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Introducing PrEP Into HIV Combination Prevention - Kenya (IPCP-Kenya)

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ClinicalTrials.gov Identifier: NCT02755350
Recruitment Status : Unknown
Verified March 2016 by LVCT Health.
Recruitment status was:  Recruiting
First Posted : April 28, 2016
Last Update Posted : April 28, 2016
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
Sex Workers Outreach Project
National AIDS Control Council
National AIDS and STI Control Programme
Health Options for Young Men with AIDS/STI
Bar Hostess Empowerment & Support Programme
Gay and Lesbian Coalition Kenya
ISHTAR MSM
Kenya Sex Workers Alliance
London School of Hygiene and Tropical Medicine
Imperial College London
Results for Development
O' Neill Institute
AVAC
Nyanza Western Kenya LGBTI Coalition
World Health Organization
International AIDS Vaccine Initiative
Centres for Disease Control and Prevention, Kenya.
Information provided by (Responsible Party):
LVCT Health

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.

Condition or disease Intervention/treatment Phase
HIV Drug: Truvada Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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)
Study Start Date : August 2015
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Truvada

Arm Intervention/treatment
Experimental: Truvada
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
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.
Other Name: Pre Exposure Prophylaxis (PrEP)




Primary Outcome Measures :
  1. 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. [ Time Frame: 4 months ]
    Validation of tools for risk identification and indication for PrEP initiation

  2. 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. [ Time Frame: 4 months ]
    Validation of tools for risk identification and indication for PrEP initiation

  3. Number of participants adhering to oral PrEP as measured using the MEMS cap and MedAmigo system. [ Time Frame: 12 months ]
  4. Proportion of participants enrolled and retained in a HIV combination prevention package that includes PrEP over a period of 12 months. [ Time Frame: 12 months ]
  5. Number of enrolled participants reporting side effects as recorded on the clinical and adverse event forms [ Time Frame: 12 months ]
  6. Unit cost analysis of identifying and enrolling clients on PrEP in a 'real world' setting identified through mathematical modelling [ Time Frame: 12 months ]
  7. Cost estimates for providing PrEP to high risk populations determined through cost models [ Time Frame: 12 months ]
  8. Number of enrolled participants reporting pregnancy complications as recorded on the pregnancy outcome forms [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02755350


Contacts
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Contact: Michael K Kiragu, MBChB +254 20 2646692, 2633212 ext 1404 mkiragu@lvcthealth.org
Contact: Wanjiru Mukoma, PhD +254 20 2646692, 2633212 ext 1507 wmukoma@lvcthealth.org

Locations
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Kenya
LVCT Health Recruiting
Nairobi, Kenya, 00202
Contact: Michael K Kiragu, MBChB    +254 20 2646692, 2633212 ext 1404    mkiragu@lvcthealth.org   
Contact: Wanjiru Mukoma, PhD    +254 20 2646692, 2633212 ext 1507    wmukoma@lvcthealth.org   
Sponsors and Collaborators
LVCT Health
Bill and Melinda Gates Foundation
Sex Workers Outreach Project
National AIDS Control Council
National AIDS and STI Control Programme
Health Options for Young Men with AIDS/STI
Bar Hostess Empowerment & Support Programme
Gay and Lesbian Coalition Kenya
ISHTAR MSM
Kenya Sex Workers Alliance
London School of Hygiene and Tropical Medicine
Imperial College London
Results for Development
O' Neill Institute
AVAC
Nyanza Western Kenya LGBTI Coalition
World Health Organization
International AIDS Vaccine Initiative
Centres for Disease Control and Prevention, Kenya.
Investigators
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Principal Investigator: 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
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Responsible Party: LVCT Health
ClinicalTrials.gov Identifier: NCT02755350    
Other Study ID Numbers: NON-SSC NO. 456
OPP1104919 ( Other Grant/Funding Number: Bill & Melinda Gates Foundation )
First Posted: April 28, 2016    Key Record Dates
Last Update Posted: April 28, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by LVCT Health:
PrEP
HIV Prevention
combination prevention
demonstration project
Additional relevant MeSH terms:
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Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents