“Early Adopters” of PrEP in SEARCH study in rural Kenya and Uganda James Ayieko, M.B.Ch.B, MPH For SEARCH Study We thank the organisers of this conference for giving us an opportunity to share our findings on Early adopters within the SEARCH study.

Disclosures None

Background PrEP is now recommended for high-risk persons in Africa. There are limited data on PrEP uptake in Africa Outside of clinical efficacy trials. Within ongoing HIV test and treat programs Using population level risk assessment (vs key populations such as young women)   Analysis of “Early PrEP adopters” can provide insights for program strengthening PrEP is now recommended for high risk persons in Africa. However, there are limited data on PrEP uptake in Africa outside of clinical efficacy trials or conducted within ongoing test and treat programs or even using population level risk assessment vs the traditional key populations such as young women. Analysis of Early PrEP adopters(starting within 30 days) can provide insights for program strengthening. We therefore conducted our analysis within the SEARCH study, a population based, test and treat trial

SEARCH Study Ongoing Cluster randomized trial (NCT01864603) 320,000 persons 32 communities in rural Uganda and Kenya Intervention Phase 1 (2013-2017): Population-based multi-disease “test and treat” exceeded 90-90-90 Phase 2 (2016-2020) Targeted PrEP, HIV testing and cascade optimization SEARCH study is an ongoing population-based, cluster randomised trial involving over 320,000 persons in 32 communities in rural East Africa For Phase 1, we conducted population based multi-disease test and treat and exceeded the UNAIDS 90-90-90 targets as presented in Durban Last year. In Phase 2 we added on targeted PrEP alongside HIV testing and cascade optimization

Phase 2: Population level PrEP Intervention 1. Community Mobilisation and Sensitization 2. Community wide testing: Health fair(CHC) and Home based (Assessment of PrEP eligibility) 3. PrEP offered to: High risk group based on score(R) Self referrals (S) 4. PrEP offered at: Community Health Campaign(CHC) Clinic For our population level PrEP intervention,we conducted community mobilisation and sensitization on PrEP followed by Community wide testing via our community health fairs(for 2 weeks) and home based testing for those who did not attend the health fairs over 1 month. PrEP was offered to two groups of persons: 1) a high risk group based on a score we developed and 2) Those who self referred themselves based on knowledge of their risk We offered PrEP at the community health Campaign or at the clinic. Ongoing PrEP continued to be offered for all HIV sero-discordant relationships and persons newly self identifying as at risk after our community testing 5. Ongoing PrEP offered: for all HIV sero-discordant partnerships and persons newly self identified at risk after community wide testing

Objectives of this Analysis Report on initial PrEP roll out in 5 SEARCH PrEP Intervention Phase 2 communities In the context of ongoing “test and treat” program and population level assessment of HIV acquisition risk Describe Early PrEP adopters (uptake within 30 days) among eligible Characteristics of early PrEP adopters Predictors of early PrEP uptke The objective of this analysis is to report on the initial roll out of PrEP in 5 of our Intervention communities. Remember our context is an ongoing test and treat setting with population level assessment of HIV exposure risk. We sought to describe Early PrEP adopters defined as those starting PrEP within 30 days , their characteristics and the predictors of early PrEP uptake.

Analysis Population Adult >15 years Resident on one of five SEARCH intervention communities 3 in Kenya, 2 in SW Uganda Eligible for PrEP: Self assessment (S) or Risk score (R) Based on Age, gender, marital status, polygamy, education, circumcision, occupation, alcohol assessed at testing Our analysis population comprised adults >15years, resident in one of the five SEARCH intervention communities in Kenya and Uganda. Eligible for PrEP either by way of self referral or by risk score that was based on characteristics such as age ,gender marital status,polygamy, education, circumcision, occupation, alcohol use assessed at testing.

Statistical Analysis We assessed: Cumulative probability of initiating PrEP* From assessment of eligibility up to 30 days Characteristics of “Early Adopters”* Univariate and multivariate predictors of initiating PrEP within 30 days Logistic regression Cluster robust standard error (clustered by household), community included as fixed effect * data updated from abstract For statistical analysis we assessed 30 day Cumulative probability of initiating PrEP and the characteristics of early adopters by way of logistic regression.

HIV uninfected individuals PrEP Uptake HIV uninfected individuals N=21,212 Identified for PrEP 4,064 Based on Risk Score(R) 2,991(74%) Self Assessed(S) 1,073(26%) This slide summarizes the PrEP uptake numbers in our analysis. 21,000 individuals were identified to be HIV negative,4,064 of these were identified for PrEP,2900, Comprising 74% were eligible by our risk score while 1,073 were self referrals. Of those identified based on the risk score,321 were early adopters and 78% of them started PrEP on the same day. Of those who self referred, 418 were early adopters and 77% of these started PrEP on the same day Early Adopters(R) 321(11%) Early Adopters(S) 418(39%) Same day Start 250(78%) Same day Start 321(77%)

Characteristics of 4064 Persons Identified for PrEP The following were the characteristics of the 4064 individuals identified for PrEP. Males comprised slightly more than half, about half were aged 18-25, 2/3 had primary level of education and 3/4 were tested at our community health fairs vs home based testing.

