African study on PrEP uptake and adherence

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An interim survey of PrEP uptake and adherence in the SEARCH study in Kenya and Uganda, has found that just over a quarter of people who were either assessed, or assessed themselves, as being at high risk of HIV, started PrEP, reports Aidsmap. Of those only 56% consistently engaged with the PrEP programme, and of those, 66% had adherence sufficient to prevent HIV infection – defined as evidence of four or more PrEP pills taken in a week – though this varied significantly between subgroups.

The report says this implies that roughly 10% of those who tested HIV-negative in the SEARCH study and were at elevated risk of HIV were using enough PrEP for it to be consistently effective in preventing HIV.

The programme found that uptake and adherence rates were, as has been observed from other studies, significantly lower in younger people and especially in young women, and in frequently mobile people – exactly the groups at highest risk of HIV infection. On the other hand, people who were polygamous and/or divorced, separated and widowed, and people with HIV-positive partners, especially female partners of HIV positive men, were more likely to take PrEP.

But by far the biggest influence on whether someone had engagement with the PrEP programme, and high adherence, was that they considered themselves to be at current HIV risk. The researchers, headed by Dr Catherine Koss from the University of San Francisco, reported the first interim analysis of population data from the PrEP extension of the Sustainable East Africa Research in Community Health (SEARCH) study . This is the second phase of a study whose first phase produced some of the highest proportions of people on treatment and virally undetectable in community-randomised strategies of its type.

Abstract
Background: Optimal strategies for pre-exposure prophylaxis (PrEP) engagement in generalised HIV epidemics are unknown. We aimed to assess PrEP uptake and engagement after population-level HIV testing and universal PrEP access to characterise gaps in the PrEP cascade in rural Kenya and Uganda.
Methods: We did a 72-week interim analysis of observational data from the ongoing SEARCH (Sustainable East Africa Research in Community Health) study. Following community sensitisation and PrEP education, we did HIV testing and offered PrEP at health fairs and facilities in 16 rural communities in western Kenya, eastern Uganda, and western Uganda. We provided enhanced PrEP counselling to individuals 15 years and older who were assessed as having an elevated HIV risk on the basis of serodifferent partnership or empirical risk score, or who otherwise self-identified as being at high risk but were not in serodifferent partnerships or identified by the risk score. PrEP follow-up visits were done at facilities, homes, or community locations. We assessed PrEP uptake within 90 days of HIV testing, programme engagement (follow-up visit attendance at week 4, week 12, and every 12 weeks thereafter), refills, self-reported adherence up to 72 weeks, and concentrations of tenofovir in hair samples from individuals reporting HIV risk and adherence during follow-up, and analysed factors associated with uptake and adherence. This study is registered with ClinicalTrials.gov, NCT01864603.

Findings: Between June 6, 2016, and June 23, 2017, 70 379 community residents 15 years or older who had not previously been diagnosed with HIV were tested during population-level HIV testing. Of these individuals, 69 121 tested HIV-negative, 12 935 of whom had elevated HIV risk (1353 [10%] serodifferent partnership, 6938 [54%] risk score, 4644 [36%] otherwise self-identified risk). 3489 (27%) initiated PrEP, 2865 (82%) of whom did so on the same day as HIV testing and 1733 (50%) of whom were men. PrEP uptake was lower among individuals aged 15–24 years (adjusted odds ratio 0·55, 95% CI 0·45–0·68) and mobile individuals (0·61, 0·41–0·91). At week 4, among 3466 individuals who initiated PrEP and did not withdraw or die before the first visit, 2215 (64%) were engaged in the programme, 1701 (49%) received medication refills, and 1388 (40%) self-reported adherence. At week 72, 1832 (56%) of 3274 were engaged, 1070 (33%) received a refill, and 900 (27%) self-reported adherence. Among participants reporting HIV risk at weeks 4–72, refills (89–93%) and self-reported adherence (70–76%) were high. Among sampled participants self-reporting adherence at week 24, the proportion with tenofovir concentrations in the hair reflecting at least four doses taken per week was 66%, and reflecting seven doses per week was 44%. Participants who stopped PrEP accepted HIV testing at 4274 (83%) of 5140 subsequent visits; half of these participants later restarted PrEP. 29 participants of 3489 who initiated PrEP had serious adverse events, including seven deaths. Five adverse events (all grade 3) were assessed as being possibly related to the study drug.
Interpretation: During population-level HIV testing, inclusive risk assessment (combining serodifferent partnership, an empirical risk score, and self-identification of HIV risk) was feasible and identified individuals who could benefit from PrEP. The biggest gap in the PrEP cascade was PrEP uptake, particularly for young and mobile individuals. Participants who initiated PrEP and had perceived HIV risk during follow-up reported taking PrEP, but one-third had drug concentrations consistent with poor adherence, highlighting the need for novel approaches and long-acting formulations as PrEP roll-out expands.
Funding: National Institutes of Health, President's Emergency Plan for AIDS Relief, Bill & Melinda Gates Foundation, and Gilead Sciences

Authors
Catherine A Koss, Edwin D Charlebois, James Ayieko, Dalsone Kwarisiima, Jane Kabami, Laura B Balzer, Mucunguzi Atukunda, Florence Mwangwa, James Peng, Yusuf Mwinike, Asiphas Owaraganise, Gabriel Chamie, Vivek Jain, Norton Sang, Winter Olilo, Lillian B Brown, Carina Marquez, Kevin Zhang, Theodore D Ruel, Carol S Camlin, James F Rooney, Douglas Black, Tamara D Clark, Monica Gandhi, Craig R Cohen, Elizabeth A Bukusi, Maya L Petersen, Moses R Kamya, Diane V Havlir

Full Aidsmap report

The Lancet article

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