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Introduction: Healthcare providers' role in co‐creating health interventions and implementation strategies has evolved significantly, and yet, there is little documentation of this from low‐resource settings. This study aims to share the dilemmas of engaging healthcare providers in co‐creating locally adapted clinical guidelines for maternity facilities in Dar es Salaam, Tanzania, and strategies used to address them. Methods: An ethnographic study explored the co‐creation of locally adapted clinical guidelines for childbirth care within five maternity facilities in Dar es Salaam. Participant observations were conducted during 11 co‐creation workshops. Six in‐depth interviews explored participant experiences. Data were analyzed using Attride‐Stirling's thematic network analysis framework. Results: The analysis revealed four themes representing dilemmas in the co‐creation process and strategies to improve co‐creation: (i) navigating diverse contexts: adapting a single set of guidelines to various, diverse facilities was challenging; this was addressed through engaging in dialogue and flexibility while adjusting care practices. (ii) Competing knowledge systems and sources: differing knowledge sources between researchers and healthcare providers challenged discussions on recommended practices. However, validating scientific recommendations with practical care experience in this context helped bridge this gap. (iii) Fostering meaningful participation: participation was time‐consuming for some. However, early stakeholder engagement and facility‐led participant selection facilitated the meaningful involvement of healthcare providers. (iv) Power imbalances: power dynamics influenced the co‐creation process; involving stakeholders in planning and co‐facilitating workshops helped mitigate these imbalances and encourage more equal participation. Conclusion: Navigating contextual variation, differences in knowledge systems, meaningful participation and power dynamics were key challenges in the co‐creation process. However, reflexivity, open and honest dialogue with stakeholders and early engagement enhanced the co‐creation process. Co‐creating locally adapted clinical guidelines with frontline healthcare workers and scientific experts is essential for feasibility and safety. Further research is needed to explore context specificity, decision‐making and the efficacy of co‐creation in low‐resource settings. Patient or Public Contribution: Healthcare providers and health managers from five maternity facilities who participated in the co‐creation process were actively involved in this study by providing their consent to be interviewed about their experiences of participation. Clinical Trial Registration: This study is a substudy within the PartoMa project. PartoMa is a registered clinical trial with the trial registration number NCT04685668. PartoMa's date of initial trial registration is 28 December 2020. [ABSTRACT FROM AUTHOR]

Effective, low-cost clinical interventions to improve facility-based care during childbirth are critical to reduce maternal and perinatal mortality and morbidity in low-resource settings. While health interventions for low- and lower-middle-income countries are often developed and implemented top-down, needs and circumstances vary greatly across locations. Our pilot study in Zanzibar improved care through locally co-created intrapartum clinical practice guidelines (CPGs) and associated training (the PartoMa intervention). This intervention was context-tailored with health-care providers in Zanzibar and now scaled up within five maternity units in Dar es Salaam, Tanzania. This PartoMa Scale-up Study thereby provides an opportunity to explore the co-creation process and modification of the intervention in another context and how scale-up might be successfully achieved. The overall protocol is presented in a separate paper. The aim of the present paper is to account for the Scale-up Study's programme theory and qualitative methodology. We introduce social practice theory and argue for its value within the programme theory and towards qualitative explorations of shifts in clinical practice. The theory recognizes that the practice we aim to strengthen – safe and respectful clinical childbirth care – is not practiced in a vacuum but embedded within a socio-material context and intertwined with other practices. Methodologically, the project draws on ethnographic and participatory methodologies to explore current childbirth care practices. In line with our programme theory, explorations will focus on meanings of childbirth care, material tools and competencies that are being drawn upon, birth attendants' motivations and relational contexts, as well as other everyday practices of childbirth care. Insights generated from this study will not only elucidate active ingredients that make the PartoMa intervention feasible (or not) but develop the knowledge foundation for scaling-up and replicability of future interventions based on the principles of co-creation and contextualisation. [ABSTRACT FROM AUTHOR]

