Understanding the acceptability of broadly neutralizing antibodies for HIV prevention among at-risk populations and feasibility considerations for product introduction in India: A qualitative study protocol (Preprint)

Abstract

Acceptability and preference research play a crucial role in the design, evaluation and implementation of any new prevention product in any geographical setting. They also play a critical role in the development of clinical guidance and policies. A wide range of acceptability studies have been conducted in diverse general and key populations for various new HIV prevention products across the globe. As the clinical development strategy is being developed for clinical studies of the broadly neutralizing antibodies (bNAbs) as potential HIV prevention products, appropriately tailoring it to address the type of HIV epidemic at hand would be critical for efficient uptake within in-country public health systems and decrease adoption and adherence challenges. Accomplishing this will require comprehensive acceptability and feasibility studies to inform multisectoral efforts that increases access to these products and national policies supportive of access to healthcare for those in most need. Thus, it is both opportune and important to undertake focused efforts towards informing product development strategies.

The objectives of the study include: (1) understanding preferences for product attributes and key behavioral factors influencing adoption and uptake of bNAb prevention products among end-users including female sex workers (FSW), Men who have sex with men (MSM), Transgender women (TGW), People who inject drugs (PWID) and Adolescent girls and young women (AGYW) populations in India; and (2) understanding key health system and programmatic perspectives towards the introduction of bNAb prevention products from health service providers and policy makers in India.

The multi-site study will take place in Delhi, Mumbai and Chennai regions to ensure broad coverage of perceptions from all parts of India and to capture the differences in perspectives among diverse end-users and key informants across the country. The study will employ a multi-methods design using - Focus group discussions (FGDs); In-depth interviews (IDIs); Simulated behavioral experiments (SBE) and Key informant interviews (KIIs). A total of 30 FGDs, 45 IDIs, 15 SBE sessions and 15 KIIs will be conducted across 3 sites.

The data collected and analyzed will enable insights on which specific product attributes matter the most to the populations and why some attributes are less preferred; contextual drivers of preferences and choices at individual, interpersonal, social and structural levels and key decision levers; relative positioning of bNAb product among other potential HIV prevention products. Insights from the health service providers and policy makers will provide a critical understanding of the need perception of the potential product in the existing product landscape, what additional efforts and resources are required for potential introduction, delivery and uptake of the bNAb products in the Indian context.

Insights generated from all the above objectives will represent perspectives of populations of interest across geographies in India and will provide an overview of the acceptability of bNAb products and feasibility of its introduction in this region and will inform product development strategies.