HIV Negative People Identified at Substantial Risk for HIV Infection Clinical Trial
Official title:
Expanding Options for HIV Prevention Through Pre-exposure Prophylaxis in Hhohho Region, Swaziland
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.
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