HIV Clinical Trial
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)
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:
- HIV prevention packages, provider training, quality management and service delivery
guidelines and standard operating guidelines will be developed.
- PrEP eligibility and screening tools for target populations will be piloted and
validated prior to project implementation. For young women, a test of understanding
will be additionally administered to screen for eligibility.
- Community sensitization and demand creation activities will be conducted prior to and
during implementation. Existing peer educators for FSW and MSM from each site will
reach out to these populations through hot spots. For young women at high HIV risk,
outreach activities will be done by peer educators and community health volunteers
(CHVs) through 1) community-based organizations which work with young women (such as
youth groups, organised social gatherings [chamas], [government administrative meetings
such as chief barazas] 2) political leaders such as women representatives 3) existing
services reaching sexually active young women such as family planning, maternal-child
health (MCH) 4) community radio and 5) anywhere that young women gather such as water
points.
- To ensure adherence to good participatory practice guidelines (GPP) that outline
community engagement in clinical and research activities, a national community advisory
board (CAB) and community advisory committees (CAC) at each project site will be
formed. The CAB and CACs will participate in the development and execution of demand
creation activities, development of community education materials, peer education and
mobilization, strategy development, project design, implementation and advocacy.
Project procedures:
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.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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