HIV Negative People Identified at Substantial Risk for HIV InfectionNCT03254550
PrEP Demonstration Study in Swaziland
A study testing PrEP Promotion Package in people with HIV Negative People Identified at Substantial Risk for HIV Infection, run by Clinton Health Access Initiative Inc. at 6 sites in Eswatini.
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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Negative People Identified at Substantial Risk for HIV Infection
- What is being tested?
- PrEP Promotion Package
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 517 participants
- Where
- 6 sitesEswatini
- Study dates
- 1 Aug 2017to 2 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Eswatini6 sites
Hhukwini Clinic
Hhukwini, Hhohho Region
Horo Clini
Horo, Hhohho Region
Ndvwabangeni Nazarene Clinic
Ndvwabangeni, Hhohho Region
Ndzingeni Nazarene Clinic
Ndzingeni, Hhohho Region
Nfontjeni Clinic
Nfontjeni, Hhohho Region
Siphocosini Clinic
Siphocosini, Hhohho Region
About this study
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.
Read the 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 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.
- Being tested
- PrEP Promotion Package
- Keywords
- PrEP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrEP Promotion PackageOther
A PrEP promotion package will be developed to test if this will change uptake, acceptance, retention and PrEP knowledge
| Study group | Role | What they receive |
|---|---|---|
| Control phase | No intervention | 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. |
| Intervention phase | Experimental | 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. Receives: Other: PrEP Promotion Package |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake
The monthly number of clients who was initiated on PrEP
Measured: 18 months
Secondary outcomes (6)
Risk assessment
The monthly number of clients who underwent a risk assessment for PrEP eligibility
Measured: 18 months
Substantial risk
The monthly number of clients who was identified as being at a substantial risk of acquiring HIV
Measured: 18 months
Acceptance conditional on risk
% of HIV-negative clients at substantial risk for HIV infection who accepted a PrEP offer
Measured: 18 months
Linkage
The monthly number of clients who either took up PrEP or were linked to antiretroviral therapy
Measured: 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.
Measured: 6 months
HIV incidence
% of clients initiated on PrEP who seroconverted during the first six months after taking up PrEP.
Measured: 18 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start1 Aug 2017
- Primary completion31 Jan 2019
- Study completion2 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV Negative People Identified at Substantial Risk for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a stepped-wedge randomized design (there was no option for stepped-wedge design in the drop-down menu) with two sequences (each consisting of three healthcare facilities) and three periods.
- Masking
- None (open label)
- Enrolment
- 517 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinton Health Access Initiative Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Swaziland, Heidelberg University, Mylan Laboratories, World Health Organization
- Responsible party
- Sponsor
- Investigators
- Sindy Matse, MPH, Principal investigator, Eswatini National AIDS Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03254550
- Sponsor's protocol ID
- Swazi PrEP study
- Status last verified
- Jul 2019
- First submitted
- 17 Aug 2017
- Last updated
- 11 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding Options for HIV Prevention Through Pre-exposure Prophylaxis in Hhohho Region, Swaziland
- ClinicalTrials.gov ID
- NCT03254550
- Acronym / sponsor ID
- Swazi PrEP study
- Keywords
- PrEP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 517 participants (actual)
- Lead sponsor
- Clinton Health Access Initiative Inc.University, hospital or other
- Collaborators
- Ministry of Health, Swaziland, Heidelberg University, Mylan Laboratories, World Health Organization
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 2 Mar 2019 (actual)
- First posted
- 18 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a stepped-wedge randomized design (there was no option for stepped-wedge design in the drop-down menu) with two sequences (each consisting of three healthcare facilities) and three periods.
| Arm | Type | Receives |
|---|---|---|
| Control phase | No intervention | –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. |
| Intervention phase | Experimental | Other: PrEP Promotion PackageThis 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrEP Promotion PackageA PrEP promotion package will be developed to test if this will change uptake, acceptance, retention and PrEP knowledge | Other | Intervention phase |
Primary outcome
Uptake
Time frame: 18 months
The monthly number of clients who was initiated on PrEP
6 secondary outcomes
Risk assessment
Time frame: 18 months
Substantial risk
Time frame: 18 months
Acceptance conditional on risk
Time frame: 18 months
Linkage
Time frame: 12 months
Retention at 6 months
Time frame: 6 months
HIV incidence
Time frame: 18 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2019.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sindy Matse, MPH principal investigator
Eswatini National AIDS Program
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PrEP Promotion Package in people with HIV Negative People Identified at Substantial Risk for HIV Infection, run by Clinton Health Access Initiative Inc. at 6 sites in Eswatini.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Eswatini. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uptake (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2019.