on clinical outcomes. METHODS AND FINDINGS: Primary care attendees aged 18-65 years screened with moderately severe to severe depression on the Patient Health Questionnaire 9 (PHQ-9) were randomised to either HAP plus enhanced usual care (EUC) (n = 247) or EUC alone (n = 248), of whom 95% completed assessments at 3 months, and 91% at 12 months. Primary outcomes were severity on the Beck Depression Inventory-II (BDI-II) and remission on the PHQ-9. HAP participants maintained the gains they showed at the end of treatment through the 12-month follow-up (difference in mean BDI-II score between 3 and 12 months = -0.34; 95% CI -2.37, 1.69; p = 0.74), with lower symptom severity scores than participants who received EUC alone (adjusted mean difference in BDI-II score = -4.45; 95% CI -7.26, -1.63; p = 0.002) and higher rates of remission (adjusted prevalence ratio [aPR] = 1.36; 95% CI 1.15, 1.61; p < 0.009). They also fared better on most secondary outcomes, including recovery (aPR = 1.98; 95% CI 1.29, 3.03; p = 0.002), any response over time (aPR = 1.45; 95% CI 1.27, 1.66; p < 0.001), higher likelihood of reporting a minimal clinically important difference (aPR = 1.42; 95% CI 1.17, 1.71; p < 0.001), and lower likelihood of reporting suicidal behaviour (aPR = 0.71; 95% CI 0.51, 1.01; p = 0.06). HAP plus EUC also had a marginal effect on WHO Disability Assessment Schedule score at 12 months (aPR = -1.58; 95% CI -3.33, 0.17; p = 0.08); other outcomes (days unable to work, intimate partner violence toward females) did not statistically significantly differ between the two arms. Economic analyses indicated that HAP plus EUC was dominant over EUC alone, with lower costs and better outcomes; uncertainty analysis showed that from this health system perspective there was a 95% chance of HAP being cost-effective, given a willingness to pay threshold of Intl$16,060-equivalent to GDP per capita in Goa-per quality-adjusted life year gained. Patient-reported behavioural activation level at 3 months mediated the effect of the HAP intervention on the 12-month depression score (ß = -2.62; 95% CI -3.28, -1.97; p < 0.001). Serious adverse events were infrequent, and prevalence was similar by arm. We were unable to assess possible episodes of remission and relapse that may have occurred between our outcome assessment time points of 3 and 12 months after randomisation. We did not account for or evaluate the effect of mediators other than behavioural activation. CONCLUSIONS: HAP's superiority over EUC at the end of treatment was largely stable over time and was mediated by patient activation. HAP provides better outcomes at lower costs from a perspective covering publicly funded healthcare services and productivity impacts on patients and their families. TRIAL REGISTRATION: ISRCTN registry ISRCTN95149997.

The Healthy Activity Program lay counsellor delivered treatment for severe depression in India: systematic development and randomised evaluation.

BACKGROUND: Reducing the global treatment gap for mental disorders requires treatments that are economical, effective and culturally appropriate. AIMS: To describe a systematic approach to the development of a brief psychological treatment for patients with severe depression delivered by lay counsellors in primary healthcare. METHOD: The treatment was developed in three stages using a variety of methods: (a) identifying potential strategies; (b) developing a theoretical framework; and (c) evaluating the acceptability, feasibility and effectiveness of the psychological treatment. RESULTS: The Healthy Activity Program (HAP) is delivered over 6-8 sessions and consists of behavioral activation as the core psychological framework with added emphasis on strategies such as problem-solving and activation of social networks. Key elements to improve acceptability and feasibility are also included. In an intention-to-treat analysis of a pilot randomised controlled trial (55 participants), the prevalence of depression (Beck Depression Inventory II ⩾19) after 2 months was lower in the HAP than the control arm (adjusted risk ratio = 0.55, 95% CI 0.32-0.94,P= 0.01). CONCLUSIONS: Our systematic approach to the development of psychological treatments could be extended to other mental disorders. HAP is an acceptable and effective brief psychological treatment for severe depression delivered by lay counsellors in primary care.

The systematic development and pilot randomized evaluation of counselling for alcohol problems, a lay counselor-delivered psychological treatment for harmful drinking in primary care in India: the PREMIUM study.

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.

Determinants of postnatal depression in rural ghana: findings from the don population based cohort study.

BACKGROUND: Risk factors for postnatal depression (PND), one of the most pervasive complications of child bearing, are poorly understood in Africa. A recent systematic review of 31 studies found that the strongest predictors are social and economic disadvantage and gender-based factors; only six of these studies were community based, and almost all were in South Asia. METHODS: Cohort study nested within 4 weekly surveillance of all women of reproductive age to identify pregnancies and collect data on births and deaths in the Kintampo Health Research Centre study area of Ghana. Women were screened for depression during pregnancy and after birth using the Patient Health Questionnaire to ascertain DSM-IV major or minor depression. Information was collected on determinants relating to the mother, birth, and baby, which were examined using logistic regression; effect sizes reported as relative risks with 95% confidence intervals. RESULTS: Thirteen thousand nine hundred and twenty nine women were screened both during pregnancy and after birth, of whom 13,360 (95.9%) had complete data on potential determinants. Two hundred and fifty five (3.8%, 95% CI: 3.5%, 4.1%) had PND. Antenatal depression (AND) was the strongest determinant accounting for 34.4% of PND cases. Other determinants were season of delivery, peripartum/postpartum complications, newborn ill health, still birth, or neonatal death. Common determinants were observed for onset and persistent depression. CONCLUSIONS: Although most AND resolves in this setting, more than a third of women with PND also had AND. Adverse birth- and baby-related outcomes are the other main determinants. We recommend that programs detect and treat depression during pregnancy and provide support to women with adverse birth outcomes.

Effect of the Newhints home-visits intervention on neonatal mortality rate and care practices in Ghana: a cluster randomised controlled trial.

