Status:
COMPLETED
PrEP Demonstration Study in Swaziland
Lead Sponsor:
Clinton Health Access Initiative Inc.
Collaborating Sponsors:
Ministry of Health, Swaziland
Heidelberg University
Conditions:
HIV Negative People Identified at Substantial Risk for HIV Infection
Eligibility:
All Genders
16+ years
Phase:
NA
Brief Summary
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...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Confirmed HIV negative by rapid antibody test following the National HIV testing services (HTS) algorithm on the day of PrEP initiation
- \> 16 years of age
- Willing and able to provide written informed consent
- Identified at substantial risk of acquiring HIV infection
- No current or recent illness (within past month) consistent with acute HIV infection in combination with a preceding high risk exposure for HIV
- No contraindications to the use of Tenofovir(TDF)/Lamivudine (3TC)
- Ready to adhere to PrEP and willing to attend the follow up evaluations including repeat HIV testing and monitoring for side-effects
Exclusion
- Younger than 16 years of age
- Currently having symptoms of acute HIV infection
- Suspicion of window period following a potential exposure to HIV
- Body weight \< 40 kg
- Creatinine clearance \<60 ml/min
- Using other nephrotoxic drugs (e.g. aminoglycosides)
- Not willing to come for follow up visits every 3 months which will include HIV testing and counselling and monitoring for side-effects.
Key Trial Info
Start Date :
August 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 2 2019
Estimated Enrollment :
517 Patients enrolled
Trial Details
Trial ID
NCT03254550
Start Date
August 1 2017
End Date
March 2 2019
Last Update
July 11 2019
Active Locations (6)
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1
Hhukwini Clinic
Hhukwini, Hhohho Region, Eswatini
2
Horo Clini
Horo, Hhohho Region, Eswatini
3
Ndvwabangeni Nazarene Clinic
Ndvwabangeni, Hhohho Region, Eswatini
4
Ndzingeni Nazarene Clinic
Ndzingeni, Hhohho Region, Eswatini