Using GRADE as a framework to guide research on the sexual and reproductive health and rights (SRHR) of women living with HIV - methodological opportunities and challenges.

In March 2016, WHO reviewed evidence to develop global recommendations on the sexual and reproductive health and rights (SRHR) of women living with HIV. Systematic reviews and a global survey of women living with HIV informed the guideline development decision-making process. New recommendations covered abortion, Caesarean section, safe disclosure, and empowerment and self-efficacy interventions. Identification of key research gaps is part of the WHO guidelines development process, but consistent methods to do so are lacking. Our method aimed to ensure consistency and comprised the systematic application of a framework based on GRADE (Grading of Recommendations, Assessment, Development and Evaluation) to the process. The framework incorporates the strength and quality rating of recommendations and the priorities reported by women in the survey to inform research prioritisation. For each gap, we also articulated: (1) the most appropriate and robust study design to answer the question; (2) alternative pragmatic designs if the ideal design is not feasible; and (3) the methodological challenges facing researchers through identifying potential biases. We found 12 research gaps and identified five appropriate study designs to address the related questions: (1) Cross-sectional surveys; (2) Qualitative interview-driven studies; (3) Registries; (4) Randomised controlled trials; and (5) Medical record audit. Methodological challenges included selection, recruitment, misclassification, measurement and contextual biases, and confounding. In conclusion, a framework based on GRADE can provide a systematic approach to identifying research gaps from a WHO guideline. Incorporation of the priorities of women living with HIV into the framework systematically ensures that women living with HIV can shape future policy decisions affecting their lives. Implementation science and participatory research are appropriate over-arching approaches to enhance uptake of interventions and to ensure inclusion of women living with HIV at all stages of the research process.