The longitudinal association of stressful life events with depression remission among SHARP trial participants with depression and hypertension or diabetes in Malawi.

Depressive disorders are leading contributors to morbidity in low- and middle-income countries and are particularly prevalent among people with non-communicable diseases (NCD). Stressful life events (SLEs) are risk factors for, and can help identify those at risk of, severe depressive illness requiring more aggressive treatment. Yet, research on the impact of SLEs on the trajectory of depressive symptoms among NCD patients indicated for depression treatment is lacking, especially in low resource settings. This study aims to estimate the longitudinal association of SLEs at baseline with depression remission achievement at three, six, and 12 months among adults with either hypertension or diabetes and comorbid depression identified as being eligible for depression treatment. Participants were recruited from 10 NCD clinics in Malawi from May 2019-December 2021. SLEs were measured by the Life Events Survey and depression remission was defined as achieving a Patient Health Questionaire-9 (PHQ-9) score <5 at follow-up. The study population (n = 737) consisted predominately of females aged 50 or higher with primary education and current employment. At baseline, participants reported a mean of 3.5 SLEs in the prior three months with 90% reporting ≥1 SLE. After adjustment, each additional SLE was associated with a lower probability of achieving depression remission at three months (cumulative incidence ratio (CIR) 0.94; 95% confidence interval: 0.90, 0.98, p = 0.002), six months (0.95; 0.92, 0.98, p = 0.002) and 12 months (0.96; 0.94, 0.99, p = 0.011). Re-expressed per 3-unit change, the probability of achieving depression remission at three, six, and 12 months was 0.82, 0.86, and 0.89 times lower per 3 SLEs (the median number of SLEs). Among NCD patients identified as eligible for depression treatment, recent SLEs at baseline were associated with lower probability of achieving depression remission at three, six, and 12 months. Findings suggest that interventions addressing SLEs during integrated NCD and depression care interventions (e.g., teaching and practicing SLE coping strategies) may improve success of depression treatment among adult patient populations in low-resource settings and may help identify those at risk of severe and treatment resistant depression.

Implementation strategies to build mental health-care capacity in Malawi: a health-economic evaluation.

BACKGROUND: Depression is a major contributor to morbidity and mortality in sub-Saharan Africa. Due to low system capacity, three in four patients with depression in sub-Saharan Africa go untreated. Despite this, little attention has been paid to the cost-effectiveness of implementation strategies to scale up evidence-based depression treatment in the region. In this study, we investigate the cost-effectiveness of two different implementation strategies to integrate the Friendship Bench approach and measurement-based care in non-communicable disease clinics in Malawi. METHODS: The two implementation strategies tested in this study are part of a trial, in which ten clinics were randomly assigned (1:1) to a basic implementation package consisting of an internal coordinator acting as a champion (IC-only group) or to an enhanced package that complemented the basic package with quarterly external supervision, and audit and feedback of intervention delivery (IC + ES group). We included material costs, training costs, costs related to project-wide meetings, transportation and medication costs, time costs related to internal champion activities and depression screening or treatment, and costs of external supervision visits if applicable. Outcomes included the number of patients screened with the patient health questionnaire 2 (PHQ-2), cases of remitted depression at 3 and 12 months, and disability-adjusted life-years (DALYs) averted. We compared the cost-effectiveness of both packages to the status quo (ie, no intervention) using a micro-costing-informed decision-tree model. FINDINGS: Relative to the status quo, IC + ES would be on average US$10 387 ($1349-$17 365) more expensive than IC-only but more effective in achieving remission and averting DALYs. The cost per additional remission would also be lower with IC + ES than IC-only at 3 months ($119 vs $223) and 12 months ($210 for IC + ES; IC-only dominated by the status quo at 12 months). Neither package would be cost-effective under the willingness-to-pay threshold of $65 per DALY averted currently used by the Malawian Ministry of Health. However, the IC + ES package would be cost-effective in relation to the commonly used threshold of three times per-capita gross domestic product per DALY averted. INTERPRETATION: Investing in supporting champions might be an appropriate use of resources. Although not currently cost-effective by Malawian willingness-to-pay standards compared with the status quo, the IC + ES package would probably be a cost-effective way to build mental health-care capacity in resource-constrained settings in which decision makers use higher willingness-to-pay thresholds. FUNDING: National Institute of Mental Health.

Two implementation strategies to support the integration of depression screening and treatment into hypertension and diabetes care in Malawi (SHARP): parallel, cluster-randomised, controlled, implementation trial.

