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AbstractIntroductionVery few pragmatic and community‐level effectiveness trials integrate the use of qualitative research over all stages of the trial, to inform trial design, implementation optimization, results interpretation and post‐trial policy recommendations. This is despite the growing demand for mixed methods research from funding agencies and awareness of the vital importance of qualitative and mixed methods research for understanding trial successes and challenges.DiscussionWe offer examples from work we have been involved in to illustrate how qualitative research conducted within trials can reveal vital contextual factors that influence implementation and outcomes, can enable an informed adaptation of trials as they are being conducted and can lead to the formulation of theory regarding the social and behavioural pathways of intervention, while also enabling community engagement in trial design and implementation. These examples are based on published findings from qualitative studies embedded within two ongoing large‐scale studies demonstrating the population‐level impacts of universal HIV testing and treatment strategies in southern and eastern Africa, and a qualitative study conducted alongside a clinical trial testing the adaptation, acceptability and experience of short‐cycle therapy in children and adolescents living with HIV.ConclusionsWe advocate for the integration of qualitative with clinical and survey research methods in pragmatic clinical and community‐level trials and implementation studies, and for increasing visibility of qualitative and mixed methods research in medical journals. Qualitative research from trials ideally should be published along with clinical outcome data, either integrated into the "main" trial papers or published concurrently in the same journal issue. Integration of qualitative research within trials can help not only to understand the why behind success or failure of interventions in different contexts, but also inform the adaptation of interventions that can facilitate their success, and lead to new alternative strategies and to policy changes that may be vital for achieving public health goals, including the end of AIDS.

AbstractIntroductionMobility is associated with worse outcomes across the HIV treatment cascade, especially among men. However, little is known about the mechanisms that link mobility and poor HIV outcomes and what types of mobility most increase the risk of treatment interruption among men in southern Africa.MethodsFrom August 2021 to January 2022, we conducted a mixed‐methods study with men living with HIV (MLHIV) but not currently receiving antiretroviral therapy (ART) in Malawi. Data collection was embedded within two larger trials (ENGAGE and IDEaL trials). We analysed baseline survey data of 223 men enrolled in the trials who reported being mobile (defined as spending ≥14 nights away from home in the past 12 months) using descriptive statistics and negative binomial regressions. We then recruited 32 men for in‐depth interviews regarding their travel experiences and ART utilization. We analysed qualitative data using constant comparative methods.ResultsSurvey data showed that 34% of men with treatment interruptions were mobile, with a median of 60 nights away from home in the past 12 months; 69% of trips were for income generation. More nights away from home in the past 12 months and having fewer household assets were associated with longer periods out of care. In interviews, men reported that travel was often unplanned, and men were highly vulnerable to exploitive employer demands, which led to missed appointments and ART interruption. Men made major efforts to stay in care but were often unable to access care on short notice, were denied ART refills at non‐home facilities and/or were treated poorly by providers, creating substantial barriers to remaining in and returning to care. Men desired additional multi‐month dispensing (MMD), the ability to refill treatment at any facility in Malawi, and streamlined pre‐travel refills at home facilities.ConclusionsMen prioritize ART and struggle with the trade‐offs between their own health and providing for their families. Mobility is an essential livelihood strategy for MLHIV in Malawi, but it creates conflict with ART retention, largely due to inflexible health systems. Targeted counselling and peer support, access to ART services anywhere in the country, and MMD may improve outcomes for mobile men.

This study examined the relationships between domains of stress (work-related, familyrelated, finances-related, health-related), coping style, substance use, and symptoms of depression with level of job functioning among women and men in the U.S. armed forces. Multivariate cumulative logistic regression analyses were conducted with data from the 1995 Department of Defense Survey of Health Related Behaviors among Military Personnel. Results showed that both military men and women were nearly twice as likely to report higher levels of stress at work (39%) than in their family or personal lives (22%). In contrast, women (29%) were more likely than men (22%) to experience high levels of family stress. Additionally, 33% of women experienced high stress due to being a woman in the military. The effects of stress and depression on job functioning were quite similar for women and men. For both genders, higher levels of work-related stress, health-related stress, and number of depressive symptoms increased the odds of a lower level of job functioning. In addition, for men only, higher levels of family-related stress, use of a negative coping style, illicit drug use, and being a heavy drinker increased the likelihood of lower job functioning. Findings suggest that it may be useful for military health providers to focus on interventions to identify, prevent, and provide care for stress-related problems and depressive symptoms for military personnel.

AbstractIntroductionPerson‐centred HIV prevention delivery models that offer structured choices in product, testing and visit location may increase coverage. However, data are lacking on the actual uptake of choices among persons at risk of HIV in southern Africa. In an ongoing randomized study (SEARCH; NCT04810650) in rural East Africa, we evaluated the uptake of choices made when offered in a person‐centred, dynamic choice model for HIV prevention.MethodsUsing the PRECEDE framework, we developed a persont‐centred, Dynamic Choice HIV Prevention (DCP) intervention for persons at risk of HIV in three settings in rural Kenya and Uganda: antenatal clinic (ANC), outpatient department (OPD) and in the community. Components include: provider training on product choice (predisposing); flexibility and responsiveness to client desires and choices (pre‐exposure prophylaxis [PrEP]/post‐exposure prophylaxis [PEP], clinic vs. off‐site visits and self‐ or clinician‐based HIV testing) (enabling); and client and staff feedback (reinforcing). All clients received a structured assessment of barriers with personalized plans to address them, mobile phone access to clinicians (24 hours/7 days/week) and integrated reproductive health services. In this interim analysis, we describe the uptake of choices of product, location and testing during the first 24 weeks of follow‐up (April 2021−March 2022).ResultsA total of 612 (203 ANC, 197 OPD and 212 community) participants were randomized to the person‐centred DCP intervention. We delivered the DCP intervention in all three settings with diverse populations: ANC: 39% pregnant; median age: 24 years; OPD: 39% male, median age 27 years; and community: 42% male, median age: 29 years. Baseline choice of PrEP was highest in ANC (98%) vs. OPD (84%) and community (40%); whereas the proportion of adults selecting PEP was higher in the community (46%) vs. OPD (8%) and ANC (1%). Personal preference for off‐site visits increased over time (65% at week 24 vs. 35% at baseline). Interest in alternative HIV testing modalities grew over time (38% baseline self‐testing vs. 58% at week 24).ConclusionsA person‐centred model incorporating structured choice in biomedical prevention and care delivery options in settings with demographically diverse groups, in rural Kenya and Uganda, was responsive to varying personal preferences over time in HIV prevention programmes.

