PrEP Demonstration Study in Swaziland
HIV Negative People Identified at Substantial Risk for HIV Infection
About this trial
This is an interventional health services research trial for HIV Negative People Identified at Substantial Risk for HIV Infection focused on measuring PrEP
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Hhukwini Clinic
- Horo Clini
- Ndzingeni Nazarene Clinic
- Nfontjeni Clinic
- Siphocosini Clinic
- Ndvwabangeni Nazarene Clinic
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Control phase
Intervention phase
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.