BACKGROUND: Although evidence-based treatments for depression in low-resource settings are established, implementation strategies to scale up these treatments remain poorly defined. We aimed to compare two implementation strategies in achieving high-quality integration of depression care into chronic medical care and improving mental health outcomes in patients with hypertension and diabetes. METHODS: We conducted a parallel, cluster-randomised, controlled, implementation trial in ten health facilities across Malawi. Facilities were randomised (1:1) by covariate-constrained randomisation to either an internal champion alone (ie, basic strategy group) or an internal champion plus external supervision with audit and feedback (ie, enhanced strategy group). Champions integrated a three-element, evidence-based intervention into clinical care: universal depression screening; peer-delivered psychosocial counselling; and algorithm-guided, non-specialist antidepressant management. External supervision involved structured facility visits by Ministry officials and clinical experts to assess quality of care and provide supportive feedback approximately every 4 months. Eligible participants were adults (aged 18-65 years) seeking hypertension and diabetes care with signs of depression (Patient Health Questionnaire-9 score ≥5). Primary implementation outcomes were depression screening fidelity, treatment initiation fidelity, and follow-up treatment fidelity over the first 3 months of treatment, analysed by intention to treat. This trial is registered with ClinicalTrials.gov, NCT03711786, and is complete. FINDINGS: Five (50%) facilities were randomised to the basic strategy and five (50%) to the enhanced strategy. Between Oct 1, 2019, and Nov 30, 2021, in the basic group, 587 patients were assessed for eligibility, of whom 301 were enrolled; in the enhanced group, 539 patients were assessed, of whom 288 were enrolled. All clinics integrated the evidence-based intervention and were included in the analyses. Of 60 774 screening-eligible visits, screening fidelity was moderate (58% in the enhanced group vs 53% in the basic group; probability difference 5% [95% CI -38% to 47%]; p=0·84) and treatment initiation fidelity was high (99% vs 98%; 0% [-3% to 3%]; p=0·89) in both groups. However, treatment follow-up fidelity was substantially higher in the enhanced group than in the basic group (82% vs 20%; 62% [36% to 89%]; p=0·0020). Depression remission was higher in the enhanced group than in the basic group (55% vs 36%; 19% [3% to 34%]; p=0·045). Serious adverse events were nine deaths (five in the basic group and four in the enhanced group) and 26 hospitalisations (20 in the basic group and six in the enhanced group); none were treatment-related. INTERPRETATION: The enhanced implementation strategy led to an increase in fidelity in providers' follow-up treatment actions and in rates of depression remission, consistent with the literature that follow-up decisions are crucial to improving depression outcomes in integrated care models. These findings suggest that external supervision combined with an internal champion could offer an important advance in integrating depression treatment into general medical care in low-resource settings. FUNDING: The National Institute of Mental Health.

Improving integrated depression and non-communicable disease care in Malawi through engaged leadership and supportive implementation climate.

BACKGROUND: Low- and middle-income countries often lack access to mental health services, leading to calls for integration within other primary care systems. In sub-Saharan Africa, integration of depression treatment in non-communicable disease (NCD) settings is feasible, acceptable, and effective. However, leadership and implementation climate challenges often hinder effective integration and quality of services. The aim of this study was to identify discrete leadership strategies that facilitate overcoming barriers to the integration of depression care in NCD clinics in Malawi and to understand how clinic leadership shapes the implementation climate. METHODS: We conducted 39 in-depth interviews with the District Medical Officer, the NCD coordinator, one NCD provider, and the research assistant from each of the ten Malawian NCD clinics (note one District Medical Officer served two clinics). Based on semi-structured interview guides, participants were asked their perspectives on the impact of leadership and implementation climate on overcoming barriers to integrating depression care into existing NCD services. Thematic analysis used both inductive and deductive approaches to identify emerging themes and compare among participant type. RESULTS: The results revealed how engaged leadership can fuel a positive implementation climate where clinics had heightened capacity to overcome implementation barriers. Effective leaders were approachable and engaged in daily operations of the clinic and problem-solving. They held direct involvement with and mentorship during the intervention, providing assistance in patient screening and consultation with treatment plans. Different levels of leadership utilized their respective standings and power dynamics to influence provider attitudes and perceptions surrounding the intervention. Leaders acted by informing providers about the intervention source and educating them on the importance of mental healthcare, as it was often undervalued. Lastly, they prioritized teamwork and collective ownership for the intervention, increasing provider responsibility. CONCLUSION: Training that prioritizes leadership visibility and open communication will facilitate ongoing Malawi Ministry of Health efforts to scale up evidence-based depression treatment within NCD clinics. This proves useful where extensive and external monitoring may be limited. Ultimately, these results can inform successful strategies to close implementation gaps to achieve integration of mental health services in low-resource settings through improved leadership and implementation climate. TRIAL REGISTRATION: These findings are reported from ClinicalTrials.gov, NCT03711786. Registered on 18/10/2018. https://clinicaltrials.gov/ct2/show/NCT03711786 .

