PrEP Demonstration Study in Swaziland

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03254550
• Other study ID #: Swazi PrEP study
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: March 2, 2019

Study information

• Verified date: July 2019
• Source: Clinton Health Access Initiative Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 517
• Est. completion date: March 2, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections
• HIV Negative People Identified at Substantial Risk for HIV Infection

Intervention

Other:
• PrEP Promotion Package
A PrEP promotion package will be developed to test if this will change uptake, acceptance, retention and PrEP knowledge

Locations

Country	Name	City	State
Swaziland	Hhukwini Clinic	Hhukwini	Hhohho Region
Swaziland	Horo Clini	Horo	Hhohho Region
Swaziland	Ndvwabangeni Nazarene Clinic	Ndvwabangeni	Hhohho
Swaziland	Ndzingeni Nazarene Clinic	Ndzingeni	Hhohho Region
Swaziland	Nfontjeni Clinic	Nfontjeni	Hhohho Region
Swaziland	Siphocosini Clinic	Siphocosini	Hhohho Region

Sponsors (5)

Lead Sponsor	Collaborator
Clinton Health Access Initiative Inc.	Heidelberg University, Ministry of Health, Swaziland, Mylan Laboratories, World Health Organization

Country where clinical trial is conducted

Swaziland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uptake	The monthly number of clients who was initiated on PrEP	18 months
Secondary	Risk assessment	The monthly number of clients who underwent a risk assessment for PrEP eligibility	18 months
Secondary	Substantial risk	The monthly number of clients who was identified as being at a substantial risk of acquiring HIV	18 months
Secondary	Acceptance conditional on risk	% of HIV-negative clients at substantial risk for HIV infection who accepted a PrEP offer	18 months
Secondary	Linkage	The monthly number of clients who either took up PrEP or were linked to antiretroviral therapy	12 months
Secondary	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.	6 months
Secondary	HIV incidence	% of clients initiated on PrEP who seroconverted during the first six months after taking up PrEP.	18 month