Continued attendance in a PrEP program despite low adherence and non-protective drug levels among adolescent girls and young women in Kenya: Results from a prospective cohort study

Abstract

Background In sub-Saharan Africa (SSA), adolescent girls and young women (AGYW) ages 15 to 24 years represent <10% of the population yet account for 1 in 5 new HIV infections. Although oral pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) can be highly effective, low persistence in PrEP programs and poor adherence have limited its ability to reduce HIV incidence among women. Methods and findings A total of 336 AGYW participating in the PEPFAR-funded DREAMS PrEP program in western Kenya were enrolled into a study of PrEP use conducted between 6/2019 to 1/2020. AGYW, which used daily oral TDF/FTC, completed interviews and provided dried blood spots (DBS) for measurement of tenofovir-diphosphate (TFV-DP) concentrations at enrollment and 3 months later, and 176/302 (58.3%, 95% confidence interval [95% CI 52.3 to 63.8]) met our definition of PrEP persistence: having expressed intention to use PrEP and attended both the second interview and an interim refill visit. Among AGYW with DBS taken at the second interview, only 9/197 (4.6%, [95% CI 1.6 to 7.5]) had protective TFV-DP levels (≥700 fmol/punch) and 163/197 (82.7%, [95% CI 77.5 to 88]) had levels consistent with no recent PrEP use (<10 fmol/punch). Perception of being at moderate-to-high risk for HIV if not taking PrEP was associated with persistence (adjusted odds ratio, 10.17 [95% CI 5.14 to 20.13], p < 0.001) in a model accounting for county of residence and variables that had p-value <0.1 in unadjusted analysis (age, being in school, initiated PrEP 2 to 3 months before the first interview, still active in DREAMS, having children, having multiple sex partners, partner aware of PrEP use, partner very supportive of PrEP use, partner has other partners, AGYW believes that a partner puts her at risk, male condom use, injectable contraceptive use, and implant contraceptive use). Among AGYW who reported continuing PrEP, >90% indicated they were using PrEP to prevent HIV, although almost all had non-protective TFV-DP levels. Limitations included short study duration and inclusion of only DREAMS participants. Conclusions Many AGYW persisted in the PrEP program without taking PrEP frequently enough to receive benefit. Notably, AGYW who persisted had a higher self-perceived risk of HIV infection. These AGYW may be optimal candidates for long-acting PrEP.

How a menu of adherence support strategies facilitated high adherence to HIV prevention products among adolescent girls and young women in sub‐Saharan Africa: a mixed methods analysis

“…Collaboration, Kampala, Uganda; 5 Wits Reproductive Health and HIV Institute, Johannesburg, South Africa; 6 University of Zimbabwe Clinical Trials Research Centre, Harare, Zimbabwe; 7 Desmond Tutu HIV Centre, Cape Town, South Africa; 8 FHI 360, Durham, North Carolina, USA; 9 Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Center, Seattle, Washington, USA; 10 Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA; 11 School of Public Health, Jomo Kenyatta University of Agriculture and Technology, Nairobi, Kenya; 12 Department of Global Health, University of Washington, Seattle, Washington, USA; 13 Center for Dissemination and Implementation Science, University of Illinois Chicago, Chicago, Illinois, USA…”

“…However, low adherence significantly reduces the effectiveness of both products in preventing HIV acquisition [2,[4][5][6]. Oral PrEP adherence has been low among AGYW across multiple studies in the region, and persistence in programmatic settings has averaged 2 months or less [7][8][9][10][11][12][13]. Young women have also had challenges with ring use, with significantly lower adherence than their adult counterparts in phase III trials [4,[14][15][16].…”

Microarray patch for HIV prevention and as a multipurpose prevention technology to prevent HIV and unplanned pregnancy: an assessment of potential acceptability, usability, and programmatic fit in Kenya

“…In the same year, the estimated HIV prevalence for women aged 15-49 was more than twice as high as that for men aged 15-49 (6.6% vs. 3.1%). HIV infection rates among young people (15)(16)(17)(18)(19)(20)(21)(22)(23)(24) accounted for 35% of new infections, with two-thirds of cases among adolescent girls and young women (AGYW) (3,4). Also, the most recent national statistics (from 2016) showed an HIV prevalence of 18.2% among men who have sex with men (MSM) and 29.3% among female sex workers (FSW) (5).…”

“…Women, particularly AGYW, who face a persistent unmet need for contraception tend to have a higher risk of HIV infection (11)(12)(13). The high incidence of HIV among AGYW is exacerbated by low uptake of HIV prevention methods, such as pre-exposure prophylaxis (PrEP) (14,15).…”

A phase I study to assess safety, pharmacokinetics, and pharmacodynamics of a vaginal insert containing tenofovir alafenamide and elvitegravir

“…Currently, oral tenofovir disoproxil fumarate (TDF) 300 mg in combination with emtricitabine (FTC) 200 mg (Truvada®) is approved for prevention of HIV-1 acquisition in men and women in the United States and several other countries worldwide ( Grant et al., 2010 ; Baeten et al., 2012 ; Thigpen et al., 2012 ). The daily dosing requirement and systemic side effects, primarily gastrointestinal (GI), among other barriers including stigma and lack of support from family or partner, have made it difficult, particularly for AGYWs, to adhere to daily oral TDF/FTC for HIV-1 prevention ( Van Damme et al., 2012 ; Magazi et al., 2014 ; van der Straten et al., 2014b ; Corneli et al., 2015 ; Marrazzo et al., 2015 ; Corneli et al., 2016 ; Amico et al., 2017 ; Joseph Davey et al., 2022 ; Tapsoba et al., 2022 ). Oral tenofovir alafenamide (TAF) combined with FTC (Descovy®), which shows fewer side effects, was recently approved by the United States Food and Drug Administration for HIV-1 prevention, but only among individuals whose primary risk of HIV-1 acquisition is not through vaginal exposure ( Mayer et al., 2020 ).…”