While facility births are increasing in many low-resource settings, quality of care often does not follow suit; maternal and perinatal mortality and morbidity remain unacceptably high. Therefore, realistic, context-tailored clinical support is crucially needed to assist birth attendants in resource-constrained realities to provide best possible evidence-based and respectful care. Our pilot study in Zanzibar suggested that co-created clinical practice guidelines (CPGs) and low-dose, high-frequency training (PartoMa intervention) were associated with improved childbirth care and survival. We now aim to modify, implement, and evaluate this multi-faceted intervention in five high-volume, urban maternity units in Dar es Salaam, Tanzania (approximately 60,000 births annually). This PartoMa Scale-up Study will include four main steps: I. Mixed-methods situational analysis exploring factors affecting care; II. Co-created contextual modifications to the pilot CPGs and training, based on step I; III. Implementation and evaluation of the modified intervention; IV. Development of a framework for co-creation of context-specific CPGs and training, of relevance in comparable fields. The implementation and evaluation design is a theory-based, stepped-wedged cluster-randomised trial with embedded qualitative and economic assessments. Women in active labour and their offspring will be followed until discharge to assess provided and experienced care, intra-hospital perinatal deaths, Apgar scores, and caesarean sections that could potentially be avoided. Birth attendants' perceptions, intervention use and possible associated learning will be analysed. Moreover, as further detailed in the accompanying article, a qualitative in-depth investigation will explore behavioural, biomedical, and structural elements that might interact with non-linear and multiplying effects to shape health providers' clinical practices. Finally, the incremental cost-effectiveness of co-creating and implementing the PartoMa intervention is calculated. Such real-world scale-up of context-tailored CPGs and training within an existing health system may enable a comprehensive understanding of how impact is achieved or not, and how it may be translated between contexts and sustained. Trial registration number: NCT04685668 [ABSTRACT FROM AUTHOR]

Background: The meaningful engagement of male partners in antenatal care (ANC) can positively impact maternal and newborn health outcomes. The Tanzania National Plan for the Elimination of Mother to Child Transmission of HIV recommends male partners attend the first ANC appointment as a strategy for HIV prevention and treatment. This recommendation seeks to increase uptake of HIV and reproductive healthcare services, but unintended consequences of these guidelines may negatively impact women's ANC experiences. This study qualitatively examined the impact of policy promoting male engagement on women's ANC experiences.Methods: The study was conducted in two urban clinics in Kilimanjaro Region, Tanzania. In-depth interviews were conducted with 19 participants (13 women and 6 male partners) attending a first ANC appointment. A semi-structured guide was developed, applying Kabeer's Social Relations Approach. Data were analyzed using applied thematic analysis, combining memo writing, coding, synthesis, and comparison of themes.Results: Male attendance impacted the timing of women's presentation to ANC and experience during the first ANC visit. Women whose partners could not attend delayed their presentation to first ANC due to fears of being interrogated or denied care because of their partner absence. Women presenting with partners were given preferential treatment by clinic staff, and women without partners felt discriminated against. Women perceived that the clinic prioritized men's HIV testing over involvement in pregnancy care.Conclusions: Study findings indicate the need to better assess and understand the unintended impact of policies promoting male partner attendance at ANC. Although male engagement can benefit the health outcomes of mothers and newborn children, our findings demonstrate the need for improved methods of engaging men in ANC. ANC clinics should identify ways to make clinic settings more male friendly, utilize male attendance as an opportunity to educate and engage men in pregnancy and newborn care. At the same time, clinic policies should be cognizant to not discriminate against women presenting without a partner. [ABSTRACT FROM AUTHOR]

HIV stigma is a persistent barrier to curbing the spread of HIV and improving quality of life for people living with HIV. We developed and pilot tested Maisha, an HIV stigma reduction intervention in antenatal care (ANC) with two objectives: 1) among individuals living with HIV, reduce internalized and anticipated HIV stigma, with subsequent improvements in HIV care engagement, and 2) among individuals who are HIV-seronegative, reduce HIV stigmatizing attitudes. We enrolled and baselined 1039 women and 492 male partners presenting to a first ANC appointment and randomized them to standard of care or the Maisha intervention. All women living with HIV (WLHIV) and a subset of HIV-negative participants completed a 3-month follow-up assessment. Participation in the three Maisha sessions was high (99.6%, 92.8%, 89.3%), and nearly all participants noted satisfaction with the intervention content (99.8%) and counselor (99.8%). Among 55 WLHIV, care engagement outcomes did not differ by condition. Among 293 HIV-negative participants, Maisha participants had significantly greater reductions in the moral judgment sub-scale of the stigma attitudes measure (p <.001), but not the social distancing subscale. The ANC setting, where women and their partners are routinely tested for HIV, is an ideal venue for addressing HIV stigma. The Maisha intervention was feasible and acceptable, and had an impact on HIV stigma attitudes. A full trial is needed to examine impacts on HIV outcomes; modifications to the intervention should be considered to reduce social alienation of PLWH. [ABSTRACT FROM AUTHOR]

HIV status disclosure can reduce transmission risks and improve care engagement. Individuals may have strong feelings about HIV disclosure even prior to diagnosis. We assessed willingness to disclose a positive HIV status among pregnant women and their male partners awaiting routine HIV testing during antenatal care in Tanzania (n = 939). Logistic regression models were used to examine factors associated with willingness to disclose to one's inner circle (partner/family member) and outer circle (friend/neighbor) in the event of an HIV diagnosis. Almost all (93%) were willing to disclose to at least one person; participants were more willing to disclose to their inner circle (91%) vs outer circle (52%). Individuals with some form of employment, more stigmatizing attitudes of social distancing of PLWH, greater anticipated HIV stigma, more perceived social support, and prior contact with someone living with HIV were more likely to disclose to their inner circles. Individuals who were older, male, and who had higher levels of perceived social support were more willing to disclose to their outer circle. These findings increase the understanding of the intra- and interpersonal factors that influence HIV disclosure decisions. Tailored pre- and post- HIV test counseling are needed to facilitate social support and overcome barriers to disclosure if they test positive for HIV. [ABSTRACT FROM AUTHOR]

Background: HIV-related stigma significantly impacts HIV care engagement, including in prevention of mother-to-child transmission of HIV (PMTCT) programs. Maisha is a stigma-based counseling intervention delivered during the first antenatal care (ANC) visit, complementing routine HIV counseling and testing. The goal of Maisha is to promote readiness to initiate and sustain treatment among those who are HIV-positive, and to reduce HIV stigmatizing attitudes among those who test negative.Methods: A pilot randomized control trial will assess the feasibility and acceptability of delivering Maisha in a clinical setting, and the potential efficacy of the intervention on HIV care engagement outcomes (for HIV-positive participants) and HIV stigma constructs (for all participants). A total of 1000 women and approximately 700 male partners will be recruited from two study clinics in the Moshi municipality of Tanzania. Participants will be enrolled at their first ANC visit, prior to HIV testing. It is estimated that 50 women (5%) will be identified as HIV-positive. Following consent and a baseline survey, participants will be randomly assigned to either the control (standard of care) or the Maisha intervention. The Maisha intervention includes a video and counseling session prior to HIV testing, and two additional counseling sessions if the participant tests positive for HIV or has an established HIV diagnosis. A subset of approximately 500 enrolled participants (all HIV-positive participants, and a random selection of HIV-negative participants who have elevated stigma attitude scores) will complete a follow-up assessment at 3 months. Measures will include health outcomes (care engagement, antiretroviral adherence, depression) and HIV stigma outcomes. Quality assurance data will be collected and the feasibility and acceptability of the intervention will be described. Statistical analysis will examine potential differences between conditions in health outcomes and stigma measures, stratified by HIV status.Discussion: ANC provides a unique and important entry point to address HIV stigma. Interventions are needed to improve retention in PMTCT care and to improve community attitudes toward people living with HIV. Results of the Maisha pilot trial will be used to generate parameter estimates and potential ranges of values to estimate power for a full cluster-randomized trial in PMTCT settings, with extended follow-up and enhanced adherence measurement using a biomarker.Trial Registration: ClinicalTrials.gov, NCT03600142. Registered on 25 July 2018. [ABSTRACT FROM AUTHOR]

