Many Cooks in the Kitchen: Iterating a Qualitative Analysis Process Across Multiple Countries, Sites, and Teams.

Establishing and proving methodological rigor has long been a challenge for qualitative researchers where quantitative methods prevail, but much published literature on qualitative analysis assumes a relatively small number of researchers working in relative proximity. This is particularly true for research conducted with a grounded theory approach. Different versions of grounded theory are commonly used, but this methodology was originally developed for a single researcher collecting and analyzing data in isolation. Although grounded theory has evolved since its development, little has been done to reconcile this approach with the changing nature and composition of international research teams. Advances in technology and an increased emphasis on transnational collaboration have facilitated a shift wherein qualitative datasets have been getting larger and the teams collecting and analyzing them more diverse and diffuse. New processes and systems are therefore required to respond to these conditions. Data for this article are drawn from the experiences of the Innovations for Choice and Autonomy (ICAN) Research Consortium. ICAN aims to understand how self-injectable contraceptives can be implemented in ways that best meet women's needs in Kenya, Uganda, Malawi, and Nigeria. We found that taking a structured approach to analysis was important for maintaining consistency and making the process more manageable across countries. However, it was equally important to allow for flexibility within this structured approach so that teams could adapt more easily to local conditions, making data collection and accompanying analysis more feasible. Meaningfully including all interested researchers in the analysis process and providing support for learning also increased rigor. However, competing priorities in a complex study made it difficult to adhere to planned timelines. We conclude with recommendations for both funders and study teams to design and conduct global health studies that ensure more equitable contributions to analysis while remaining logistically feasible and methodologically sound.

Preventing HIV and achieving pregnancy among HIV sero-different couples: Pilot study of a safer conception intervention in Zimbabwe.

Safer conception services are needed to minimize HIV transmission among HIV sero-different couples desiring pregnancy. Few studies have evaluated the choices couples make when offered multiple safer conception methods or real-world method acceptability and effectiveness. We piloted a comprehensive safer conception program (Clintrials.gov identifier: NCT03049176) for HIV sero-different couples planning pregnancy in Zimbabwe to measure feasibility, method uptake, acceptability, pregnancy outcome, and HIV transmission. This study was not designed to compare rates of HIV transmission by safer conception method choice but rather to understand choices couples make when seeking to minimize risk of HIV transmission and maximize likelihood of pregnancy. Couples in this prospective, non-randomized study were given a choice of one or more currently available safer conception methods: antiretroviral therapy (ART) with monthly viral load (VL) monitoring for the HIV-positive partner (ART/VL), pre-exposure prophylaxis (PrEP) for the HIV-negative partner, vaginal insemination (VI) for couples with an HIV-positive woman, and semen washing (SW) for couples with an HIV-positive man. Couples were followed monthly for up to 12 months of pregnancy attempts, quarterly during pregnancy, and 12 weeks post-partum. At each visit, data on method use, urine for pregnancy testing, and blood for HIV antibody testing, or viral load if HIV-positive, were obtained. Infants born to HIV-positive women were tested for HIV at 6 and 12 weeks. Between March 2017 and June 2019, 46 individuals from 23 HIV sero-different partnerships were enrolled and followed. At enrollment, all couples chose ART/VL, and all couples chose at least one additional method; 74% chose PrEP, 36% chose SW, and 25% chose VI. During pre-pregnancy follow-up visits, three couples discontinued SW, and one couple discontinued VI; all four of these couples opted for ART/VL plus PrEP. Satisfaction with safer conception methods was high among those who chose ART/VL and PrEP. Twelve couples achieved pregnancy. There were no cases of HIV transmission to partners, and no infants tested positive for HIV. This safer conception program is feasible and acceptable, allowing sero-different couples to safely achieve pregnancy. Sero-different couples in Zimbabwe seek a combination of HIV prevention methods, particularly ART/VL plus PrEP. Trial Registration: Clintrials.gov, NCT03049176.

Analyzing fast and slow: Combining traditional and rapid qualitative analysis to meet multiple objectives of a complex transnational study.

Much of the methodological literature on rapid qualitative analysis describes processes used by a relatively small number of researchers focusing on one study site and using rapid analysis to replace a traditional analytical approach. In this paper, we describe the experiences of a transnational research consortium integrating both rapid and traditional qualitative analysis approaches to develop social theory while also informing program design. Research was conducted by the Innovations for Choice and Autonomy (ICAN) consortium, which seeks to understand how self-injection of the contraceptive subcutaneous depot medroxyprogesterone acetate (DMPA-SC) can be implemented in a way that best meets women's needs, as defined by women themselves. Consortium members are based in Kenya, Uganda, Malawi, Nigeria, and the United States. Data for the ICAN study was collected in all four countries in sub-Saharan Africa. In order to both illuminate social phenomena across study sites and inform the program design component of the study, researchers developed tools meant to gather both in-depth information about women's contraceptive decision-making and data targeted specifically to program design during the formative qualitative phase of the study. Using these two bodies of data, researchers then simultaneously conducted both a traditional qualitative and rapid analysis to meet multiple study objectives. To complete the traditional analysis, researchers coded interview transcripts and kept analytical memos, while also drawing on data collected by tools developed for the rapid analysis. Rapid analysis consisted of simultaneously collecting data and reviewing notes developed specifically for this analysis. We conclude that integrating traditional and rapid qualitative analysis enabled us to meet the needs of a complex transnational study with the added benefit of grounding our program design work in more robust primary data than normally is available for studies using a human-centered design approach to intervention development. However, the realities of conducting a multi-faceted study across multiple countries and contexts made truly "rapid" analysis challenging.

Transforming masculine norms to improve men's contraceptive acceptance: results from a pilot intervention with men in western Kenya.

Men's adherence to constraining male gender norms can lead them to resist contraceptive use. Very few interventions have attempted to transform masculine norms to encourage greater contraceptive acceptance and gender equality. We designed and evaluated a small-scale community-based intervention targeting the masculine norms tied to contraceptive resistance among partnered men (N = 150) in two western Kenya communities (intervention vs. control). Pre-post survey data fit to linear and logistic regression models evaluated differences in post-intervention outcomes, accounting for pre-intervention differences. Intervention participation was associated with increases in contraceptive acceptance scores (adjusted coefficient (aß) 1.04; 95% confidence interval (CI) 0.16, 1.91; p = 0.02) and contraceptive knowledge scores (aß 0.22; 95% CI 0.13, 0.31; p < 0.001) and with contraceptive discussions with one's partner (adjusted Odds Ratio (aOR) 3.96; 95% CI 1.21, 12.94; p = 0.02) and with others (aOR 6.13; 95% CI 2.39, 15.73; p < 0.001). The intervention was not associated with contraceptive behavioural intention or use. Our findings demonstrate the promise of a masculinity-driven intervention on increasing men's contraceptive acceptance and positive contraceptive involvement. A larger randomised trial is needed to test the effectiveness of the intervention among men as well as among couples.

Measuring Men's Gender Norm Beliefs Related to Contraception: Development of the Masculine Norms and Family Planning Acceptance Scale.

Male partner resistance is identified as a key factor that influences women's contraceptive use. Examination of the masculine norms that shape men's resistance to contraception-and how to intervene on these norms-is needed. To assess a gender-transformative intervention in Kenya, we developed and evaluated a masculinity-informed instrument to measure men's contraceptive acceptance-the Masculine Norms and Family Planning Acceptance (MNFPA) scale. We developed draft scale items based on qualitative research and administered them to partnered Kenyan men (n = 150). Item response theory-based methods were used to reduce and psychometrically evaluate final scale items. The MNFPA scale had a Cronbach's α of 0.68 and loaded onto a single factor. MNFPA scores were associated with self-efficacy and intention to accept a female partner's use of contraception; scores were not associated with current contraceptive use. The MNFPA scale is the first rigorously developed and psychometrically evaluated tool to assess men's contraceptive acceptance as a function of male gender norms. Future work is needed to test the MNFPA measure in larger samples and across different contexts. The scale can be used to evaluate interventions that seek to shift gender norms to increase men's positive engagement in pregnancy spacing and prevention.

Estimated costs for the delivery of safer conception strategies for HIV-discordant couples in Zimbabwe: a cost analysis.

BACKGROUND: In recent years, safer conception strategies have been developed to help HIV-serodiscordant couples conceive a child without transmitting HIV to the seronegative partner. The SAFER clinical trial assessed implementation of these strategies in Zimbabwe. METHODS: As a part of the SAFER study, we estimated the costs (in 2017 $US) associated with individual and combination strategies, in the trial setting and real-world practice, from a healthcare system perspective. Safer conception strategies included: 1) ART with frequent viral load testing until achieving undetectable viral load (ART-VL); 2) daily oral pre-exposure prophylaxis (PrEP); 3) semen-washing with intrauterine insemination; and 4) manual self-insemination at home. For costs in the trial, we used a micro-costing approach, including a time and motion study to quantify personnel effort, and estimated the cost per couple for individual and combination strategies for a mean of 6 months of safer services. For real-world practice, we modeled costs for three implementation scenarios, representing differences from the trial in input prices (paid by the Ministry of Health and Child Care [MOHCC]), intervention intensity, and increments to current HIV prevention and treatment practices and guidelines. We used one-way sensitivity analyses to assess the impact of uncertainty in input variables. RESULTS: Individual strategy costs were $769-$1615 per couple in the trial; $185-$563 if using MOHCC prices. Under the target intervention intensity and using MOHCC prices, individual strategy costs were $73-$360 per couple over and above the cost of current HIV clinical practices. The cost of delivering the most commonly selected combination, ART-VL plus PrEP, ranged from $166-$517 per couple under the three real-world scenarios. Highest costs were for personnel, lab tests, and strategy-specific consumables, in variable proportions by clinical strategy and analysis scenario. Total costs were most affected by uncertainty in the price of PrEP, number of semen-washing attempts, and scale-up of semen-washing capacity. CONCLUSIONS: Safer conception methods have costs that may be affordable in many low-resource settings. These cost data will help implementers and policymakers add safer conception services. Cost-effectiveness analysis is needed to assess value for money for safer conception services overall and for safer strategy combinations. TRIAL REGISTRATION: Registry Name: Clinicaltrials.gov. TRIAL REGISTRATION NUMBER: NCT03049176 . Registration date: February 9, 2017.

Educating men about vaginal microbicides: considerations from Kenya.

Men desire to be involved in their partner's decision-making about vaginal microbicide use. This coincides with women's desire to inform male partners about their microbicide use. Educating men about microbicides may enhance acceptability and generate critical support for the female participants of microbicide trials. In this multiphase mixed-methods study, we adapted an educational intervention on vaginal microbicides and tested it among men (n = 45) to determine its effect on men's knowledge regarding HIV/STI, vaginal microbicides and microbicide trials. We also conducted focus group discussions (FGDs) with the female partners (K = 3, n = 43) of the study participants and community representatives (K = 2, n = 24) to obtain their views on male partner microbicide education. We analysed FGD data for key themes using content analysis. HIV and vaginal microbicide knowledge scores increased significantly among men after the educational intervention. Both women and men highly supported male partner microbicide education, in the context of existing gender relations, to increase men's understanding about microbicides, promote adherence and help women gain their partners' trust. Complex gender dynamics should be considered when designing male partner educational interventions to improve acceptability and the use of microbicides and other female-initiated HIV prevention methods.

Ethical and scientific considerations on the establishment of a controlled human infection model for schistosomiasis in Uganda: report of a stakeholders' meeting held in Entebbe, Uganda.

Controlled human infection (CHI) models are gaining recognition as an approach to accelerating vaccine development, for use in both non-endemic and endemic populations: they can facilitate identification of the most promising candidate vaccines for further trials and advance understanding of protective immunity. Helminths present a continuing health burden in sub-Saharan Africa. Vaccine development for these complex organisms is particularly challenging, partly because protective responses are akin to mechanisms of allergy. A CHI model for Schistosoma mansoni (CHI-S) has been developed at Leiden University Medical Centre, the Netherlands. However, responses to schistosome infections, and candidate vaccines, are likely to be different among people from endemic settings compared to schistosome-naïve Dutch volunteers. Furthermore, among volunteers from endemic regions who have acquired immune responses through prior exposure, schistosome challenge can be used to define responses associated with clinical protection, and thus to guide vaccine development.  To explore the possibility of establishing the CHI-S in Uganda, a Stakeholders' Meeting was held in Entebbe in 2017. Regulators, community members, researchers and policy-makers discussed implementation challenges and recommended preparatory steps: risk assessment; development of infrastructure and technical capacity to produce the infectious challenge material in Uganda; community engagement from Parliamentary to grass-roots level; pilot studies to establish approaches to assuring fully informed consent and true voluntariness, and strategies for selection of volunteers who can avoid natural infection during the 12-week CHI-S; the building of regulatory capacity; and the development of study protocols and a product dossier in close consultation with ethical and regulatory partners. It was recommended that, on completion, the protocol and product dossier be reviewed for approval in a joint meeting combining ethical, regulatory and environment management authorities. Most importantly, representatives of schistosomiasis-affected communities emphasised the urgent need for an effective vaccine and urged the research community not to delay in the development process.

Medicalization of HIV and the African response.

Since the discovery of HIV, the advent of anti-retrovirals in the late 80s heralded an era of medicalization of HIV and fostered major advancements in the management of the disease. Africa, despite its high HIV burden, lagged behind in the adoption of these advancements due to major resource and logistical constraints. Innovative responses such as family-centered models of care, community systems strengthening, integration of HIV care with existing health services, and economic and mobile phone- based approaches have been critical in the successful roll-out of evidence-based HIV/AIDS treatment even in the most resource- limited settings.