An interventional study of PrEP Promotion Package in HIV Negative People Identified at Substantial Risk for HIV Infection, sponsored by Clinton Health Access Initiative Inc.. Completed at 6 sites in Swaziland. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-11.
Sponsored by Clinton Health Access Initiative Inc. · Not applicable, Interventional, and Health services research
This stepped-wedge cluster-randomized trial is embedded in an 18-month observational cohort study that has the aim to assess the operationalization of oral Pre-Exposure Prophylaxis (PrEP) in Swaziland as an additional HIV combination prevention method among individuals at high risk of HIV infection. The trial aims to determine the effect of a healthcare facility-based PrEP promotion package on the number of clients who take up PrEP.
The study will assess who will be reached with an introduction to and an offer of PrEP - and who will take up PrEP - when PrEP becomes available through different delivery points in the public-sector health system, including outpatient department (OPD), antenatal care (ANC), postnatal care (PNC) , family planning (FP) , and following HIV counseling and testing (VCT).
In addition to PrEP reach and PrEP uptake, the study aims to establish PrEP retention and average costs per client, by different health systems delivery points and to assess the effectiveness of a feasible and low-cost PrEP Promotion Package (PPP). The exact composition of PPP will be informed by findings from in-depth- interviews with clients, providers, and PrEP stakeholders. The effect of the PPP on the monthly number of clients who are initiated on PrEP will be studied using a stepped-wedge cluster-randomized design. Specifically, the trial will have two sequences with three healthcare facilities in each sequence, and three periods. In the first period, all healthcare facilities will be in the control phase; in the second period three healthcare facilities will implement the PPP; and in the third period all six healthcare facilities will implement the PPP.
Exclusion Criteria:
This is the provision of PrEP without the use of the PrEP Promotion Package. PrEP promotion in the control phase consists of each clinic displaying posters that advertise PrEP, pamphlets, and palm cards that patients can take home from the clinic.
This is the provision of PrEP as in the control phase plus the addition of five PrEP promotion components, which constitute the PrEP Promotion Package (PPP). These five additions are: 1) a PrEP promotion video to be played in the waiting room, 2) T-shirts advertising PrEP to be worn by healthcare workers, iii) a flipchart to support healthcare workers' PrEP counseling, iv) an informational booklet for clients to take home, and v) self-risk assessment forms to be displayed in the waiting room.
Other: PrEP Promotion Package
A PrEP promotion package will be developed to test if this will change uptake, acceptance, retention and PrEP knowledge
Uptake
The monthly number of clients who was initiated on PrEP
Time frame: 18 months
Risk assessment
The monthly number of clients who underwent a risk assessment for PrEP eligibility
Time frame: 18 months
Substantial risk
The monthly number of clients who was identified as being at a substantial risk of acquiring HIV
Time frame: 18 months
Acceptance conditional on risk
% of HIV-negative clients at substantial risk for HIV infection who accepted a PrEP offer
Time frame: 18 months
Linkage
The monthly number of clients who either took up PrEP or were linked to antiretroviral therapy
Time frame: 12 months
Retention at 6 months
% of clients taking PrEP who were retained at six months after PrEP initiation. Retention was defined as attending all follow-up visits during the first 180 days after PrEP initiation not more than seven days after the scheduled appointment.
Time frame: 6 months
HIV incidence
% of clients initiated on PrEP who seroconverted during the first six months after taking up PrEP.
Time frame: 18 month
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Plan to share: No
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Clinton Health Access Initiative Inc.