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Simplified PrEP Dispensing Halves Clinic Visits, Maintains or Improves Adherence in Kenya
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AIDS 2022, July 29-August 2, Montreal
Mark Mascolini
A simplified 6-month PrEP dispensing program halved clinic visits in a randomized implementation trial in Kenya without hurting HIV testing, prescription refilling, or adherence [1]. In fact, the 6-month dispensing program significantly improved PrEP adherence among singly enrolled women.
Researchers from Seattle's Fred Hutchinson Cancer Center and collaborators in Kenya told AIDS 2022 attendees that public healthcare facilities usually deliver PrEP in sub-Saharan Africa, typically at quarterly clinic visits. This PrEP delivery method presents challenges to many in low-income areas because of high cost, long distance to the facility, and time spent plus stigma at the facility. These researchers asked whether fewer clinic visits enabled by HIV self-testing could make PrEP easier to implement without compromising outcomes.
This noninferiority individual-level randomized trial had a simple plan: Participants in two experimental arms got a 6-month PrEP supply instead of a 3-month supply. They visited the PrEP facility every 6 months instead of every 3 months. And they got HIV self-tests for between-visit testing [2]. Participants had to be 18 or older, HIV-negative, and using PrEP for 1 month. They could be women in a couple with an HIV-positive partner, men in a couple with an HIV-positive partner, or singly enrolled women not in a known relationship with an HIV-positive partner.
Researchers randomized them in a 1-1-1 ratio to (1) a 3-month PrEP supply with quarterly clinic visits (the standard of care), (2) a 6-month PrEP supply with twice-yearly clinic visits plus oral HIV self-tests to use in the quarters between the two clinic visits, or (3) a 6-month PrEP supply with twice-yearly clinic visits plus blood-based HIV self-tests to use in the quarters between clinic visits.
Primary 6-month outcomes were (1) testing for HIV at any time in the past 6 months, by self-report, (2) refilled PrEP at 6 months, by pharmacy record, and (3) PrEP adherence measured by tenofovir level in dried blood spots at 6 months. Primary 12-month outcomes were (1) any HIV testing in the past 6 months at 12 months and HIV testing 3 or more times since enrollment, by self-report, (2) refilled PrEP at 12 months and refilled PrEP at 6 and 12 months, by pharmacy records, and (3) PrEP adherence measured by tenofovir levels in dried blood spots at 12 months and at 6 and 12 months.
The study included 165 men in serodifferent couples, 130 women in serodifferent couples, and 200 singly enrolled women. Researchers randomized 166 people to the standard-care group, 163 to the 6-month PrEP-dispensing group with oral HIV self-testing, and 166 to the 6-month PrEP dispensing group with blood-based HIV self-tests. The standard-care group was similar to the combined 6-month PrEP/self-test group in median age (33 and 32), years of education (10 and 8), married status (76% and 78%), inconsistent condom use in past month (87% and 79%), or exchanging sex for goods or money in the past month (12% and 9%).
Dispensing PrEP every 6 months with interim HIV self-testing was noninferior to the standard of care at 6 months in HIV testing, as these investigators recently published [3]: 329 people in the combined 6-month PrEP arms and 140 in the standard-care arm tested for HIV (83% and 84%, risk difference -1.15%, 95% confidence interval lower bound -6.89, proving noninferiority). Prescription refilling and adherence to PrEP also proved noninferior in the combined 6-month PrEP arms compared with the standard-care arm.
After 12 months, the combined 6-month PrEP/self-test group remained noninferior to the standard-care 3-month group in (1) testing for HIV, either in the past 6 months (69.9% and 69.9%) or 3 or more times (65.4% and 64.5%), (2) refilling PrEP at 12 months (59.6% and 62.7%) and at 6 and 12 months (56.5% and 56.6%), and (3) adherence to PrEP at 12 months (45.9% and 42.2%) and at 6 and 12 months (41.0% and 38.6%). The group of singly enrolled women with 6-month PrEP dispensing and HIV self-testing had significantly improved PrEP adherence at 12 months (34.6% vs 17.9%) and at 6 and 12 months (30.8% vs 14.9%) compared with the standard-care group.
The halving of clinic visits plus the noninferiority (or superiority) of twice-yearly visits in testing for HIV, refilling PrEP, and PrEP adherence prompted the researchers to argue that HIV self-testing "should be considered to support PrEP continuation and increase health system efficiencies."
References
1. Ortblad KF, et al. The effect of six-month PrEP dispensing supported with interim HIV self-testing on PrEP continuation at 12 months in Kenya: a randomized implementation trial. AIDS 2022, July 29-August 2, Montreal. Abstract OAE0105.
2. Ortblad KF, Kearney JE, Mugwanya K, et al. HIV-1 self-testing to improve the efficiency of pre-exposure prophylaxis delivery: a randomized trial in Kenya. Trials. 2019;20:396. doi: 10.1186/s13063-019-3521-2. https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3521-2
3. Ngure K, Ortblad KF, Mogere P, et al. Efficiency of 6-month PrEP dispensing with HIV self-testing in Kenya: an open-label, randomised, non-inferiority, implementation trial. Lancet HIV. 2022;9(7):e464-e473. doi: 10.1016/S2352-3018(22)00126-6. https://pubmed.ncbi.nlm.nih.gov/35777410/
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