AbstractIntroductionThere are significant knowledge gaps concerning complex forms of mobility emergent in sub‐Saharan Africa, their relationship to sexual behaviours, HIV transmission, and how sex modifies these associations. This study, within an ongoing test‐and‐treat trial (SEARCH, NCT01864603), sought to measure effects of diverse metrics of mobility on behaviours, with attention to gender.MethodsCross‐sectional data were collected in 2016 from 1919 adults in 12 communities in Kenya and Uganda, to examine mobility (labour/non‐labour‐related travel), migration (changes of residence over geopolitical boundaries) and their associations with sexual behaviours (concurrent/higher risk partnerships), by region and sex. Multilevel mixed‐effects logistic regression models, stratified by sex and adjusted for clustering by community, were fitted to examine associations of mobility with higher‐risk behaviours, in past 2 years/past 6 months, controlling for key covariates.ResultsThe population was 45.8% male and 52.4% female, with mean age 38.7 (median 37, IQR: 17); 11.2% had migrated in the past 2 years. Migration varied by region (14.4% in Kenya, 11.5% in southwestern and 1.7% in eastern and Uganda) and sex (13.6% of men and 9.2% of women). Ten per cent reported labour‐related travel and 45.9% non‐labour‐related travel in past 6 months—and varied by region and sex: labour‐related mobility was more common in men (18.5%) than women (2.9%); non‐labour‐related mobility was more common in women (57.1%) than men (32.6%). In 2015 to 2016, 24.6% of men and 6.6% of women had concurrent sexual partnerships; in past 6 months, 21.6% of men and 5.4% of women had concurrent partnerships. Concurrency in 2015 to 2016 was more strongly associated with migration in women [aRR = 2.0, 95% CI(1.1 to 3.7)] than men [aRR = 1.5, 95% CI(1.0 to 2.2)]. Concurrency in past 6 months was more strongly associated with labour‐related mobility in women [aRR = 2.9, 95% CI(1.0 to 8.0)] than men [aRR = 1.8, 95% CI(1.2 to 2.5)], but with non‐labour‐related mobility in men [aRR = 2.2, 95% CI(1.5 to 3.4)].ConclusionsIn rural eastern Africa, both longer‐distance/permanent, and localized/shorter‐term forms of mobility are associated with higher‐risk behaviours, and are highly gendered: the HIV risks associated with mobility are more pronounced for women. Gender‐specific interventions among mobile populations are needed to combat HIV in the region.

AbstractIntroductionThe Streamlined Antiretroviral Therapy Initiation Strategy (START‐ART) study found that a theory‐based intervention using opinion leaders to inform and coach health care providers about the risks of treatment delay, provision of point of care (POC) CD4 testing machines (PIMA) and reputational incentives, led to rapid rise in ART initiation. We used qualitative research methods to explore mechanisms of provider behaviour change.MethodsWe conducted in‐depth interviews (IDIs) with 24 health care providers and nine study staff to understand perceptions, attitudes and the context of changes in ART initiation practices. Analyses were informed by the Theoretical Domains Framework.ResultsRapid dissemination of new practices was enabled in the environmental context of an existing relationship based on communication, implementation and accountability between Makerere University Joint AIDS Program (MJAP), a Ugandan University‐affiliated organization that provided technical oversight for HIV service delivery at the health facilities where the intervention was implemented, and a network of health facilities operated by the Uganda Ministry of Health. Coaching carried out by field coordinators from MJAP strengthened influence and informal accountability for carrying out the intervention. Frontline health workers held a pre‐existing strong sense of professional identity. They were proud of attainment of new knowledge and skills and gratified by providing what they perceived to be higher quality care. Peer counsellors, who were not explicitly targeted in the intervention design, effectively substituted some functions of health care providers; as role models for successful ART uptake, they played a crucial role in creating demand for rapid ART initiation through interactions with patients. Point of care (POC) CD4 testing enabled immediate action and relieved providers from frustrations of lost or delayed laboratory results, and led to higher patient satisfaction (due to reduced costs because of ability to initiate ART right away, requiring fewer return trips to clinic).ConclusionsQualitative data revealed that a multicomponent intervention to change provider behaviour succeeded in the context of strong institutional and individual relationships between a University‐affiliated organization, government facilities, and peer health workers (who acted as a crucial link between stakeholders) and the community. Fostering stable institutional relationships between institutional actors (non‐governmental organization (NGOs) and ministry‐operated facilities) as well as between facilities and the community (through peer health workers) can enhance uptake of innovations targeting the HIV cascade in similar clinical settings.

