Introducing PrEP Into HIV Combination Prevention - Kenya

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.

Conditions

• HIV

Interventions

DRUG

Truvada

Daily oral PrEP will be provided to a cohort of 2100 participants (female sex workers, men who have sex with men and young women at high HIV risk) in Kenya. Baseline data will be collected from all participants at enrolment. PrEP users will be followed up at multiple intervals, in months 1, 4, 7, 10 and 12) for 12 months. The PrEP users will attend 7 visits at the project sites over the project period and in between these visits, they will return to the pharmacy for PrEP refill, adherence counselling and assessment of side effects.

Sponsors & Collaborators

• Bill and Melinda Gates Foundation

  collaborator OTHER

• Sex Workers Outreach Project

  collaborator UNKNOWN

• National AIDS Control Council

  collaborator UNKNOWN

• National AIDS and STI Control Programme

  collaborator UNKNOWN

• Health Options for Young Men with AIDS/STI

  collaborator UNKNOWN

• Bar Hostess Empowerment & Support Programme

  collaborator UNKNOWN

• Gay and Lesbian Coalition Kenya

  collaborator OTHER

• ISHTAR MSM

  collaborator UNKNOWN

• Kenya Sex Workers Alliance

  collaborator UNKNOWN

• London School of Hygiene and Tropical Medicine

  collaborator OTHER

• Imperial College London

  collaborator OTHER

• Results for Development

  collaborator UNKNOWN

• O' Neill Institute

  collaborator UNKNOWN

• AVAC

  collaborator UNKNOWN

• Nyanza Western Kenya LGBTI Coalition

  collaborator UNKNOWN

• World Health Organization

  collaborator OTHER

• International AIDS Vaccine Initiative

  collaborator NETWORK

• Centres for Disease Control and Prevention, Kenya.

  collaborator OTHER

• LVCT Health

  lead OTHER

Principal Investigators

• Serah N Njenga, BA · LVCT Health

• Lawrence J Gelmon, MD.MPH · Sex Workers Outreach Project

• Nduku S Kilonzo, PhD · National AIDS Control Council, Kenya

• Helgar K Musyoki, MPH · National AIDS and STIs Control Program, Kenya

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

15 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-08-31

Primary Completion

2016-11-30

Completion

2017-04-30

Countries

• Kenya

Study Locations