Siyaphambili protocol: An evaluation of randomized, nurse-led adaptive HIV treatment interventions for cisgender female sex workers living with HIV in Durban, South Africa

Abstract

In South Africa, 60% of female sex workers are estimated to be living with human immunodeficiency virus (HIV). Many of these women face structural and individual-level barriers to initiating, accessing, and adhering to antiretroviral therapy (ART). While data are limited, it is estimated that less than 40% of sex workers living with HIV achieve viral suppression, leading to suboptimal clinical outcomes and sustained risks of onward sexual and vertical HIV transmission. Siyaphambili, a NINR/NIH-funded study, focuses on studying optimal implementation strategies for meeting HIV treatment needs among cisgender female sex workers living with HIV who are not virally suppressed. Here, we present the study protocol of this sequential multiple assignment randomized trial. In total, 800 viremic female sex workers will be enrolled into an 18-month adaptive implementation study to 1) compare the effectiveness and durability of a nurse-led decentralized ART treatment program versus an individualized case management approach, in isolation or in combination to achieve viral suppression and 2) estimate incremental cost-effectiveness of interventions and combinations of interventions. The primary outcome is a combined intention-to-treat outcome of retention in ART care and viral suppression at 18 months with secondary implementation outcomes. Siyaphambili aims to inform the implementation of and scale-up of HIV treatment services for female sex workers by determining the minimal package of services needed to achieve viral suppression and by characterizing individuals in need of more intensive HIV treatment approaches.

Keywords: adherence/compliance; community public health; cost and cost analysis; design development; epidemiology; health care delivery; infectious disease; recruit/retain participants; social and economic aspects of illness; women's health.

Figure 1.

Siyaphambili SMART study design is presented across the top of the figure for the 18-month study duration. The anticipated sample size is also presented below each cell.

Figure 2.

The Siyaphambili study inclusion criterion (left) and the exclusion criterion (right) are presented.

Figure 3.

The recruitment script for the Siyaphambili study. The peer case managers lead the recruitment of cisgender female sex workers in Durban, South Africa and utilize the standardized recruitment script during the recruitment process.

Figure 4.

The Siyaphambili recruitment flyer (left) and business card (right) are used to support recruitment activities and are distributed throughout the community and at the TB HIV Care drop-in center.