BACKGROUND: In 2009, on the basis of promising evidence from trials in south Asia, WHO and UNICEF issued a joint statement about home visits as a strategy to improve newborn survival. In the Newhints trial, we aimed to test this home-visits strategy in sub-Saharan Africa by assessing the effect on all-cause neonatal mortality rate (NMR) and essential newborn-care practices. METHODS: The Newhints cluster randomised trial was undertaken in 98 zones in seven districts in the Brong Ahafo Region, Ghana. 49 zones were randomly assigned to the Newhints intervention and 49 to the control intervention by use of restricted randomisation with stratification to ensure comparability between interventions. Community-based surveillance volunteers (CBSVs) in Newhints zones were trained to identify pregnant women in their community and to make two home visits during pregnancy and three in the first week of life to promote essential newborn-care practices, weigh and assess babies for danger signs, and refer as necessary. Primary outcomes were NMR and coverage of key essential newborn-care practices. Analyses were by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00623337. FINDINGS: 16,168 (99%) of 16,329 deliveries between November, 2008, and December, 2009, were livebirths; the status at 1 month was known for 15,619 (97%) livebirths. 482 neonatal deaths were recorded. Coverage data were available from 6029 women in Newhints zones; of these 4358 (72%) reported having CBSV visits during pregnancy and 3815 (63%) reported having postnatal visits. This coverage increased substantially from June, 2009, after the introduction of new implementation strategies and reached almost 90% for pregnancy visits by the end of the trial and 75% for postnatal visits. The Newhints intervention significantly increased coverage of key essential newborn-care behaviours, except for four or more antenatal-care visits (5975 [76%] of 7859 vs 5988 [74%] of 8121, respectively; relative risk 1·02, 95% CI 0·96-1·09; p=0·52) and baby delivered in a facility (5373 [68%] vs 5539 [68%], respectively; 0·97, 0·81-1·14; p=0·69). The largest increase was for care-seeking, with 102 (77%) of 132 sick babies in Newhints zones taken to a hospital or clinic compared with 77 (55%) of 139 in control zones (1·43, 1·17-1·76; p=0·001). Increases were also noted in bednet use during pregnancy (5398 [69%] of 7859 vs 5135 [63%] of 8121, respectively; 1·12, 1·03-1·21; p=0·005), money saved for delivery or emergency (5730 [86%] of 6681 vs 5525 [80%] of 6941, respectively; 1·09, 1·05-1·12; p<0·0001), transport arranged in advance for facility (2496 [37%] vs 2061 [30%], respectively; 1·30, 1·12-1·49; p=0·0004), birth assistant for home delivery washed hands with soap (1853 [93%] of 1992 vs 1817 [87%] of 2091, respectively; 1·05, 1·02-1·09; p=0·001), initiation of breastfeeding in less than 1 h of birth (3743 [49%] of 7673 vs 3280 [41%] of 7921, respectively; 1·22, 1·07-1·40; p=0·004), skin to skin contact (3355 [44%] vs 1931 [24%], respectively; 2·30, 1·85-2·87; p=0·0002), first bath delayed for longer than 6 h (3131 [41%] vs 2269 [29%], respectively; 1·65, 1·27-2·13; p<0·0001), exclusive breastfeeding for 26-32 days (1217 [86%] of 1414 vs 1091 [80%] of 1371; 1·10, 1·04-1·16; p=0·001), and baby sleeping under bednet for 8-56 days (4548 [79%] of 5756 vs 4291 [73%] of 5846; 1·09, 1·03-1·15; p=0·002). There were 230 neonatal deaths in the Newhints zones compared with 252 in the control zones. The overall NMRs per 1000 livebirths were 29·8 and 31·9, respectively (0·92, 0·75-1·12; p=0·405). INTERPRETATION: The reduction in NMR with Newhints is consistent with the reductions achieved in three trials undertaken in programme settings in south Asia. Because there is no suggestion of any heterogeneity (p=0·850) between these trials and Newhints, the meta-analysis summary estimate of a reduction of 12% (95% CI 5-18) provides the best evidence for the likely effect of the home-visits strategy delivered within programmes in sub-Saharan Africa and in south Asia. Improvements in the quality of delivery and neonatal care in health facilities and development of innovative, effective strategies to increase coverage of home visits on the day of birth could lead to the achievement of more substantial reductions. FUNDING: WHO, Bill & Melinda Gates Foundation, and UK Department for International Development.

Balancing Ethics and Culture: A Scoping Review of Ethico-Cultural and Implementation Challenges of the Individual-Based Consent Model in African Research.

Objective: This review explores the ethico-cultural and implementation challenges associated with the individual-based informed consent (IC) model in the relatively collectivistic African context and examines suggested approaches to manage them. Methods: We searched four databases for peer-reviewed studies published in English between 2000 to 2023 that examined the ethico-cultural and implementation challenges associated with the IC model in Africa. Results: Findings suggest that the individual-based IC model largely misaligns with certain African social values and ethos and subverts the authority and functions of community gatekeepers. Three recommendations were proffered to manage these challenges, that researchers should: adopt a multi-step approach to IC, conduct a rapid ethical assessment, and generate an African-centered IC model. Conclusions: A pluriversal, context-specific, multi-step IC model that critically harmonizes the cultural values of the local population and the general principles of IC can minimize ethics dumping, safeguard the integrity of the research process, and promote respectful engagement.

Factor structure of the alcohol expectancies questionnaire among adolescents in rural Ghana.