Champion and audit and feedback strategy fidelity and their relationship to depression intervention fidelity: A mixed method study.

Background: Globally, mental health disorders rank as the greatest cause of disability. Low and middle-income countries (LMICs) hold a disproportionate share of the mental health burden, especially as it pertains to depression. Depression is highly prevalent among those with non-communicable diseases (NCDs), creating a barrier to successful treatment. While some treatments have proven efficacy in LMIC settings, wide dissemination is challenged by multiple factors, leading researchers to call for implementation strategies to overcome barriers to care provision. However, implementation strategies are often not well defined or documented, challenging the interpretation of study results and the uptake and replication of strategies in practice settings. Assessing implementation strategy fidelity (ISF), or the extent to which a strategy was implemented as designed, overcomes these challenges. This study assessed fidelity of two implementation strategies (a 'basic' champion strategy and an 'enhanced' champion + audit and feedback strategy) to improve the integration of a depression intervention, measurement based care (MBC), at 10 NCD clinics in Malawi. The primary goal of this study was to assess the relationship between the implementation strategies and MBC fidelity using a mixed methods approach. Methods: We developed a theory-informed mixed methods fidelity assessment that first combined an implementation strategy specification technique with a fidelity framework. We then created corresponding fidelity indicators to strategy components. Clinical process data and one-on-one in-depth interviews with 45 staff members at 6 clinics were utilized as data sources. Our final analysis used descriptive statistics, reflexive-thematic analysis (RTA), data merging, and triangulation to examine the relationship between ISF and MBC intervention fidelity. Results: Our mixed methods analysis revealed how ISF may moderate the relationship between the strategies and MBC fidelity. Leadership engagement and implementation climate were critical for clinics to overcome implementation barriers and preserve implementation strategy and MBC fidelity. Descriptive statistics determined champion strategy fidelity to range from 61 to 93% across the 10 clinics. Fidelity to the audit and feedback strategy ranged from 82 to 91% across the 5 clinics assigned to that condition. MBC fidelity ranged from 54 to 95% across all clinics. Although correlations between ISF and MBC fidelity were not statistically significant due to the sample of 10 clinics, associations were in the expected direction and of moderate effect size. A coefficient for shared depression screening among clinicians had greater face validity compared to depression screening coverage and functioned as a proximal indicator of implementation strategy success. Conclusion: Fidelity to the basic and enhanced strategies varied by site and were influenced by leadership engagement and implementation climate. Champion strategies may benefit from the addition of leadership strategies to help address implementation barriers outside the purview of champions. ISF may moderate the relationship between strategies and implementation outcomes.

Evaluating the validity of depression-related stigma measurement among diabetes and hypertension patients receiving depression care in Malawi: A mixed-methods analysis.

Mental illness stigma research is sparse in Malawi. Our team previously analyzed the reliability and statistical validity of a quantitative tool to measure depression-related stigma among participants with depressive symptoms using quantitative psychometric methods. This analysis aims to further evaluate the content validity of the stigma tool by comparing participants' quantitative responses with qualitative data. The SHARP project conducted depression screening and treatment at 10 noncommunicable disease clinics across Malawi from April 2019 through December 2021. Eligible participants were 18-65 years with depressive symptoms indicated by a PHQ-9 score ≥5. Questionnaires at each study timepoint included a vignette-based quantitative stigma instrument with three thematic domains: disclosure carryover (i.e., concerns about disclosure), treatment carryover (i.e., concerns about external stigma because of receiving depression treatment), and negative affect (i.e., negative attitudes about people having depression). Sub-scores were aggregated for each domain, with higher scores indicating greater stigma. To better understand participants' interpretation of this quantitative stigma questionnaire, we asked a subset of six participants a parallel set of questions in semi-structured qualitative interviews in a method similar to cognitive interviewing. Qualitative responses were linked with participants' most recent quantitative follow-up interviews using Stata 16 and NVivo software. Participants with lower quantitative stigma disclosure sub-scores had qualitative responses that indicated less stigma around disclosure, while participants with higher quantitative stigma sub-scores had qualitative responses indicating greater stigma. Similarly, in the negative affect and treatment carryover domains, participants had parallel quantitative and qualitative responses. Further, participants identified with the vignette character in their qualitative interviews, and participants spoke about the character's projected feelings and experiences based on their own lived experiences. The stigma tool was interpreted appropriately by participants, providing strong evidence for the content validity of the quantitative tool to measure these stigma domains.