IntroductionThe Streamlined Antiretroviral Therapy Initiation Strategy (START-ART) study found that a theory-based intervention using opinion leaders to inform and coach health care providers about the risks of treatment delay, provision of point of care (POC) CD4 testing machines (PIMA) and reputational incentives, led to rapid rise in ART initiation. We used qualitative research methods to explore mechanisms of provider behaviour change.MethodsWe conducted in-depth interviews (IDIs) with 24 health care providers and nine study staff to understand perceptions, attitudes and the context of changes in ART initiation practices. Analyses were informed by the Theoretical Domains Framework.ResultsRapid dissemination of new practices was enabled in the environmental context of an existing relationship based on communication, implementation and accountability between Makerere University Joint AIDS Program (MJAP), a Ugandan University-affiliated organization that provided technical oversight for HIV service delivery at the health facilities where the intervention was implemented, and a network of health facilities operated by the Uganda Ministry of Health. Coaching carried out by field coordinators from MJAP strengthened influence and informal accountability for carrying out the intervention. Frontline health workers held a pre-existing strong sense of professional identity. They were proud of attainment of new knowledge and skills and gratified by providing what they perceived to be higher quality care. Peer counsellors, who were not explicitly targeted in the intervention design, effectively substituted some functions of health care providers; as role models for successful ART uptake, they played a crucial role in creating demand for rapid ART initiation through interactions with patients. Point of care (POC) CD4 testing enabled immediate action and relieved providers from frustrations of lost or delayed laboratory results, and led to higher patient satisfaction (due to reduced costs because of ability to initiate ART right away, requiring fewer return trips to clinic).ConclusionsQualitative data revealed that a multicomponent intervention to change provider behaviour succeeded in the context of strong institutional and individual relationships between a University-affiliated organization, government facilities, and peer health workers (who acted as a crucial link between stakeholders) and the community. Fostering stable institutional relationships between institutional actors (non-governmental organization (NGOs) and ministry-operated facilities) as well as between facilities and the community (through peer health workers) can enhance uptake of innovations targeting the HIV cascade in similar clinical settings.

AbstractIntroductionThe concept of "therapeutic citizenship" has drawn attention to ways in which public testimony, the "story‐telling in the public sphere" undertaken by people living with HIV (PLHIV), has shaped the global response to the epidemic. This paper presents qualitative findings from two large studies in eastern Africa that reveal how the advent of population‐based HIV testing campaigns and efforts to accelerate antiretroviral "treatment for all" has precipitated a rapidly expanding therapeutic citizenship "project," or social movement. The title of this paper refers to Goffman's original conceptualization of stigma as a social process through which a person's identity is rendered "spoiled."MethodsData were derived from qualitative studies embedded within two clinical trials, Sustainable East African Research in Community Health (SEARCH) (NCT# 01864603) in Kenya and Uganda, and START‐ART (NCT# 01810289) in Uganda, which aimed to offer insights into the pathways through which outcomes across the HIV care continuum can be achieved by interventions deployed in the studies, any unanticipated consequences, and factors that influenced implementation. Qualitative in‐depth semi‐structured interviews were conducted among cohorts of adults in 2014 through 2015; across both studies and time periods, 217 interviews were conducted with 166 individuals. Theoretically informed, team‐based analytic approaches were used for the analyses.ResultsNarratives from PLHIV, who have not always been conceptualized as actors but rather usually as targets of HIV interventions, revealed strongly emergent themes related to these individuals' use of HIV biomedical resources and discourses to fashion a new, empowered subjecthood. Experiencing the benefits of antiretroviral therapy (ART) emboldens many individuals to transform their "spoiled" identities to attain new, valorized identities as "advocates for ART" in their communities. We propose that the personal revelation of what some refer to as the "gospel of ARVs," the telling of personal stories about HIV in the public sphere and actions to accompany other PLHIV on their journey into care, is driven by its power to redeem the "spoiled identity:" it permits PLHIV to overcome self‐stigma and regain full personhood within their communities.ConclusionsPLHIV are playing an unanticipated but vital role in the successful implementation of HIV care cascade interventions.

