Demonstrating Effective Delivery of Daily Oral HIV Pre-Exposure Prophylaxis as Part of HIV Combination Prevention Intervention Among Young Women at High HIV Risk, Female Sex Workers and Men Who Have Sex With Men in Kenya (IPCP-KENYA)

The project will be undertaken in 3 counties of Kenya (Nairobi, Kisumu and Homa Bay) that have high HIV prevalence. 5 sites (2 government and 3 non-governmental) have been purposively selected for the demonstration because they serve high risk populations, have existing HIV prevention services and have adequate cohort of HIV negative clients who are potential candidates for PrEP. The sites include LVCT Health's Nairobi CBD and Tivoli sites, SWOP City clinic, Homa Bay County Referral Hospital and Korogocho Health Centre. The demonstration project will use a prospective cohort design employing mixed-methods. A cohort of 2100 PrEP users (female sex workers aged 18 and above, men who have sex with men aged 18 and above, young women at high HIV risk aged 15 -29) will be followed over 12 months to assess biological and behavioral outcomes through laboratory and survey assessments. This will be complemented by review of routine service delivery statistics (to assess PrEP uptake), cost data, and qualitative data to be obtained from in-depth interviews and focus groups with health providers, PrEP users, and peer educators/community health workers at multiple points in time.This project will be implemented in a 'real life' or 'real world' setting where there will be no control or comparison arms. However, pregnant women at enrolment and female participants who become pregnant during project implementation, who choose to continue on PrEP will be enrolled in a sub-group and followed through 12 months post-partum.

Activities to be undertaken prior and during project implementation:

• HIV prevention packages, provider training, quality management and service delivery guidelines and standard operating guidelines will be developed.
• PrEP eligibility and screening tools for target populations will be piloted and validated prior to project implementation. For young women, a test of understanding will be additionally administered to screen for eligibility.
• Community sensitization and demand creation activities will be conducted prior to and during implementation. Existing peer educators for FSW and MSM from each site will reach out to these populations through hot spots. For young women at high HIV risk, outreach activities will be done by peer educators and community health volunteers (CHVs) through 1) community-based organizations which work with young women (such as youth groups, organised social gatherings [chamas], [government administrative meetings such as chief barazas] 2) political leaders such as women representatives 3) existing services reaching sexually active young women such as family planning, maternal-child health (MCH) 4) community radio and 5) anywhere that young women gather such as water points.
• To ensure adherence to good participatory practice guidelines (GPP) that outline community engagement in clinical and research activities, a national community advisory board (CAB) and community advisory committees (CAC) at each project site will be formed. The CAB and CACs will participate in the development and execution of demand creation activities, development of community education materials, peer education and mobilization, strategy development, project design, implementation and advocacy.

Project procedures:

At the screening visit, eligible and willing participants will be provided with full information about PrEP, results of efficacy trials, known side effects and potential adverse events, and daily dosing schedule. They will receive counselling on adherence to PrEP including discussions between PrEP users and service providers on developing new routines and cues as a way to facilitate good adherence. They will also receive detailed information about the project, including the number and sequence of project visits, procedures at each visit, use of MEMS Caps, and the option to discontinue PrEP use during the course of the project. They will also be counselled on available combination prevention strategies such as condom use and provided with free condoms. Participants will also be informed that PrEP will only be available for 12 months.