INTRODUCTION: Children's early experiences with alcohol inform the development of alcohol-related beliefs which are known to predict alcohol consumption during the critical stage of adolescence. Yet, there has been considerably less research into these alcohol-related cognitions in low- and middle-income countries (LMIC) and existing measures of these beliefs are highly reflective of Western contexts, which may not be fully appropriate for use in LMICs. The aim is to ascertain the construct validity of the Alcohol Expectancies Questionnaire (AEQ) in a non-Western sample. METHODS: A cross-sectional diagnostic accuracy study involving 500 adolescents aged 10 to 18 years randomly selected from the database of the Navrongo Health and Demographic Surveillance System. Participants were administered the locally back translated version of the 34-item AEQ. Confirmatory factor analysis using the lavaan package in R was conducted to generate indices for the factor structure of the AEQ. RESULTS: Confirmatory factor analyses showed that while groupings of positive and negative expectancies were similar to those observed when expectancies have been assessed previously in Western studies, these formed a single 'alcohol expectancy' factor. Questions relating to positive tension reduction and negative physical expectancies showed inconsistent responses in this study. DISCUSSION AND CONCLUSIONS: Commonly used tools for the assessment of alcohol expectancies may not be suitable for use in Ghana, possibly owing to their development and validation in Western contexts. These findings have implications for the assessment of alcohol-related beliefs in LMIC settings and begin to map out a research agenda to develop more contextually and culturally attune alcohol assessments.

Adolescent health and well-being check-up programme in three African cities (Y-Check): protocol for a multimethod, prospective, hybrid implementation-effectiveness study.

BACKGROUND: During adolescence, behaviours are initiated that will have substantial impacts on the individual's short-term and long-term health and well-being. However, adolescents rarely have regular contact with health services, and available services are not always appropriate for their needs. We co-developed with adolescents a health and well-being check-up programme (Y-Check). This paper describes the methods to evaluate the feasibility, acceptability, short-term effects and cost-effectiveness of Y-Check in three African cities. METHOD: This is a multi-country prospective intervention study, with a mixed-method process evaluation. The intervention involves screening, on-the-spot care and referral of adolescents through health and well-being check-up visits. In each city, 2000 adolescents will be recruited in schools or community venues. Adolescents will be followed-up at 4 months. The study will assess the effects of Y-Check on knowledge and behaviours, as well as clinical outcomes and costs. Process and economic evaluations will investigate acceptability, feasibility, uptake, fidelity and cost effectiveness. ETHICS AND DISSEMINATION: Approval has been received from the WHO (WHO/ERC Protocol ID Number ERC.0003778); Ghana Health Service (Protocol ID Number GHS-ERC: 027/07/22), the United Republic of Tanzania National Institute for Medical Research (Clearance No. NIMR/HQ/R.8a/Vol.IX/4199), the Medical Research Council of Zimbabwe (Approval Number MRCZ/A/2766) and the LSHTM (Approval Numbers 26 395 and 28312). Consent and disclosure are addressed in the paper. Results will be published in three country-specific peer-reviewed journal publications, and one multicountry publication; and disseminated through videos, briefs and webinars. Data will be placed into an open access repository. Data will be deidentified and anonymised. TRIAL REGISTRATION NUMBER: NCT06090006.

Sociodemographic and Behavioral Factors Associated With Hypertension and Depression in 4 Rural Communities in Northern Ghana: A Cross-Sectional Study.

OBJECTIVES: The prevalences of hypertension and depression in sub-Saharan Africa are substantial and rising, despite limited data on their sociodemographic and behavioral risk factors and their interactions. We undertook a cross-sectional study in 4 communities in the Upper East Region of Ghana to identify persons with hypertension and depression in the setting of a pilot intervention training local nurses and health volunteers to manage these conditions. METHODS: We quantified hypertension and depression prevalence across key sociodemographic factors (age, sex, occupation, education, religion, ethnicity, and community) and behavioral factors (tobacco use, alcohol use, and physical activity) and tested for association by multivariable logistic regression. RESULTS: Hypertension prevalence was higher in older persons (7.6% among 35- to 50-year-olds vs 16.4% among 51- to 70-year-olds) and among those reporting alcohol use (18.9% vs 8.5% between users and nonusers). In multivariable models, only older age (AOR 2.39 [1.02, 5.85]) and residence in the community of Wuru (AOR 7.60 [1.81, 32.96]) were independently associated with hypertension, and residence in Wuru (AOR 23.58 [7.75-78.25]) or Navio (AOR 7.41 [2.30-24.74]) was the only factor independently associated with depression. CONCLUSIONS: We report a high prevalence of both diseases overall and in select communities, a trend that requires further research to inform targeted chronic disease interventions.

