Protocol for the pilot quasi-experimental controlled trial of a gender-responsive implementation strategy with providers to improve HIV outcomes in Uganda.

ABSTRACT

BACKGROUND: Antiretroviral treatment (ART) is the most effective clinical intervention for reducing morbidity and mortality among persons living with HIV. However, in Uganda, there are disparities between men and women in viral load suppression and related HIV care engagement outcomes, which suggests problems with the implementation of ART. Gender norms are a known driver of HIV disparities in sub-Saharan Africa, and patient-provider relationships are a key factor in HIV care engagement; therefore, the role of gender norms is important to consider in interventions to achieve the equitable provision of treatment and the quality of ART counseling. METHODS: The overall research objective of this study is to pilot test an implementation strategy (i.e., methods to improve the implementation of an evidence-based intervention) to increase providers' capacity to provide gender-responsive treatment and counseling to men and women on HIV treatment in Uganda. Delivered to HIV providers, this group training adapts evidence-based strategies to reduce gender biases and increase skills to deliver gender-specific and transformative HIV counseling to patients. The implementation strategy will be piloted through a quasi-experimental controlled trial. Clinics will be randomly assigned to either the intervention or control conditions. The trial will assess feasibility and acceptability and explore barriers and facilitators to implementation and future adoption while gathering preliminary evidence on the implementation strategy's effectiveness by comparing changes in patient (N = 240) and provider (N = 80-140) outcomes across intervention and control clinics through 12-month follow-up. Quantitative data will be descriptively analyzed, qualitative data will be analyzed through thematic analysis, and these data will be mixed during the presentation and interpretation of results where appropriate. DISCUSSION: This pilot intervention trial will gather preliminary evidence on the acceptability, feasibility, and potential effect of a novel implementation strategy to improve men and women's HIV care engagement, with the potential to reduce gender disparities in HIV outcomes. TRIAL REGISTRATION Clinicaltrials.gov NCT05178979 , retrospectively registered on January 5, 2022.