The overall goal of the proposed mentored career development award is to support Dr. Rena Patel's research training to develop as an independent, mixed methods researcher in HIV and women's health. Dr. Patel is currently an infectious diseases fellow at the University of California, San Francisco. Conducting the proposed studies in this application will facilitate her training goals of gaining a background in pharmacology, advancing her skills in epidemiology/biostatistics and qualitative research methods, and formalizing her experiences in implementation sciences. The proposal builds on the unique skills that she already has in the social sciences, qualitative research, and epidemiology while leveraging UCSF's world-class mentors, researchers, and facilities to ensure her success in becoming an independent investigator. The research objective of this proposal is to determine if interactions between efavirenz and contraceptive implants lead to contraceptive failures (i.e. unintended pregnancies). Unintended pregnancies among HIV-positive women impact HIV and maternal morbidity and vertical transmission of HIV. Optimizing contraception to avoid unintended pregnancies is imperative. Some pharmacokinetic data regarding drug-drug interactions between efavirenz and hormonal contraception have raised concerns for increased contraceptive failures. However, critical gaps exist in the literature and current HIV treatment guidelines with regard to concomitant use of efavirenz-based antiretroviral therapy (ART), now recommended as first-line ART in resource-limited settings, and contraceptive implants. In order to address the issue of potential interactions between efavirenz and implants comprehensively, we aim to conduct three distinct studies in western Kenya.
For Aim 1, we will determine if implant etonogestrel concentrations decrease following initiation of efavirenz-based ART.
For Aim 2, we will compare contraceptive failure or pregnancy rates among women using implants on efavirenz- vs. non-efavirenz based ART in a large clinic-based Kenyan cohort. Lastly, for Aim 3, we will determine how HIV-positive women, their partners, and providers reach decisions regarding concomitant ART and contraception initiation and choices, how potential data on interactions between ART and contraception would influence their choices, and to assess acceptability of alternative ART and/or contraceptive strategies. We hypothesize that implant etonogestrel concentrations will decrease following efavirenz-based ART initiation and pregnancy rates will be higher in implant users on efavirenz vs. non-efavirenz-based ART. The above aims will be among the first to comprehensively address the questions surrounding interactions between efavirenz-based ART and implants, and by the completion of this award, Dr. Patel will be in an excellent position to submit an R01 that furthers the research agenda in HIV and reproductive health.

Public Health Relevance

The proposed project examining interactions between efavirenz-based antiretroviral therapy (ART) and contraceptive implants will significantly impact HIV treatment guidelines' recommendations on the concomitant use of ART and contraception. Findings from this project will help avoid unintended pregnancies among HIV- positive women, improve women's health, and prevent vertical transmission of HIV in resource-limited settings, where efavirenz-based ART is now first-line therapy and hormonal contraceptives are increasingly used.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Mentored Patient-Oriented Research Career Development Award (K23)
Project #
5K23AI120855-03
Application #
9088349
Study Section
Acquired Immunodeficiency Syndrome Research Review Committee (AIDS)
Program Officer
Bacon, Melanie C
Project Start
2015-07-01
Project End
2020-06-30
Budget Start
2016-07-01
Budget End
2017-06-30
Support Year
3
Fiscal Year
2016
Total Cost
Indirect Cost
Name
University of Washington
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
605799469
City
Seattle
State
WA
Country
United States
Zip Code
98195
Patel, Rena C; Leddy, Anna M; Odoyo, Josephine et al. (2018) What motivates serodiscordant couples to prevent HIV transmission within their relationships: findings from a PrEP implementation study in Kenya. Cult Health Sex 20:625-639
Patel, Rena C; Bukusi, Elizabeth A; Baeten, Jared M (2018) Current and future contraceptive options for women living with HIV. Expert Opin Pharmacother 19:1-12
Ayieko, James; Ti, Angeline; Hagey, Jill et al. (2017) HIV status and treatment influence on fertility desires among women newly becoming eligible for antiretroviral therapy in western Kenya: insights from a qualitative study. Reprod Health 14:93
King, Caroline C; Ellington, Sascha R; Davis, Nicole L et al. (2017) Prevalence, Magnitude, and Correlates of HIV-1 Genital Shedding in Women on Antiretroviral Therapy. J Infect Dis 216:1534-1540
Patel, Rena C; Morroni, Chelsea; Scarsi, Kimberly K et al. (2017) Concomitant contraceptive implant and efavirenz use in women living with HIV: perspectives on current evidence and policy implications for family planning and HIV treatment guidelines. J Int AIDS Soc 20:21396
Patel, Rena C; Baeten, Jared M; Heffron, Renee et al. (2017) Brief Report: Hormonal Contraception Is Not Associated With Reduced ART Effectiveness Among Women Initiating ART: Evidence From Longitudinal Data. J Acquir Immune Defic Syndr 75:91-96
Patel, Rena C; Odoyo, Josephine; Anand, Keerthana et al. (2016) Facilitators and Barriers of Antiretroviral Therapy Initiation among HIV Discordant Couples in Kenya: Qualitative Insights from a Pre-Exposure Prophylaxis Implementation Study. PLoS One 11:e0168057
Patel, Rena C; Stanford-Moore, Gaelen; Odoyo, Josephine et al. (2016) ""Since both of us are using antiretrovirals, we have been supportive to each other"": facilitators and barriers of pre-exposure prophylaxis use in heterosexual HIV serodiscordant couples in Kisumu, Kenya. J Int AIDS Soc 19:21134
Hagey, Jill M; Akama, Eliud; Ayieko, James et al. (2015) Barriers and facilitators adolescent females living with HIV face in accessing contraceptive services: a qualitative assessment of providers' perceptions in western Kenya. J Int AIDS Soc 18:20123
Patel, Rena C; Onono, Maricianah; Gandhi, Monica et al. (2015) Pregnancy rates in HIV-positive women using contraceptives and efavirenz-based or nevirapine-based antiretroviral therapy in Kenya: a retrospective cohort study. Lancet HIV 2:e474-82