HIV PrEP is more than ART-lite: Longitudinal study of real-world PrEP services data identifies missing measures meaningful to HIV prevention programming.

INTRODUCTION: Evidence indicates HIV oral pre-exposure prophylaxis (PrEP) is highly efficacious and effective. Substantial early discontinuation rates are reported by many programs, which may be misconstrued as program failure. However, PrEP use may be non-continuous and still effective, since HIV risk fluctuates. Real-world PrEP use phenomena, like restarting and cyclical use, and the temporal characteristics of these use patterns are not well described. The objective of our study was to characterize and identify predictors of use patterns observed in large PrEP scale-up programs in Africa. METHODS: We analysed demographic and clinical data routinely collected during client visits between 2017 and 2019 in three Jhpiego-supported programs in Kenya, Lesotho and Tanzania. We characterized duration on/off PrEP and, using ordinal regression, modelled the likelihood of spending additional time off and identified factors associated with increasing cycle number. The Andersen-Gill model was used to identify predictors of time to PrEP discontinuation. To analyse factors associated with a client's first return following initiation, we used a two-step Heckman probit. RESULTS: Among 47,532 clients initiating PrEP, approximately half returned for follow-up. With each increase in cycle number, time off PrEP between use cycles decreased. The Heckman first-step model showed an increased probability of returning versus not by older age groups and among key and vulnerable population groups versus the general population; in the second-step model older age groups and key and vulnerable populations were less likely in Kenya, but more likely in Lesotho, to return on-time (refill) versus delayed (restarting). CONCLUSIONS: PrEP users frequently cycle on and off PrEP. Early discontinuation and delays in obtaining additional prescriptions were common, with broad predictive variability noted. Time off PrEP decreased with cycle number in all countries, suggesting normalization of use with experience. More nuanced measures of use are needed than exist for HIV treatment if effective use of PrEP is to be meaningfully measured. Providers should be equipped with measures and counselling messages that recognize non-continuous and cyclical use patterns so that clients are supported to align fluctuating risk and use, and can readily restart PrEP after stopping, in effect empowering them further to make their own prevention choices.

Implementation and Operational Research: Evaluation of Loss-to-Follow-up and Postoperative Adverse Events in a Voluntary Medical Male Circumcision Program in Nyanza Province, Kenya.

BACKGROUND: More than 4.7 million voluntary medical male circumcisions (VMMCs) had been provided by HIV prevention programs in sub-Saharan Africa through 2013. All VMMC clients are recommended to return to the clinic for postoperative follow-up, although adherence is variable. The clinical status of clients who do not return is largely unknown. METHODS: VMMC clients from Nyanza Province, Kenya, aged older than or equal to 13 years, were recruited immediately after surgery from April to October 2012 from high-volume sites. Medical record reviews at 13-14 days after surgery indicated which clients had been adherent with recommended follow-up (ADFU) and which were lost-to-follow-up (LTFU). Clients in the LTFU group received clinical evaluations at home approximately 2 weeks postsurgery. Adverse events (AEs) and AE rates were compared between the ADFU and LTFU groups. RESULTS: Of 4504 males approached in 50 VMMC sites, 1699 (37.7%) were eligible and enrolled and 1600 of 1699 (94.2%) contributed to follow-up and AE data. Medical record review indicated 897 of 1600 (56.1%) were LTFU, and 762 (84.9%) of these received home-based clinical evaluations. The rate of moderate or severe AE diagnosis was 6.8% in the LTFU group vs. 3.3% in the ADFU group (relative risk = 2.1, 95% confidence interval: 1.3 to 3.4). CONCLUSIONS: The moderate or severe AE diagnosis rate was approximately 2 times higher in the LTFU group. National programs should consider instituting surveillance systems to detect AEs that might otherwise go unnoticed. Providers should emphasize the importance of follow-up and actively contact LTFU clients to ensure care is provided throughout the entire postoperative course for all.

Voluntary medical male circumcision: an HIV prevention priority for PEPFAR.

As the science demonstrating strong evidence for voluntary medical male circumcision (VMMC) for HIV prevention has evolved, the President's Emergency Plan for AIDS Relief (PEPFAR) has collaborated with international agencies, donors, and partner country governments supporting VMMC programming. Mathematical models forecast that quickly reaching a large number of uncircumcised men with VMMC in strategically chosen populations may dramatically reduce community-level HIV incidence and save billions of dollars in HIV care and treatment costs. Because VMMC is a 1-time procedure that confers life-long partial protection against HIV, programs for adult men are vital short-term investments with long-term benefits. VMMC also provides a unique opportunity to reach boys and men with HIV testing and counseling services and referrals for other HIV services, including treatment. After formal recommendations by WHO in 2007, priority countries have pursued expansion of VMMC. More than 1 million males have received VMMC thus far, with the most notable successes coming from Kenya's Nyanza Province. However, a myriad of necessary cultural, political, and ethical considerations have moderated the pace of overall success. Because many millions more uncircumcised men would benefit from VMMC services now, US President Barack Obama committed PEPFAR to provide 4.7 million males with VMMC by 2014. Innovative circumcision methods-such as medical devices that remove the foreskin without injected anesthesia and/or sutures-are being rigorously evaluated. Incorporation of safe innovations into surgical VMMC programs may provide the opportunity to reach more men more quickly with services and dramatically reduce HIV incidence for all.