Evaluating the Knowledge Change Before and After Continuing Cancer Education in Malawian Nurses.

Malawi has a high cancer incidence and mortality. Efforts to train and educate oncology nurses have been identified as an area of need. This study evaluates the educational needs of oncology nurses in Malawi and the effects of a virtual cancer education program on improving the knowledge of cancer epidemiology, treatment, and nursing care of common cancers among oncology nurses in Malawi. The educational programs consisted of four sessions at one-month intervals focused on Cancer Screening, Survivorship, Radiation Therapy, and Complementary and Alternative Therapies. A pretest-posttest design was used. Overall, there was an increase in knowledge at each session: cancer screening (47% vs 95%), survivorship (22% vs 100%), radiation therapy (66% vs 100%), and complementary and alternative therapies (63% vs 88%). Using virtual continuing education sessions is an effective tool to enhance the knowledge of oncology nurses in Malawi. These education sessions can serve as an example of how other Schools of Nursing and cancer centers in high-resource countries can collaborate with hospitals and Schools of Nursing in low- and middle-resource countries to support the advancement of oncology nursing knowledge, and ultimately, oncologic care.

Systematic review of psychosocial interventions for adult cancer patients and their family caregivers in Sub-Saharan Africa.

Cancer is becoming a public health issue in the Sub-Saharan Africa (SSA). This systematic review aims to synthesise psychosocial interventions and their effects on the health outcomes of adult cancer patients and their family caregivers in SSA. We identified eligible publications in English language from PubMed, Cumulative Index of Nursing and Allied Health Literature Plus with Full Text, Embase, APA PsycInfo, Scopus, and African Index Medicus databases. We included psychosocial interventions targeted adult cancer patients/survivors or their family caregivers in SSA. This review identified five psychosocial interventions from six studies that support adult cancer patients and their family caregivers in SSA. The interventions focused on providing informational, psycho-cognitive, and social support. Three interventions significantly improved quality of life outcomes for cancer patients and their caregivers. Significant gaps exist between the rapidly increasing cancer burdens and the limited psychosocial educational interventions supporting adult cancer patients and their families in SSA. The reviewed studies provide preliminary evidence on development and testing interventions that aim to improve patients' and caregivers' quality of life.

Estimating the effect of anticipated depression treatment-related stigma on depression remission among people with noncommunicable diseases and depressive symptoms in Malawi.

PURPOSE: While mental health stigma research is sparse in Malawi, research in other settings suggests that stigma represents a barrier to mental health treatment and recovery. Accordingly, we conducted an analysis to understand the role of treatment-related stigma in depression care in Malawi by estimating the effect of patients' baseline anticipated treatment-related stigma on their 3-month probability of depression remission when newly identified with depression. METHODS: We conducted depression screening and treatment at 10 noncommunicable disease (NCD) clinics across Malawi from April 2019 through December 2021. Eligible cohort participants were 18-65 years with depressive symptoms indicated by a PHQ-9 score ≥5. Questionnaires at the baseline and 3-month interviews included a vignette-based quantitative stigma instrument that measured treatment-related stigma, i.e., concerns about external stigma because of receiving depression treatment. Using inverse probability weighting to adjust for confounding and multiple imputation to account for missing data, this analysis relates participants' baseline levels of anticipated treatment stigma to the 3-month probability of achieving depression remission (i.e., PHQ-9 score < 5). RESULTS: Of 743 included participants, 273 (37%) achieved depression remission by their 3-month interview. The probability of achieving depression remission at the 3-month interview among participants with high anticipated treatment stigma (0.31; 95% Confidence Interval [CI]: 0.23, 0.39)) was 10 percentage points lower than among the low/neutral stigma group (risk: 0.41; 95% CI: 0.36, 0.45; RD: -0.10; 95% CI: -0.19, -0.003). CONCLUSION: In Malawi, a reduction in anticipated depression treatment-related stigma among NCD patients initiating depression treatment could improve depression outcomes. Further investigation is necessary to understand the modes by which stigma can be successfully reduced to improve mental health outcomes and quality of life among people living with depression.

Assessing suicidality during the SARS-CoV-2 pandemic: Lessons learned from adaptation and implementation of a telephone-based suicide risk assessment and response protocol in Malawi.

The SARS-CoV-2 pandemic led to the rapid transition of many research studies from in-person to telephone follow-up globally. For mental health research in low-income settings, tele-follow-up raises unique safety concerns due to the potential of identifying suicide risk in participants who cannot be immediately referred to in-person care. We developed and iteratively adapted a telephone-delivered protocol designed to follow a positive suicide risk assessment (SRA) screening. We describe the development and implementation of this SRA protocol during follow-up of a cohort of adults with depression in Malawi enrolled in the Sub-Saharan Africa Regional Partnership for Mental Health Capacity Building (SHARP) randomized control trial during the COVID-19 era. We assess protocol feasibility and performance, describe challenges and lessons learned during protocol development, and discuss how this protocol may function as a model for use in other settings. Transition from in-person to telephone SRAs was feasible and identified participants with suicidal ideation (SI). Follow-up protocol monitoring indicated a 100% resolution rate of SI in cases following the SRA during this period, indicating that this was an effective strategy for monitoring SI virtually. Over 2% of participants monitored by phone screened positive for SI in the first six months of protocol implementation. Most were passive risk (73%). There were no suicides or suicide attempts during the study period. Barriers to implementation included use of a contact person for participants without personal phones, intermittent network problems, and pre-paid phone plans delaying follow-up. Delays in follow-up due to challenges with reaching contact persons, intermittent network problems, and pre-paid phone plans should be considered in future adaptations. Future directions include validation studies for use of this protocol in its existing context. This protocol was successful at identifying suicide risk levels and providing research assistants and participants with structured follow-up and referral plans. The protocol can serve as a model for virtual SRA development and is currently being adapted for use in other contexts.

Psychosocial experiences of cancer survivors and their caregivers in sub-Saharan Africa: A synthesis of qualitative studies.

OBJECTIVE: To synthesize and examine current literature on survivorship experiences and psychosocial oncologic care programs of individuals affected by cancer in sub-Saharan Africa (SSA). METHODS: This was a systematic review guided by the PRISMA 2020 guidelines. We searched 6 databases for articles published from inception to 21 October 2021. Articles were appraised using the Johanna Briggs Institute's Checklist for Qualitative Research. For data synthesis, we used the World Health Organization (WHO) quality of life framework [WHOQOL] to organize experiences into 6 domains/themes. RESULTS: Twenty-five qualitative studies were included in the synthesis. Studies focused on psychosocial care of adults (>18 years) affected by cancer in SSA. The common WHOQOL domains were social relations, spirituality/religion/personal beliefs, and psychological. CONCLUSION: Findings echo need for individuals with cancer and their caregivers. Healthcare professionals are an essential resource for information and support services that can be tailored to individuals need. This synthesis highlighted caregiver stress and stressors from the community that could impact care of individuals with cancer. A holistic approach is needed that incorporates professional and social aspects of care.

Cancer-Related Stigma in Malawi: Narratives of Cancer Survivors.

PURPOSE: Stigma is an impediment across the cancer care continuum, leading to delayed presentation to care, elevated morbidity and mortality, and reduced quality of life. The goal of this study was to qualitatively examine the drivers, manifestations, and impacts of cancer-related stigma among individuals who received cancer treatment in Malawi, and to identify opportunities to address stigma. METHODS: Individuals who had completed treatment for lymphoma (n = 20) or breast cancer (n = 9) were recruited from observational cancer cohorts in Lilongwe, Malawi. Interviews explored the individual's cancer journey, from first symptoms through diagnosis, treatment, and recovery. Interviews were audio-recorded and translated from Chichewa to English. Data were coded for content related to stigma, and thematically analyzed to describe the drivers, manifestations, and impacts of stigma along the cancer journey. RESULTS: Drivers of cancer stigma included beliefs of cancer origin (cancer as infectious; cancer as a marker of HIV; cancer due to bewitchment), perceived changes in the individual with cancer (loss of social/economic role; physical changes), and expectations about the individual's future (cancer as death sentence). Cancer stigma manifested through gossip, isolation, and courtesy stigma toward family members. The impacts of cancer stigma included mental health distress, impediments to care engagement, lack of cancer disclosure, and self-isolation. Participants suggested the following programmatic needs: community education about cancer; counseling in health facilities; and peer support from cancer survivors. CONCLUSION: The results highlight multifactorial drivers, manifestations, and impacts of cancer-related stigma in Malawi, which may affect success of cancer screening and treatment programs. There is a clear need for multilevel interventions to improve community attitudes toward people with cancer, and to support individuals along the continuum of cancer care.

