Introducing PrEP Into HIV Combination Prevention - Kenya

• Status: Unknown status
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Daily oral PrEP will be delivered to men who have sex with men (MSM), female sex workers (FSWs) and young women (YW) as part of a defined package of HIV combination prevention intervention for 12 months in 5 sites in Kenya. The project will assess adherence, adverse events, side effects, user satisfaction, cost, facility preparedness and provider competencies. PrEP eligibility and screening tools for MSM, YW and FSWs will be piloted and validated. Pregnant women will be enrolled in a sub-group and followed through 12 months post- partum to measure mother and infant outcomes that include health status, birth outcomes, birth defects, risk behavior and PrEP adverse effects. With lessons from initial PrEP studies in West and Central Africa, this project will apply good participatory practice guidelines through 1) continuous engagement with communities of FSWs, YW and MSM and 2) development and use of a communication engagement and advocacy strategy that will provide correct information, address attitudes and concerns whilst increasing demand for PrEP uptake. The actual cost of delivering HIV combination prevention which includes PrEP will also be assessed and cost effectiveness modeled.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: LVCT Health
• Collaborators: AVAC; Bar Hostess Empowerment & Support Programme; Bill and Melinda Gates Foundation; Centres for Disease Control and Prevention, Kenya.; Gay and Lesbian Coalition Kenya; Health Options for Young Men with AIDS/STI; Imperial College London; International AIDS Vaccine Initiative; ISHTAR MSM; Kenya Sex Workers Alliance; London School of Hygiene and Tropical Medicine; National AIDS and STI Control Programme; National AIDS Control Council; Nyanza Western Kenya LGBTI Coalition; O' Neill Institute; Results for Development; Sex Workers Outreach Project; World Health Organization
• Treatments: Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Criteria

Inclusion Criteria:

• Self-reported interest in and willingness to take PrEP

• Score cut-off on PrEP screening tool

• HIV- negative test at time of enrollment (per testing algorithm)

• No clinical symptoms of acute HIV infection including fever, lymphadenopathy, pharyngitis, skin rash, myalgias/arthralgias.

• Hepatitis-B virus antigen negative (upon screening)

• Creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula) (upon screening)

• Not breastfeeding

• Not currently taking PrEP or enrolled in another PrEP demonstration project

• Willingness to visit the project site of choice for follow up visits throughout the project period

• Knowledge of spoken English or Kiswahili

• Is in good general health and does not report a medical condition which may make their participation unsafe.

• Is not currently taking post exposure prophylaxis (PEP).

• Willing to provide contact information and be contacted by project staff between visits for follow up and support.

• Able to summarise the purpose of the demonstration project and their role as participants.

• Sexually active - having had sex in the last 3 months

Specific eligibility criteria for each project population are as follows:

• MSM: Age 18 and above; Self-reported anal sex with a man

• FSW: Age 18 and above; Self-identification as a sex worker;

• Young Women: Aged 15-29 ;Among young women aged 15-17, a test of understanding will also be administered to further determine their eligibility.

Exclusion Criteria:

• HIV positive

• Breastfeeding

• HIV positive

• Women above 29 years

• Those who fail test of understanding

• Those who do not meet the score cut-off on PrEP screening tool

• Not sexually active