HIV Clinical Trial
— IPCP-KenyaOfficial 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)
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.
Status | Recruiting |
Enrollment | 2100 |
Est. completion date | April 2017 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 15 Years and older |
Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Kenya | LVCT Health | Nairobi |
Lead Sponsor | Collaborator |
---|---|
LVCT Health | 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 |
Kenya,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Primary | 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 | No |
Primary | Number of participants adhering to oral PrEP as measured using the MEMS cap and MedAmigo system. | 12 months | Yes | |
Primary | Proportion of participants enrolled and retained in a HIV combination prevention package that includes PrEP over a period of 12 months. | 12 months | Yes | |
Primary | Number of enrolled participants reporting side effects as recorded on the clinical and adverse event forms | 12 months | Yes | |
Primary | Unit cost analysis of identifying and enrolling clients on PrEP in a 'real world' setting identified through mathematical modelling | 12 months | No | |
Primary | Cost estimates for providing PrEP to high risk populations determined through cost models | 12 months | No | |
Primary | Number of enrolled participants reporting pregnancy complications as recorded on the pregnancy outcome forms | 12 months | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06162897 -
Case Management Dyad
|
N/A | |
Completed |
NCT03999411 -
Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients
|
Phase 4 | |
Completed |
NCT02528773 -
Efficacy of ART to Interrupt HIV Transmission Networks
|
||
Active, not recruiting |
NCT05454839 -
Preferences for Services in a Patient's First Six Months on Antiretroviral Therapy for HIV in South Africa
|
||
Recruiting |
NCT05322629 -
Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum Women
|
N/A | |
Completed |
NCT02579135 -
Reducing HIV Risk Among Adolescents: Evaluating Project HEART
|
N/A | |
Active, not recruiting |
NCT01790373 -
Evaluating a Youth-Focused Economic Empowerment Approach to HIV Treatment Adherence
|
N/A | |
Not yet recruiting |
NCT06044792 -
The Influence of Primary HIV-1 Drug Resistance Mutations on Immune Reconstruction in PLWH
|
||
Completed |
NCT04039217 -
Antiretroviral Therapy (ART) Persistence in Different Body Compartments in HIV Negative MSM
|
Phase 4 | |
Active, not recruiting |
NCT04519970 -
Clinical Opportunities and Management to Exploit Biktarvy as Asynchronous Connection Key (COMEBACK)
|
N/A | |
Completed |
NCT04124536 -
Combination Partner HIV Testing Strategies for HIV-positive and HIV-negative Pregnant Women
|
N/A | |
Recruiting |
NCT05599581 -
Tu'Washindi RCT: Adolescent Girls in Kenya Taking Control of Their Health
|
N/A | |
Active, not recruiting |
NCT04588883 -
Strengthening Families Living With HIV in Kenya
|
N/A | |
Completed |
NCT02758093 -
Speed of Processing Training in Adults With HIV
|
N/A | |
Completed |
NCT02500446 -
Dolutegravir Impact on Residual Replication
|
Phase 4 | |
Completed |
NCT03805451 -
Life Steps for PrEP for Youth
|
N/A | |
Active, not recruiting |
NCT03902431 -
Translating the ABCS Into HIV Care
|
N/A | |
Completed |
NCT00729391 -
Women-Focused HIV Prevention in the Western Cape
|
Phase 2/Phase 3 | |
Recruiting |
NCT05736588 -
Elimisha HPV (Human Papillomavirus)
|
N/A | |
Recruiting |
NCT03589040 -
Darunavir and Rilpivirine Interactions With Etonogestrel Contraceptive Implant
|
Phase 2 |