The cross-sectional association of stressful life events with depression severity among patients with hypertension and diabetes in Malawi.

Depressive disorders are a leading cause of global morbidity and remain disproportionately high in low- and middle-income settings. Stressful life events (SLEs) are known risk factors for depressive episodes and worsened depressive severity, yet are under-researched in comparison to other depression risk factors. As depression is often comorbid with hypertension, diabetes, and other noncommunicable diseases (NCDs), research into this relationship among patients with NCDs is particularly relevant to increasing opportunities for integrated depression and NCD care. This study aims to estimate the cross-sectional association between SLEs in the three months preceding baseline interviews and baseline depressive severity among patients with at least mild depressive symptoms who are seeking NCD care at 10 NCD clinics across Malawi. SLEs were measured by the Life Events Survey and depressive severity (mild vs. moderate to severe) was measured by the Patient Health Questionnaire-9. The study population (n = 708) was predominately currently employed, grand multiparous (5-8 children) women with a primary education level. Two thirds (63%) had mild depression while 26%, 8%, and 3% had moderate, moderately severe, and severe depression, respectively. Nearly all participants (94%) reported at least one recent SLE, with the most common reported SLEs being financial stress (48%), relationship changes (45%), death of a family member or friend (41%), or serious illness of a family member or friend (39%). Divorce/separation, estrangement from a family member, losing source of income, and major new health problems were significant predictors of greater (moderate or severe) depressive severity compared to mild severity. Having a major new health problem or experiencing divorce/separation resulted in particularly high risk of more severe depression. After adjustment, each additional SLE was associated with a 9% increased risk of moderate or worse depressive severity compared to mild depressive severity (RR: 1.09; (95% CI: 1.05, 1.13), p<0.0001). Among patients with NCDs with at least mild depressive symptoms, SLEs in the prior 3 months were associated with greater depressive severity. While many SLEs may not be preventable, this research suggests that assessment of SLEs and teaching of positive coping strategies when experiencing SLEs may play an important role in integrated NCD and depression treatment models.

Does the Ring Work? Perceptions and Understanding of the Efficacy of a Dapivirine Vaginal Ring for HIV Prevention Amongst Women in a Placebo-Controlled Trial.

As demonstrated by the Phase III clinical trial, MTN-020/ASPIRE, the monthly dapivirine vaginal ring is well tolerated and reduces the risk of HIV-1 as a woman-initiated prevention option. This analysis uses data from the follow-on MTN-032/Assessment of ASPIRE and HOPE Adherence (AHA) qualitative study to understand how perceptions (or misperceptions) of ring efficacy may have influenced behavior during ASPIRE, and affected intention to use the ring in future ring projects, specifically HOPE, the planned open-label extension study. Single in-depth interviews (n = 98) and 12 focus group discussions (n = 89) were conducted with women at seven sites in Malawi, South Africa, Uganda and Zimbabwe. Eligibility included participation in the ASPIRE active arm, and ring use for ≥ 3 months or at least 1 month if seroconversion occurred. Interviews were audio-recorded, transcribed into English, coded in Dedoose and thematically analyzed. Demographic and behavioral questionnaire data were summarized in Stata. Most AHA participants perceived the ring to be effective, and described simply trusting it or having confidence in it because they, or other participants in risky situations, remained HIV-uninfected. Participants described ring efficacy after receiving ASPIRE results as a binary assessment: the ring worked or not. Many did not remember exact efficacy percentages because of lack of comprehension or memory but recalled key details about age differences. The majority expressed interest in future ring use. There is a need to investigate improved ways of explaining placebo-controlled trials and efficacy to women in Sub-Saharan Africa. Now that ring efficacy, is known, these benefits must be well communicated, and understood by end-users and key stakeholders. Engagement with end-users to construct effective messages and to develop tools to measure understanding of partial efficacy will be essential.

Contextualising men's role and participation in PMTCT programmes in Malawi and Zambia: A hegemonic masculinity perspective.

This study sought to explore and contextualise the man's role in antenatal services, and the barriers and strategies for engaging men in prevention of mother-to-child HIV transmission (PMTCT). We conducted 143 interviews with pregnant and breastfeeding women, male partners, health workers and policy makers in Malawi and Zambia. We employed thematic and critical discourse analysis using the hegemonic masculinity perspective. We found that men's roles in PMTCT reflected hegemonic masculinities. As breadwinners, men supported their partners with material and financial resources. As decision makers, men were involved in decision making on the health of their partners. As social protectors, men supported their partners in accessing and adhering to antenatal care, HIV treatment and care. Barriers and challenges to male involvement in antenatal care were often the result of conflict between the clinic operating hours and men's working hours, the perception of antenatal care services as female spaces, and men's fear of HIV testing. Proposed strategies to increase male engagement in PMTCT included sensitising men about HIV and pregnancy; engaging leaders and employers, providing services outside working hours, and providing incentives. We conclude that men's role and participation in PMTCT services are an extension and adaptation of hegemonic masculinities.

"Thandi should feel embarrassed": describing the validity and reliability of a tool to measure depression-related stigma among patients with depressive symptoms in Malawi.

PURPOSE: There are no validated tools in Malawi to measure mental health stigma. Accordingly, this study evaluates the validity and reliability of a short quantitative instrument to measure depression-related stigma in patients exhibiting depressive symptoms in Malawi. METHODS: The SHARP study began depression screening in 10 NCD clinics across Malawi in April 2019; recruitment is ongoing. Eligible participants were 18-65 years, had a patient health questionnaire (PHQ-9) score ≥ 5, and were new or current diabetes or hypertension patients. Participants completed a baseline questionnaire that measured depression-related stigma, depressive symptoms, and sociodemographic information. The stigma instrument included a vignette of a depressed woman named Thandi, and participants rated their level of agreement with statements about Thandi's situation in nine prompts on a 5-point Likert scale. Inter-item reliability was assessed with Cronbach's alpha. Exploratory factor analysis (EFA) was used to assess structural validity, and OLS regression models were used to assess convergent and divergent validity between measured levels of depression-related stigma and covariates. RESULTS: The analysis of patient responses (n = 688) to the stigma tool demonstrated acceptable inter-item reliability across all scales and subsequent subscales of the instrument, with alpha values ranging from 0.70 to 0.87. The EFA demonstrated clustering around three domains: negative affect, treatment carryover, and disclosure carryover. Regression models demonstrated convergence with several covariates and demonstrated divergence as expected. CONCLUSION: This study supports the reliability and validity of a short stigma questionnaire in this population. Future studies should continue to assess the validity of this stigma instrument in this population.

Quality of life among patients with cancer and their family caregivers in the Sub-Saharan region: A systematic review of quantitative studies.

Guided by the World Health Organization quality of life (WHOQOL) framework, this systematic review aimed to examine evidence about the prevalence and severity of QOL-related health problems and their influencing factors in Sub-Saharan Africa (SSA). We identified eligible publications in English language from PubMed, Cumulative Index of Nursing and Allied Health Literature Plus with Full Text, Embase, APA PsycInfo, Scopus, and African Index Medicus databases. We included quantitative descriptive studies that measured overall and subdomains of QOL as the outcome in adult patients/survivors with cancer in SSA. Twenty-six descriptive cross-sectional studies (27 papers) that were conducted since 1988 in different SSA countries among patients with various types of cancer met our inclusion criteria. We found inconsistencies in how the prevalence and severity of QOL-related health problems have been researched and reported across studies, which complicated comparing findings and drawing conclusions. The most common factors that influenced the overall and subdomains of QOL included coping; internal and external locus of control; symptoms and symptom management; and religious beliefs and religious care. Demographics (e.g., age and marital status), cancer-related factors (cancer stage and type of treatment), and social determinants of health (e.g., education, access to information and resources, financial distress, and urban vs rural residency) also impacted QOL and its subdomains. Our findings indicate the significant need for recognizing and managing QOL-related problems for cancer patients and caregivers in SSA. Research needs to use culturally adapted, standardized assessment tools and analysis approaches to better understand the QOL challenges this population faces. Comprehensive supportive care is needed to address the complex QOL issues in resource-limited SSA.

