HIV Treatment Retention Interventions for Women Living With HIV (Siyaphambili Study)

Summary

The Siyaphambili Study is a sequential multistage adaptive randomized trial (SMART) to compare the effectiveness and durability of two behavioral interventions on the HIV-1 virologic response among female sex workers (FSW) living with HIV in Durban, South Africa. The interventions are: 1) nurse-led decentralized treatment program (DTP) and 2) individualized case management (ICM). Viral suppression is defined as a viral load assessment \<50 RNA copies/mL. The design will also estimate the incremental cost-effectiveness of study interventions and combinations of interventions compared with maintaining the South African standard of HIV care and treatment.

Conditions

• HIV-1 Virologic Response

Interventions

BEHAVIORAL

DTP

Provision of antiretroviral therapy (ART) in the community through a mobile-van DTP managed by a nurse capable of initiating and managing ART.

BEHAVIORAL

ICM

Peer-led ICM through quarterly face-to-face meetings, monthly phone calls and biweekly text messages.

Sponsors & Collaborators

• University of the Western Cape

  collaborator OTHER

• TB HIV Care

  collaborator OTHER

• University of Toronto

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• National Institute for Communicable Diseases, South Africa

  collaborator OTHER

• Johns Hopkins Bloomberg School of Public Health

  lead OTHER

Principal Investigators

• Stefan Baral, MD, MPH · Johns Hopkins Bloomberg School of Public Health

• Harry Hausler, MD, MPH · TB HIV Care

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-06-22

Primary Completion

2021-11-24

Completion

2022-01-05

Countries

• South Africa

Study Locations