Introducing PrEP Into HIV Combination Prevention - Kenya (IPCP-Kenya)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
|First Submitted Date ICMJE||November 12, 2015|
|First Posted Date ICMJE||April 28, 2016|
|Last Update Posted Date||April 28, 2016|
|Study Start Date ICMJE||August 2015|
|Estimated Primary Completion Date||November 2016 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title ICMJE||Introducing PrEP Into HIV Combination Prevention - Kenya|
|Official Title ICMJE||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)|
|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.|
The project will be undertaken in 3 counties of Kenya (Nairobi, Kisumu and Homa Bay) that have high HIV prevalence. 5 sites (2 government and 3 non-governmental) have been purposively selected for the demonstration because they serve high risk populations, have existing HIV prevention services and have adequate cohort of HIV negative clients who are potential candidates for PrEP. The sites include LVCT Health's Nairobi CBD and Tivoli sites, SWOP City clinic, Homa Bay County Referral Hospital and Korogocho Health Centre. The demonstration project will use a prospective cohort design employing mixed-methods. A cohort of 2100 PrEP users (female sex workers aged 18 and above, men who have sex with men aged 18 and above, young women at high HIV risk aged 15 -29) will be followed over 12 months to assess biological and behavioral outcomes through laboratory and survey assessments. This will be complemented by review of routine service delivery statistics (to assess PrEP uptake), cost data, and qualitative data to be obtained from in-depth interviews and focus groups with health providers, PrEP users, and peer educators/community health workers at multiple points in time.This project will be implemented in a 'real life' or 'real world' setting where there will be no control or comparison arms. However, pregnant women at enrolment and female participants who become pregnant during project implementation, who choose to continue on PrEP will be enrolled in a sub-group and followed through 12 months post-partum.
Activities to be undertaken prior and during project implementation:
At the screening visit, eligible and willing participants will be provided with full information about PrEP, results of efficacy trials, known side effects and potential adverse events, and daily dosing schedule. They will receive counselling on adherence to PrEP including discussions between PrEP users and service providers on developing new routines and cues as a way to facilitate good adherence. They will also receive detailed information about the project, including the number and sequence of project visits, procedures at each visit, use of MEMS Caps, and the option to discontinue PrEP use during the course of the project. They will also be counselled on available combination prevention strategies such as condom use and provided with free condoms. Participants will also be informed that PrEP will only be available for 12 months.
Willing participants will sign an informed consent form, and complete a survey questionnaire to provide baseline information on their demographics, sexual risk behaviours, risk perceptions, medical history, alcohol and drug use, contraceptive use, fertility intentions, and use of other combination HIV prevention services. They will receive HIV testing and counselling (HTC), tests for Hepatitis B surface antigen, STI syndromic screening and management as well as testing for gonorrhoea, blood draw for creatinine level and pregnancy test where applicable. Individuals who test HIV positive are ineligible for the project and will be referred to care and treatment according to standard practice. Pregnant women and women who become pregnant during the project implementation will be enrolled in a pregnancy sub group, upon their consent. Those who decline participation will receive referrals to prenatal care.
Participants will return to the project site after 14 days (2 weeks), for an enrolment visit where they will receive a one month PrEP prescription, a HIV re-test and counselling on adherence, side effects, and available supportive interventions. Participants will be asked to return after 2 weeks for assessment of adherence and side effects. They will then return to the site for the first follow up visit (1 month after enrollment visit) where they will receive the following services: counselling on HIV risk behaviours, adherence, side effects/experience with PrEP, HTC, pregnancy test (for women), creatinine level test, STI syndromic screening and management, gonorrhoea test, drug level testing, and PrEP prescription for one month (with refills from pharmacy at months 2 and 3). Every 10th participant will complete a quantitative survey at exit.
Participants will then return to the site for a quarterly visit at months 4, 7, and 10 after enrolment. The services provided during these visit will be similar to those at the first follow up visit. Participants who display high adherence will be provided with a 3 months' supply of PrEP. Those who need close monitoring will be provided with a one month's supply and will return for pharmacy refills monthly.
Participants will finally return for an exit visit, 12 months after enrolment. They will receive services similar to those at enrolment. They will also complete an exit survey, and discuss post project PrEP access with the health provider.
Individuals who want to discontinue PrEP use will be allowed to do so, and asked to consent for in depth interview to discuss their experience and decision to stop. Those who display poor adherence will be discontinued from PrEP. Those who sero-convert will be referred to care and treatment services as per standard practice.
Key strategies for retention will include 1) follow up of participants by peer educators and community health volunteers, 2) using text messages for appointment reminders and adherence support 3) enrolling participants in support groups, and 4) adherence buddies.
Indepth interviews with PrEP users and health providers, focus group discussions with peer educators, CHWs, and support group members will be conducted at Months 1, 6 and 12. The actual cost of implementing HIV combination prevention that includes PrEP will be collected throughout the project implementation period.
Ethical considerations observed in the implementation of this project include protocol approval by KEMRI ethics research committee, informed consent for participants, confidentiality of participants and their data and ensuring safety of participants.
|Study Type ICMJE||Interventional|
|Study Phase ICMJE||Not Applicable|
|Study Design ICMJE||Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
|Intervention ICMJE||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)
|Study Arms ICMJE||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.
Intervention: Drug: Truvada
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Estimated Enrollment ICMJE
|Original Estimated Enrollment ICMJE||Same as current|
|Estimated Study Completion Date ICMJE||April 2017|
|Estimated Primary Completion Date||November 2016 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
Specific eligibility criteria for each project population are as follows:
|Ages ICMJE||15 Years and older (Child, Adult, Older Adult)|
|Accepts Healthy Volunteers ICMJE||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Kenya|
|Removed Location Countries|
|NCT Number ICMJE||NCT02755350|
|Other Study ID Numbers ICMJE||NON-SSC NO. 456
OPP1104919 ( Other Grant/Funding Number: Bill & Melinda Gates Foundation )
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement ICMJE||
|Responsible Party||LVCT Health|
|Study Sponsor ICMJE||LVCT Health|
|PRS Account||LVCT Health|
|Verification Date||March 2016|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP