Progress towards HIV elimination will stall unless we overcome persistent drivers of new HIV infections by jointly optimizing HIV treatment and effectively delivering HIV prevention modalities.
We aim to determine how to reduce HIV incidence to <0.1% using innovative strategies for HIV prevention and treatment to concurrently reach ?persistent driver? populations with scalable interventions optimized and evaluated in two phases. ? In Phase A (years 1-2), we will conduct individually randomized controlled trials (RCTs) to optimize the following prevention and treatment packages: 1) Dynamic Choice HIV Prevention with flexible Pre- exposure/post-exposure prophylaxis (PrEP/PEP) access integrated at family planning, antenatal care and HIV clinics and at community Youth Hubs that generate demand by also offering provision of life-skills, micro-finance and vocational training. 2) Dynamic Choice HIV Treatment with individual and system care options and services tailored for youth, men, mobile populations, and heavy drinkers. ? In Phase B (years 3-5), we will test the hypothesis that a multi-sector intervention, offering dynamic choice of biomedical HIV prevention and treatment for persistent driver populations will increase viral suppression and prevention coverage and lead to a reduction in HIV incidence greater than standard of care.
Aim 1 : Optimize dynamic prevention and treatment interventions: We will conduct RCTs of PrEP/PEP dynamic prevention at multiple venues with high risk populations, and dynamic treatment interventions for multiple populations with unsuppressed viral load. Primary efficacy outcomes (HIV prevention coverage and viral suppression) will be used with implementation outcomes, costing, modelling projections, and stakeholder input to optimize dynamic prevention and treatment intervention packages for Phase B.
Aim 2 : a) Compare the effect of Dynamic Choice Prevention and Dynamic Choice Treatment interventions vs. standard-of-care on prevention coverage, viral suppression, HIV incidence and community health outcomes at 3 years. We will use a community randomized 2x2 factorial design to identify effect of each intervention package and their combination on prevention coverage, viral suppression, and other health outcomes. b) Elucidate pathways of intervention impact via evaluation of implementation and process outcomes and of socio-behavioral pathways of action at the community, clinic, and individual levels.
Aim 3 : Determine sustainability and inform policy. We will conduct multi-site costing of each aspect of the multi-component intervention and estimate costs per HIV infection averted and impacts on multi-disease disability-adjusted life-years (DALYs). Modelling incorporating study data will be used to inform stakeholders on anticipated long-term health impact and costs of alternative prevention and treatment strategies. Significance: This study will address major knowledge gaps on how to overcome key factors fueling the HIV epidemic that inform stakeholders and guide policies towards accelerating the path to HIV elimination.

Public Health Relevance

The number of new HIV infections in Sub-Saharan Africa remain well above global elimination targets. The study aims to accelerate the path to HIV elimination with new innovative combination strategies for HIV prevention and treatment that are effective, efficient, scalable and reduce preventable infections and deaths.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project--Cooperative Agreements (U01)
Project #
1U01AI150510-01A1
Application #
10085144
Study Section
Special Emphasis Panel (ZAI1)
Program Officer
Roe, Joanad'Arc C
Project Start
2020-09-25
Project End
2025-06-30
Budget Start
2020-09-25
Budget End
2021-06-30
Support Year
1
Fiscal Year
2020
Total Cost
Indirect Cost
Name
University of California San Francisco
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
094878337
City
San Francisco
State
CA
Country
United States
Zip Code
94118