Tonse Pamodzi: Developing a combination strategy to support adherence to antiretroviral therapy and HIV pre-exposure prophylaxis during pregnancy and breastfeeding.

To eliminate mother-to-child transmission of HIV (EMTCT), scalable strategies to enhance antiretroviral adherence for both antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP) are needed as part of integrated HIV and maternal-child health services. We developed Tonse Pamodzi ("all of us together"), an adaptable intervention integrating biomedical and behavioral components to support HIV treatment and prevention. We describe our intervention development process, which comprised formative qualitative research, a review of the literature, and technical input from stakeholders representing the community, health systems, and policymakers. The resulting intervention, described herein, integrates patient-centered counseling and engagement of a patient-selected adherence supporter for pregnant and breastfeeding women initiating ART or PrEP. Patients receiving the intervention engage in Integrated Next Step Counseling (iNSC) sessions delivered by trained counselors to build and maintain adherence skills. Each patient also has the option of selecting an adherence supporter (partner, family member, or friend) who may participate in iNSC sessions and provide adherence support outside of these sessions. This flexible intervention is adaptable not only to ART or PrEP use, but also to the needs and preferences of each woman and the clinical context. If shown to be acceptable and feasible, the Tonse Pamodzi intervention may be an important tool in continuing efforts for EMTCT.

Facilitators, barriers and potential solutions to the integration of depression and non-communicable diseases (NCDs) care in Malawi: a qualitative study with service providers.

BACKGROUND: Integration of depression services into infectious disease care is feasible, acceptable, and effective in sub-Saharan African settings. However, while the region shifts focus to include chronic diseases, additional information is required to integrate depression services into chronic disease settings. We assessed service providers' views on the concept of integrating depression care into non-communicable diseases' (NCD) clinics in Malawi. The aim of this analysis was to better understand barriers, facilitators, and solutions to integrating depression into NCD services. METHODS: Between June and August 2018, we conducted nineteen in-depth interviews with providers. Providers were recruited from 10 public hospitals located within the central region of Malawi (i.e., 2 per clinic, with the exception of one clinic where only one provider was interviewed because of scheduling challenges). Using a semi structured interview guide, we asked participants questions related to their understanding of depression and its management at their clinic. We used thematic analysis allowing for both inductive and deductive approach. Themes that emerged related to facilitators, barriers and suggested solutions to integrate depression assessment and care into NCD clinics. We used CFIR constructs to categorize the facilitators and barriers. RESULTS: Almost all providers knew what depression is and its associated signs and symptoms. Almost all facilities had an NCD-dedicated room and reported that integrating depression into NCD care was feasible. Facilitators of service integration included readiness to integrate services by the NCD providers, availability of antidepressants at the clinic. Barriers to service integration included limited knowledge and lack of training regarding depression care, inadequacy of both human and material resources, high workload experienced by the providers and lack of physical space for some depression services especially counseling. Suggested solutions were training of NCD staff on depression assessment and care, engaging hospital leaders to create an NCD and depression care integration policy, integrating depression information into existing documents, increasing staff, and reorganizing clinic flow. CONCLUSION: Findings of this study suggest a need for innovative implementation science solutions such as reorganizing clinic flow to increase the quality and duration of the patient-provider interaction, as well as ongoing trainings and supervisions to increase clinical knowledge. Trial registration This study reports finding of part of the formative phase of "The Sub-Saharan Africa Regional Partnership (SHARP) for Mental Health Capacity Building-A Clinic-Randomized Trial of Strategies to Integrate Depression Care in Malawi" registered as NCT03711786.

Impact of Women's Home Environment on Use of the Dapivirine Vaginal Ring for HIV Prevention in Sub-Saharan Africa.

The monthly dapivirine vaginal ring has proven efficacious in reducing HIV incidence in two Phase 3 clinical trials. When considering the potential future availability of the ring to the public, key questions remain about the feasibility of integrating the ring as an HIV prevention intervention into women's lives. We conducted qualitative mapping interviews (n = 66) among women enrolled in MTN-025/HOPE, an open-label trial conducted in Malawi, South Africa, Uganda and Zimbabwe, to examine how home environments influenced use of the dapivirine vaginal ring. Most women had secure places to store their rings including wardrobes, suitcases, and bags. The primary concerns for ring storage were potential tampering from children or rodents. Household overcrowding limited the privacy some women had which made removal and insertion of vaginal rings challenging. Despite these challenges, ring storage, insertion, and removal was feasible across social and living contexts.