Cumulative PrEP uptake by days since contact date This bar graph shows the cumulative PrEP uptake by days since contact date, the red bar represents those who self referred while the blue bar represents those who were identified using our risk score. The graph shows that most uptake occurred on the day of contact with minimal additional uptake over time

Cumulative PrEP uptake by days since contact date This KM curve also linearly depicts PrEP uptake, the red line represents those who self referred while the blue line represents those identified by our risk score.

Self Perceived risk Prior to PrEP and result counseling, participants were asked whether they considered themselves currently at risk for HIV infection. Eligible by risk score(R) - 30% Eligible by self assessment(S) - 49% This was followed by PrEP education and counseling We asked participants their self perceived risk prior to PrEP and HIV result counseling. Only 30 % of those identified by the risk score perceived themselves at risk while 49% of those who self-referred eventually perceived themselves at current risk. We then proceeded to offer PrEP education and counseling before uptake

Predictors of early uptake of PrEP among Rs ( Risk score) On our multivariate model, being male, in a polygamous relationship, being in an serodiscordant relatioship, perceiving yourself at current risk of HIV acquisition and being tested at our Community health fairs were associated with higher odds of initiating PrEP within 30 days among those identified using our risk score. However having a secondary level of education was associated with lower odds of initiating PrEP within 30 days of contact. *adjusted for region, community, occupation, alcohol intake, circumcision in multivariate model

Predictors of early uptake of PrEP among Ss ( Self identified) For those who self referred for PrEP, we observed a linear increase in unadjusted odds of initiating PrEP as age increases though we lose that association on the multivariate model.Our multivariate model shows that being older(46-55 years) was associated with higher odds of initiating PrEP within 30 days of contact. However any level of education vs. none or being tested at our community health fairs vs home based testing was associated with lower odds of initiating PrEP within 30 days of contact. *adjusted for region, community, occupation, alcohol intake, circumcision in multivariate model

Summary Among those PrEP eligible by risk score(R) There were 739 PrEP “early adopters” ( within 30 days) in a population based approach in rural Uganda and Kenya Most (78%) started PrEP the same day as offered Among those PrEP eligible by risk score(R) Only 30% perceived themselves currently at risk prior to counseling After counseling, only 11% started PrEP within 30 days Men, those in a polygamous or serodiscordant marriage, and those who self-perceived at risk and those who attended the health campaign were more like to be early PrEP adopters Among those PrEP eligible by self assessment(S) 49% perceived themselves currently at risk prior to counseling After counseling, 39% started within 30 days Older people(45-54 years), and those with no formal education were more like to uptake, while youth were less likely. In summary, we had 739 early adopters of PrEP in a population based approach in rural Uganda and Kenya. Majority started PrEP the same day as offered. Among those PrEP eligible by risk score(R) Only 30% perceived themselves currently at risk prior to counseling After counseling, only 11% started PrEP within 30 days Among those PrEP eligible by self assessment(S) 49% perceived themselves currently at risk prior to counseling After counseling, 39% started within 30 days Also important to point out is that two-thirds were married and perceived themselves as high-risk. We also observed that women often had to seek consent from spouses in many cases before starting PrEP. Our PrEP uptake may have been affected by the consent process since this was done within a study setting.

Conclusions Population based PrEP delivery and uptake is acceptable and feasible in real life rural African settings. However, because the majority of persons identified as “high risk” neither perceived themselves at risk or were not “early adopters” -- Barriers to PrEP need to be addressed with new approaches . SEARCH has ongoing efforts to address barriers and measure and optimize PrEP continuation. In conclusion, Population based PrEP delivery and uptake is acceptable and feasible in real life rural African settings. However, Barriers to PrEP need to be addressed with new approaches because majority of persons identified as “high risk” by empiric risk score neither perceived themselves at risk nor were they “early adopters” SEARCH has ongoing efforts to address barriers and optimize PrEP continuation.

Related Poster Presentations WEPEC 0913 Survey of Early Barriers to PrEP Uptake among Clients and Community Members in the SEARCH Study in Rural Kenya and Uganda (Catherine Koss and SEARCH team) Wednesday 12:30 pm WEPEC0951 Understanding PrEP demand among adolescents/young adults and HIV discordant couples in SEARCH – Qualitative findings (Carol Camlin and the SEARCH team) Here are some related posters presentations addressing barriers to PrEP uptake as well as an evaluation of PrEP demands among adolescents/young adults and sero-dicordant couples that may interest you.

Acknowledgement Research reported in this presentation was supported by Division of AIDS, NIAID of the National Institutes of Health under award number U01AI099959 and in part by the President’s Emergency Plan for AIDS Relief, Bill and Melinda Gates Foundation, and Gilead Sciences. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH, PEPFAR, Bill and Melinda Gates Foundation or Gilead. The SEARCH project gratefully acknowledges the Ministries of Health of Uganda and Kenya, our research team, collaborators and advisory boards, and especially all communities and participants involved We would like to acknowledge our funders, partners and collaborators. Thank you.