Towards implementation of context-specific integrated district mental healthcare plans: A situation analysis of mental health services in five districts in Ghana.

BACKGROUND: Access to quality mental health services in Ghana remains poor, yet little is known about the extent of the access gaps and provision of mental health services at the district level in Ghana. We aimed to conduct an analysis of mental health infrastructure and service provision in five districts in Ghana. METHODS: A cross-sectional situation analysis was conducted using a standardised tool to collect secondary healthcare data, supplemented by interviews with key informants, across five purposively selected districts in Ghana. The Programme for Improving Mental Health Care (PRIME) situation analysis tool was adapted to the Ghanaian context and used for data collection. RESULTS: The districts are predominantly rural (>60%). There were severe challenges with the provision of mental healthcare: there were no mental healthcare plans, supervision of the few mental health professionals was weak and unstructured, access to regular supplies of psychotropic medications was a major challenge, and psychological treatments were extremely limited given the lack of trained clinical psychologists. There were no available data on treatment coverage, but we estimate this to be <1% for depression, schizophrenia, and epilepsy across districts. Opportunities for mental health systems strengthening include: the commitment and willingness of leadership, the existence of the District Health Information Management System, a well-established network of community volunteers, and some collaboration with traditional and faith-based mental health service providers. CONCLUSION: There is poor mental health infrastructure across the five selected districts of Ghana. There are opportunities for strengthening mental health systems through interventions at the district healthcare organisation, health facility, and community levels. A standardised situation analysis tool is useful for informing district-level mental healthcare planning in low-resource settings in Ghana and potentially other sub-Saharan African countries.

Mental health and disability research in Ghana: a rapid review.

The objective of this rapid review was to explore the current evidence base for mental health and disability research in Ghana. The PRISMA-ScR (Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews) checklist was followed. Online databases were used to identify primary studies, systematic reviews, meta-analyses, rapid reviews, or guidelines published between 2010 and 2020. All relevant published (both peer-reviewed articles and grey literature) on mental health and/or disability research conducted in or on Ghana between 2010 and 2020 were included in this review. 4,791 articles were identified in the initial search. After the removal of duplicates, followed by title and abstract screening, 930 articles were selected for full-text review. An additional 8 articles identified from reference lists of included articles were also included in full-text review. After review, 375 articles were selected for inclusion; 234 (62%) were on mental health while the remaining 141 (38%) were on disability. There is an increasing trend in the absolute number of mental health and/or disability studies. Most of the mental health studies included in this review were either observational quantitative studies (n=132; 56%) or observational qualitative studies (n=79; 34%). There were very few interventional studies (n=6; 3%). A similar finding was noted for the disability studies. External funding accounted for 51% of mental health articles. Although there was a steady year-on-year increase in the absolute number of mental health and/or disability studies conducted between 2010 to 2020, there is a need for more intervention studies to evaluate what mental health and/or disability interventions work, for whom, and under what circumstances. These should include evaluations of the cost, benefits, effectiveness, and acceptability of various interventions for policy and planning. Further, there is a need for the Ministry of Health to prioritize research funding for mental health and disability and enhance technical and methodological capacity of researchers to conduct disability and mental health research in Ghana.

Predictors of spontaneous remission and recovery among women with untreated perinatal depression in India and Pakistan.

Background: Mothers with perinatal depression can show different symptom trajectories and may spontaneously remit from depression, however, the latter is poorly understood. This is the first study which sought to investigate predictors of spontaneous remission and longer-term recovery among untreated women with perinatal depression. Methods: We analysed data from two randomised controlled trials in women with perinatal depression in India and Pakistan. Analyses were restricted to women in the control groups who did not receive active treatment. Generalised estimating equations and logistic regressions were used to estimate odds ratios (ORs) and 95% confidence intervals (CIs), adjusting for within-person correlation. Results: In multivariable analyses, remission was associated with a husband who is not working (adjusted OR, aOR = 2.04, 95% CI 1.02-4.11), lower Patient Health Questionnaire-9 score at baseline (aOR = 0.43, 95% CI 0.20-0.90 for score of ≥20 vs. 10-14) and better social support at baseline (aOR = 2.37, 95% CI 1.32-4.27 for high vs. low social support). Conclusions: Women with low baseline severity may remit from perinatal depression with adequate social support from family and friends. These factors are important contributors to the management of perinatal depression and the prevention of clinical worsening, and should be considered when designing low-threshold psychological interventions.

Mental health and disability research priorities and capacity needs in Ghana: findings from a rapid review and research priority ranking survey.

BACKGROUND: Identification of national research agendas for mental health and disability can be supported by well-designed research priority-setting studies. Few low- and middle-income countries (LMICs) have undertaken such studies. OBJECTIVE: To identify mental health and disability research priorities in Ghana. METHODS: A mixed methods study comprising a rapid review, research priority ranking survey, and research capacity needs assessment survey was employed. Participants in the surveys included five expert pools identified from online search and existing database on mental health civil society organisations/non-governmental organisations. The research priority ranking was completed in two stages, using the Child and Nutrition Research Initiative (CHNRI) method to identify priority questions for immediate and short term (0 to 5 years) and medium to long term (>5 years) in stage two. Both surveys were deployed online using google forms. Analysis for the ranking survey involved computing total scores from the CHNRI criteria and generating ranks for the research questions. RESULTS: A total of 68 experts (97% response rate), generated 94 and 92 questions for the short and long term, respectively. Forty experts (58% response rate) completed the ranking stage. The top 10 ranked research questions included: 4 questions addressing health systems; 2 questions on epidemiology; and 4 questions on interventions. All research questions were considered urgent and should be conducted in the immediate to short term (0-5 years). The methodological capacity of researchers to conduct disability and mental health research is weak. CONCLUSION: Our approach has generated an agenda for mental health and disability research priorities for Ghana and demonstrated that it is feasible to employ a systematic methodology for research priority setting that includes key parameters of context and research capacity.

Effectiveness of the Thinking Healthy Programme for perinatal depression delivered through peers: Pooled analysis of two randomized controlled trials in India and Pakistan.

BACKGROUND: The Thinking Healthy Programme (THP) is recommended to treat perinatal depression in resource-limited settings, but scale-up is hampered by a paucity of community health workers. THP was adapted for peer-delivery (THPP) and evaluated in two randomized controlled trials in India and Pakistan. Our aim was to estimate the effectiveness of THPP on maternal outcomes across these two settings, and evaluate effect-modification by country and other pre-defined covariates. METHODS: Participants were pregnant women aged≥18 years with depression (Patient Health Questionnaire (PHQ-9) score≥10), randomized to THPP plus enhanced usual care (EUC) or EUC-only. Primary outcomes were symptom severity and remission (PHQ-9 score<5) 6 months post-childbirth. Secondary outcomes included further measures of depression, disability and social support at 3 and 6 months post-childbirth. RESULTS: Among 850 women (280 India; 570 Pakistan), 704 (83%) attended 6-month follow-up. Participants in the intervention arm had lower symptom severity (PHQ-9 score adjusted mean difference -0.78 (95% confidence interval -1.47,-0.09)) and higher odds of remission (adjusted odds ratio 1.35 (1.02,1.78)) versus EUC-only. There was a greater intervention effect on remission among women with short chronicity of depression, and those primiparous. There were beneficial intervention effects across multiple secondary outcomes. LIMITATIONS: The trials were not powered to assess effect-modifications. 10-20% of participants were missing outcome data. CONCLUSIONS: This pooled analysis demonstrates the effectiveness, acceptability and feasibility of THPP, which can be scaled-up within a stepped-care approach by engaging with the existing health care systems and the communities to address the treatment gap for perinatal depression in resource-limited settings.