Although HIV care and treatment initiatives, as well as scale-up of prevention activities, have dramatically reduced HIV infection rates in much of sub-Saharan Africa (SSA), young women there experience among the highest HIV incidence rates in the world. Several programs have been launched to address the ongoing high HIV risk among AGYW in SSA. The most ambitious among them is the DREAMS initiative. This layered intervention package focuses on four areas: empowering AGYW and reducing their risk, reducing risk in their sexual partners, strengthening families, and mobilizing communities for change. The package also includes access to the critical biomedical intervention component Pre-Exposure Prophylaxis (PrEP). The potential effectiveness of oral antiretroviral medications to prevent the sexual acquisition of HIV (PrEP) has been well established in placebo-controlled, randomized clinical trials and open-label studies. In these trials, drug efficacy is dependent on adherence. No efficacy was seen in several studies among women where adherence to the drug was low. The existing tools to monitor PrEP adherence include self-report, pill count, electronic pill bottles, and PBMC?s. Currently the DREAMS program relies on health provider assessment which is inconsistently recorded and based on either self-report, pill count, or PrEP program persistence. A drug concentration is a more objective measure of adherence and closely correlates with the clinical outcomes of PrEP. In this study, we propose to collect dried blood spot specimens via finger stick to measure PrEP adherence by intracellular tenofovir-diphosphate level and evaluate concordance between the objective drug levels, self- reported adherence, and study persistence measures.

Public Health Relevance

Adolescent girls and young women (AGYW) experience among the highest rates of HIV infection in the world. Pre- exposure prophylaxis (PrEP) is a daily pill that can prevent the acquisition of HIV infection. In AGYW it is only effective if taken as prescribed. However, it is difficult to know if those prescribe PrEP be taking it regularly. This proposal will collect and analyze reliable drug adherence measurements to supplement the self-reported adherence data collected in Aim 1 of the parent grant.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Project (R01)
Project #
3R01HD094682-02S1
Application #
9753587
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Lee, Sonia S
Project Start
2017-08-01
Project End
2022-06-30
Budget Start
2019-01-01
Budget End
2019-06-30
Support Year
2
Fiscal Year
2019
Total Cost
Indirect Cost
Name
Fred Hutchinson Cancer Research Center
Department
Type
DUNS #
078200995
City
Seattle
State
WA
Country
United States
Zip Code
98109