AbstractIntroductionAdolescents and young adults living with HIV (AYAH) have the lowest rates of retention in HIV care and antiretroviral therapy (ART) adherence, partly due to the demands of school associated with this life stage, to HIV‐related stigma and to fears of serostatus disclosure. We explore the implications of school‐based stigma and disclosure on the development of agency during a critical life stage in rural Kenya and Uganda.MethodsWe conducted a qualitative study in the baseline year of the SEARCH Youth study, a combination intervention using a life‐stage approach among youth (15–24 years old) living with HIV in western Kenya and southwestern Uganda to improve viral load suppression and health outcomes. We conducted in‐depth, semi‐structured interviews in 2019 with three cohorts of purposively selected study participants (youth [n = 83], balanced for sex, life stage and HIV care status; recommended family members of youth [n = 33]; and providers [n = 20]). Inductive analysis exploring contextual factors affecting HIV care engagement revealed the high salience of schooling environments.ResultsStigma within school settings, elicited by non‐consensual serostatus disclosure, medication schedules and clinic appointments, exerts a constraining factor around which AYAH must navigate to identify and pursue opportunities available to them as young people. HIV status can affect cross‐generational support and cohort formation, as AYAH differ from non‐AYAH peers because of care‐related demands affecting schooling, exams and graduation. However, adolescents demonstrate a capacity to overcome anticipated stigma and protect themselves by selectively disclosing HIV status to trusted peers and caregivers, as they develop a sense of agency concomitant with this life stage. Older adolescents showed greater ability to seek out supportive relationships than younger ones who relied on adult caregivers to facilitate this support.ConclusionsSchool is a potential site of HIV stigma and also a setting for learning how to resist such stigma. School‐going adolescents should be supported to identify helpful peers and selectively disclose serostatus as they master decision making about when and where to take medications, and who should know. Stigma is avoided by fewer visits to the clinic; providers should consider longer refills, discreet packaging and long‐acting, injectable ART for students.

AbstractIntroductionThe rollout of antiretroviral therapy (ART) has been associated with reductions in HIV‐related stigma, but pathways through which this reduction occurs are poorly understood. In the newer context of universal test and treat (UTT) interventions, where rapid diffusion of ART uptake takes place, there is an opportunity to understand the processes through which HIV‐related stigma can decline, and how UTT strategies may precipitate more rapid and widespread changes in stigma. This qualitative study sought to evaluate how a UTT intervention influenced changes in beliefs, attitudes and behaviours related to HIV.MethodsLongitudinal qualitative in‐depth semi‐structured interview data were collected within a community‐cluster randomized UTT trial, the Sustainable East Africa Research in Community Health (SEARCH) study, annually over three rounds (2014 to 2016) from two cohorts of adults (n = 32 community leaders, and n = 112 community members) in eight rural communities in Uganda and Kenya. Data were inductively analysed to develop new theory for understanding the pathways of stigma decline.ResultsWe present an emergent theoretical model of pathways through which HIV‐related stigma may decline: internalized stigma may be reduced by two processes accelerated through the uptake and successful usage of ART: first, a reduced fear of dying and increased optimism for prolonged and healthy years of life; second, a restoration of perceived social value and fulfilment of subjective role expectations via restored physical strength and productivity. Anticipated stigma may be reduced in response to widespread engagement in HIV testing, leading to an increasing number of HIV status disclosures in a community, "normalizing" disclosure and reducing fears. Improvements in the perceived quality of HIV care lead to people living with HIV (PLHIV) seeking care in nearby facilities, seeing other known community members living with HIV, reducing isolation and facilitating opportunities for social support and "solidarity." Finally, enacted stigma may be reduced in response to the community viewing the healthy bodies of PLHIV successfully engaged in treatment, which lessens the fears that trigger enacted stigma; it becomes no longer socially normative to stigmatize PLHIV. This process may be reinforced through public health messaging and anti‐discrimination laws.ConclusionsDeclines in HIV‐related stigma appear to underway and explained by social processes accelerated by UTT efforts. Widespread implementation of UTT shows promise for reducing multiple dimensions of stigma, which is critical for improving health outcomes among PLHIV.