Introduction: Alcohol use is a key risk factor for disease worldwide. Consumption of alcohol is increasing in sub Saharan Africa, where youth are already at high risk of HIV due to its high prevalence in the region. Studies show that youth begin drinking alcohol early; however, there is a need to further explore the initiation of alcohol use in order to design appropriate interventions in this population. Methods: We conducted a qualitative study with youth in Mwanza and Kilimanjaro regions in Tanzania to explore alcohol consumption among youth. Participants were a purposive sample of youth aged 15–24 composed of secondary school and college students, and formal and informal sector employees. We conducted 35 in-depth interviews using a semi-structured guide to understand youth’s personal experiences with alcohol consumption. Two social scientists conducted a multi stage, inductive analysis of the data. Findings: Alcohol consumption was reported to mainly start during adolescence, although in some cases it started as early as at 10 years of age. Young women reported drinking less, and initiated drinking later compared to males. Social space assumed a primary role in alcohol initiation. The social environment and influence of important social actors were key aspects of youth’s social space. Youth reported starting to consume alcohol at home, social events and in stressful environments with key influencers being parents, relatives, peers and intimate partners. Conclusions: Our findings show that the social space (social environment and interactions) plays an important role in influencing youth initial consumption of alcohol. Interventions addressing alcohol initiation among the population need to address the social spaces where initiation takes place and engage the significant actors in these spaces. There is need to further explore underlying societal drinking norms to better understand how they shape social environments and young people’s initiation of alcohol use. [ABSTRACT FROM AUTHOR]

Voluntary Medical Male Circumcision (VMMC) for HIV prevention in Tanzania was introduced by the Ministry of Health and Social Welfare in 2010 as part of the national HIV prevention strategy. A qualitative study was conducted prior to a cluster randomized trial which tested effective strategies to increase VMMC up take among men aged ≥20 years. During the formative qualitative study, we conducted in-depth interviews with circumcised males (n = 14), uncircumcised males (n = 16), and participatory group discussions (n = 20) with men and women aged 20–49 years in Njombe and Tabora regions of Tanzania. Participants reported that mothers and female partners have an important influence on men’s decisions to seek VMMC both directly by denying sex, and indirectly through discussion, advice and providing information on VMMC to uncircumcised partners and sons. Our findings suggest that in Tanzania and potentially other settings, an expanded role for women in VMMC communication strategies could increase adult male uptake of VMMC services. [ABSTRACT FROM AUTHOR]

Background: Complex health interventions must incorporate user preferences to maximize their potential effectiveness. Discrete choice experiments (DCEs) quantify the strength of user preferences and identify preference heterogeneity across users. We present the process of using a DCE to supplement conventional qualitative formative research in the design of a demand creation intervention for voluntary medical male circumcision (VMMC) to prevent HIV in Tanzania.Methods: The VMMC intervention was designed within a 3-month formative phase. In-depth interviews (n = 30) and participatory group discussions (n = 20) sought to identify broad setting-specific barriers to and facilitators of VMMC among adult men. Qualitative results informed the DCE development, identifying the role of female partners, service providers' attitudes and social stigma. A DCE among 325 men in Njombe and Tabora, Tanzania, subsequently measured preferences for modifiable VMMC service characteristics. The final VMMC demand creation intervention design drew jointly on the qualitative and DCE findings.Results: While the qualitative research informed the community mobilization intervention, the DCE guided the specific VMMC service configuration. The significant positive utilities (u) for availability of partner counselling (u = 0.43, p < 0.01) and age-separated waiting areas (u = 0.21, p < 0.05) led to the provision of community information booths for partners and provision of age-separated waiting areas. The strong disutility of female healthcare providers (u = - 0.24, p < 0.01) led to re-training all providers on client-friendliness.Conclusion: This is, to our knowledge, the first study documenting how user preferences from DCEs can directly inform the design of a complex intervention. The use of DCEs as formative research may help increase user uptake and adherence to complex interventions. [ABSTRACT FROM AUTHOR]