Mugwanya, Kenneth K., Pintye, Jillian, Kinuthia, John, Abuna, Felix, Lagat, Harrison, Begnel, Emily R., Dettinger, Julia C., John-Stewart, Grace, and Baeten, Jared M.
Background: Young women account for a disproportionate fraction of new HIV infections in Africa and are a priority population for HIV prevention, including implementation of preexposure prophylaxis (PrEP). The overarching goal of this project was to demonstrate the feasibility of integrating PrEP delivery within routine family planning (FP) clinics to serve as a platform to efficiently reach at-risk adolescent girls and young women (AGYW) for PrEP in HIV high-burden settings. Methods and findings: The PrEP Implementation in Young Women and Adolescents (PrIYA) program is a real-world implementation program to demonstrate integration of PrEP delivery for at-risk AGYW in FP clinics in Kisumu, Kenya. Between November 2017 and June 2018, women aged 15 to 45 from the general population seeking FP services at 8 public health clinics were universally screened for HIV behavioral risk factors and offered PrEP following national PrEP guidelines. We evaluated PrEP uptake and continuation, and robust Poisson regression methods were used to identify correlates of uptake and early continuation of PrEP, with age included as a one-knot linear spline. Overall, 1,271 HIV-uninfected women accessing routine FP clinics were screened for PrEP; the median age was 25 years (interquartile range [IQR]: 22–29), 627 (49%) were <24 years old, 1,026 (82%) were married, more than one-third (34%) had partners of unknown HIV status, and the vast majority (n = 1,200 [94%]) reported recent condom-less sex. Of 1,271 women screened, 278 (22%) initiated PrEP, and 114 (41%) returned for at least one refill visit after initiation. PrEP uptake was independently associated with reported male-partner HIV status (HIV-positive 94%, unknown 35%, HIV-negative 8%; p < 0.001) and marital status (28% unmarried versus married 21%; p = 0.04), and a higher proportion of women ≥24 years (26%; 191/740) initiated PrEP compared to 16% (87/531) of young women <24 years (p < 0.001). There was a moderate and statistically non-significant unadjusted increase in PrEP uptake among women using oral contraception pills (OCPs) compared to women using injectable or long-acting reversible contraception methods (OCP 28% versus injectable/implants/intrauterine devices [IUDs] 18%; p = 0.06). Among women with at least one post-PrEP initiation follow-up visit (n = 278), no HIV infection was documented during the project period. Overall, continuation of PrEP use at 1, 3, and 6 months post initiation was 41%, 24%, and 15%, respectively. The likelihood for early continuation of PrEP use (i.e., return for at least one PrEP refill within 45 days post initiation) was strongly associated with reported male-partner HIV status (HIV-positive 67%, -negative 39%, unknown 31%; overall effect p = 0.001), and a higher proportion of women ≥24 years old continued PrEP at 1 month compared with young women <24 years old (47% versus 29%; p = 0.002). For women ≥24 years old, the likelihood to continue PrEP use at 1 month post initiation increased by 3% for each additional year of a woman's age (adjusted prevalence ratio [PR]: 1.03; 95% confidence interval [CI]: 1.01–1.05; p = 0.01). In contrast, for women <24 years old, the likelihood of continuing PrEP for each additional year of a woman's age was high in magnitude (approximately 6%) but statistically non-significant (adjusted PR: 1.06; 95% CI: 0.97–1.16; p = 0.18). Frequently reported reasons for discontinuing PrEP were low perceived risk of HIV (25%), knowledge that partner was HIV negative (24%), experiencing side effects (20%), and pill burden (17%). Study limitations include lack of qualitative work to provide insights into women's decision-making on PrEP uptake and continuation, the small number of measured covariates imposed by the program data, and a nonrandomized design limiting definitive ascertainment of the robustness of a PrEP-dedicated nurse-led implementation strategy. Conclusions: In this real-world PrEP implementation program in Kenya, integration of universal screening and counseling for PrEP in FP clinics was feasible, making this platform a potential "one-stop" location for FP and PrEP. There was a high drop-off in PrEP continuation, but a subset of women continued PrEP use at least through 1 month, possibly indicating further reflection or decision-making on PrEP use. Greater efforts to support PrEP normalization and persistence for African women are needed to help women navigate their decisions about HIV prevention preferences as their reproductive goals and HIV vulnerability evolve. Kenneth Mugwanya and colleagues report on implementation of a pre-exposure prophylaxis programme for young women and adolescent girls at risk of HIV infection, in Kenya. Author summary: Why was this study done?: Adolescent girls and young women (AGYW) in Africa are disproportionately affected by HIV infections because of cultural, structural, biological, and behavior factors. Preexposure prophylaxis (PrEP), as a highly potent and recommended discreet user-controlled HIV prevention strategy, has the potential to substantially reduce new HIV infections in African women if delivered with high coverage and if used with sufficient adherence. However, data are limited on "real-world" implementation approaches to efficiently reach at-risk women who may benefit from PrEP. Family planning (FP) clinics provide care to young women at risk for acquiring HIV and have in-built staffing, supply chain, and HIV testing access, which could contribute to more efficient PrEP implementation with less cost, but no study has evaluated this model in "real-world" settings. What did the researchers do and find?: We conducted a pilot open-label, "real-world" implementation program to evaluate the feasibility of integrating PrEP delivery into routine FP clinics to reach HIV at-risk young women. General-population women accessing FP services were universally screened for HIV behavior risk factors and were counseled for PrEP by program-dedicated nurses embedded in 8 public health FP clinics in a high–HIV-prevalence region in Kenya. We found that FP clinics can be an effective platform to efficiently reach HIV at-risk women who may benefit from PrEP. PrEP screening was feasible, and 22% of the general population of women took PrEP home. There was a high drop-off in early PrEP continuation (41% PrEP continuation at 1 month) particularly among AGYW <24 years old, but a subset of women persisted on PrEP (25% at month 3 and 15% at month 6), with higher continuation among women with HIV-positive partners, possibly indicating further reflection or decision-making on PrEP use. Women's perceived risk for HIV, including having an HIV-positive partner, was an important driver of initiation and continuation on PrEP. What do these findings mean?: To our knowledge, this project provides the first demonstration of "real-world" delivery of PrEP for at-risk AGYW integrated into FP clinics in Africa, a priority population for HIV prevention. These findings demonstrate that it may be feasible to integrate PrEP delivery in public health FP clinics, making this a platform potential "one-stop" location for FP and PrEP. With expanding PrEP awareness, uptake and continuation are likely to increase among women at risk. Evidence from this work will inform next steps for wider delivery of PrEP and next-generation PrEP formulations (e.g., multipurpose HIV prevention and contraception technologies) in FP clinics, not only in Kenya but in other resource-limited settings globally. [ABSTRACT FROM AUTHOR]