Introducing PrEP Into HIV Combination Prevention - Kenya

NCT02755350 | Unknown DMC

• 2 other identifiers: NON-SSC NO. 456OPP1104919
• Study Type: interventional
• Target: 2,100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

PrEP; HIV Prevention; combination prevention; demonstration project

Outcome Measures

Primary Outcomes (8)

• Number of young women, female sex workers and men who have sex with men correctly identified as being at high risk of HIV, in need of and willing to take PrEP.

  Validation of tools for risk identification and indication for PrEP initiation

  4 months

• Proportion of men who have sex with men, female sex workers and young women at high risk of HIV enrolled into a HIV combination prevention intervention package that includes PrEP.

  Validation of tools for risk identification and indication for PrEP initiation

  4 months

• Number of participants adhering to oral PrEP as measured using the MEMS cap and MedAmigo system.

  12 months

• Proportion of participants enrolled and retained in a HIV combination prevention package that includes PrEP over a period of 12 months.

  12 months

• Number of enrolled participants reporting side effects as recorded on the clinical and adverse event forms

  12 months

• Unit cost analysis of identifying and enrolling clients on PrEP in a 'real world' setting identified through mathematical modelling

  12 months

• Cost estimates for providing PrEP to high risk populations determined through cost models

  12 months

• Number of enrolled participants reporting pregnancy complications as recorded on the pregnancy outcome forms

  12 months

Study Arms (1)

Truvada

EXPERIMENTAL

Daily oral PrEP (Truvada) is provided to a cohort of 2100 participants who 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. In between some visits, they will return to the pharmacy for a refill of PrEP, counselling on adherence and medication of side effects.

Drug: Truvada

Interventions

Truvada DRUG

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.

Also known as: Pre Exposure Prophylaxis (PrEP)

Truvada

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

LVCT Health

Nairobi, Nairobi County, 00202, Kenya

RECRUITING

MeSH Terms

Interventions

Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Pre-Exposure Prophylaxis

Intervention Hierarchy (Ancestors)

Tenofovir; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations; Primary Prevention; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Public Health Practice; Public Health; Environment and Public Health

Study Officials

• Serah N Njenga, BA

  LVCT Health

  PRINCIPAL INVESTIGATOR

• Lawrence J Gelmon, MD.MPH

  Sex Workers Outreach Project

  PRINCIPAL INVESTIGATOR

• Nduku S Kilonzo, PhD

  National AIDS Control Council, Kenya

  PRINCIPAL INVESTIGATOR

• Helgar K Musyoki, MPH

  National AIDS and STIs Control Program, Kenya

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael K Kiragu, MBChB

CONTACT

+254 20 2646692, 2633212; mkiragu@lvcthealth.org

Wanjiru Mukoma, PhD

CONTACT

+254 20 2646692, 2633212; wmukoma@lvcthealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2015
• First Posted: April 28, 2016
• Study Start: August 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: April 1, 2017
• Last Updated: April 28, 2016

Record last verified: 2016-03

Locations

KE (1)